Sex: F
Vaccine: UNK
Symptoms: Apgar score normal, Foetal exposure during pregnancy, Large for dates baby
Clinical narrative: Foetal exposure during pregnancy; Birth weight 5049 g; This is an observational study case, initially received from other health professional on 20-May-2020, concerning a neonate, female subject whose mother was a 28-year-old, pregnant female subject of body weight: 173.4 lbs, height: 71.3 inches and body mass index (BMI): 24, enrolled in a prospective observational safety study.  The subject's mother's current condition included exercise induced asthma.    The subject's mother's concomitant medications included Prenatal vitamins (mineral nos, vitamin nos) for pregnancy and albuterol sulfate for asthma.   The subject's mother's obstetrical history included no previous pregnancies. The mother had no history of offspring with major congenital malformation (MCM) and no relevant maternal and paternal medical history. The mother did not use alcohol or illicit drugs during pregnancy.   The subject's mother's last menstrual period (LMP) date was 22-Jul-2019, the estimated delivery date (EDD) was reported as 27-Apr-2020, while corrected estimated date of delivery (CEDD) was not reported. The type of pregnancy was singleton. The paternal age was not reported.   On 17-Sep-2019, the subject's mother underwent prenatal bloodwork and no MCMs were noted.  On 24-Sep-2019, the subject's mother underwent ultrasound and no MCMs were noted.  On 09-Oct-2019, at gestational age of approximately 11 weeks (calculated per LMP), the subject's mother was administered Afluria QIV (Flu Vaccine Egg Split QIV CSL) [influenza vaccine; batch number: P100123038, dose, anatomical location, route of administration and expiration date: not reported] (explicitly coded as Foetal exposure during pregnancy') for influenza immunisation.  On 11-Oct-2019, the subject's mother underwent Gonorrhoea culture test and Chlamydia culture test and no MCMs were noted.  On 23-Oct-2019, the subject's mother underwent first trimester screen and no MCMs were noted.  On 03-Dec-2019, the subject's mother underwent anatomic scan and no MCMs were noted.  On 02-Feb-2020, the subject's mother underwent one-hour glucola test and results showed high values. Three-hour glucola test was ordered.  At gestational age of 41.4 weeks (as reported), the subject's mother vaginally delivered live birth female neonate. The neonate's birth weight was 5049 g, head circumference 36 cm and body length 59.7 cm. The appearance, pulse, grimace, activity and respiration (APGAR) scores were 7 at one minute and 9 at five minutes. APGAR score was not reported for 10 minutes. There were no major MCM identified at birth.  At the time of initial reporting, the outcome of the event of birth weight excessive' was not reported.   The event of birth weight excessive' was considered serious due to the criterion of medical significance, per company.   The reporter did not provide causality assessment.  The case is linked with the case 202001665, the corresponding mother case.  Company Comment: A female neonate subject was large for dates baby (according to birth weight of 5049 g) after foetal exposure to Afluria QIV. Vaccine was administered at gestation age of 11 weeks. Baby was born 6 months 28 days later, at gestational age of 41.4 weeks. The subject's mother's current condition included exercise induced asthma. The subject's mother's concomitant medications included Prenatal vitamins (mineral nos, vitamin nos) for pregnancy and albuterol sulfate for asthma. Approximately three months before delivery, the subject's mother underwent one-hour glucola test and results showed high values. More information regarding diagnostic findings is needed. Causal role of the suspect vaccine is assessed as not related. Foetal exposure during pregnancy is assessed as not related per company's conventions.; Sender's Comments: A female neonate subject was large for dates baby (according to birth weight of 5049 g) after foetal exposure to Afluria QIV. Vaccine was administered at gestation age of 11 weeks. Baby was born 6 months 28 days later, at gestational age of 41.4 weeks. The subject's mother's current condition included exercise induced asthma. The subject's mother's concomitant medications included Prenatal vitamins (mineral nos, vitamin nos) for pregnancy and albuterol sulfate for asthma. Approximately three months before delivery, the subject's mother underwent one-hour glucola test and results showed high values. More information regarding diagnostic findings is needed. Causal role of the suspect vaccine is assessed as not related. Foetal exposure during pregnancy is assessed as not related per company's conventions.