Sex: F
Vaccine: FLUC4
Symptoms: Apgar score normal, Foetal exposure during pregnancy, Small for dates baby
Clinical narrative: Foetal exposure during pregnancy; Birth length 43.2 cm; This is an observational study case, initially received from other health professional on 09-Jun-2020, concerning female neonate, whose mother was a 21-year-old pregnant female subject of body weight: 197 lbs, height: 64 inches and body mass index (BMI): 33.8, who was enrolled in, a prospective observational safety study.  The neonate's mother's medical history included high body mass index and asthma.  The neonate's mother's concomitant medications included Prenatal vitamin (minerals nos, vitamins nos) for pregnancy.  The neonate's mother had one previous pregnancy with spontaneous abortion as an outcome. The neonate's mother had no history of offspring with major congenital malformation (MCM) and no maternal or paternal history with MCMs. The neonate's mother did not use tobacco, illicit drugs and alcohol during pregnancy. The paternal age was 23-year-old.  The neonate's mother's last menstrual period (LMP) was on 23-Jul-2019. The type of pregnancy was singleton. The mother's estimated delivery date (EDD) and corrected estimated date of delivery (CEDD) were reported as 28-Apr-2019.  On 16-Sep-2019, the neonate's mother underwent ultrasound scan, no MCM was noted.  On 14-Oct-2020, the neonate's mother underwent panorama test, no MCM was noted.  On the same day, at gestational age of 11 weeks (calculated per LMP), the neonate's mother was administered Flucelvax QIVc (Flu Vaccine Cell Subunit QIV NVD) [influenza vaccine, subunit influenza virus vaccine polyvalent; batch number: 261218, dose: 0.5 ml, route of administration, anatomical location and expiry date: not reported] (explicitly coded as Foetal exposure during pregnancy') for influenza immunisation.  On 11-Nov-2019, the neonate's mother underwent ultrasound scan, no MCM was noted.  On 10-Jan-2020, the neonate's mother developed gestational diabetes.  On 19-Feb-2020, the neonate's mother's pregnancy status was collected, and it was noted that the pregnancy was complicated with dysmature placenta. Also, the neonate's mother underwent ultrasound scan, no MCM was noted.  On 25-Mar-2020 and 08-Apr-2020, the neonate's mother underwent ultrasound scan, no MCM was noted.  At gestational age of 39.3 weeks (as reported), the subject vaginally delivered a female neonate. The birth weight of the neonate was not reported, head circumference was 30.5 cm and body length was 43.2 cm. Appearance, pulse, grimace, activity and respiration (APGAR) score at one minute: 8, at five minutes: 9 and at ten minutes was not provided. No MCM was identified at birth.   On the same day, the neonate's mother recovered from gestational diabetes and dysmature placenta.  At the time of this report, the outcome of the event small for dates baby' was not reported.  The event of 'small for dates baby' was considered serious due to the criterion of medical significance per company.  The reporter did not provide a causality assessment to Flucelvax QIV.  This case is linked to case 202003783 (the corresponding mother case).  Company Comment: A female neonate was small for dates baby (based on birth length 43.2 cm) six months after foetal exposure to the suspect product Flucelvax QIVc. The neonate's mother was administered Flucelvax QIVc at approximately 11 weeks of gestation. Causal role of the suspect product is assessed as not related, due to biological implausibility and unsuggestive chronology. Foetal exposure during pregnancy is assessed as not related per company conventions.; Sender's Comments: A female neonate was small for dates baby (based on birth length 43.2 cm) six months after foetal exposure to the suspect product Flucelvax QIVc. The neonate's mother was administered Flucelvax QIVc at approximately 11 weeks of gestation. Causal role of the suspect product is assessed as not related, due to biological implausibility and unsuggestive chronology. Foetal exposure during pregnancy is assessed as not related per company conventions.