Sex: F
Vaccine: FLU4
Symptoms: Apgar score normal, Caesarean section, Foetal exposure during pregnancy, Large for dates baby, Urinary tract disorder
Clinical narrative: Birth weight was 4590 g/Large for gestational age; Fetal urinary tract dilation; Foetal exposure during pregnancy; This is a serious spontaneous case, initially received from other health professional on 10-Jul-2019, concerning a female neonate patient.  The patient's mother was a 29-year-old female of height 65 inches, body weight 152.8 lbs and body mass index (BMI): 25.4. The patient's mother had 3 previous pregnancies which included one full term live birth and two spontaneous abortion. After first pregnancy, the patient's mother had post-partum depression for two months (on an unspecified date) and the current condition included migraines (since an unspecified date). The patient's mother had no maternal and paternal history of major congenital malformations. Also, had no history of offspring with major congenital malformations. The concomitant medications included Prenatal vitamin (minerals NOS and vitamins NOS) for pregnancy.  The last menstrual period (LMP) date of the patient's mother was 21-Aug-2018. The type of pregnancy was singleton. The patient's mother did not consume tobacco, alcohol or illicit-drugs during pregnancy. On 20-Oct-2018, the patient's mother underwent cystic fibrosis mutation analysis and the blood work (PNBW) were performed which showed no major congenital malformation. On an unspecified date, first trimester screening was performed which showed no major congenital malformation.   On 06-Nov-2018, at gestational age of approximately 11 weeks, the patient was exposed to Afluria Quadrivalent (Influenza Vaccine, batch number: YF41708, route of administration: transplacental, dose, anatomical location and expiry date: not reported) (explicitly coded to foetal exposure during pregnancy) for an unknown indication.   On 07-Jan-2019, 2 months and 1 day after vaccination, the anatomic scan of the patient's mother was performed, which showed hydronephrosis of right fetal kidney. On 04-Mar-2019, the patient's mother was transferred to high-risk center for care.  At gestational age of 39 weeks, the mother gave live birth to a female neonate (patient) via low transverse caesarean section due to large for gestational age (LGA) more than 99 percentage. Fetal urinary tract dilatation was observed as pregnancy complications. The birth weight of the foetus was 4590 grams (explicitly coded as large for gestational age), head circumference and length were not reported. Appearance, pulse, grimace, activity and respiration (APGAR) score at one minute was 8, at five minutes was 9 and no data was reported for APGAR score at ten minutes. It was unknown if major congenital malformation was identified at birth.  The estimated delivery date of the patient's mother (EDD) was reported as 02-Jun-2019.  This case is linked to a case 201900691 (mother case).; Reporter's Comments: A female neonate was diagnosed with urinary tract dilatation and large for gestational age (4590 grams) at birth, after maternal receipt of Afluria Quadrivalent vaccine at approximately 11 weeks of gestation (considered as foetal exposure during pregnancy). Considering the time frame of the events in association with vaccine administration and lack of known biological evidence, the causal role of suspect vaccine assessed as not related to the events (large for gestational age and urinary tract disorder). The event foetal exposure during pregnancy assessed as not related considering the intended use of the vaccine. The case was assessed as serious (medically significant).