Symptomtext
pregnant female accidentally received a dose of FLUZONE QIV NP from a prefilled syringe in the office on 22SEP2021 that had expired on 30JUN2021 (with no reported adverse event); accidentally received a dose of FLUZONE QIV NP from a prefilled syringe in the office on 22SEP2021 that had expired on 30JUN2021 (with no reported adverse event); Initial information received on 23-Sep-2021 regarding an unsolicited valid non-serious case received from a consumer/ Non-Healthcare Professional. This case involves a 25 years old female patient who received expired dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT], while she was 36 weeks pregnant (during third pregnancy trimester). Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The date of last menstrual period was reported as 14-Jan-2021. The estimated due date is 10-Nov-2021. Medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided. On 22-Sep-2021, the patient received (first dose in 2021) a 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UT7041NA, expiry date- 30-06-2021 via intramuscular route in the right deltoid for prophylactic vaccination. It was a case of actual medication error due to expired product administered (latency same day). It was also the case of vaccine exposure during pregnancy. It was reported "Caller states that a patient accidentally received a dose of FLUZONE QIV from a prefilled syringe in the office. Caller asked if there was anything additionally that needed to be done on her end. Caller states that she is aware of a 28 day waiting period to re-administer live vaccines and asked what the guidelines were for this situation." At time of reporting, no adverse event was reported. 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 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.