Sex: F
Vaccine: UNK
Symptoms: Foetal exposure during pregnancy, Low birth weight baby, Premature baby, Stillbirth
Clinical narrative: Stillbirth; Foetal exposure during pregnancy; Low birth weight; Preterm birth; This is a serious observational study case, initially received from other health professional on 13-Aug-2019, concerning a female neonate subject whose mother was a 42-year-old subject of body weight: 217 lbs, height: 63 inches and body mass index (BMI): 38.4, enrolled in a prospective observational safety study. The mother's current condition included gestational diabetes mellitus, uterine leiomyoma and hypertension. Concomitant medication included nifedipine (dihydropyridine derivates), labetalol (alpha and beta blocking agents), hydrochlorothiazide (thiazides), Procardia (dihydropyridine derivates), and Prenatal (vitamins and minerals) for general health.  The subject's mother obstetrical history noted that the subject had three previous pregnancies which included one full term live birth, one preterm live birth and one spontaneous abortion. The mother did not have a history of offspring with major congenital malformation. On an unspecified date, the mother's family history of major congenital malformation was collected, and the mother had no maternal/paternal history with major congenital malformations. The mother did not use tobacco, alcohol or illicit drugs during pregnancy. The mother's last menstrual period (LMP) date was on 02-Feb-2019.The pregnancy was singleton and complicated by advanced maternal age (greater than 35), chronic hypertension, gestational diabetes and leiomyoma of uterus. The corrected estimated date of delivery (EDD) was 03-Nov-2019.   On 28-Mar-2019, at approximately seven weeks of gestation, the subject's mother received Afluria Quad [flu vaccine egg split QIV CSL, batch number: YF41608, dose, expiry date, anatomical location and route of administration: not reported] (explicitly coded as foetal exposure during pregnancy) for influenza immunization.   On 16-Apr-2019 subject's mother underwent ultrasound and non-invasive prenatal testing and no congenital malformations were noted.  On 14-May-2019 subject's mother underwent maternal serum alpha-fetoprotein screening analysis and no malformation were noted.  At 27.9 weeks of gestation, mother vaginally delivered a stillbirth female neonate. The pregnancy outcome was stillbirth. The neonate's birth weight was 900, her head circumference and body length were not reported. The appearance, pulse, grimace, activity, and respiration (APGAR) scores were not reported. There was no major congenital malformation identified at birth. Advanced maternal age, chronic hypertension gestational diabetes and leiomyoma of uterus were reported as factors that may have had an impact on the fetal loss. It was unknown, whether autopsy was performed.  This case is linked to case 201903067, the corresponding maternal pregnancy report.  Company comment: Subject's mother received Afluria Quad vaccine at gestation age of seven weeks. Causality assessment is confounded by mother's class 2 obesity (BMI 38.4), age (42 years), diabetes mellitus, hypertension and uterine leiomyoma, which could have increased the risk of pregnancy complications. Nifedipine administration has been associated with embryotoxic, placentotoxic, and fetotoxic effects in animal studies. Although maternal medical history and concomitant treatment provide plausible alternative aetiology, the causal involvement of suspect product in adverse events of stillbirth, preterm birth and low birth weight is not excluded, therefore these events are assessed as related to the suspect product. Foetal exposure during pregnancy is assessed as unrelated based on company's conventions.; Reporter's Comments: Subject's mother received Afluria Quad vaccine at gestation age of seven weeks. Causality assessment is confounded by mother's class 2 obesity (BMI 38.4), age (42 years), diabetes mellitus, hypertension and uterine leiomyoma, which could have increased the risk of pregnancy complications. Nifedipine administration has been associated with embryotoxic, placentotoxic, and fetotoxic effects in animal studies. Although maternal medical history and concomitant treatment provide plausible alternative aetiology, the causal involvement of suspect product in adverse events of stillbirth, preterm birth and low birth weight is not excluded, therefore these events are assessed as related to the suspect product. Foetal exposure during pregnancy is assessed as unrelated based on company's conventions.; Reported Cause(s) of Death: Stillbirth