Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy, Haemorrhage in pregnancy, Live birth, Subchorionic haemorrhage, Ultrasound antenatal screen normal
Clinical narrative: This serious clinical study case, received from other non-health professional on 06-Oct-2017, concerning a 35-year-old adult female pregnant subject of weight 90 kg's and height 64 cm and (body mass index) BMI was 32.6, enrolled in a prospective observational safety study. The subject received simvastatin for an unknown indication and birth control pills prior to pregnancy. The subject's current condition included herpes simplex virus infection (since an unspecified date). The subject underwent heart auscultation. The subject's concomitant medications included Prenatal vitamins for pregnancy, VALTREX for herpes simplex virus infection, DHA and Omega 3 for an unknown indication. The father received unspecified vitamins prior to conception. The subject did not have any maternal medical history relevant to pregnancy and paternal medical history (hereditary disease). There was no birth defect, congenital anomaly, spontaneous abortion and still birth occurred during previous pregnancy. The subject did not use any contraceptive methods. The subject's (LMP) last menstrual period date was 29-Mar-2017 and estimated date of delivery was 05-Apr-2018. On 10-Aug-2017, the subject underwent prenatal test (ultrasound) and no malformation was noted. On 19-Sep-2017, the subject underwent prenatal test (Non-invasive prenatal testing) (NIPT) and no malformation was noted. There was no evidence of defect and adverse finding from a prenatal test and type of pregnancy was singleton, it was reported that, the subject had not used tobacco, alcohol or illicit drugs during pregnancy. On 06-Oct-2017, at 9:30 hrs, at gestational age of 14-weeks (first trimester), the subject received Influenza vaccine (dose: 0.5 ml, batch number: XF31407, route of administration and anatomical location: not reported) (explicitly coded as vaccine exposure during pregnancy). The gestation age of the infant was reported as 14-weeks. On 10-Oct-2017, the subject had given the consent to participate in the study. The reporter stated that, the subject experienced sub chronic bleed in the first trimester. On 22-Mar-2018, at gestational age of 38 weeks, the patient delivered a live birth to female baby via vaginal method of delivery. The weight of the baby was 3447 grams, body length was 52.1 cm at birth and Apgar score at one minute was 8, five minutes was 9 and ten minutes (not reported). It was reported that, the patient experienced pregnancy complication as uterine inversion at the time of delivery and no major congenital malformation (MCM) was noted at birth. Follow-up report received on 12-Oct-2017: Report type was changed from spontaneous to report from study. Amended accordingly. Follow up report received on 31-Oct-2017: The event sub chorionic bleed in first trimester was updated. The subject's prenatal test was added.  The narrative was amended accordingly. Case correction received 12-Oct-2017: The suspect vaccine was changed from  Flu Vaccine Cell Subunit QIV NVD to Flu Vaccine Egg Split QIV CSL. Follow up report received from the reporter on 24-Apr-2018: The subject's LMP date was changed from 29-Jun-2017 to 29-Mar-2017. The new serious event (uterine inversion) with onset date: 22-Mar-2018 was added. The outcome of the pregnancy was updated. It was reported that, on Mar-2018, at gestational age of 38 weeks, the patient delivered a live birth to female baby via vaginal method of delivery. The weight of the baby was 3447 grams, body length was 52.1 cm at birth and Apgar score at one minute was 8, five minutes was 9 and ten minutes (not reported). It was reported that, the patient experienced pregnancy complication as uterine inversion at the time of delivery and no major congenital malformation (MCM) was noted at birth. The narrative was amended accordingly.