Sex: F
Vaccine: FLU4
Symptoms: Delivery, Exposure during pregnancy, Gastrooesophageal reflux disease, Term birth
Clinical narrative: This is an observational study case on 16-Mar-2021 from other health professional and concerned a female neonate, whose mother was 31-year-old, pregnant, female subject, of body weight: 158 lbs., height: 61 inches and body mass index (BMI): 29.9, enrolled in, a prospective observational safety study on pregnancy outcomes in women immunized with Afluria QIV, a seasonal quadrivalent vaccine, during pregnancy. The maternal concurrent conditions included BMI high. The maternal concomitant medications were not reported. The maternal obstetrical history noted that the mother had no previous pregnancy. The neonate's mother had no maternal or paternal history with major congenital malformations (MCMs). The neonate's mother had no history of offspring with MCMs. The mother did not use tobacco, alcohol or illicit drugs during pregnancy. The maternal last menstrual period (LMP) date was 25-Jun-2020, the estimated delivery date (EDD) was 01-Apr-2021, while the corrected estimated date of delivery (CEDD) was not reported. The type of pregnancy was singleton. The paternal age was not reported. On 22-Sep-2020, the first trimester screen test revealed no MCMs. On 23-Sep-2020, the cystic fibrosis mutation analysis, fragilex and spinal muscular atrophy test (SMA) revealed no MCMs. On 28-Oct-2020, the second trimester screen test revealed no MCMs. On 20-Nov-2020, approximately at 21 weeks of gestation (calculated per LMP), the neonate's mother was administrated with Afluria QIV (Flu Vaccine Egg Split QIV) (influenza vaccine; dose, anatomical location and route of administration: not reported) (explicitly coded as Fetal exposure during pregnancy) for an influenza immunisation. The batch number reported was P100239705. On an unspecified date, an unknown amount of time after receiving Afluria Quadrivalent, the neonate's mother developed gastroesophageal reflux disease. On 04-Feb-2021, the neonate's mother started treatment with MYLANTA gas minis at dose of 42 mg, administered three times a day (TID) via oral route, and PEPCID AC at dose of 20 mg, administered two times a day (BID), via oral route for GERD. at gestational age of 37 weeks (as reported), the mother vaginally delivered live female neonate. The birth weight of the neonate was 2455 g, head circumference 32 centimeters and the length 45.7 centimeters. The appearance, pulse, grimace, activity and respiration (APGAR) score at one minute was 9, at five minutes was 9 and for ten minutes was not reported. No pregnancy complications were noted. No MCM was identified at birth. The outcome of the event 'low birth weight baby' was not reported. The reporter did not provide a causality assessment. The event of 'low birth weight baby' was considered to be medically significant by a Physician within Risk Management Department. This case is linked with the case 202101524, the corresponding mother case. Company comment: A female neonate experienced fetal exposure to the suspect product Afluria QIV. Neonate's mother was administered vaccine at approximately 21 weeks of gestation. At gestational age of 37 weeks, the mother vaginally delivered live female neonate. The birth weight of the neonate was 2455 g. The maternal concurrent conditions included BMI high. The maternal concomitant medications were not reported. The maternal obstetrical history noted that the mother had no previous pregnancy. Due to un-suggestive temporal relationship (3 months and 19 days after vaccination), causality is assessed as not related low birth weight. Fetal exposure during pregnancy is assessed as not related per company conventions. Sender's Comments: A female neonate experienced fetal exposure to the suspect product Afluria QIV. Neonate's mother was administered vaccine at approximately 21 weeks of gestation. At gestational age of 37 weeks, the mother vaginally delivered live female neonate. The birth weight of the neonate was 2455 g. The maternal concurrent conditions included BMI high. The maternal concomitant medications were not reported. The maternal obstetrical history noted that the mother had no previous pregnancy. Due to un-suggestive temporal relationship (3 months and 19 days after vaccination), causality is assessed as not related low birth weight. Fetal exposure during pregnancy is assessed as not related per company conventions.