Sex: M
Vaccine: UNK
Symptoms: Apgar score normal, Foetal exposure during pregnancy, Intensive care, Premature baby
Clinical narrative: Premature birth at 35.1 weeks; Fetal exposure during pregnancy; This is an observational study case, initially received from other health professional on 24-Jan-2020, concerning a male neonate subject, whose mother was 34-year-old, pregnant subject 2 of body weight: 148 lbs, height: 63 inches and body mass index (BMI): 26.2 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 exposure to influenza virus, dysuria, nausea, rhesus antibodies (RhD) negative, candidiasis of skin, and body mass index high. The subject's mother was in advanced maternal age.   The mother's concomitant medications included Rhogam (anti-d immunoglobulin) for RhD negative,  Diclegis (doxylamine succinate, pyridoxine hydrochloride) for nausea, Prenatal vitamins (minerals not specified (nos), vitamins nos) as vitamin, Tdap (diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid) as vaccine, Macrobid (nitrofurantoin) for dysuria, nystatin topical cream for candidiasis of skin and Tamiflu (oseltamivir phosphate) for exposure to influenza virus.  The subject's mother's obstetrical history noted that the mother had two previous full term, live birth pregnancies. The subject's mother had no history of offspring with major congenital malformation (MCM). Also, the subject's mother had no maternal or paternal history with MCM. The subject's mother did not use tobacco, alcohol or illicit drugs during pregnancy.   The mother's last menstrual period (LMP) date was 15-May-2019, the estimated date of delivery (EDD) and corrected estimated date of delivery (CEDD) was 19-Feb-2020, The type of pregnancy was singleton. The subject's father was 35-year-old. The subject's father had haemophilia.  On 16-Jul-2019, the subject's mother underwent initial ultrasound and no MCM was noted.  On 26-Jul-2019, the subject's mother underwent maternity 21 and no MCM was noted.  On 04-Sep-2019, the subject's mother underwent second trimester screen and Maternal Serum Alpha-Fetoprotein Screening (MSAFP)/serum markers and no MCM was noted.  On 27-Sep-2019, at 19 weeks of gestation, the subject's mother was administered Flucelvax QIVc (Flu Vaccine Cell Subunit QIV NVD) [influenza vaccine, subunit influenza virus vaccine polyvalent; batch number: 261207, dose: 0.5 ml, 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 underwent anatomy ultrasound and no MCM was noted.  At gestational age of 35.1 weeks, the mother vaginally delivered live male neonate. Labour complications noted: preterm premature rupture of membranes (PPROM) and progression of labour (POL). The neonate birth weight was 2580 g and no data was reported for head circumference and length. The appearance, pulse, grimace, activity and respiration (APGAR) scores were 7 (one minute) and 8 (five minutes). No data was reported for APGAR score at ten minutes. No MCM was identified at birth. The baby was admitted to neonatal intensive care unit (NICU).  At the time of initial reporting, the outcome of the event premature baby 33 to 36 weeks' was not reported.  The event of premature baby 33 to 36 weeks' was assessed as serious due to the criterion of medical significance and hospitalization.  The reporter did not provide causality assessment.  This case is linked to case 201907206, the corresponding mother case.  Company comment: A neonate subject was delivered as premature baby after foetal exposure to the suspect product Flucelvax QIVc. The vaccine was administered at 19 weeks of gestation. Temporal relationship is unsuggestive. Although, causality was confounded by advanced maternal age and treatment with concomitant medications, causal role of the suspect vaccine 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: A neonate subject was delivered as premature baby after foetal exposure to the suspect product Flucelvax QIVc. The vaccine was administered at 19 weeks of gestation. Temporal relationship is unsuggestive. Although, causality was confounded by advanced maternal age and treatment with concomitant medications, causal role of the suspect vaccine 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.