Sex: M
Vaccine: UNK
Symptoms: Caesarean section, Foetal exposure during pregnancy, Premature baby
Clinical narrative: Foetal exposure during pregnancy; Preterm bith at gestational age of 36.3 weeks; This is an observational study case, initially received from other health professional on 20-Jan-2020, concerning a neonate, male subject, whose mother was 26-year-old, female of body weight: 146 lbs, height: 67 inches and body mass index (BMI): 22.9, enrolled in a prospective observational study.  The subject's mother current conditions included bacterial infection due to streptococcus, group B and cholestasis.   The mother's concomitant medications included Prenatal (unspecified minerals and vitamins) as a vitamin and ursodiol for cholestasis.   The subject's mother obstetrical history included two previous pregnancies with one full term live birth and one spontaneous abortion. The mother did not have a history of offspring with major congenital malformation. The subject's mother had no maternal or paternal history with major congenital malformations (MCMs). The mother did not use tobacco, alcohol or illicit drugs during pregnancy.  The mother's last menstrual period (LMP) date was 31-Mar-2019, the estimated delivery date (EDD) and corrected estimated date of delivery (CEDD) were reported as 05-Jan-2020. The type of pregnancy was singleton. The subject's father was a 26-year-old.  On 26-Jun-2019, the subject's mother underwent first trimester screen and nuchal translucency screening and no MCM was noted.   On 26-Jul-2019, the subject's mother underwent second trimester screen-alpha fetoprotein test (AFP) and no MCM was noted.   On 15-Aug-2019, the subject's mother underwent anatomy ultrasound and no MCM was noted.   On 19-Sep-2019, at 24 weeks of gestation, the subject's mother was administered Flucelvax QIV (Flu Vaccine Cell Subunit QIV NVD) [influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, batch number: 261200, route of administration, expiry date and anatomical location: not reported] (explicitly coded as Fetal exposure during pregnancy') for influenza immunisation.  At 36.3 weeks of gestation, the subject's mother delivered live birth, male neonate via caesarean section method. The neonate's birth weight was 2863 g, body length, head circumference and APGAR (appearance, pulse, grimace, activity and respiration) scores were not reported. There were no major MCMs identified at birth. Delivery complications included cholestasis and preterm premature rupture of membranes.  At the time of this report, the outcome of the event of premature birth' was not reported.  The event of premature birth' was assessed as serious due to medically significance, per company.   The reporter did not provide causality assessment.  The case is linked to the case 2019005850 (the corresponding mother case).  Company comment: Reportedly, a male neonate subject was delivered as premature baby after foetal exposure during pregnancy. The mother was administered with Flucelvax QIV at gestation age of 24 weeks. Causality was confounded by subject's mother current conditions of bacterial infection due to streptococcus, group B, concomitant use of Ursodiol (for cholestasis) and obstetrical history of one spontaneous abortion. 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, a male neonate subject was delivered as premature baby after foetal exposure during pregnancy. The mother was administered with Flucelvax QIV at gestation age of 24 weeks. Causality was confounded by subject's mother current conditions of bacterial infection due to streptococcus, group B, concomitant use of Ursodiol (for cholestasis) and obstetrical history of one spontaneous abortion. Causal role of the suspect vaccine is assessed as not related. Foetal exposure during pregnancy is assessed as unrelated per company's conventions.