Sex: F
Vaccine: UNK
Symptoms: Apgar score normal, Foetal exposure during pregnancy, Premature baby
Clinical narrative: Foetal exposure during pregnancy; Premature birth; This is an observational study case, initially received from other health professional on 01-Oct-2019, concerning a female neonate subject, whose mother was 19-year-old of body weight 157 lbs, height 67 inches and body mass index 24.6, and father 17-year-old, enrolled in a prospective observational safety study.  The mother's medical history included chlamydia, bacterial vaginosis, yeast infection and anaemia.   The mother's past medications included Zithromax (azithromycin) for chlamydia, Flagyl (metronidazole) for bacterial vaginosis and Terazol (terconazole) for yeast infection. The mother's concomitant medications included Prenatal vitamins (vitamin not specified (nos), minerals nos) for pregnancy and ferrous sulfate for anaemia.   The subject's mother had no previous pregnancies. The mother did not use tobacco, alcohol or illicit drugs during pregnancy. Also, the subject's mother had no maternal or paternal history with major congenital malformations (MCMs). The mother's last menstrual period (LMP) date was 21-Apr-2018, and the expected delivery date was 26-Jan-2019. The type of pregnancy was singleton.   On 11-May-2018, the subject's mother underwent spinal muscular atrophy screening and cystic fibrosis mutation analysis and there were no MCMs noted.   On 04-Jun-2018, the subject's mother underwent ultrasound and there was no MCM noted.   On 16-Jul-2018, the subject's mother underwent Quad screen and ultrasound and there was no MCM noted.   On 08-Oct-2018, at 24 weeks of gestation, the subject's mother was administered Flucelvax QIVc [influenza vaccine, subunit influenza virus vaccine polyvalent, dose: 0.5 ml, batch number: 252664, route of administration, expiry date and anatomical location: not reported] (explicitly coded as Foetal exposure during pregnancy') for influenza immunisation.  On 15-Oct-2018, the subject's mother underwent ultrasound and there was no MCM noted.   On 24-Oct-2018, the subject's mother underwent non-stress test and there was no MCM noted.   On 15-Nov-2018, the subject's mother underwent ultrasound and there was no MCM noted.   On 28-Dec-2019, at gestational age of 35.9 week, the mother vaginally delivered live birth, female neonate. The neonate's birth weight was 2977 grams, head circumference was 33.7 cm and body length was 48.9 cm. The appearance, pulse, grimace, activity, and respiration (APGAR) scores were 8 after one minute and 9 five minutes.  There was no MCM identified at birth.   At the time of initial reporting, the outcome of the event of premature birth was not reported.  This case is linked to 201904966 (corresponding mother case).; Sender's Comments: Reportedly, the female neonate subject was delivered as premature baby after foetal exposure during pregnancy with the suspect product Flucelvax QIVc. Chronology is plausible. Mother's medical history of anaemia may have contributed to development of the events. Causality was confounded by use of concomitant drug, ferrous sulfate. Foetal exposure during pregnancy is assessed as not related per company conventions. Causal relationship between the suspect product and the event premature baby is assessed as unlikely related.