Sex: M
Vaccine: FLUX
Symptoms: Apgar score normal, Foetal exposure during pregnancy, Premature baby
Clinical narrative: Foetal exposure during pregnancy; Preterm birth at 36.7 weeks of gestational age; This is an observational study case from initially received on 02-Mar-2020, concerning a male neonate subject whose mother was 26-year-old female pregnant, of body weight 187 lbs, height 66.3 inches and body mass index (BMI) 30, enrolled in, prospective observational safety study.  The subject's mother's current conditions included increased BMI, acne and bacterial vaginosis.  The subject's mother's concomitant medications included Aczone (dapsone) for acne, Prenatal multivitamin + DHA (ascorbic acid, beta-carotene, calcium carbonate, cholecalciferol, docosahexaenoic acid, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, riboflavin, thiamine mononitrate, tocopheryl acetate, unspecified vitamin B12, zinc oxide) for pregnancy and metronidazole for bacterial vaginosis.  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 on 18-May-2019. The mother's estimated date of delivery (EDD) was reported as 22-Feb-2020, while corrected estimated date of delivery (CEDD) was reported as 18-Mar-2020. The type of pregnancy was singleton. The subject's father was 27 years old.  On 25-Jul-2019, the subject's mother underwent ultrasound and no MCMs were noted.  On 23-Sep-2019, at 18 weeks of gestation (calculated per LMP), the subject's mother was administered Afluria QIV (Flu Vaccine Egg Split QIV CSL) [influenza vaccine, subunit influenza virus vaccine polyvalent, cell cultured derived; batch number: P100118566, dose, route of administration, anatomical location and expiration date: not reported] (explicitly coded as Foetal exposure during pregnancy') for an influenza immunisation.   On 29-Oct-2019, the subject's mother underwent ultrasound and no MCMs were noted.  On 24-Feb-2020, at 36.7 weeks of gestation (as reported), the mother vaginally delivered a live male neonate. The characteristics of the neonate included birth weight: 3515 grams, length: 49.5 cm and head circumference: 32.5 cm. Appearance, pulse, grimace, activity, and respiration (APGAR) scores were 8 at one minute and 9 at five minutes. No MCMs were identified at the time of birth.   At the time of this report, the outcome for the event of premature baby was not reported.  The event of premature baby' was considered as serious due to criterion of medical significance, per company.  The reporter did not provide causality assessment to Afluria QIV.  This case is linked to case number 201905213 (corresponding mother case).  Company Comment: Subject's mother was administered Afluria QIV at 18 weeks of gestation. A neonate subject was delivered as premature baby five months later. Chronology is implausible. Concomitant use of metronidazole for bacterial vaginosis and dapsone may have contributed to development of the event. With information available, causal role of the suspect vaccine is assessed as not related. Foetal exposure during pregnancy is assessed as not related per company conventions.; Sender's Comments: Subject's mother was administered Afluria QIV at 18 weeks of gestation. A neonate subject was delivered as premature baby five months later. Chronology is implausible. Concomitant use of metronidazole for bacterial vaginosis and dapsone may have contributed to development of the event. With information available, causal role of the suspect vaccine is assessed as not related. Foetal exposure during pregnancy is assessed as not related per company conventions.