Sex: M
Vaccine: TDAP, UNK
Symptoms: Apgar score normal, Blood bilirubin increased, Foetal exposure during pregnancy, Intensive care
Clinical narrative: Bilirubin 16.06; Vaccine foetal exposure during pregnancy; This is an observational study case, initially received from other health professional on 02-Jan-2020, concerning a male neonate subject, whose mother was 22-year-old, pregnant subject of body weight: 207 lbs, height: 66 inches and body mass index (BMI): 33.4 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 obesity, bacterial vaginosis and she was positive for group B streptococcus.  The mother's concomitant medications included Prenatal vitamins (unspecified vitamins and minerals) as vitamin supplementation.   The mother did not have any previous pregnancies, nor maternal and paternal history with major congenital malformation (MCM). The mother did not consume tobacco, alcohol and illicit-drugs during pregnancy.  The mother's last menstrual period (LMP) date was 25-Mar-2019. The mother's estimated date of delivery (EDD) was 30-Dec-2019 and corrected estimated date of delivery (CEDD) was 06-Dec-2019. The type of pregnancy was singleton. The father  was 28-year-old. The pregnancy was complicated by bacterial vaginosis and the mother was treated with metronidazole vaginal gel, one applicator every day via vaginal route of administration.  On 05-Jun-2019, the subject's mother underwent first trimester screen and nuchal translucency and no MCM was noted.  On 02-Jul-2019, the subject's mother underwent second trimester screen and maternal serum alpha-fetoprotein screening (MSAFP/serum markers) and no o MCM was noted.  On 11-Jul-2019, the subject underwent anatomy ultrasound and no MCM was noted.  On 16-Sep-2019, at 25 weeks of gestation, the subject's mother was administered Flucelvax QIVc [influenza vaccine, subunit influenza virus vaccine polyvalent; batch number: 261200, dose, route of administration, anatomical location and expiration date: not reported] (explicitly coded as 'Foetal exposure during pregnancy') for influenza immunisation.   On the same day, the subject's mother was also administered co-suspect TDAP vaccine [diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid; dose: 0.5 ml, route of administration: intramuscular, anatomical location, batch number and expiration date: not reported] as vaccine.  At gestational age of 40.6 weeks, the mother vaginally delivered live male neonate. The neonate birth weight was 3470 grams and no data was reported for head circumference and length. Appearance, pulse, grimace, activity and respiration (APGAR) scores at one minute was 8 and at five minutes was 9. No data was reported for APGAR score at ten minutes. No MCM was identified at birth.   On an unknown date in Dec-2019, the neonate's bilirubin was 16.06 (units were not specified) and the subject was admitted to neonate intensive care unit (NICU), but further details were provided.  The reporter did not provide causality assessment to Flucelvax QIVc.  This case is linked to case 201906276 (the corresponding mother case).  Company comment: Company comment: The patient experienced blood bilirubin abnormal associated with Flu Vaccine Cell Subunit QIV NVD. Chronology seems plausible. Reportedly, on the same day when our product was given,the subject's mother was also administered co-suspect TDAP vaccine. on an unknown date in dec-2019 the reported event of bilirubin was noted. Babies usually have their highest bilirubin level when they're 3 to 5 days old. Newborns should be watched for jaundice every 8 to 12 hours during the first 2 days of their lives. They should then be rechecked before they're 5 days old. More information about the date of ocurrance is needed. Also co-suspect vaccine may explain reported event. Causality is assessed as unlikely related for blood bilirubin abnormal and not related for foetal exposure during pregnancy per company conventions.; Sender's Comments: Company comment: The patient experienced blood bilirubin abnormal associated with Flu Vaccine Cell Subunit QIV NVD. Chronology seems plausible. Reportedly, on the same day when our product was given,the subject's mother was also administered co-suspect TDAP vaccine. on an unknown date in dec-2019 the reported event of bilirubin was noted. Babies usually have their highest bilirubin level when they're 3 to 5 days old. Newborns should be watched for jaundice every 8 to 12 hours during the first 2 days of their lives. They should then be rechecked before they're 5 days old. More information about the date of ocurrance is needed. Also co-suspect vaccine may explain reported event. Causality is assessed as unlikely related for blood bilirubin abnormal and not related for foetal exposure during pregnancy per company conventions.