Sex: M
Vaccine: FLUC4
Symptoms: Apgar score normal, Foetal exposure during pregnancy
Clinical narrative: Right lateral cerebral ventricle 1.01; Foetal exposure during pregnancy; This is an observational study case, initially received from other health professional on 08-Oct-2019, concerning a male neonate subject. The subject's mother was 16-year-old, adult female pregnant subject of body weight: 109 Ibs, height: 60 in and body mass index (BMI) 21.3, a prospective observational safety study on pregnancy outcomes in women immunized with seasonal cell culture influenza trivalent (TIVc) or quadrivalent (QIVc) vaccine during pregnancy. The subject's father was 16-year-old.  The subject's mother had no previous pregnancies. The subject's mother had no maternal or paternal history with major congenital malformations (MCMs). 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 mother's historical medical condition included bacterial vaginosis. The mother's historical drug included Metrogel (metronidazole) for bacterial vaginosis and concomitant medication included prenatal vitamins (unspecified vitamins and minerals) for pregnancy.   The mother's last menstrual period (LMP) date was 01-Jun-2018. Estimated delivery date (EDD) was reported as 08-Mar-2019. The type of pregnancy was singleton. The pregnancy status was collected and right lateral cerebral ventricle 1.01 was reported as pregnancy complication.   On 03-Jul-2018, the subject's mother underwent cystic fibrosis mutation analysis and spinal muscular atrophy and there were no MCMs noted.  On 20-Jul-2018, 17-Aug-2018 and 20-Aug-2018, the subject's mother underwent ultrasound and no MCMs were noted.   On 19-Oct-2018, at approximately 20 weeks of gestation, the subject's mother was administered Flu Vaccine Cell Subunit QIV NVD (Flucelvax QIVc) [influenza vaccine, subunit influenza virus vaccine polyvalent, batch number: 252664, dose: 0.5 ml, route of administration, anatomical location and expiration date: not reported] (explicitly coded as Foetal exposure during pregnancy') for an influenza immunisation.   On the same day, the subject's mother underwent Qnatal and maternal serum alpha-fetoprotein screening (MSAFP/serum markers). No MCMs were noted.  On 19-Nov-2018, the subject's mother developed anaemia and was treated with ferrous sulphate, at dose of 325 mg, twice daily, orally.  On 03-Dec-2018, the subject's mother developed urinary tract infection and was treated with Macrobid (clarithromycin) 100 mg, twice daily, orally, until 10-Dec-2018  and Augmentin (amoxicillin and clavulanic acid), at dose of 875 mg + 125 mg, twice daily, orally, until 13-Dec-2018.  On 13-Dec-2018, the subject's mother recovered from the event of urinary tract infection.  On 14-Jan-2019, 22-Jan-2019, 29-Jan-2019, 07-Feb-2019, 11-Feb-2019 and 19-Feb-2019, the subject's mother underwent non-stress test and no MCMs were noted.  On 22-Feb-2019, the subject's mother underwent ultrasound and no MCMs were noted.  On 08-Mar-2019, the subject's mother recovered from the event of anaemia.  On 08-Mar-2019, at 40 gestational weeks, mother vaginally delivered a live male neonate. The neonate's birth weight was 3040 grams, body length was 52.1 cm and head circumference was 34.3 cm. The reported appearance, pulse, grimace, activity, and respiration (APGAR) scores at one minute was 8, at five minutes was 9 and no data was provided at 10 minutes. There was no MCM identified at birth.  This case is linked to case number 201905139 (corresponding mother case).  The case was assessed as serious. The reporter did not provide causality assessment to Flucelvax QIVc.; Sender's Comments: Cerebral ventricle dilatation and foetal exposure during pregnancy in a male neonate subject were reported as pregnancy complication associated with the suspect product Flucelvax QIVc. Mother's medical history of young age (16 years), bacterial vaginosis and anaemia may have contributed to development of the event. Causality was also confounded by therapy with multiple concomitant drugs. Foetal exposure during pregnancy is assessed as not related per company conventions.  It is unknown when the event occurred so causal role of the suspect product could not be assessed, making company causality unassessable.