Sex: F
Vaccine: FLUX
Symptoms: Apgar score normal, Foetal exposure during pregnancy
Clinical narrative: Intrauterine growth restriction; Exposure to influenza virus; Foetal exposure during pregnancy; This is an observational study case, initially received from other health professional on 20-Jan-2020, concerning a  female, neonate subject, whose mother was a 27-year-old female of body weight 125 lbs, height 65 inches and body mass index (BMI) 20.8, enrolled in, a prospective observational safety study.  The mother's medical history was not reported.   The subject's mother concomitant medications included Prenatal vitamins (unspecified vitamins and minerals) as vitamin supplementation and Tdap (diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid) as vaccine immunisation.    The mother had no previous pregnancies. The subject's mother had no maternal or paternal history with major congenital malformations (MCMs). The mother did not use tobacco, alcohol or illicit drugs during pregnancy.   The mother's last menstrual period (LMP) was on 16-Apr-2019 and type of pregnancy was singleton. The estimated delivery date (EDD) and corrected estimated date of delivery (CEDD) of subject's mother were reported as 21-Jan-2020. The subject's father was a 27-year-old.  On 12-Jul-2019, the subject's mother underwent first trimester screen and no MCM was noted.   On 28-Aug-2019, the subject's mother underwent second trimester screen, anatomy ultrasound scan and maternal serum alpha-fetoprotein screening and no MCM was noted.   On 21-Oct-2019, at approximately 26 weeks of gestation, the mother was administered Flucelvax QIV (Flu Vaccine Cell Subunit QIV NVD) [influenza vaccine, subunit influenza virus vaccine polyvalent, batch number: 261223, dose: 0.5 ml, route of administration, anatomical location and expiration date: not reported] (explicitly coded as Foetal exposure during pregnancy') for an influenza immunization.   On 18-Dec-2019, one month and 27 days after vaccination, the subject's mother was exposed to influenza virus and was treated with oseltamivir at dose of 75 mg, administered via oral route, every day, form 18-Dec-2019 to 28-Dec-2019.   On 15-Jan-2020, at 39.1 weeks of gestation, the subject's mother vaginally delivered a normal, female neonate. The neonate's birth weight was 2722 g, while head circumference and body length were not reported. The appearance, pulse, grimace, activity, and respiration (APGAR) scores were 8 (one minute) and 9 (five minutes). APGAR score was not reported for 10 minutes. There was no major congenital malformation identified at birth. Pregnancy complications included intrauterine growth restriction (IUGR).  At the time of initial reporting, the outcome of the events exposure to communicable disease' and fetal growth restriction' was not reported.  The events of exposure to communicable disease' and fetal growth restriction' were considered serious due to the criterion of medical significance, per company.  The reporter did not provide causality assessment.  This case is linked to 202000610 (the corresponding mother case).  Company comment: Foetal growth restriction was associated with foetal exposure during pregnancy. The mother was administered with Flucelvax QIV at gestation age of 26 weeks. Reportedly, one month and 27 days after vaccination, the subject's mother was exposed to influenza virus and was treated with oseltamivir (coded as Exposure to communicable disease). More information regarding medical history is needed. Foetal growth restriction was noted as pregnancy complication on an unknown date, so causality needs more clarification. Causality is unassessable for the event Foetal growth restriction. Causal role of the suspect vaccine is assessed as not related for Exposure to communicable disease and Foetal exposure during pregnancy are assessed as not related.; Sender's Comments: Foetal growth restriction was associated with foetal exposure during pregnancy. The mother was administered with Flucelvax QIV at gestation age of 26 weeks. Reportedly, one month and 27 days after vaccination, the subject's mother was exposed to influenza virus and was treated with oseltamivir (coded as Exposure to communicable disease). More information regarding medical history is needed. Foetal growth restriction was noted as pregnancy complication on an unknown date, so causality needs more clarification. Causality is unassessable for the event Foetal growth restriction. Causal role of the suspect vaccine is assessed as not related for Exposure to communicable disease and Foetal exposure during pregnancy are assessed as not related.