Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Alpha 1 foetoprotein normal, Amniotic band syndrome, Exposure during pregnancy, Genital herpes simplex, Glucose tolerance test normal
Clinical narrative: This is a serious observational study case from the United States, initially received from other health professional on 08-Nov-2018, concerning a 37-year-old adult female pregnant subject of height: 66.5 inches and body weight: 132.6 lbs and body mass index (BMI): 21.1, enrolled in a prospective observational safety study. The subject had no maternal and paternal history of major congenital malformations. The subject had no history of offspring with major congenital malformations. The patient's obstetrical history included two previous pregnancy (gravida II) and had 2 previous preterm live births. The patient did not have still birth, miscarriage, birth defect or congenital anomaly occurred in previous pregnancies. The subject's last menstrual period (LMP) date was 13-Jul-2018. The type of pregnancy was singleton. The subject did not use tobacco, alcohol or illicit drugs during pregnancy. The subject's current condition included frequent urinary tract infections. The subject's concomitant medication included prenatal vitamins (minerals nos, vitamins nos) (1 tablet, qd, orally) for healthy pregnancy and MACROBID (1 tablet, after intercourse as reported, orally) for urinary tract infection. On 07-Sep-2018, ultrasound prenatal test performed, and no major congenital malformation was noted. On 13-Sep-2018, prenatal blood work, haemoglobin electrophoresis and cystic fibrosis mutation analysis performed, and no major congenital malformation was noted. On 08-Oct-2018, noninvasive prenatal testing (NIPT) performed, and no major congenital malformation was noted. On 01-Nov-2018, at gestation age of 16 weeks (second trimester), the subject was administered Flu Vaccine Egg Split QIV CSL (influenza Vaccine, batch number: YF41708, dose, route of administration, anatomical location and expiry date: not reported) (explicitly coded to vaccine exposure during pregnancy) for an unknown indication. On 12-Nov-2018, maternal serum alpha-fetoprotein (MSAFP)/serum markers test performed, and no congenital malformation was noted. On 26-Nov-2018, ultrasound prenatal test was performed, and anatomic scan revealed amniotic band across cervix (ultrasound scan abnormal), but the foetus was free of band. On 18-Dec-2018, genitourinary condition- herpes simplex virus (HSV) was noted. The subject took Valacyclovir HCl for herpes simplex virus (HSV). On 14-Jan-2019, 1-hour glucose tolerance test (GTT) performed and no major congenital malformation was noted. The outcome of the event genital herpes simplex was not reported. The estimated date of delivery was reported as 19-Apr-2019. Follow up received from other health professional on 17-Jan-2019: The new events (Genital herpes simplex and ultrasound scan abnormal) were added in event tab. Treatment drug (Valacyclovir HCl) for HSV was added in the product tab. Laboratory tests and the results (ultrasound prenatal test performed on 26-Nov-2018, MSAFP/serum markers test performed on 12-Nov-2018) were added in the laboratory tests in patient tab. The narrative and case comment were amended accordingly. Reporter's Comments: A 37-year-old pregnant female patient received Flu Vaccine Egg Split QIV CSL (vaccine exposure during pregnancy). The company assessed the causality of the event vaccine exposure during pregnancy as not related to the suspect vaccine considering the intended use of the vaccine. The event amniotic band near cervix (abnormal ultrasound) was assessed as not related to suspect vaccine due implausible biological mechanism. The event genital herpes simplex was assessed as not related to suspect vaccine due to infectious aetiology of the event and implausible temporal relationship between vaccination to event onset.