Sex: M
Vaccine: UNK
Symptoms: Apgar score normal, Foetal exposure during pregnancy, Large for dates baby
Clinical narrative: Large for gestational age; Foetal exposure during pregnancy; This is an observational study case, initially received from other health professional on 24-Feb-2020, concerning a male foetal subject, whose mother was a 23-year-old, pregnant, female subject of body weight 195 lbs, height 70 inches and body mass index (BMI) 28, enrolled in a prospective observational safety study.   The subject's mother's medical history included obesity.  The subject's mother's concomitant medications included Prenatal vitamins (unspecified vitamins and minerals) for pregnancy.  The subject's mother's obstetrical history noted that the mother had no previous pregnancies. The subject's mother had no maternal or paternal history with major congenital malformations (MCMs). The subject's mother had no history of offspring with MCMs. The subject's mother did not use tobacco, alcohol or illicit drugs during pregnancy.  The subject's mother's last menstrual period (LMP) date and the estimated delivery date (EDD) were not reported, while corrected date of delivery (CEDD) was reported as 19-Dec-2019. The type of pregnancy was singleton.   On 26-Apr-2019, the subject's mother underwent an ultrasound scan and no MCMs were noted.  On 07-Oct-2019, the subject's mother underwent sequential test part 1 and nuchal translucency. No MCMs were noted.  On 05-Jul-2019, the subject's mother underwent sequential test part 2 and no MCMs were noted.  On 06-Aug-2019, the subject's mother underwent an anatomy scan and no MCMs were noted.  On 25-Oct-2019, at unspecified weeks of gestation, the subject's mother was administered Afluria QIV (Flu Vaccine Egg Split QIV CSL) [influenza vaccine; batch number: P100112488, dose, anatomical location, route of administration and expiration date: not reported] (explicitly coded as Foetal vaccine exposure during pregnancy') for influenza immunisation.   On an unspecified date in 2019, it was noted that the subject was large for gestational age, however, further details were not provided.  At approximately 40.1 weeks of gestation, the subject's mother vaginally delivered a live male neonate. The neonate's birth weight was 3331 g, while head circumference and length were not reported. The appearance, pulse, grimace, activity, and respiration (APGAR) scores were 7 (one minute) and 9 (five minutes). No data was reported for APGAR score for ten minutes. No MCMs were identified at the time of birth.   At the time of initial reporting, the outcome of the event large for gestational age was not reported.  The event of large for gestational age was assessed as serious due to criteria of medically significance, per company.   The reporter did not provide causality assessment.  This case is linked with the case 202001894, the corresponding mother case.  Company comment: The event of Large for dates baby was reported in association with foetal exposure to Afluria QIV. On an unspecified date in 2019, it was noted that the subject was large for gestational age. At approximately 40.1 weeks of gestation, the subject's mother vaginally delivered a live male neonate. However, neonate's birth weight was 3331 g.  Chronology needs more clarification. Mother's medical history of obesity may have contributed to development of the event. With information available, causal role of the suspect product is unassessable. Foetal exposure during pregnancy is assessed as not related per company conventions.; Sender's Comments: The event of Large for dates baby was reported in association with foetal exposure to Afluria QIV. On an unspecified date in 2019, it was noted that the subject was large for gestational age. At approximately 40.1 weeks of gestation, the subject's mother vaginally delivered a live male neonate. However, neonate's birth weight was 3331 g.  Chronology needs more clarification. Mother's medical history of obesity may have contributed to development of the event. With information available, causal role of the suspect product is unassessable. Foetal exposure during pregnancy is assessed as not related per company conventions.