Sex: F
Vaccine: UNK
Symptoms: Apgar score abnormal, Foetal exposure during pregnancy, Low birth weight baby, Premature baby
Clinical narrative: Foetal exposure during pregnancy; Low birth-weight; Premature baby; This is an observational study case, initially received from other health professional on 20-Dec-2019, concerning a female neonate, whose mother was a 32-year-old, pregnant, female subject of body weight 150 lbs, height 66 inches and body mass index (BMI) 24.2, enrolled in a prospective observational safety study.   The subject mother's current condition included anxiety, depression, mild pre-eclampsia, gestational diabetes. The subject mother's concomitant medications included Prenatal vitamin (vitamin nos, mineral nos), trazodone and sertraline, both for anxiety and depression and betamethasone for pre-eclampsia.  The subject mother's obstetrical history noted that mother had one previous pregnancy with one elective abortion. The subject's mother had no history of offspring with major congenital malformation (MCM) and no relevant maternal and paternal medical history. The subject's mother did not use tobacco, alcohol or illicit drugs during pregnancy.   The subject mother's last menstrual period (LMP) date was 03-Mar-2019. Estimated delivery date (EDD) and corrected delivery date (CEDD) were 08-Dec-2019. The pregnancy was singleton and complicated with eclampsia, retained placenta with postpartum haemorrhage.The father's age was 36 year.  On 02-Jul-2019, the subject's mother underwent inheritest and maternal serum alpha fetoprotein (MSAFP) / serum marker tests and no MCM was noted.  On 10-Jul-2019 and 10-Sep-2019, the subject's mother underwent ultrasound and no MCM was noted.  On 16-Oct-2019, at gestational age at 32 weeks, the subject's mother was administered with Flu Vaccine Egg Split QIV CSL (Afluria Quad) [influenza vaccine; batch number: P100118566, dose, anatomical location, route of administration and expiration date: not reported] (explicitly coded as Foetal exposure during pregnancy') for influenza immunisation.  On 25-Oct-2019, the subject's mother underwent ultrasound and no MCM was noted.  At gestational age of 36 weeks, the subject's mother vaginally delivered live birth, female neonate. The neonate's birth weight was 2183 g, her head circumference and length were not reported. The appearance, pulse, grimace, activity, and respiration (APGAR) scores were 4 (one minute) and 7 (five minutes). There was no major congenital malformation identified at birth.   At the time of initial reporting, the outcome of the events low birth weight baby' and premature baby' was not reported.   The event of low birth weight baby' and premature baby' were assessed as serious due to criterion of medical significance, per company.  The reporter did not provide causality assessment.  The case is linked to case 201907459, the corresponding mother case.  Company comment: The subject experienced preterm birth and low birth weight 25 days after maternal receipt of Afluria QIV. The subject's mother was administered vaccine at approximately 32 weeks of gestation. Chronology is plausible. Although causality was confounded by mother's medical history of mild pre-eclampsia, gestational diabetes and treatment with concomitant medications, causal role of the suspect vaccine cannot be totally excluded and is assessed as related. Foetal exposure during pregnancy is assessed as unrelated per company's conventions.; Sender's Comments: The subject experienced preterm birth and low birth weight 25 days after maternal receipt of Afluria QIV. The subject's mother was administered vaccine at approximately 32 weeks of gestation. Chronology is plausible. Although causality was confounded by mother's medical history of mild pre-eclampsia, gestational diabetes and treatment with concomitant medications, causal role of the suspect vaccine cannot be totally excluded and is assessed as related. Foetal exposure during pregnancy is assessed as unrelated per company's conventions.