Reporte zur Charge UJ220AA

Symptomtext

ActHib portion of Pentacel was administered to patient more than 5 years old with no adverse event; patient received the ActHib portion of Pentacel reconstituted with sterile water with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from a consumer/non-health care professional via Medical Information (Reference number- 00420275) and transmitted to Sanofi on 07-Jan-2021. The case involved a 5 years 10 months old female patient who received the ACT-HIB portion of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (product administered to patient of inappropriate age) (lot: powder UJ220AA, diluent U6540AC, expiry date not reported, dose 4), but it was reconstituted with sterile water (product preparation issue)once via intramuscular route in the left thigh, for prophylactic vaccination, on 23-Oct-2020. Relevant medical history, past medical treatment, vaccination details and family history were not provided. Concomitant medications included MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD) and PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR). It was a case of actual medication error due to product preparation issue and inappropriate age at vaccine administration (latency same day). It was reported that the liquid DTaP-IPV portion was not administered. The reporter discovered this on an audit. Their electronic system contributed to the error because the easier way to enter a Pentacel order was by separating the two components. Reporter stated the system would allow it to be entered another way as a single product, but it was more difficult to enter it that way in the system. The reporter had already notified someone about the electronic order entry issue. The patient had an appointment this coming Monday and the office might have an opportunity to give the Pentacel dose properly at that time. The reporter asked if it hurt the ActHIB component and was the ActHIB portion was considered a valid dose. No adverse event was reported, at the time of reporting. This suspected adverse reaction report was 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 was 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 had contributed to or was to be held liable for the occurrence of this medication error.