Symptomtext
This case involves a six-month-old male patient who received second dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (batch number and expiry date not reported) via an intramuscular route in the left thigh for prophylactic vaccination two weeks and 1 day later instead of 4 weeks on 09-Mar-2021 (inappropriate schedule of product administration). The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included DIPHTHERIA VACCINE TOXOID, HIB VACCINE CONJ (TET TOX), PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, POLIO VACCINE INACT 3V (MRC 5), TETANUS VACCINE TOXOID (PENTACEL), PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for prophylactic vaccination. On 22-Feb-2021, the patient also received a first dose of the same vaccine (lot UT7081KA and expiry date: 30-Jun-2021) via an unknown route in an unknown administration site for prophylactic vaccination. The physician asked should the child be revaccinated. This was a case of actual medication error case due to drug dose administration interval too short (latency same day). 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.