Sex: F
Vaccine: FLUX
Symptoms: Caesarean section, Foetal exposure during pregnancy, Premature baby, Small for dates baby
Clinical narrative: Fetal exposure during pregnancy; Low birth weight, 1616 grams; Birth at 31.9 gestational weeks; Birth length 39.4 cm; This is an observational study case, initially received from other health professional on 06-Apr-2020, concerning a neonate female subject, whose mother was a 40-year-old, pregnant female ), of body weight 219 lbs, height 60 inches and body mass index (BMI) 42.8, enrolled in a prospective observational safety study.   The subject's mother's current medical conditions included body mass index high (BMI 42.8) and pregnancy with advanced maternal age.   The subject's mother's concomitant medication included Prenatal (unspecified vitamins and minerals) for pregnancy.  The subject's mother's obstetrical history included no previous pregnancies. The subject's mother had no history of offspring with major congenital malformations (MCMs). Also, the subject's mother had no maternal or paternal history with MCMs.   The subject's mother's last menstrual period (LMP) date was 07-Jul-2019. The estimated delivery date (EDD) was reported as 09-Apr-2020 and corrected estimated date of delivery (CEDD) was reported as 07-Apr-2020. The mother did not use tobacco, alcohol or illicit drugs during pregnancy. The subject's father was 41 years old.   On 06-Sep-2019, the mother underwent ultrasound scan and no MCM was noted.   On 18-Sep-2019, the mother underwent Maternit 21 and no MCM was noted.   On 16-Oct-2019, at approximately 14 weeks of gestation (calculated per LMP), the subject's mother was administered Flucelvax QIV (Flu Vaccine Cell Subunit QIV NVD) [influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, batch number: 261226, route of administration, anatomical location and expiration date: not reported] (explicitly coded as Foetal exposure during pregnancy') for influenza immunization.   On an unspecified date, the subject's mother experienced placental abruption and preterm premature rupture of membranes.   At 31.9 weeks of gestation (as reported), the subject's mother gave a live birth to a female neonate, delivered by caesarean method of delivery. The neonate's birth weight was 1616 grams, body length was 39.4 centimetres and head circumference was not reported. The appearance, pulse, grimace, activity and respiration (APGAR) scores at one, five and ten minutes were not reported.    At the time of this report, the outcome of events premature baby 26 to 32 weeks', low birth weight baby' and small for gestational age' was not reported.  The of events of premature baby 26 to 32 weeks', low birth weight baby' and small for gestational age' were assessed as serious due to criterion of medical significance, per company.  The reporter did not provide causality assessment.  This case is linked to case 202002761 (the corresponding mother case).  Company Comment: A foetal subject experienced premature birth with low birth weight 3 months 27 days after foetal exposure to the suspect product, Flucelvax QIVc. Birth baby length was 39.4 centimetres, which is assessed as small for gestational age of 31.9 weeks. (coded as small for dates baby) Chronology is unsuggestive. Causality was highly confounded by placental abruption and preterm premature rupture of membranes which occurred on an unknown date and likely attributed to preterm delivery. Advanced maternal age (40) also may have contributed to development of the events. Causal role of the suspect vaccine is assessed as not related for all events. Foetal exposure during pregnancy is assessed as not related per company's conventions.; Sender's Comments: A foetal subject experienced premature birth with low birth weight 3 months 27 days after foetal exposure to the suspect product, Flucelvax QIVc. Birth baby length was 39.4 centimetres, which is assessed as small for gestational age of 31.9 weeks. (coded as small for dates baby) Chronology is unsuggestive. Causality was highly confounded by placental abruption and preterm premature rupture of membranes which occurred on an unknown date and likely attributed to preterm delivery. Advanced maternal age (40) also may have contributed to development of the events. Causal role of the suspect vaccine is assessed as not related for all events. Foetal exposure during pregnancy is assessed as not related per company's conventions.