Age: 32.0
Sex: F
Vaccine: UNK
Symptoms: Single umbilical artery, Ultrasound antenatal screen, Ultrasound antenatal screen normal
Clinical narrative: 2 vessel umbilical cord, single artery; Anxiety; Heartburn; Anemia; Vaccine exposure during pregnancy; This is a serious observational study case,, initially received from other health professional on 18-Jun-2019, concerning a 32-old adult female pregnant subject of body weight 132 lbs, height : 64 inches and body mass index (BMI) 22.7, enrolled in a prospective observational safety study on pregnancy outcomes in women immunized with Afluria QIV, a seasonal quadrivalent vaccine, during pregnancy.  The subject had two previous pregnancies in which one was full term live birth with no birth defects, and one was spontaneous abortion. The subject did not have a history of offspring with major congenital malformation. On an unknown date, the subject's family history of major congenital malformation was collected, and the subject had no maternal history with major congenital malformations. The subject's paternal history included that the subject's husband's half-sister was born with DiGeorge's syndrome. The subject's current condition included headache. The subject's concomitant medication included Prenatal Vitamins (unspecified) as a supplement.  The subject's last menstrual period date (LMP) was 28-Sep-2018. The type of pregnancy was singleton. The subject did not use tobacco, alcohol or illicit drugs during pregnancy.  On 16-Oct-2018, at approximately 2 weeks of gestation, the pregnant subject was administered Flu Vaccine Egg Split QIV CSL [influenza vaccine, batch number: YF41608, dose, route of administration, expiry date and anatomical location: not reported] (explicitly coded as vaccine exposure during pregnancy) for an unknown indication.   On 28-Nov-2018, the subject underwent ultrasound scan and no major congenital malformation was noted.  On 12-Dec-2018, the subject underwent Sequential 1 (prenatal test) and no major congenital malformation was noted.  On 11-Jan-2019, the subject underwent Sequential 2 and inheritest core tests and no major congenital malformations were noted.  On 14-Jan-2019, the subject underwent Nuchal translucency test and no major congenital malformation was noted.  On an unknown date, the pregnancy status of the subject was collected, and pregnancy complications was noted as 2 vessel umbilical cord, single artery.  On 06-May-2019, 6 months and 20 days after vaccination, the subject developed anemia and was treated with iron (dosage: 325 mg, qd, orally from 06-May-2019 and ongoing). On 13-May-2019, 6 months and 27 days after vaccination, the subject developed heartburn and was treated with esomeprazole (dosage: 20 mg, qd, orally, from 13-May-2019 and ongoing). On an unknown date, the subject developed anxiety and was treated with hydroxyzine (dosage: 25 mg, every 6 hours, orally from, 13-May-2019 and ongoing).  The outcome of the event single umbilical artery was not reported and of all the other events was not recovered.  The subject's corrected estimated delivery date (CEDD) was reported as 28-Jun-2019 and estimated delivery date (EDD) was reported as 06-Jul-2019.; Reporter's Comments: A 32-year-old pregnant subject was diagnosed with single umbilical artery (SUA) and experienced anxiety, unspecified period after receipt of Flu Vaccine Egg Split QIV (considered as vaccine exposure during pregnancy). The subject was exposed to vaccine at approximately 2 weeks of gestation. Although, event SUA lacks onset latency, the vaccine exposure is approximately around the time of umbilical cord development. The cause of SUA is unknown and possible theories include primary agenesis or secondary atrophy of one of the arteries occurs resulting in single umbilical artery. Considering the lack of biological evidence associated with inactivated influenza vaccine and this reported event, causality assessed as not related. The obstetrical history of the subject, multigravida is considered as the known risk factor. The event anxiety lacks onset latency hence, causality assessed as unassessable. The event vaccine exposure during pregnancy assessed as not related considering intended use of the vaccine. The subject was diagnosed with anemia and heart burn, more than 6 months post vaccination. Considering implausible temporal relationship between vaccination and these events, causality assessed as not related to study vaccine. The case will be further assessed upon receipt of follow-up information. The company assessed this case as serious (medically significant).