Age: 24.0
Sex: F
Vaccine: UNK
Symptoms: Abortion spontaneous, Exposure during pregnancy, Foetal malformation, Ultrasound antenatal screen abnormal
Clinical narrative: Spontaneous abortion; Vaccine exposure during pregnancy; This is an observational study case, initially received from other health professional on 20-Jul-2020, concerning a 24-year-old pregnant, female subject of body weight 184 lbs, height 64 inches and body mass index (BMI) 31.6, enrolled in a prospective observational safety study.  The subject's medical history included BMI high.  The subject's concomitant medications were not provided.  The subject's obstetrical history noted that the subject had no previous pregnancies. The subject had no history of offspring with major congenital malformation (MCM). The subject had no maternal and paternal history with MCMs. The subject did not use tobacco, alcohol and illicit drugs during pregnancy.  The subject's last menstrual period (LMP) date was on 12-Sep-2019. The subject's estimated delivery date (EDD) and corrected estimated date of delivery (CEDD) were both reported as 18-Jun-2020. The type of pregnancy was singleton.  On 14-Oct-2019, the subject underwent cystic fibrosis mutation analysis and spinal muscular atrophy test, and no MCMs were noted.  On 21-Oct-2019, at approximately 5 weeks of gestation (calculated per LMP), the subject was administered Flucelvax QIVc (Flu Vaccine Cell Subunit QIV NVD) [influenza vaccine, subunit influenza virus vaccine polyvalent, batch number: 261218, dose: 0.5 ml, route of administration, anatomical location and expiry date: not reported) (explicitly coded as Vaccine exposure during pregnancy') for influenza immunisation.  On 31-Oct-2019, the subject underwent ultrasound and no MCMs were noted.  On 06-Nov-2019, the subject underwent ultrasound and MCM was noted, but it was not specified which one.  On 12-Nov-2019, approximately 22 days after vaccination, at gestational age of 8.7 weeks (as reported), the subject underwent ultrasound and spontaneous abortion was noted. The cause for a foetal loss was not reported.  At the time of initial reporting, the outcome for the event of spontaneous abortion was not reported.  Per company, the event of spontaneous abortion was considered serious due to the criterion of medical significance.  The reporter did not provide the causality assessment to Flucelvax QIV.  The case is linked to 202003962, the corresponding baby case.  Company comment: A pregnant subject was administered Flucelvax QIV on 21-Oct-2019, at approximately 5 weeks of gestation. On 06-Nov-2019, the subject underwent ultrasound and major congenital malformation (MCM) was noted, but it was not specified which one. On 12-Nov-2019, the subject underwent ultrasound and spontaneous abortion was identified. It was unknown whether autopsy was performed. It was likely associated with MCM, however, causal role of the suspect vaccine is unassessable for spontaneous abortion due to lack of autopsy results. Vaccine exposure during pregnancy assessed as not related per company's conventions.; Sender's Comments: A pregnant subject was administered Flucelvax QIV on 21-Oct-2019, at approximately 5 weeks of gestation. On 06-Nov-2019, the subject underwent ultrasound and major congenital malformation (MCM) was noted, but it was not specified which one. On 12-Nov-2019, the subject underwent ultrasound and spontaneous abortion was identified. It was unknown whether autopsy was performed. It was likely associated with MCM, however, causal role of the suspect vaccine is unassessable for spontaneous abortion due to lack of autopsy results. Vaccine exposure during pregnancy assessed as not related per company's conventions.