Sex: U
Vaccine: FLUX
Symptoms: Apgar score normal, Foetal exposure during pregnancy, Low birth weight baby, Premature baby, Ultrasound antenatal screen normal
Clinical narrative: Preterm birth at 35.4 weeks of gestational age; Low birth weight, 2020 grams; Foetal exposure during pregnancy; This observational study case was received on 26-Mar-2021 from other health professional and concerned a neonate patient of an unreported gender whose mother was 26-year-old pregnant, female subject of body weight: 143.5 lbs, height: 62.8 inches and body mass index (BMI): 25.6, enrolled in a prospective observational safety study on pregnancy outcomes in women immunized with Afluria QIV, a seasonal quadrivalent vaccine, during pregnancy.  The maternal concurrent conditions included increased BMI, anxiety, morning sickness, migraines and subchorionic haematoma. The maternal concomitant medications included Prenatal + DHA (unspecified minerals and vitamins, docosahexaenoic acid) for pregnancy and Diclegis (doxylamine succinate, pyridoxine hydrochloride) for morning sickness. The maternal past medications included Bonjesta (doxylamine succinate, pyridoxine hydrochloride) used for morning sickness.  The maternal obstetrical history noted two previous pregnancies which included one full-term live birth and one spontaneous abortion. The neonate's mother had no history of offspring with major congenital malformation (MCM) and no maternal or paternal history with MCM. The neonate's mother did not use tobacco, alcohol or illicit drugs during pregnancy.   The maternal last menstrual period (LMP) date was reported as 08-Jun-2020, the estimated delivery date (EDD) was reported as 15-Mar-2021 and corrected estimated date of delivery (CEDD) was reported as 30-Mar-2021. The type of pregnancy was singleton.  On 12-Aug-2020, ultrasound scan revealed no MCMs.  On 02-Sep-2020, ultrasound scan, counsyl chromosomes 13, 18, 21, sex chromosome analysis and counsyl fundamental panel with fragile X revealed no MCMs.  On 04-Sep-2020 and 08-Sep-2020, ultrasound scans revealed no MCMs.  On 08-Oct-2020, at gestational age of 17 weeks (calculated per LMP), the neonate's mother was vaccinated with Afluria QIV vaccine (Flu Vaccine Egg Split QIV CSL) (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 05-Nov-2020, ultrasound scan revealed no MCMs.  At gestational age of 35.4 weeks (as reported), the mother vaginally delivered a live birth neonate. The neonate' gender was not reported. The neonate's characteristics included: birth weight: 2020 grams, head circumference: 31 cm and body length: 48.3 cm. Appearance, pulse, grimace, activity, and respiration (APGAR) scores were 8 (one minute), 9 (five minutes) and no data was reported for ten minutes. No pregnancy complication and no MCMs were identified at birth.  The outcome of 'premature baby 33 to 36 weeks' and 'low birth weight baby' was not reported.   The reporter did not provide a causality assessment.  Events of 'premature baby 33 to 36 weeks' and 'low birth weight baby' were considered to be medically significant by a Physician within Seqirus's Pharmacovigilance and Risk Management Department.  This case is linked with 202005866 (the corresponding mother case).  Company comment: A neonate whose mother was 26-year-old, pregnant female subject experienced foetal exposure to Afluria QIV. The subject was administered vaccine at gestational age of 17 weeks. At gestational age of 35.4 weeks, the mother vaginally delivered a live birth neonate. The neonate' gender was not reported. The neonate's birth weight was 2020 grams. The maternal concurrent conditions included increased BMI, anxiety, morning sickness, migraines and subchorionic haematoma. The maternal obstetrical history noted two previous pregnancies which included one full-term live birth and one spontaneous abortion. Chronology is unsuggestive. For the event of premature birth, causality was confounded by medical history. The event of low birth weight is expected for premature birth. Causal role of the suspect vaccine is assessed as not related. Foetal exposure during pregnancy is assessed as not related to the suspect vaccine.; Sender's Comments: A neonate whose mother was 26-year-old, pregnant female subject experienced foetal exposure to Afluria QIV. The subject was administered vaccine at gestational age of 17 weeks. At gestational age of 35.4 weeks, the mother vaginally delivered a live birth neonate. The neonate' gender was not reported. The neonate's birth weight was 2020 grams. The maternal concurrent conditions included increased BMI, anxiety, morning sickness, migraines and subchorionic haematoma. The maternal obstetrical history noted two previous pregnancies which included one full-term live birth and one spontaneous abortion. Chronology is unsuggestive. For the event of premature birth, causality was confounded by medical history. The event of low birth weight is expected for premature birth. Causal role of the suspect vaccine is assessed as not related. Foetal exposure during pregnancy is assessed as not related to the suspect vaccine.