Sex: M
Vaccine: UNK
Symptoms: Apgar score normal, Foetal exposure during pregnancy, Low birth weight baby, Premature baby, Small for dates baby
Clinical narrative: Foetal exposure during pregnancy; Birth at 36.1 weeks of gestational age; Birth weight 2339 grams; Birth length 45.1 cm; This is an observational study case, initially received from other health professional on 18-May-2020, concerning a neonate, male subject, whose mother was a 28-year-old, pregnant, female subject of body weight: 132 lbs, height: 65 inches and body mass index (BMI): 22, enrolled in a prospective observational safety study.   The subject's mother had no relevant medical history.  The subject's mother's concomitant medications included OB Complete (fish oil, doconexent, icosapent, calcium ascorbate, cholecalciferol, alpha-tocopherol acetate, d-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, biotin, calcium threonate, calcium malate, calcium carbonate, iron, ferrous asparto glycinate, potassium iodide, magnesium oxide, zinc oxide, and cupric sulfate) for healthy pregnancy.   The subject's mother's obstetrical history included one previous pregnancy with one spontaneous abortion. The subject' mother had no history of offspring with major congenital malformation (MCM) and no relevant maternal and paternal medical history. The subject's mother did not use tobacco, alcohol or illicit drugs during pregnancy.   The subject's mother's last menstrual period (LMP) date was 14-Jul-2019, the estimated delivery date (EDD) was reported as 19-Apr-2020, while the corrected estimated date of delivery (CEDD) was not reported. The type of pregnancy was singleton. The paternal age was not reported.  On 21-Sep-2019, at approximately nine 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] for influenza immunization (explicitly coded as 'Foetal exposure during pregnancy').  On 05-Oct-2019, the subject's mother underwent first trimester screen and cystic fibrosis mutation analysis and no MCM was noted.  On 02-Nov-2019, the subject's mother underwent second trimester screen and no MCM was noted.  On 04-Jan-2020, the subject's mother underwent one-hour glucose test and no MCM was noted.  On 01-Feb-2020, the subject's mother experienced vulvar itching and started treatment with Lotrisone cream (betamethasone dipropionate, clotrimazole), at dose of 0.05 percent, to apply to affected area, two times per day.   On 15-Feb-2020, the subject's mother recovered from vulvar itching and treatment with Lotrisone cream was completed.   On 14-Mar-2020, the subject's mother underwent group B strep test and no MCM was noted.  At gestational age of 36.1 weeks (as reported) the subject's mother vaginally delivered a live birth male neonate. The neonate's birth weight was 2339 g, head circumference 30.5 cm and body length 45.1 cm. The appearance, pulse, grimace, activity and respiration (APGAR) scores were 9 at one minute and 9 at five minutes. APGAR score was not reported for 10 minutes. There was no major congenital malformation identified at birth.    At the time of initial reporting, the outcome of the events low birth weight baby', small for gestational age', and preterm birth' was not reported.   The events of low birth weight baby', small for gestational age' and preterm birth' were assessed as serious due to the criteria of medical significance, per company.   The reporter did not provide causality assessment.  This case is linked with the case 202002737, the corresponding mother case.  Company Comment: The male neonate subject was delivered as premature baby, with low birth weight approximately six months after foetal exposure to the suspect product, Afluria QIV. The event of small for dates baby was also associate with suspect vaccine, since birth length 45.1 cm. 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). Low birth weight and small for dates baby were likely due to premature birth, therefore were assessed as not related to the vaccine. Foetal exposure during pregnancy is assessed as unrelated per company's conventions.; Sender's Comments: The male neonate subject was delivered as premature baby, with low birth weight approximately six months after foetal exposure to the suspect product, Afluria QIV. The event of small for dates baby was also associate with suspect vaccine, since birth length 45.1 cm. 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). Low birth weight and small for dates baby were likely due to premature birth, therefore were assessed as not related to the vaccine. Foetal exposure during pregnancy is assessed as unrelated per company's conventions.