Sex: F
Vaccine: UNK
Symptoms: Apgar score normal, Drug withdrawal syndrome neonatal, Foetal exposure during pregnancy
Clinical narrative: Foetal exposure during pregnancy; Neonatal abstinence syndrome; This is an observational study case, initially received from other health professional on 02-Jan-2020, concerning a female neonate subject. The subject's mother was 30-year-old, female pregnant subject, of body weight 148 lbs, height 66 inches and body mass index (BMI) 23.9 enrolled in,  a prospective observational safety study. The age of subject's father was not reported.  The mother's current medical conditions included anxiety, morning sickness and opioid abuse (as reported).  The mother's concomitant medications included Prenatal (unspecified vitamins and minerals) for pregnancy, buprenorphine for opioid abuse, Bonjesta (doxylamine succinate, pyridoxine hydrochloride) for morning sickness and escitalopram for anxiety.  The subject's mother had three previous pregnancies which included one full term live birth, one elective abortion and one spontaneous abortion. The subject's mother had no maternal or paternal history with major congenital malformations (MCMs) and had no history of offspring with MCM. The subject's mother did not use tobacco or alcohol during pregnancy.  The mother's last menstrual period (LMP) date was 09-Mar-2019. The mother's estimated date of delivery (EDD) was reported as 14-Dec-2019 and corrected estimated date of delivery (CEDD) was reported as 10-Dec-2019. The type of pregnancy was singleton.   On 05-Jun-2019, the subject's mother underwent first trimester screen with nuchal translucency scan. There was no MCM noted.  On 03-Jul-2019, the subject's mother underwent second trimester alpha-fetoprotein (APF) screen. There was no MCM noted.  On 19-Sep-2019, at approximately 27 weeks of gestation, the subject's mother was administered Flucelvax QIVc [Influenza vaccine, subunit influenza virus vaccine polyvalent, dose: 0.5 ml, batch number: 259809, route of administration, anatomical location and expiration date: not reported] (explicitly coded as Foetal exposure during pregnancy') for an influenza immunisation.  On 13-Dec-2019, at gestational age of 40.4 weeks, mother vaginally delivered a live birth female neonate. The neonate's birth weight was 3118 grams, body length and head circumference were not reported. The appearance, pulse, grimace, activity, and respiration (APGAR) scores at one minute was 8, at five minutes was 9 and at 10 minutes no data was provided. No MCM was identified at birth. However, the subject developed neonatal abstinence syndrome due to which was admitted to pediatrics (PEDS). No further information was provided.  At the time of this report, the outcome of the event neonatal abstinence syndrome was not reported.  Per company, the event of neonatal abstinence syndrome was considered serious due to criterion of medical significance.  The reporter did not provide causality assessment to Flucelvax QIV.  This case is linked to case number 202000006 (corresponding mother case).  Company comment: A female neonate patient was exposed to Flucelvax QIVc after maternal receipt of vaccine at 10 weeks of gestation. The mother's current medical conditions included opioid abuse. Reportedly, the subject developed drug withdrawal syndrome neonatal. 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: A female neonate patient was exposed to Flucelvax QIVc after maternal receipt of vaccine at 10 weeks of gestation. The mother's current medical conditions included opioid abuse. Reportedly, the subject developed drug withdrawal syndrome neonatal. Causal role of the suspect vaccine is assessed as not related. Foetal exposure during pregnancy is assessed as unrelated per company's conventions.