Sex: F
Vaccine: UNK
Symptoms: Apgar score normal, Caesarean section, Foetal exposure during pregnancy, Large for dates baby
Clinical narrative: Foetal exposure during pregnancy; Birth weight 4451 g; This is an observational study case, initially received from other health professional on 15-Apr-2020, concerning a female neonate, whose mother was 27-year-old pregnant female subject of body weight: 156.6 Ibs, height: 67 in and body mass index (BMI) 24.5, enrolled in a prospective observational safety study.  The subject's mother's current conditions included Rhesus (RhD) D negative and depression.  The subject's mother's concomitant medications included Prenatal (vitamin not otherwise specified (nos); mineral nos) as obstetrical (OB) care, sertraline for depression, Rhophylac (anti-d immunoglobulin) for RHD negative and TDAP (diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid) as vaccine.  The subject's mother's obstetrical history included two previous pregnancies, two with full term live births. 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 27-Jun-2019, the estimated delivery date (EDD) and corrected estimated delivery date (CEDD) were reported as 02-Apr-2020. The type of pregnancy was singleton. The subject's father was 38-year-old.  On 12-Sep-2019, the subject's mother underwent ultrasound dates, and no MCMs were noted.  On 12-Sep-2019, at approximately 11 weeks of gestation (calculated per LMP), the subject's mother was administered Flucelvax QIV (Flu Vaccine Cell Subunit QIV NVD) [influenza vaccine, subunit influenza virus vaccine polyvalent; batch number: 261200, dose: 0.5 ml, route of administration, anatomical location and expiration date: not reported] (explicitly coded as Foetal exposure during pregnancy') for an influenza immunisation.  On 07-Nov-2019, the subject's mother underwent anatomy ultrasound, and no MCMs were noted.  On 07-Jan-2020, the subject's mother developed pelvic abdominal pain right lower quadrant and was treated with cyclobenzaprine.  On 08-Jan-2020, the subject's mother underwent ultrasound follow-up growth test, and no MCMs were noted.  On 30-Jan-2020, the subject's mother developed vaginitis, and was treated with Terazol 7 (terconazole).  On 07-Feb-2020, the subject's mother recovered from the vaginitis.  On 10-Feb-2020, the subject's mother developed candidiasis of skin and was treated with nystatin.  On 20-Feb-2020, the subject's mother underwent ultrasound follow-up growth test, and no MCMs were noted.  At 39.1 weeks of gestation (reported as), the subject's mother delivered live birth, female neonate via caesarean method of delivery. The neonate's birth weight was 4451g, her head circumference and length were not provided. The appearance, pulse, grimace, activity, and respiration (APGAR) scores were 8 (one minute), 9 (five minutes) and for ten minutes was not provided. No MCM was noted on birth. No pregnancy complications were noted on delivery.  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 202003297, the corresponding mother case.  Company comment: Reportedly, large for dates baby were associated with Flucelvax QIV. The subject's mother was vaccinated at approximately 11 weeks of gestation. The event of was noted on delivery, 6 months 15 days later. Chronology is unsuggestive. The subject's mother's current conditions included Rhesus (RhD) D negative and depression. The subject's mother's concomitant medications included Prenatal (vitamin not otherwise specified mineral) as obstetrical (OB) care, sertraline for depression, Rhophylac (anti-d immunoglobulin) for RHD negative and TDAP vaccine (diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid). No information of conditions such as maternal obesity or diabetes was provided. Reported birth weight was 4451g. Per some sources, the range of normal is between 2.5 and 4.5 kilograms. The risk of fetal macrosomia increases with each pregnancy. Causal role of the suspect vaccine is assessed as not related for the event large for dates baby. Foetal exposure during pregnancy is assessed as not related.; Sender's Comments: Reportedly, large for dates baby were associated with Flucelvax QIV. The subject's mother was vaccinated at approximately 11 weeks of gestation. The event of was noted on delivery, 6 months 15 days later. Chronology is unsuggestive. The subject's mother's current conditions included Rhesus (RhD) D negative and depression. The subject's mother's concomitant medications included Prenatal (vitamin not otherwise specified mineral) as obstetrical (OB) care, sertraline for depression, Rhophylac (anti-d immunoglobulin) for RHD negative and TDAP vaccine (diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid). No information of conditions such as maternal obesity or diabetes was provided. Reported birth weight was 4451g. Per some sources, the range of normal is between 2.5 and 4.5 kilograms. The risk of fetal macrosomia increases with each pregnancy. Causal role of the suspect vaccine is assessed as not related for the event large for dates baby. Foetal exposure during pregnancy is assessed as not related.