Sex: F
Vaccine: UNK
Symptoms: Caesarean section, Foetal exposure during pregnancy, Kidney malrotation, Renal aplasia
Clinical narrative: Malrotated rt kidney; Agenesis of rt kidney; Foetal exposure during pregnancy; This is a serious observational study case, initially received from other health professional on 04-Oct-2019, concerning a female neonate subject. The subject's mother was a 21-year-old, adult female pregnant subject of body weight: 105 Ibs, height: 61 in and body mass index (BMI) 19.8 enrolled in a prospective observational safety study. The subject's father was 28-year-old.  The subject's mother had one previous full-term, live birth pregnancy with no birth defects. 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 had used tobacco during pregnancy (eight cigarettes per day consumed). The subject's mother did not use alcohol or illicit drugs during pregnancy.  The subject's mother's current conditions included nausea and vomiting. Concomitant medications included prenatal vitamins (unspecified vitamins and minerals) for pregnancy and promethazine for nausea.   The subject's mother's last menstrual period (LMP) was on 05-Jun-2018. Estimated delivery date (EDD) was reported as 21-Mar-2019. The type of pregnancy was singleton. The pregnancy status of the was collected, and no MCMs were noted.   On 27-Aug-2018, the subject's mother underwent ultrasound and no MCMs were noted.  On 05-Oct-2018, at approximately 17 weeks of gestation, the mother was administered Flu Vaccine Cell Subunit QIV NVD (Flucelvax QIV) [influenza vaccine, subunit influenza virus vaccine polyvalent, cell cultured derived, 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 influenza immunisation.   On the same day, the subject's mother underwent ultrasound, maternal serum alpha-fetoprotein screening (MSAFP/serum markers) and quadscreen. No MCMs were noted.  On 04-Dec-2018, the subject's mother developed anaemia and was treated with ferrous sulfate 325 mg, twice daily, orally.  On 16-Jan-2019, the subject's mother underwent ultrasound and malrotated right kidney was noted.  On 30-Jan-2019, the subject's mother underwent panorama and non-stress test and no MCMs were noted.  On 11-Feb-2019, 19-Feb-2019, 28-Feb-2019 and 06-Mar-2019, the subject's mother underwent non-stress test and no MCMs were noted.  On 14-Mar-2019, the subject's mother recovered from the event of anaemia.  On 14-Mar-2019, at 39 gestational weeks, mother delivered a live female neonate via Caesarean section. The neonate's birth weight was 3175 grams. The neonate's body length, head circumference and appearance, pulse, grimace, activity, and respiration (APGAR) scores were not provided. It was reported that the neonate had agenesis of right (rt) kidney.  This case is linked to case number 201905081 (corresponding mother case).  The case was assessed as serious. The reporter did not provide causality assessment to Flucelvax QIV.; Sender's Comments: The female neonate subject was delivered with right renal aplasia after foetal exposure during pregnancy with the suspect product Flu Vaccine Cell Subunit QIV NVD. Right kidney malrotation was also reported during prenatal ultrasound scan. Chronology is unclear. Foetal exposure during pregnancy is assessed as not related per company conventions. Because of this conflicting information right kidney malrotation and renal aplasia of the same kidney, causal role of the suspect product is unassessable.