Sex: M
Vaccine: FLUX
Symptoms: Apgar score normal, Foetal exposure during pregnancy, Premature baby
Clinical narrative: Foetal exposure during pregnancy; Birth at gestational age of 35.7 weeks; This is an observational study case initially received on 18-May-2020, concerning a male neonate, whose mother was 23-year-old pregnant female subject, of body weight: 113 lbs, height: 63 inches and body mass index (BMI): 20, enrolled in a prospective observational safety study.  The subject's mother's medical history was not reported.   The subject's mother's concomitant medications included Prenatal vitamins (unspecified vitamins and minerals) for pregnancy.  The subject's mother had no previous pregnancies. The subject's mother had no history of offspring with major congenital malformations (MCMs) and no relevant maternal or paternal history. The subject's mother did not use tobacco, alcohol or illicit drugs during pregnancy.   The subject's mother's last menstrual period (LMP) was on 25-Jul-2019. The estimated delivery date (EDD) was reported as 15-Apr-2020, corrected estimated date of delivery (CEDD) was not reported. Type of pregnancy was singleton. The subject's father was 23-year-old.  On 10-Sep-2019, at approximately eight weeks of gestation (calculated per LMP), the subject's mother was administered Afluria QIV (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 influenza immunization.  On 17-Sep-2019, the subject's mother underwent cystic fibrosis mutation analysis, and no MCM was noted.   On 09-Oct-2019, the subject's mother underwent the first trimester screen, and no MCM was noted.   On 23-Oct-2019, the subject's mother underwent the second trimester screen, and no MCM was noted.   On 11-Nov-2019, the subject's mother developed bacterial vaginosis, gas and leg cramps. Also, she started treatment with Metrogel (metronidazole) at dose of 0.75%, every day, vaginally for bacterial vaginosis, Caltrate 600-D (calcium carbonate, colecalciferol) at dose of 600 mg, every day, orally for leg cramps and simethicone at dose of 80 mg, three times daily, via oral route of administration for gas.  On 16-Nov-2019, the subject's mother finished treatment with Metrogel (metronidazole). After using full course of medication, the subject's mother had no complaints on bacterial vaginosis.   On 21-Nov-2019, the subject's mother finished treatment with simethicone.   On 27-Dec-2019, the subject's mother underwent one-hour glucola test, and no MCM was noted.  On 23-Jan-2020, the subject's mother developed anemia and was treated with Ferrosul (ascorbic acid, cyanocobalamin, ferrous sulfate, folic acid) at a dose of 325 mg via oral route of administration.  On 19-Feb-2020, the subject's mother recovered from gas and the outcome of leg cramp was resolved. However, the subject was still using Caltrate 600-D (calcium carbonate, colecalciferol).   At 35.7 weeks of gestation (reported as), the subject's mother vaginally delivered live birth, male neonate. The neonate's birth weight was 2659 g, his head circumference was reported as 32 cm and length was reported as 47 cm. The Appearance, Pulse, Grimace, Activity, and Respiration (APGAR) scores were 9 (one minute), 10 (five minutes) and for ten minutes was not provided. No MCM was noted on birth.   At the time of this report, the outcome of the event premature baby' was not reported.  The event of premature baby' was assessed as serious due to criterion of medical significance, per company.  The reporter did not provide causality assessment.  This case is linked to the case 202000013, the corresponding mother case.  Company Comment: The male neonate subject was delivered as premature baby, approximately six months after foetal exposure to the suspect product, Flucelvax QIVc. Chronology is unsuggestive. The subject's mother's medical history was not reported. No alternative aetiology was provided. For premature baby, causal role of the suspect product cannot be totally excluded and is assessed as unlikely related. (defaults to "related" in the safety database for reporting purposes). Foetal exposure during pregnancy is assessed as unrelated per company's conventions.; Sender's Comments: The male neonate subject was delivered as premature baby, approximately six months after foetal exposure to the suspect product, Flucelvax QIVc. Chronology is unsuggestive. The subject's mother's medical history was not reported. No alternative aetiology was provided. For premature baby, causal role of the suspect product cannot be totally excluded and is assessed as unlikely related. (defaults to "related" in the safety database for reporting purposes). Foetal exposure during pregnancy is assessed as unrelated per company's conventions.