Symptomtext
patient is currently pregnant with no reported adverse event; patient received an expired FLUZONE QIV NP with no reported adverse event; Initial information received on 11-Sep-2023 regarding an unsolicited valid non-serious case received from an other health professional. This case involves a 20 years old female pregnant patient who was exposed to vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] where patient received an expired fluzone qiv np with no reported adverse event. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported patient received an expired FLUZONE QIV NP with no reported adverse event occurred at 14 weeks of pregnancy during second pregnancy trimester for INFLUENZA QUADRIVAL A-B VACCINE. The date of last menstrual period was reported as 11-Jun-2023. The estimated due date is 17-Mar-2024. The patient's past medical history, medical treatment(s), concomitant medication(s), vaccination(s) and family history were not provided. On 11-Sep-2023, the patient received 0.5 ml (TOTAL) dose 1 of suspect influenza quadrival a-b vaccine Suspension for injection (batch number- UT7680NA and expiration date- 30-Jun-2023) via unknown route in unknown administration site (strength: not provided) for Immunisation (expired product administered) (latency- same day). On an unknown date the patient is currently pregnant with no reported adverse event (exposure during pregnancy) (unknown latency). Action taken- not applicable. At time of reporting, the outcome was Unknown for both the events. Additionally, at time of reporting, the pregnancy is still ongoing. 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.