Sex: F
Vaccine: FLU4
Symptoms: Apgar score normal, Foetal exposure during pregnancy, Premature baby, Pyelocaliectasis
Clinical narrative: Fetal pylectasis; Pre-term birth at 36.9 weeks; Foetal exposure during pregnancy; This is an observational study case, initially received from other health professional on 15-Jun-2020, concerning a female foetus, whose mother was 19-year-old pregnant female subject of body weight: 147 Ibs, height: 63 in and body mass index (BMI) 26, enrolled in, a prospective observational safety study on pregnancy outcomes in woman immunized with Afluria QIV, a seasonal quadrivalent vaccine, during pregnancy.  The foetus' mother's medical history included BMI high and adolescent pregnancy.  The foetus' mother's concomitant medications included Prenatal vitamins (unspecified vitamins and minerals) for pregnancy.  The foetus' mother's obstetrical history noted that foetus' mother had no previous pregnancies. The foetus' mother had no maternal or paternal history with major congenital malformations (MCMs) and had no history of offspring with MCM. The foetus' mother did not use tobacco, alcohol or illicit drugs during pregnancy.  The foetus' mother's last menstrual period (LMP) date was 15-Jul-2019, the estimated delivery date (EDD) was reported as 20-Apr-2020 and corrected estimated date of delivery (CEDD) was reported as 11-Apr-2020. The type of pregnancy was singleton.  The foetus' father's age was not pervaded.  On 16-Sep-2019, the foetus' mother ultrasound scan and there were no MCMs noted.  On 01-Oct-2019, the foetus' mother underwent nuchal translucency and first sequential tests and there were no MCMs noted.  On 29-Oct-2019, the foetus' mother underwent second sequential test and there were no MCMs noted.  On 26-Nov-2019, the foetus' mother underwent 20 week anatomy ultrasound and there were no MCMs noted.  On 08-Jan-2020, at approximately 25 weeks of gestation (calculated per LMP), the foetus' mother was administered Afluria QIV (Flu Vaccine Egg Split QIV CSL) [influenza vaccine; batch number: P100112488, dose, anatomical location, route of administration and expiration date: not reported] (explicitly coded as Foetal exposure during pregnancy') for influenza immunisation.  On the same day, the foetus' mother developed anaemia and was treated with ferrous sulfate, at dose of 325 mg, orally, once a day.   On 25-Feb-2020, the foetus' mother stopped treatment with ferrous sulfate.  At 36.9 weeks of gestation (reported as), the foetus' mother vaginally delivered live birth, female neonate. The neonate's birth weight was 3204 g, her head circumference and length were not reported. The appearance, pulse, grimace, activity, and respiration (APGAR) scores were for 8 (one minute), 9 (five minutes) and for ten minutes was not provided. No MCM was noted on birth. Pregnancy complication was reported as foetal pylectasis.  At the time of this report, the outcome of events 'pyelectasia' and premature baby' was not reported.  The events of 'pyelectasia' and premature baby' were assessed as serious due to criterion of medical significance, per company.  The reporter did not provide causality assessment.  This case is linked to the case 202002355, the corresponding mother case.  Company Comment: A female neonate experienced premature birth (at 36.9 weeks of gestation), 2 months and 12 days after foetal exposure to the suspect product, Afluria QIV. Chronology is unsuggestive. The event of pyelocaliectasis was noted on an unknown date. Chronology needs more clarification. For premature baby, causal role of the suspect product is assessed as not related due to chronological and biological/ pharmacological implausibility. Regarding pyelocaliectasis, in most cases it resolves normally, having no ill effects on the baby. Causality is assessed as not related. Foetal exposure during pregnancy is assessed as unrelated per company's conventions.; Sender's Comments: A female neonate experienced premature birth (at 36.9 weeks of gestation), 2 months and 12 days after foetal exposure to the suspect product, Afluria QIV. Chronology is unsuggestive. The event of pyelocaliectasis was noted on an unknown date. Chronology needs more clarification. For premature baby, causal role of the suspect product is assessed as not related due to chronological and biological/ pharmacological implausibility. Regarding pyelocaliectasis, in most cases it resolves normally, having no ill effects on the baby. Causality is assessed as not related. Foetal exposure during pregnancy is assessed as unrelated per company's conventions.