Reporte zur Charge UT700CA

Symptomtext

expired dose of Fluzone Quadrivalent was administered with no reported adverse event; a pregnant patient received an expired dose of Fluzone Quadrivalent with no reported adverse event; Initial information received on 10-Nov-2021 regarding an unsolicited valid non-serious case from a consumer or other nonprofessional via Global Media information (under the reference 00852655). This case involves a 25-year-old female patient receiving expired dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] and a pregnant patient received an expired dose of fluzone quadrivalent (maternal exposure during pregnancy). Data regarding this pregnancy were received prospectively. At unknown gestation period and the patient was exposed to INFLUENZA QUADRIVAL A-B VACCINE at 13 weeks of pregnancy, during first pregnancy trimester for INFLUENZA QUADRIVAL A-B VACCINE. The date of last menstrual period was reported as 27-Aug-2021. The estimated due date was not reported. The actual date of delivery was not reported. The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided. On 10-Nov-2021, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B VACCINE [Once, lot UT700CA, expiry date: 30-Jun-2021] via intramuscular route in the left deltoid for prophylactic vaccination. This case is medication error due to expired vaccine used (latency same day). It was the case of vaccine exposure during pregnancy (latency same day). The patient was pregnant when she received FLUZONE QUADRIVALENT. Additionally, at time of reporting, the outcome of the pregnancy is 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 by the regulatory authority. 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.