Sex: F
Vaccine: FLUX
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 female neonatal subject whose mother was 24-year-old female, pregnant subject, of body weight: 154 lbs, height: 63 inches and body mass index (BMI): 27.3, enrolled in a prospective observational safety study.  The subject's mother medical history included increased BMI.  The subject's mother's concomitant medications included Citranatal Harmony (calcium citrate, colecalciferol, dl-alpha tocopheryl acetate, docosahexaenoic acid, docusate sodium, folic acid, iron pentacarbonyl, pyridoxine hydrochloride) for pregnancy.  The subject's mother had no previous pregnancies. The subject's mother had no maternal or paternal history with major congenital malformations (MCMs). Also, the subject's mother had no history of offspring with MCM. The subject's mother used 2-3 cigarettes per day, during pregnancy. The subject's mother did not use alcohol or illicit drugs during pregnancy.   The subject's mother's last menstrual period (LMP) date was on 05-Mar-2019. The subject's mother's estimated delivery date (EDD) was reported as 10-Dec-2019, while corrected estimated delivery date (CEDD) was reported as 18-Dec-2019. The type of pregnancy was singleton. The subject's father age was not reported.  On 11-Jun-2019, the subject's mother underwent nuchal translucency and sequential 1 and no MCMs were noted.  On 08-Jul-2019, the subject's mother underwent sequential 2 and no MCMs were noted.   On 15-Oct-2019, at approximately 32 weeks of gestation, the subject's mother was administered Afluria QIV (Flu Vaccine Egg Split QIV CSL) [influenza vaccine, subunit influenza virus vaccine polyvalent, cell cultured derived; 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.   On an unspecified date, the subject was large for gestational age.  At approximately 39 weeks of gestation, the subject gave live birth to a female neonate vaginally. The characteristics of the neonate included birth weight: 3570 grams, length: 54.5 cm, while head circumference was not reported. Appearance, pulse, grimace, activity, and respiration (APGAR) scores were 8 at one minute and 8 at five minutes. No MCMs were identified at the time of birth.   At the time of this report, the outcome for the event of large for gestational age' was not reported.  The event of large for gestational age' was considered as serious due to criterion of medical significance, per company.  The causality assessment was not provided.  This case is linked to case number 202001892 (the corresponding mother case).  Company comment: Reportedly, large for dates baby was associated with Afluria QIV. A subject's mother was vaccinated at approximately 32 weeks of gestation. The event of large for dates baby was noted on an unspecified date. Chronology needs more clarification. It was reported that birth weight was 3570 grams. Causality was confounded by mother's BMI increased, 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 32 weeks of gestation. The event of large for dates baby was noted on an unspecified date. Chronology needs more clarification. It was reported that birth weight was 3570 grams. Causality was confounded by mother's BMI increased, 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.