Foetal exposure during pregnancy; Shoulder dystocia; Birth weight 4508 grams; This is an observational study case, initially received from other health professional on 18-Aug-2020, concerning a male neonate whose mother was a female, pregnant subject of body weight: 171 lbs, height: 63 inches and body mass index (BMI): 30.3, enrolled in a prospective observational study.  The neonate's mother medical history included obesity (BMI 30.3) and bipolar disorder. The mother was varicella non-immune.   The neonate's mother concomitant medications included lamotrigine for bipolar disorder, Makena (hydroxyprogesterone caproate) for history of preterm labor and Prenatal vitamin (unspecified vitamins and minerals) as a vitamin.    The neonate's mother obstetrical history included one previous pregnancy with preterm live birth (history of premature delivery). The mother did not have a history of offspring with major congenital malformation (MCM). The neonate's mother maternal history included a sister with a congenital heart defect. The neonate's father had a cystic fibrosis trait.   The neonate's mother last menstrual period (LMP) date was 28-Aug-2019. Estimated delivery date (EDD) was reported as 03-Jun-2020, while corrected estimated date of delivery (CEDD) was reported as 07-Jul-2020. The type of pregnancy was singleton. The mother did not use tobacco, alcohol or illicit drugs during pregnancy. The neonate's father was 26 years old.   On 19-Nov-2019, the neonate's mother underwent ultrasound date change and no MCM was noted.  On 25-Nov-2019, the neonate's mother underwent inheritest core and no MCM was noted.  On 27-Dec-2019, the neonate's mother underwent first trimester screen and nuchal translucency and no MCM was noted.   On 10-Jan-2020, at approximately 19 weeks of gestation (calculated per LMP), the neonate'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: 252678, route of administration, anatomical location and expiry date: not reported] (explicitly coded as Foetal exposure during pregnancy') for influenza immunisation.   On 10-Feb-2020, the neonate's mother underwent anatomy ultrasound and no MCM was noted.   On unspecified dates, an unknown amount of time after vaccination, the neonate's mother developed attention deficit hyperactivity disorder, genital herpes, anxiety, depression and asthma.   At 39.0 weeks of gestation (as reported), the mother delivered live birth male neonate, by vaginal (vaginal birth after caesarean (VBAC)) method of delivery. The neonate experienced shoulder dystocia during labor. The neonate's birth weight was 4508 grams, head circumference and body length were not reported. The appearance, pulse, grimace, activity, and respiration (APGAR) scores were 8 at one minute and 9 at five minutes. APGAR score was not reported for ten minutes. There was no major congenital malformation identified at birth.   At the time of this report, the outcome of events shoulder dystocia and birth weight excessive' was not reported.   The events of shoulder dystocia and birth weight excessive' were considered serious due to the criterion of medical significance, per company.   The reporter did not provide causality assessment.  This case is linked to 202004109 (corresponding mother case).  Company Comment: A male neonate was delivered as large for dates baby (4508 grams) and experienced shoulder dystocia after maternal receipt of Flucelvax QIV vaccine at approximately 19 weeks of gestation (considered as foetal exposure during pregnancy). Mother's medical history of obesity (BMI 30.3) may have contributed to development of the events. The event of large for dates baby may provide aetiology for shoulder dystocia. Causal role of the suspect product is assessed as not related for both events, due to biological implausibility. Foetal exposure during pregnancy is assessed as not related per company conventions.; Sender's Comments: A male neonate was delivered as large for dates baby (4508 grams) and experienced shoulder dystocia after maternal receipt of Flucelvax QIV vaccine at approximately 19 weeks of gestation (considered as foetal exposure during pregnancy). Mother's medical history of obesity (BMI 30.3) may have contributed to development of the events. The event of large for dates baby may provide aetiology for shoulder dystocia. Causal role of the suspect product is assessed as not related for both events, due to biological implausibility. Foetal exposure during pregnancy is assessed as not related per company conventions.