Sex: U
Vaccine: FLUX
Symptoms: Alpha 1 foetoprotein abnormal, Exposure during pregnancy, Foetal disorder, Placenta praevia, Ultrasound antenatal screen abnormal
Clinical narrative: Lymphangioma; Fuid collection noted near left kidney; Foetal exposure during pregnancy; This observational study case, received on 21-Dec-2020 with processed together received on 29-Dec-2020 from other health professional and concerned a foetus which mother was 28-year-old, female, pregnant subject of body weight: 133 lbs, height: 63.3 inches and body mass index (BMI): 23.3, enrolled in a prospective observational safety study.  The foetus' mother's concurrent conditions included anxiety, acid reflux and morning sickness. The foetus' mother's past medications included Bonjesta (doxylamine succinate, pyridoxine hydrochloride) used for morning sickness, Nexium (esomeprazole) and famotidine, both used for acid reflux. The foetus' mother's concomitant medications included Dexilant (dexlansoprazole), cimetidine and sucralfate for acid reflux, citalopram from anxiety, Phenergan (promethazine) and Zofran (ondansetron) for morning sickness and prenatal plus DHA (unspecified vitamins, docosahexaenoic acid) for pregnancy.  The foetus' mother's obstetrical history included one previous pregnancy with one full term live birth. The foetus' mother had no history of offspring with major congenital malformation (MCM). The foetus' mother had no maternal or paternal medical history 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 reported as 24-Jun-2020. The foetus' mother's estimated delivery date (EDD) was reported as 31-Mar-2021 and corrected estimated date of delivery (CEDD) was reported as 01-Apr-2021. The type of pregnancy was singleton. The foetus' father was 32-year-old.   On 25-Aug-2020, the ultrasound scan revealed no MCMs.  On 02-Sep-2020, the counsyl chromosome 13, 18, 21 plus sex chromosome analysis and ultrasound scans revealed no MCMs.  On 12-Oct-2020, at approximately 15 weeks of gestation (calculated per LMP), the foetus' mother was vaccinated with Afluria QIV (Flu Vaccine Egg Split QIV) (influenza vaccine; dose, route of administration and anatomical location: not reported) (explicitly coded as 'Foetal exposure during pregnancy') for an influenza immunisation. The batch number reported was P100253284.   On the same day, the maternal serum alpha fetoprotein screening (MSAFP/Serum marker) revealed borderline elevation for spina bifida and it was unknown if MCM was noted.  On 20-Oct-2020, the MSAFP/Serum marker - repeat revealed no MCM.  On 03-Nov-2020, the ultrasound scan revealed partial placenta previa and fluid near left kidney related to baby and no MCMs.  On 01-Dec-2020, the ultrasound revealed MCMs. It was lymphangioma.  The outcome of events lymphangioma and 'perinephric fluid collection' was not reported.  The reporter did not provide causality assessment.  the events lymphangioma and 'perinephric fluid collection' were considered to be medically significant by a Physician within Seqirus' Pharmacovigilance and Risk Management Department.  The case is linked to 202005981, the corresponding mother case.  Company comment: Lymphangioma and perinephric fluid collection have developed after foetal exposure during pregnancy to the suspect product Afluria QIV. Chronology is plausible. As reported, the foetus' mother's (subject) obstetrical history included one previous pregnancy with one full term live birth. The foetus' mother had no history of offspring with major congenital malformation (MCM). The subject did not use tobacco, alcohol or illicit drugs during pregnancy. Lymphangioma was not noted on the ultrasound three weeks after vaccination. Lymphangioma was revealed by ultrasound after approximately 7 weeks. No significant information regarding the medical history and concomitant medications have been reported. With information presented, causality for the events lymphangioma and perinephric fluid collection cannot be totally excluded and is assessed as possible (defaults to related in the safety database for reporting purposes). Causality for foetal exposure during pregnancy is assessed as not related (as per company specific guidelines).; Sender's Comments: Lymphangioma and perinephric fluid collection have developed after foetal exposure during pregnancy to the suspect product Afluria QIV. Chronology is plausible. As reported, the foetus' mother's (subject) obstetrical history included one previous pregnancy with one full term live birth. The foetus' mother had no history of offspring with major congenital malformation (MCM). The subject did not use tobacco, alcohol or illicit drugs during pregnancy. Lymphangioma was not noted on the ultrasound three weeks after vaccination. Lymphangioma was revealed by ultrasound after approximately 7 weeks. No significant information regarding the medical history and concomitant medications have been reported. With information presented, causality for the events lymphangioma and perinephric fluid collection cannot be totally excluded and is assessed as possible (defaults to related in the safety database for reporting purposes). Causality for foetal exposure during pregnancy is assessed as not related (as per company specific guidelines).