Sex: F
Vaccine: FLUC4
Symptoms: Apgar score abnormal, Caesarean section, Congenital cystic kidney disease, Death neonatal, Foetal exposure during pregnancy
Clinical narrative: Polycystic kidney; Anhydramnios (and oligohydramnios); (Anhydramnios and) oligohydramnios; Fetal exposure during pregnancy; Preterm birth; Infant passed away 10 minutes shy of being 24 hours old; This is an observational serious study case, initially received from other health professional on 20-Sep-2019, concerning a 24-hour-old female neonate subject. The mother was a 30-year-old subject (Ethnicity: Not reported) of body weight: 197 lbs, height: 65 inches and body mass index (BMI): 32.8, enrolled in 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 mother's historical condition included neurofibromatosis. The mother's current conditions included yeast, HSV 2, anxiety and migraines. Concomitant medication included prenatal vitamins (unspecified vitamins), terconasole and Zoloft (sertraline hydrochloride).  The subject's mother obstetrical history noted that the mother had five previous pregnancies with 2 full term live birth, 2 preterm live birth and 1 elective abortion. The subject's mother had no maternal or paternal history with major congenital malformations. The mother did not have a prior history of use of illicit drugs during pregnancy. The subject's mother had a prior history of using alcohol (reported as 2 or less). The mother's last menstrual period (LMP) date was 25-Jun-2018 and the pregnancy was singleton. The estimated delivery date (EDD) and the corrected estimated date of delivery (CEDD) were 01-Apr-2019.  On 21-Aug-2018, 04-Sep-2018 and 02-Oct-2018, the subject's mother underwent Ultrasound scan and no major congenital malformation noted.  On 16-Oct-2018, at gestation age of 16 weeks, the subject's mother was administered Flucelvax QIVc [influenza vaccine, subunit influenza virus vaccine polyvalent, batch number: 252664, dose, expiration date, route of administration, and anatomical location: not reported] (explicitly coded as Fetal exposure during pregnancy'] for influenza immunisation.  On 18-Oct-2018, the subject's mother underwent ultrasound scan and quad screen and no major congenital malformation noted.  On 09-Jan-2019, the subject's mother underwent ultrasound scan and non stress test and polycystic kidneys, oligohydramnios and anhydramnios noted.  On 22-Jan-2019, the subject's mother underwent non stress test and polycystic kidneys, oligohydramnios and anhydramnios noted.  On 23-Jan-2019, the subject's mother underwent ultrasound scan and polycystic kidneys, oligohydramnios and anhydramnios noted.  On 25-Jan-2019, the subject's mother underwent non stress test and polycystic kidneys, oligohydramnios and anhydramnios noted.  On 29-Jan-2019, the subject's mother underwent ultrasound scan and polycystic kidneys, oligohydramnios and anhydramnios noted.  On 07-Feb-2019, the subject's mother underwent genetic testing and no major congenital malformation noted. Ultrasound scan was performed on the same day and the results showed polycystic kidneys, oligohydramnios and anhydramnios noted.  On 13-Feb-2019, the subject's mother underwent non stress test and polycystic kidneys, oligohydramnios and anhydramnios noted.  On 14-Feb-2019, 21-Feb-2019 and 01-Mar-2019, the subject's mother underwent biophysical profile and polycystic kidneys, oligohydramnios and anhydramnios noted.  At gestational age of 36.3 weeks, the mother delivered live birth, female neonate by Caesarean section (explicitly coded as Premature baby'). The neonate's birth weight was 2780 g, head circumference and length were not reported. The appearance, pulse, grimace, activity, and respiration (APGAR) scores were 1 at one minute, 3 at five minutes and 5 at ten minutes.  Major congenital malformations (MCM) identified at birth were oligohydramnios, anhydramnios and polycystic kidneys. Other factors contributing to the MCM were unknown. As reported: "Baby passed away 10 minutes shy of being 24 hours old."(outcome: fatal). Information regarding autopsy was not reported.  This case is linked to 201904743, corresponding mother case.  Company Comment: Reportedly, the female neonate subject was delivered as premature baby with congenital cystic kidney disease, oligohydramnios and anhydramnios after foetal exposure during pregnancy, at gestation age of 16 weeks, with the suspect product Flucelvax QIV. Chronology is plausible. The neonate died at 24 h and 10 minutes of age. Mother's medical history of HSV 2 and neurofibromatosis may have contributed to development of the events. Causality was confounded by therapy with multiple concomitant medications.  Foetal exposure during pregnancy is assessed as not related. For all other events, causal role of the suspect product cannot be totally excluded and is assessed as related.; Reporter's Comments: Reportedly, the female neonate subject was delivered as premature baby with congenital cystic kidney disease, oligohydramnios and anhydramnios after foetal exposure during pregnancy, at gestation age of 16 weeks, with the suspect product Flucelvax QIV. Chronology is plausible. The neonate died at 24 h and 10 minutes of age. Mother's medical history of HSV 2 and neurofibromatosis may have contributed to development of the events. Causality was confounded by therapy with multiple concomitant medications.  Foetal exposure during pregnancy is assessed as not related. For all other events, causal role of the suspect product cannot be totally excluded and is assessed as related.; Reported Cause(s) of Death: Unknown