Symptomtext
a patient received an expired dose of FLUZONE QUADRIVALENT vaccine/ No AE; a pregnant patient received an dose of FLUZONE QUADRIVALENT vaccine/ No AE; Initial information received on 01-Oct-2021 regarding an unsolicited valid non-serious case received from a other health care professional via consumer via phone via regulatory authority number: 00794278. This case involves a 25 year old female pregnant patient who was exposed to an expired dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] at 32 weeks of pregnancy during third pregnancy trimester (expired product administered and exposure during pregnancy). Data regarding this pregnancy were received prospectively, i.e., before pregnancy outcome was known. The date of last menstrual period was reported as 18-Feb-2021. The estimated due date is 25-Nov-2021. It was not reported if patient had previous pregnancy. The patient's medical history, past medical treatments, vaccinations and family history were not provided. Concomitant Medication: None. On 30-Sep-2021, the patient received a 0.5 ml first dose of suspect INFLUENZA QUADRIVAL A-B VACCINE prefilled syringe lot number: UT7073NA, expiry date: 30-Jun-2021, frequency: once, strength: standard via intramuscular route in the left deltoid for prophylactic vaccination. It was a case of vaccine exposure during pregnancy and also a case of actual medication error due to expired vaccine used (latency: same day). It was reported "Caller states that a patient received an injection of FLUZONE QIV No Preservative (NP) from a prefilled syringe on 30SEP2021 that had expired on 30JUN2021. Caller asked if this was considered a valid dose or if it would have to be repeated. Caller asked for information on how to proceed." Product used: used and still using product: no. Adverse event (AE) symptoms: No AE. 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.