Symptomtext
Menactra liquid was accidentally mixed with Proquad powder before administration to a patien/ No AE; Proquad powder given instead of Adacel/No AE; Initial and additional information received on 26-Feb-2021 regarding an unsolicited valid non-serious case received from a nurse via physician via other health care professional via Regulatory Authority (Reference number- 00495489). This case involves a 11 years old male patient who was administered MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] liquid dose: 0.5 ml, lot number: U6787AA, expiry date: 08-NOV-2021 via unknown route in the right arm on 26-Feb-2021 for prophylactic vaccination which was accidentally mixed with MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) [PROQUAD] powder before administration (product preparation issue) given instead of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (wrong product administered). The patient's medical history, medical treatments, vaccinations and family history were not provided. Concomitant medications included Human papillomavirus (HPV) VACCINE for prophylactic vaccination. It was an actual medication error due to inappropriate reconstitution technique and wrong vaccine administered (latency same day). Potential product technical complaint (PTC): No. Description: Nurse reports that MENACTRA was accidentally mixed with another vaccine before administration. Nurse reports that today, a medical assistant (MA) was supposed to administer Menactra and Proquad vaccines to an 11 year-old male. When preparing the vaccines, the MA did not reconstitute the Proquad correctly, instead mixing the Menactra liquid with the Proquad powder. Reporter relationship: health care professional (HCP). Product used. Therapy ongoing: Unknown. Related to company product: Not reported. Nurse has called back to correct previously reported information. Nurse had reported that patient was supposed to receive HPV, Menactra and Proquad vaccines. After going back through the records, he realized that the doctor's order was actually for HPV, Menactra and Adacel. After administering the Proquad diluted with Menactra, the Adacel was not given. At the time of reporting no adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.