Sex: M
Vaccine: UNK
Symptoms: Apgar score normal, Caesarean section, Foetal exposure during pregnancy, Large for dates baby, Premature baby
Clinical narrative: Foetal exposure during pregnancy; Birth weight 4055g; This is an observational study case, initially received from other health professional on 10-Feb-2020, concerning a male neonate, whose mother was 35-year-old, pregnant female subject of body weight: 312 Ibs, height: 68 in and body mass index (BMI) 47.4, enrolled in a prospective observational safety study.  The subject's mother's past medical history included gastric bypass. The subject's mother's current conditions included advanced maternal age, high BMI, muscle spasm, nausea, vomiting, gastroesophageal reflux disease (GERD), anxiety and depression.  The subject's mother's historical drug included cyclobenzaprine for muscle spasm. The subject's mother's concomitant medications included buspirone and clonazepam, both used for anxiety, ondansetron for nausea and vomiting, Protonix (omeprazole) for GERD and Zoloft (sertraline) for depression.   The subject's mother's obstetrical history included three previous pregnancies, two with full term live births and one spontaneous abortion. The subject's mother had a history of caesarean section. The subject's mother had no maternal or paternal history with major congenital malformations (MCMs) and had no history of offspring with MCM. The subject's mother did not use tobacco, alcohol or illicit drugs during pregnancy.  The subject's mother's last menstrual period (LMP) date was 04-Feb-2019, the estimated delivery date (EDD) was reported as 11-Nov-2019 and corrected estimated delivery date (CEDD) was reported as 25-Nov-2019. The type of pregnancy was singleton.  The subject's father's age was not provided.  On 01-May-2019, the subject's mother underwent Maternit21 test and there were no MCMs noted.  On 17-May-2019, the subject's mother underwent gastric bypass panel and there were no MCMs noted.  On 21-Jun-2019, the subject's mother underwent maternal serum alpha-fetoprotein (MSAFP) /serum markers and there were no MCMs noted.  On 11-Jul-2019, the subject's mother's pregnancy status was collected, and polyhydramnios was noted in foetus.   On the same day, the subject's mother underwent targeted ultrasound and there were no MCMs noted.   On 30-Sep-2019, the subject's mother's pregnancy status was collected, and single umbilical artery was noted in foetus.  On 10-Oct-2019, at approximately 35 weeks of gestation (calculated per LMP), the subject's mother was administered Afluria QIV (Flu Vaccine Egg Split QIV CSL) [Influenza Vaccine, batch number: P100112488, dose, route of administration, anatomical location and expiration date: not reported] (explicitly coded as Foetal exposure during pregnancy') for an influenza immunisation.  At 37.6 weeks of gestation (reported as), the subject's mother delivered live birth, male neonate via caesarean method of delivery. The neonate's birth weight was 4055 g, his head circumference and length were not provided. The appearance, pulse, grimace, activity, and respiration (APGAR) scored were 8 (one minute), 9 (five minutes) and for ten minutes was not provided. No MCM was noted on birth. Pre-eclampsia was noted as pregnancy complication. On the same day, polyhydramnios and single umbilical artery were resolved.  At the time of this report, the outcome of the event large for dates baby' was not reported.  The event of large for dates baby' was assessed as serious due to criterion of medical significance, per company.  The reporter did not provide causality assessment.  This case is linked to the case 201905905, the corresponding mother case.  Company comment: Reportedly, large for dates baby was associated with Afluria QIV. A subject's mother was vaccinated at approximately 35 weeks of gestation. The event of large for dates baby was noted 29 days later. Chronology is plausible. It was reported that birth weight was 4055 grams. Causality was confounded by advanced maternal age and high BMI, however causal role of the suspect vaccine cannot be totally excluded and is assessed as unlikely related (defaults to "related" in the safety database for reporting purposes). Foetal exposure during pregnancy is assessed as unrelated per company's conventions.; Sender's Comments: Reportedly, large for dates baby was associated with Afluria QIV. A subject's mother was vaccinated at approximately 35 weeks of gestation. The event of large for dates baby was noted 29 days later. Chronology is plausible. It was reported that birth weight was 4055 grams. Causality was confounded by advanced maternal age and high BMI, however causal role of the suspect vaccine cannot be totally excluded and is assessed as unlikely related (defaults to "related" in the safety database for reporting purposes). Foetal exposure during pregnancy is assessed as unrelated per company's conventions.