Reporte zur Charge UT738NA

Symptomtext

The first FLUZONE QIV NP vaccine in her office on 21SEP2021 vaccine in her office on 21SEP2021 with no ae; Initial information received on 14-Dec-2021 regarding an unsolicited valid non-serious case received from a other health care professional. This case involves a 62 years old female patient who was administered an after receiving INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] (inappropriate schedule of product administration). The patient's medical history, medical treatments, vaccinations, concomitant medications and family history were not provided. Concomitant medications included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE). On 14-Dec-2021, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number and expiry date not reported via intramuscular route in unknown administration site for prophylactic vaccination. On 21-Sep-2021 she also received a dose of the same vaccine lot number: UT738NA and expiry date not reported via intramuscular route in unknown administration site for prophylactic vaccination respectively. It was case of an actual medication error 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 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.