Sex: M
Vaccine: UNK
Symptoms: Apgar score normal, Foetal exposure during pregnancy, Heterotaxia, Low birth weight baby
Clinical narrative: Foetal vaccine exposure during pregnancy; Isomerism, stomach and gallbladder on left; Low birth weight baby; This is a serious observational study case, finitially received from other health care professional on 20-Sep-2019, concerning a neonate, male subject.   The mother was a 38-year-old, adult female pregnant subject of body weight: 286 lbs, height: 65 inches and body mass index (BMI): 47.6 enrolled in a study on pregnancy outcomes in women immunized with seasonal cell culture influenza trivalent (TIVc) or quadrivalent (QIVc) vaccine during pregnancy.  The mother's obstetrical history included 6 previous pregnancies with 1 full term live birth, 1 preterm birth, 2 spontaneous abortions and 2 stillbirths. The mother had no maternal or paternal history with major congenital malformations.   The mother did not use tobacco, alcohol or illicit drugs during pregnancy.   The mother's last menstrual period (LMP) was 18-Jun-2018, estimated delivery date (EDD) and corrected estimated date of delivery (CEDD) was 10-Mar-2019. The type of pregnancy was singleton.  The mother's current conditions included gestational diabetes, obesity, chronic hypertension, asthma, ADHD (attention deficit hyperactivity disorder), shortness of breath and acid reflux. The mother's concomitant medications included prenatal vitamins (minerals nos, vitamins nos) for pregnancy, Albuterol (salbutamol) for shortness of breath, Makena (hydroxyprogesterone caproate) for history of preterm birth, Clatirine (loratadine) for allergies and Zantac (ranitidine hydrochloride) for acid reflux.  On 02-Aug-2018, the mother underwent cystic fibrosis mutation analysis and spinal muscular atrophy test and no major congenital malformation (MCM) was noted.  On 06-Aug-2018, the mother underwent ultrasound scan and no MCM was noted.  On 16-Aug-2018, the mother underwent Qnatal test and no MCM was noted.  On 24-Sep-2018, the mother underwent ultrasound scan and no MCM was noted.  On 08-Oct-2018, at 16 weeks of gestation, the mother was administered with Flu Vaccine Cell Subunit QIV NVD (influenza vaccine, subunit influenza virus vaccine polyvalent, batch number: 252664, route of administration, anatomical location, expiration date: not reported) (explicitly coded as foetal exposure during pregnancy) for influenza immunisation.  On 10-Jan-2019, 17-Jan-2019, 25-Jan-2019, 31-Jan-2019 and 07-Feb-2019, the mother underwent non-stress test and no MCM was noted.  On 08-Feb-2019, the mother underwent ultrasound scan and MCM was noted.  On 11-Feb-2019 and 13-Feb-2019, the mother underwent non-stress test and no MCM was noted.  On 18-Feb-2019, the mother underwent ultrasound scan and no MCM was noted.  On 19-Feb-2019, four months and eleven days after vaccination, at 37.3 weeks gestation, the mother gave a live birth to a male neonate by vaginal delivery. The neonate's birth weight was 2268 grams (explicitly coded as low birth weight baby), head circumference 32.4 centimetres and body length 45.7cm. 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.   On the same date, major congenital malformation was noted: isomerism, stomach and gallbladder on left.   At the time of initial report, outcome of the isomerism, stomach and gallbladder on left and low birth weight baby was not reported.   The reported did not provide causality and seriousness criteria.  This case is linked to 201904749, the corresponding mother report.  Company Comment: Reportedly, the male neonate subject was delivered as low birth weight baby with heterotaxia after foetal exposure during pregnancy, at gestation age of 16 weeks, with the suspect product Flu Vaccine Cell Subunit QIV NVD. Chronology is plausible for the event low birth weight baby. For the event heterotaxia temporal relationship is implausible because product was administered after organs of digestive system have already positioned themselves. Mother's medical history of gestational diabetes, obesity, chronic hypertension and asthma may have contributed to development of the events. Causality was confounded by therapy with multiple concomitant medications. Foetal exposure during pregnancy and heterotaxia is assessed as not related. For the event low birth weight baby, causal role of the suspect product cannot be totally excluded and is assessed as related.; Reporter's Comments: Reportedly, the male neonate subject was delivered as low birth weight baby with heterotaxia after foetal exposure during pregnancy, at gestation age of 16 weeks, with the suspect product Flu Vaccine Cell Subunit QIV NVD. Chronology is plausible for the event low birth weight baby. For the event heterotaxia temporal relationship is implausible because product was administered after organs of digestive system have already positioned themselves. Mother's medical history of gestational diabetes, obesity, chronic hypertension and asthma may have contributed to development of the events. Causality was confounded by therapy with multiple concomitant medications. Foetal exposure during pregnancy and heterotaxia is assessed as not related. For the event low birth weight baby, causal role of the suspect product cannot be totally excluded and is assessed as related.