Sex: M
Vaccine: UNK
Symptoms: Apgar score low, Caesarean section, Foetal exposure during pregnancy, Foetal growth restriction, Low birth weight baby
Clinical narrative: Intrauterine growth restriction (IUGR); Born at 33.7 weeks of gestation; Birth weight 1800 g; Apgar score 5 at one minute; Foetal exposure during pregnancy; This is an observational study case, initially received from other health professional on 06-May-2020, concerning a foetal subject whose mother was 28-year-old, female, pregnant subject, of body weight: 226 lbs, height: 67 inches and body mass index (BMI): 35.4, enrolled in a prospective observational safety study on pregnancy outcomes in women immunized with Afluria QIV, a seasonal quadrivalent vaccine, during pregnancy.  The subject's mother's current conditions included obesity with increased BMI, proteinuria, asthma, hypothyroid and Rhesus (Rh) negative.  The subject's mother's concomitant medications included Prenatal vitamins (unspecified vitamins and minerals) for pregnancy, Albuterol (salbutamol) and QVAR (beclometasone dipropionate) both for asthma and levothyroxine for hypothyroid.  The subject's mother's obstetrical history noted that the 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). Also, the subject's mother had no history of offspring with MCM. The subject's mother did not use tobacco, alcohol or illicit drugs during pregnancy.   The subject's mother's last menstrual period (LMP) date was on 25-May-2019. The subject's mother's estimated delivery date (EDD) was reported as 01-Mar-2020 and corrected estimated delivery date (CEDD) was not reported. The type of pregnancy was singleton.   On 22-Aug-2019, the subject's mother underwent nuchal translucency and sequential 1. There were no MCMs noted.  On 23-Sep-2019, the subject's mother underwent sequential 2 and no MCMs were noted.  On 15-Oct-2019, at approximately 20 weeks of gestation (calculated per LMP), the subject's mother was administered Afluria QIV (Flu Vaccine Egg Split QIV CSL) [influenza vaccine; batch number: P100112488, route of administration, anatomical location, dose and expiration date: not reported] (explicitly coded as Foetal exposure during pregnancy') for influenza immunisation.   On an unspecified date, after vaccination, the subject's mother developed depression and anxiety reported as pregnancy complication. Also, intrauterine growth restriction (IUGR) was noted as pregnancy complication.   At gestational age of 33.7 weeks (as reported), the subject's mother delivered a premature live birth male neonate via Caesarean method. The neonate's birth weight was 1800 g, body length and head circumference were not reported. The appearance, pulse, grimace, activity, and respiration (APGAR) scores were 5 (one minute), 7 (five minutes) and score was not provided for 10 minutes. No MCM was identified at birth.   On the same date, the subject recovered from the event of APGAR score low'.   At the time of this report, the outcome of the events 'foetal growth restriction', 'premature baby 33 to 36 weeks' and 'low birth weight baby' was not reported.  The events of 'foetal growth restriction', 'premature baby 33 to 36 weeks', 'low birth weight baby' and APGAR score low' were considered serious due to criterion of medical significance, per company.  The reporter did not provide causality assessment.  This case is linked to case number 202003307, corresponding mother case.  Company comment: A foetal subject, whose mother was 28-year-old female, pregnant subject, developed foetal growth restriction, premature baby, low birth weight baby and Apgar score low after the subject's mother was administered with Afluria QIV (Flu Vaccine Egg Split QIV CSL) for influenza immunisation at approximately 20 weeks of gestation. Reportedly, at gestational age of 33.7 weeks (as reported), the subject's mother delivered a premature live birth male neonate via Caesarean method. Foetal growth restriction, low birth weight baby and Apgar score low were also noted. Chronology seems compatible. The subject's mother's current conditions included obesity with increased BMI, proteinuria, asthma, hypothyroid and Rhesus (Rh) negative. The subject's mother's concomitant medications included Prenatal vitamins (unspecified vitamins and minerals) for pregnancy, Albuterol (salbutamol) and QVAR (beclometasone dipropionate) both for asthma and levothyroxine for hypothyroid. The subject's mother's obstetrical history noted that the mother had two previous pregnancies, one full term live birth and one spontaneous abortion. Obesity with increased BMI, hypothyroid, reported mother's events (depression and anxiety) may have influenced on preterm birth along with other reported events. With information presented, causality is assessed as unlikely related for all events. Foetal exposure during pregnancy is assessed as unrelated per company conventions. (''unlikely related'' defaults to "related" in the safety database for reporting purposes); Sender's Comments: A foetal subject, whose mother was 28-year-old female, pregnant subject, developed foetal growth restriction, premature baby, low birth weight baby and Apgar score low after the subject's mother was administered with Afluria QIV (Flu Vaccine Egg Split QIV CSL) for influenza immunisation at approximately 20 weeks of gestation. Reportedly, at gestational age of 33.7 weeks (as reported), the subject's mother delivered a premature live birth male neonate via Caesarean method. Foetal growth restriction, low birth weight baby and Apgar score low were also noted. Chronology seems compatible. The subject's mother's current conditions included obesity with increased BMI, proteinuria, asthma, hypothyroid and Rhesus (Rh) negative. The subject's mother's concomitant medications included Prenatal vitamins (unspecified vitamins and minerals) for pregnancy, Albuterol (salbutamol) and QVAR (beclometasone dipropionate) both for asthma and levothyroxine for hypothyroid. The subject's mother's obstetrical history noted that the mother had two previous pregnancies, one full term live birth and one spontaneous abortion. Obesity with increased BMI, hypothyroid, reported mother's events (depression and anxiety) may have influenced on preterm birth along with other reported events. With information presented, causality is assessed as unlikely related for all events. Foetal exposure during pregnancy is assessed as unrelated per company conventions. (''unlikely related'' defaults to "related" in the safety database for reporting purposes)