Sex: M
Vaccine: UNK
Symptoms: Apgar score normal, Caesarean section, Congenital pyelocaliectasis, Foetal exposure during pregnancy
Clinical narrative: Foetal exposure during pregnancy; Fetal Pyelectasis; This is an observational study case, initially received from other health professional on 27-Nov-2019 with additional information (being processed together) on the same day, concerning a male neonate subject whose mother was a 26-year-old, pregnant female subject of body weight: 131 lbs, height: 50 inches and body mass index (BMI): 36.8, enrolled in, a prospective observational safety study. The subject's father was a 26-year-old.  The subject's mother current condition included: anxiety, headaches, herpes simplex virus, body mass increased (BMI) and thyroid elevated.  The subject's mother concomitant medications included Prenatal vitamins (minerals nos; vitamins nos) for pregnancy, Valtrex (valaciclovir hydrochloride) for herpes simplex virus and Synthroid (levothyroxine sodium) for thyroid elevated.  The subject's mother had no previous pregnancies. The subject's mother had no history of offspring with major congenital malformation (MCM) and no relevant maternal and paternal medical history. The mother did not use tobacco and alcohol but was marijuana user.   The subject's mother last menstrual period (LMP) date was 28-Jan-2019. The type of pregnancy was singleton. The subject's mother estimated delivery date (EDD) and corrected estimated date of delivery (CEDD) was reported as 04-Nov-2019.   On 21-Mar-2019, the subject's mother underwent cystic fibrosis mutation analysis and spinal muscular atrophy and no MCM was noted.  On 16-Apr-2019, the subject' s mother underwent ultrasound and no MCM was noted.  On 11-Oct-2019, at approximately 36 weeks of gestation, the subject's mother was administered with Flu Vaccine Cell Subunit QIV NVD [influenza vaccine, subunit influenza virus vaccine polyvalent, batch number: 261218, dose: 0.5 ml, anatomical location, route of administration and expiration date: not reported] (explicitly coded as Foetal exposure during pregnancy') for an influenza immunization.  On 04-Nov-2019, 24 days after vaccination, at gestational age of 40 weeks, the subject's mother with caesarean method delivered, male neonate of body weight 3425 grams, head circumference 36.8 cm and body length 49.5 cm. The appearance, pulse, grimace, activity, and respiration (APGAR) scores were 8 at one minute and 9 at five minutes. APGAR score was not reported for 10 minutes.   At birth the baby was identified foetal pyelectasis. Factors contributing to the MCM were unknown.  At the time of initial reporting the outcome of foetal pyelectasis was not reported.  The event of pyelectasia was considered serious due to criterion of medically significant and congenital anomaly, per company.   The reporter did not provide causality assessment.  This case was linked to cases 201907050 (mother case).  Company comment: A male neonate patient experienced pyelocaliectasis, 24 days after maternal receipt of Flu Vaccine Cell Subunit QIV NVD at 36 weeks of gestation (considered as foetal exposure during pregnancy). Chronology is plausible and causal role of the suspect vaccine cannot be totally excluded, it is assessed as related. Foetal exposure during pregnancy is assessed as unrelated per company's conventions.; Sender's Comments: A male neonate patient experienced pyelocaliectasis, 24 days after maternal receipt of Flu Vaccine Cell Subunit QIV NVD at 36 weeks of gestation (considered as foetal exposure during pregnancy). Chronology is plausible and causal role of the suspect vaccine cannot be totally excluded, it is assessed as related. Foetal exposure during pregnancy is assessed as unrelated per company's conventions.