Symptomtext
an expired FLUZONE QIV PFS administered to a pregnant patient, with no adverse event; an expired FLUZONE QIV PFS administered to a pregnant patient, with no adverse event; Initial information received on 22-Sep-2021 regarding an unsolicited valid non-serious case from nurse, consumer/non-healthcare professional and physician via Agency (under reference 00780606). This case involves a 31 years old female pregnant (30 week) patient who received an expired dose of QUADRIVALENT INFLUENZA VACCINE (FLUZONE QIV) [expired product administered and exposure during pregnancy]. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported event occurred during 30 weeks of gestation period. The date of last menstrual period was not reported. The estimated due date was 22-Nov-2021. The information on patient's previous pregnancy/ies were not reported. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On 15-Sep-2021, the patient received a 0.5mL dose of suspect FLUZONE QIV (Total, lot UT7002DA and expiration date: 30-Jun-2021) via intramuscular route in the right deltoid for prophylactic vaccination. It was an actual medication error due to expired vaccine used (same day latency). It was also a case of vaccine exposure during pregnancy (same day latency). It was reported "Would like to know if the dose is considered valid?" At time of reporting, the outcome was unknown for the reported events. Additionally, at time of reporting, the outcome of the pregnancy was unknown. 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.
