Sex: F
Vaccine: UNK
Symptoms: Apgar score normal, Foetal exposure during pregnancy, Intensive care, Neonatal respiratory distress syndrome
Clinical narrative: Respiratory distress syndrome (RDS); Foetal exposure during pregnancy; This is an observational study case, initially reported by other health professional on 15-Apr-2020, concerning a female, neonate subject whose mother was 20-year-old, female of body weight 119.8 lbs, height 62 inches and body mass index (BMI) 21.9, enrolled in a prospective observational safety study.   The subject's mother's current condition included anxiety and negative Rhesus antibodies (RhD).  The subject's mother's concomitant medication included TDAP (diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid) as vaccine, Rhophylac (anti-D immunoglobulin) for RhD negative and sertraline for anxiety.  The subject's mother's obstetrical history noted that the mother had one previous pregnancy of full-term live birth with no birth defects. The subject's mother had no maternal or paternal history with major congenital malformations (MCMs). The subject's mother 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 last menstrual period (LMP) date was 01-Jul-2019. The estimated delivery date (EDD) was reported as 06-Apr-2020, while corrected estimated date of delivery (CEDD) was not reported. The type of pregnancy was singleton. The subject's father was a 24-year-old.  On 26-Sep-2019, at approximately 12 weeks of gestation (calculated per LMP), the subject's mother was administered Flucelvax QIVc (Flu Vaccine Cell Subunit QIV NVD) [influenza vaccine, subunit influenza virus vaccine polyvalent; batch number: 261207, 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 the same day, the subject's mother underwent first trimester screen and no MCMs were noted.  On 28-Oct-2019, the subject's mother underwent second trimester screen and maternal serum alpha fetoprotein (MSAFP) screening. No MCMs were noted.  On 11-Nov-2019, the subject's mother underwent anatomy ultrasound and no MCMs were noted.  On 02-Mar-2020, the subject's mother underwent growth ultrasound and no MCMs were noted.  At 39.1 weeks of gestation (as reported), the mother vaginally delivered a live female neonate. The neonate's birth weight was 3204 grams, while body length and head circumference were not reported. The appearance, pulse, grimace, activity, and respiration (APGAR) score at one minute was 8, at five minutes was 9 and no data was provided at ten minutes. No MCMs were identified at the time of birth.   On an unspecified date in 2020, the subject developed respiratory distress syndrome (RDS) and was admitted to neonatal intensive care unit (NICU).  At the time of this report, the outcome for the event of 'respiratory distress syndrome in new born' was not reported.  The event of 'respiratory distress syndrome in new born' was considered as serious due to criterion of medical significance and hospitalisation, per company.  The causality assessment was not provided.  This case is linked to the case 202002951, the corresponding mother case.  Company comment: A subject experienced neonatal respiratory distress syndrome and was admitted to neonatal intensive care unit (NICU), on an unspecified date in 2020. The subject's mother was administered vaccine at 12 weeks of gestation. Chronology is unsuggestive. The medical history of subject's mother included negative Rhesus antibodies (RhD). Causal role of the suspect vaccine is assessed as not related, since baby was born at 39.1 weeks of gestation, birth weight was 3204 grams, Apgar score at one minute was 8, at five minutes was 9. Foetal exposure during pregnancy assessed as not related per company's conventions.; Sender's Comments: A subject experienced neonatal respiratory distress syndrome and was admitted to neonatal intensive care unit (NICU), on an unspecified date in 2020. The subject's mother was administered vaccine at 12 weeks of gestation. Chronology is unsuggestive. The medical history of subject's mother included negative Rhesus antibodies (RhD). Causal role of the suspect vaccine is assessed as not related, since baby was born at 39.1 weeks of gestation, birth weight was 3204 grams, Apgar score at one minute was 8, at five minutes was 9. Foetal exposure during pregnancy assessed as not related per company's conventions.