Sex: F
Vaccine: UNK
Symptoms: Apgar score normal, Foetal exposure during pregnancy, Premature baby, Small for dates baby
Clinical narrative: Foetal exposure during pregnancy; Born at 36.3 weeks of gestation; Birth weight 1990 g/Lenght 41.9 cm; This is an observational study case, initially received from other health professional on 09-Apr-2020  concerning a female neonatal subject whose mother was 28-year-old female, pregnant subject of body weight: 130 lbs, height: 62 inches and body mass index (BMI): 23.8, enrolled in a prospective observational safety study.  The subject's mother's relevant medical history was not reported.   The subject's mother's concomitant medications included Vitafol one (ascorbic acid, betacarotene, colecalciferol, cupric oxide, cyanocobalamin, folic acid, magnesium oxide, nicotinamide, omega-3 fatty acids, polysaccharide-iron complex, potassium iodide, pyridoxine hydrochloride, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide) and OB complete one (ascorbic acid, betacarotene, calcium carbonate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, magnesium oxide, nicotinamide, potassium iodide, pyridoxine hydrochloride, riboflavin, sodium fluoride, taurine, thiamine mononitrate, tocopheryl acetate, zinc sulfate monohydrate), both for healthy pregnancy.  The subject's mother's obstetrical history noted that the mother had three previous pregnancies which included one full term live birth and two elective abortions. The subject's mother had no history of offspring with major congenital malformation (MCM). Also, the subject's mother had no maternal or paternal history with MCM. The subject's mother did not use tobacco, alcohol or illicit drugs during pregnancy.   The subject's mother last menstrual period (LMP) was on 21-May-2019. The subject's mother estimated date of delivery (EDD) was reported as 25-Feb-2020, while corrected estimated date of delivery (CEDD) was not reported. Type of pregnancy was singleton. The subject's father age was not reported.  On 14-Aug-2019, the subject's mother underwent first trimester screen and no MCM was noted.   On 11-Sep-2019, at approximately 16 weeks of gestation (calculated per LMP), the subject's mother was administered Afluria Quadrivalent (Flu Vaccine Egg Split QIV CSL) [influenza vaccine; batch number: P100110950, dose, route of administration, anatomical location and expiration date: not reported] (explicitly coded as Foetal exposure during pregnancy') for an influenza immunization.   On the same day, the subject's mother underwent second trimester screen and no MCM was noted.   On 24-Sep-2019, the subject's mother experienced bacterial vaginosis and vomiting. The subject's mother started with treatment medications Zofran (ondansetron) at a dose of 8 mg, consumed three times daily and oral vitamin B6 tablets, at a dose of 25 mg, once daily, both for vomiting.   On 26-Sep-2019, the subject's mother started with treatment medication Metrogel (metronidazole) at the dose of 0.75 %, consumed once daily and vaginally for bacterial vaginosis.  On 30-Sep-2019, the subject's mother recovered from bacterial vaginosis and finished the treatment with Metrogel.  On 24-Oct-2019, the subject's mother recovered from vomiting and finished the treatment with Zofran and Vitamin B6.  On 13-Nov-2019, the subject' mother underwent one-hour glucose challenges test and no MCM was noted.  At 36.3 weeks of gestation (as reported), the subject's mother vaginally delivered a female neonate. The neonate's birth weight was 1990 grams, length was 41.9 cm and head circumference were 30 cm. The appearance, pulse, grimace, activity, and respiration (APGAR) scores were 9 at one minute and 9 at five minutes. The APGAR score for ten minutes was not reported. No MCMs were identified at the time of birth.   At the time of this report, the outcome for events of 'birth premature' and small for dates baby' was not reported.  The events of 'birth premature' and small for dates baby' were considered as serious due to criterion of medical significance, per company.  The reporter did not provide causality assessment.  This case is linked to case number 202000012 (the corresponding mother case).  Company comment: A female neonatal subject, whose mother was 28-year-old female pregnant subject, developed premature baby and small for dates baby after her mother was vaccinatedn with the suspect product Afluria Quadrivalent for an influenza immunization. Reportedly, at 36.3 weeks of gestation (as reported), the subject's mother vaginally delivered a female neonate. Chronology seems compatible. The subject's mother's obstetrical history noted that the mother had three previous pregnancies which included one full term live birth and two elective abortions. The subject's mother had no history of offspring with major congenital malformation (MCM). During pregnancy the subject's mother experienced bacterial vaginosis (treated with metronidazole) and vomiting (treated with ondansetron). The subject's mother's relevant medical history was not reported. The subject's mother's concomitant medications included Vitafol one (ascorbic acid, betacarotene, colecalciferol, cupric oxide, cyanocobalamin, folic acid, magnesium oxide, nicotinamide, omega-3 fatty acids, polysaccharide-iron complex, potassium iodide, pyridoxine hydrochloride, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide) and OB complete one (ascorbic acid, betacarotene, calcium carbonate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, magnesium oxide, nicotinamide, potassium iodide, pyridoxine hydrochloride, riboflavin, sodium fluoride, taurine, thiamine mononitrate, tocopheryl acetate, zinc sulfate monohydrate), both for healthy pregnancy. With information presented, causality is assessed as unlikely related for both events. Foetal exposure during pregnancy is assessed as unrelated per company conventions. (''unlikely related'' defaults to "related" in the safety database for reporting purposes); Sender's Comments: A female neonatal subject, whose mother was 28-year-old female pregnant subject, developed premature baby and small for dates baby after her mother was vaccinatedn with the suspect product Afluria Quadrivalent for an influenza immunization. Reportedly, at 36.3 weeks of gestation (as reported), the subject's mother vaginally delivered a female neonate. Chronology seems compatible. The subject's mother's obstetrical history noted that the mother had three previous pregnancies which included one full term live birth and two elective abortions. The subject's mother had no history of offspring with major congenital malformation (MCM). During pregnancy the subject's mother experienced bacterial vaginosis (treated with metronidazole) and vomiting (treated with ondansetron). The subject's mother's relevant medical history was not reported. The subject's mother's concomitant medications included Vitafol one (ascorbic acid, betacarotene, colecalciferol, cupric oxide, cyanocobalamin, folic acid, magnesium oxide, nicotinamide, omega-3 fatty acids, polysaccharide-iron complex, potassium iodide, pyridoxine hydrochloride, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide) and OB complete one (ascorbic acid, betacarotene, calcium carbonate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, magnesium oxide, nicotinamide, potassium iodide, pyridoxine hydrochloride, riboflavin, sodium fluoride, taurine, thiamine mononitrate, tocopheryl acetate, zinc sulfate monohydrate), both for healthy pregnancy. With information presented, causality is assessed as unlikely related for both events. Foetal exposure during pregnancy is assessed as unrelated per company conventions. (''unlikely related'' defaults to "related" in the safety database for reporting purposes)