Sex: F
Vaccine: UNK
Symptoms: Foetal exposure during pregnancy, Premature baby
Clinical narrative: Foetal exposure during pregnancy; Preterm birth at 35.9 weeks of gestation; This is an observational study case, initially received from other health professional on 05-Aug-2020, concerning a female, neonate whose mother was 38-year-old, pregnant, female subject of body weight: 198 lbs, height: 68.4 inches and body mass index (BMI): 29.8, enrolled in a prospective observational safety study.  The neonate's mother's medical history included obesity, hypothyroidism, asthma, genital herpes simplex, pregnancy with advanced maternal age and allergies.  The neonate's mother's concomitant medications included Prenatal vitamins (unspecified vitamins and minerals) as obstetrical (OB) supplement, levothyroxine for hypothyroidism, Advair (fluticasone propionate, salmeterol xinafoate) for asthma, cetirizine for allergies, acyclovir for genital herpes simplex and TDAP (diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid) as vaccine.  The neonate's mother's obstetrical history included no previous pregnancies. The neonate's mother had no history of offspring with major congenital malformation (MCM) and no maternal and paternal medical history with MCM. The neonate's mother did not use tobacco, alcohol or illicit drugs during pregnancy.   The neonate's mother's last menstrual period (LMP) date was on 15-May-2019. The neonate's mother's estimated delivery date (EDD) and corrected estimated date of delivery (CEDD) were both reported as 19-Feb-2020. The type of pregnancy was singleton. The neonate's father was a 39-year-old.  On 26-Jul-2019, the neonate's mother underwent MaterniT21 and no MCMs were noted.  On 10-Sep-2019, the neonate's mother underwent maternal serum alpha-fetoprotein (MSAFP) /serum markers and second trimester screen and no MCMs were noted.  On 03-Oct-2019, the neonate's mother underwent anatomy ultrasound and no MCMs were noted.  On 31-Oct-2019, at approximately 24 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; batch number: 261223, dose: 0.5 ml, route of administration, anatomical location and expiration date: not reported] (explicitly coded as 'Foetal exposure during pregnancy') for an influenza immunization.  On an unspecified date in Jan-2020, reported as either week of 06-Jan-2020 or 17-Jan-2020, the neonate's mother developed pre-eclampsia.  At gestational age of 35.9 weeks (as reported), the neonate's mother delivered a live birth, female neonate via vaginal method of delivery. The neonate's birth weight was 2977 grams. The neonate's length was 49.5 cm, while head circumference was not reported. The appearance, pulse, grimace, activity, and respiration (APGAR) scores at one minute, five and ten minutes were not reported. No MCMs were identified at the time of birth.   On the same date, the neonate's mother recovered from the event of pre-eclampsia.  At the time of this report, the outcome of event premature birth' was not reported.  The event of premature birth' was considered as serious due to criterion of medical significance, per company.  The reporter did not provide causality assessment.   This case is linked to case 202004084 (the corresponding mother's case).  Company comment: A pregnant subject was administered Flucelvax QIV at 24 weeks of gestation. The subject delivered a live birth, female neonate via vaginal method of delivery. The subject's medical history included obesity, hypothyroidism and advanced maternal age (38). Causality was confounded. Causal role of the suspect vaccine is assessed as not related for premature birth, due to presented confounders, biological implausibility and unsuggestive chronology. Foetal exposure during pregnancy assessed as not related per company's conventions.; Sender's Comments: A pregnant subject was administered Flucelvax QIV at 24 weeks of gestation. The subject delivered a live birth, female neonate via vaginal method of delivery. The subject's medical history included obesity, hypothyroidism and advanced maternal age (38). Causality was confounded. Causal role of the suspect vaccine is assessed as not related for premature birth, due to presented confounders, biological implausibility and unsuggestive chronology. Foetal exposure during pregnancy assessed as not related per company's conventions.