Sex: U
Vaccine: UNK
Symptoms: Exposure during pregnancy, Ultrasound antenatal screen abnormal, Umbilical cord abnormality
Clinical narrative: Two vessel cord; Foetal exposure during pregnancy; This is an observational study case, initially received from other health professional on 24-Jan-2020, concerning a foetus subject of unknown gender, whose mother was a 29-year-old female of body weight: 188 lbs, height: 64 inches and body mass index (BMI) 32.3, enrolled in a prospective observational safety study.   The subject's mother medical history included anxiety and high body mass index (BMI 30+).   The subject's mother concomitant medications included Prenatal vitamins (unspecified vitamins and minerals) for vitamin and Tdap (diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid) for vaccination.  The subject's mother had two previous pregnancies, one full term live birth and one spontaneous abortion. The subject's mother had no maternal or paternal history with major congenital malformations (MCMs). The subject's mother did not use tobacco, alcohol or illicit drugs during pregnancy.   The subject's mother's last menstrual period (LMP) was on 07-May-2019, estimated delivery date (EDD) and corrected estimated date of delivery (CEDD) were 11-Feb-2020. Type of pregnancy was singleton. The subject's father was 29-year-old.  On 27-Sep-2019, at approximately 20 weeks of gestation, the mother was administered Flucelvax QIV (Flu Vaccine Cell Subunit QIV NVD) [influenza vaccine, subunit influenza virus vaccine polyvalent, batch number: 261200, dose: 0.5 ml, route of administration, anatomical location and expiration date: not reported] (explicitly coded as Foetal exposure during pregnancy') for influenza immunization.   On the same day, the subject's mother underwent anatomy ultrasound and two vessel cord was noted without MCM.  On 24-Oct-2019, the subject's mother underwent growth scan and no MCM was noted.   At the time of initial reporting, the outcome of the event of two vessel cord' was not reported.   The event of 'two vessel cord' was considered serious due to the criterion of medical significance, per company.  The reporter did not provide causality assessment to Flucelvax QIV.  This case is linked to the case 202001221 (the corresponding mother case).  Company comment: Reportedly, umbilical cord abnormality was associated with Flucelvax QIV. Vaccine was administered at 20 weeks of gestation. On the same day, the subject's mother underwent anatomy ultrasound and two vessel cord was noted. Typically, an umbilical cord has two arteries and one vein. Some babies have just one artery and vein. However, temporal relationship is implausible. Causal role of the suspect vaccine is assessed as not related. Foetal exposure during pregnancy is assessed as unrelated per company's conventions.; Sender's Comments: Reportedly, umbilical cord abnormality was associated with Flucelvax QIV. Vaccine was administered at 20 weeks of gestation. On the same day, the subject's mother underwent anatomy ultrasound and two vessel cord was noted. Typically, an umbilical cord has two arteries and one vein. Some babies have just one artery and vein. However, temporal relationship is implausible. Causal role of the suspect vaccine is assessed as not related. Foetal exposure during pregnancy is assessed as unrelated per company's conventions.