Sex: M
Vaccine: UNK
Symptoms: Apgar score normal, Foetal exposure during pregnancy, Premature baby
Clinical narrative: Fetal exposure during pregnancy; Preterm birth; This is an observational study case, initially received from other health professional on 18-Sep-2019, concerning a male, neonate subject, whose mother was 25-year-old, pregnant female subject of body weight 106 lbs, height 62 inches and body mass index 19.4, enrolled in, a prospective observational safety study on pregnancy outcomes in women immunized with seasonal cell culture influenza trivalent (TIVc) or quadrivalent (QIVc) vaccine during pregnancy.  The mother's medical history included urinary tract infection. 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) for healthy pregnancy and Macrobid (clarithromycin) for urinary tract infection.   The subject's mother had no previous pregnancies. The mother did not use tobacco, alcohol or illicit drugs during pregnancy. Also, the subject's mother had no maternal or paternal history with major congenital malformations. The mother's last menstrual period (LMP) date was 18-Aug-2018, and the expected delivery date was 25-May-2019. The type of pregnancy was singleton.   On 06-Oct-2018, the subject's mother was administered Flucelvax QIVc [influenza vaccine, subunit influenza virus vaccine polyvalent, batch number: 252232, dose: 0.5 ml, route of administration, expiration date and anatomical location: not reported] (explicitly coded as Foetal exposure during pregnancy') for influenza immunisation.  On, at gestational age of 36.9 week, the mother delivered live birth, male neonate [explicitly coded as Premature baby'] through vaginal method. The neonate's birth weight was 2765 grams, head circumference was 31 cm and body length was 50 cm. The appearance, pulse, grimace, activity, and respiration (APGAR) scores were 9 (one minute), 9 (five minutes) and 9 (ten minutes). There was no pregnancy complication noted and no major congenital malformation identified at birth.   At the time of initial reporting, the outcome of the event Birth premature' was not reported.  This case is linked to 201902925 (corresponding mother case).  Company comment: Reportedly, a male neonate subject was delivered as premature baby after foetal exposure during pregnancy, after maternal receipt of Flu Vaccine Cell Subunit QIV NVD at gestation age of 7 weeks. Chronology is plausible. The mother's concomitant treatment with clarithromycin confounds causality. However, causal role of the suspect vaccine cannot be totally excluded and is assessed as related. Foetal exposure during pregnancy is assessed as unrelated per company's conventions.; Reporter's Comments: Reportedly, a male neonate subject was delivered as premature baby after foetal exposure during pregnancy, after maternal receipt of Flu Vaccine Cell Subunit QIV NVD at gestation age of 7 weeks. Chronology is plausible. The mother's concomitant treatment with clarithromycin confounds causality. However, causal role of the suspect vaccine cannot be totally excluded and is assessed as related. Foetal exposure during pregnancy is assessed as unrelated per company's conventions.