Symptomtext
a 4 year old patient was administered FLUBLOCK with no reported adverse event; Initial information was regarding an unsolicited valid non serious case was received from a other health professional via Medical Information (Reference number- 00831464) and transmitted to Sanofi on 27-Oct-2021 in a specific country. This case involves a four-year-old female patient who received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (product administered to patient of inappropriate age). The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided. On 20-Oct-2021, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (once, lot UT7316JA, expiry date: 20-JUN-2022) via intramuscular route in the left deltoid for prophylactic vaccination. It was an actual medication error due to product administered to patient of inappropriate age (latency: same day). It was reported "The caller states that a 4 year old patient was administered FLUBLOCK." At time of reporting, no adverse event reported. 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.