Sex: U
Vaccine: UNK
Symptoms: Apgar score, Foetal exposure during pregnancy, Intensive care, Premature baby
Clinical narrative: Foetal exposure during pregnancy; Preterm delivery; This is an observational study case, initially received from other health professional with additional document (being process together) on 04-Mar-2020, concerning a neonate of unknown gender, whose mother was a 37-year-old, pregnant, female subject of body weight 191 lbs, height 65 inches and body mass index (BMI) 31.8, 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 subject's mother's current medical history included nausea, vomiting, BMI high and advanced maternal age. The subject's mother was marijuana user.   The subject's mother's concomitant medications included Prenatal vitamin (unspecified vitamins and minerals) for pregnancy.  The subject's mother's obstetrical history included three previous pregnancies with one full term live birth, one pre-term live birth and one spontaneous abortion. The subject's mother had no history of offspring with major congenital malformation (MCM) and no relevant maternal and paternal medical history with MCM. The subject's mother did not use tobacco or alcohol during pregnancy.   The subject's mother's last menstrual period (LMP) date was 29-Sep-2018. Estimated delivery date (EDD) and corrected estimated date of delivery (CEDD) were 06-Jul-2019. The pregnancy was singleton. The father's age was 29.  On 12-Nov-2019, at gestational age at six weeks (calculated per LMP), the subject's mother was administered Flucelvax QIVc (Flu Vaccine Cell Subunit QIV NVD ) [influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, batch number:252664, anatomical location, route of administration and expiration date: not reported] (explicitly coded as Foetal exposure during pregnancy') for influenza immunisation.   On 26-Nov-2018, the subject's mother underwent ultrasound and no MCM was noted.  On 24-Dec-2018, the subject's mother underwent Qnatal test and no MCM was noted.  On 24-Jan-2019, the subject's mother underwent ultrasound and no MCM was noted.  On 31-Jan-2019, the subject's mother underwent maternal serum alpha-fetoprotein (MSAFP) / serum markers test and no MCM was noted.  On 04-Mar-2019, after vaccination, the subject's mother developed gestational diabetes.  On 21-Apr-2019, after vaccination, the subject's mother developed pre-eclampsia.  On an unspecified date in 2019, at unknown gestational age (reported as preterm delivery), the subject's mother delivered live birth, neonate of unknown gender via unknown method of delivery. The neonate's birth weight, head circumference and length were not provided. The appearance, pulse, grimace, activity, and respiration (APGAR) scores at one, five and ten minutes were not provided. It was unknown if there was any pregnancy complication noted during delivery. It was unknown if there was any MCM noted at birth. It was reported that the subject was admitted in Neonatal Intensive Care Unit (NICU). On the same day at delivery, the subject's mother recovered from pre-eclampsia and gestational diabetes.  On 04-Jun-2020, the neonate was still in NICU.  On an unspecified date (reported as after delivery), the subject's mother underwent gallbladder removal, but the details were not specified  At the time of this reporting, 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 to Flucelvax QIVc.  The case is linked to case 201904700, the corresponding mother's case.  Company comment: Reportedly, premature birth was associated with Flucelvax QIVc. Subject's mother was vaccinated at six weeks of gestation and the event occurred four at unknown gestational age (reported as preterm delivery). Chronology needs more clarification. Causality was confounded by advanced maternal age. Subject's mother was marijuana user. Based on provided information, causal role of the suspect vaccine is assessed as not related. Foetal exposure during pregnancy is assessed as unrelated per company's conventions.; Sender's Comments: Reportedly, premature birth was associated with Flucelvax QIVc. Subject's mother was vaccinated at six weeks of gestation and the event occurred four at unknown gestational age (reported as preterm delivery). Chronology needs more clarification. Causality was confounded by advanced maternal age. Subject's mother was marijuana user. Based on provided information, causal role of the suspect vaccine is assessed as not related. Foetal exposure during pregnancy is assessed as unrelated per company's conventions.