Sex: M
Vaccine: UNK
Symptoms: Apgar score normal, Caesarean section, Foetal exposure during pregnancy, Low birth weight baby, Premature baby
Clinical narrative: Foetal exposure during pregnancy; Low birth weight baby; Premature birth; This is an observational study case, initially received from other health professional on 21-Nov-2019, concerning a male infant subject, whose mother was a 29-year-old female of body weight 166 lbs, height 69 inches and body mass index (BMI) 24.5, enrolled in a prospective observational safety study. The subject's father was 31-year-old.  The mother's historical vaccine included T Dap. The mother's current condition included anxiety, history of hypertension and Crohn's disease. Concomitant medication included sertraline for anxiety and prenatal vitamins (vitamin not specific (nos) and minetals nos) for OB care.  The mother's obstetrical history noted that the mother had no previous pregnancies. The subject's mother had no maternal or paternal history with major congenital malformations (MCMs). The mother did not use tobacco, alcohol or illicit drugs during pregnancy.   The mother's last menstrual period (LMP) was on 02-Feb-2019, type of pregnancy was singleton and complicated with preterm premature rupture of membranes (PPROM). The estimated date of delivery (EDD) and corrected estimated date of delivery (CEDD) was reported as 09-Nov-2019.  On 03-May-2019, the subject's mother underwent initial ultrasound and no MCM was noted.  On 10-May-2019, the subject's mother underwent nuchal translucency and first trimester screen and no MCM was noted.   On 28-May-2019, the subject's mother underwent second trimester screen alpha-fetoprotein (AFP) and no MCM was noted.   On 18-Jun-2019, the subject's mother underwent anatomy ultrasound and no MCM was noted.  On 25-Sep-2019, at approximately 33 weeks of gestation, the mother was administered Flu Vaccine Cell Subunit QIV NVD (Flucelvax QIV) [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 immunization.  On 12-Oct-2019, at gestational age of 36 weeks, the subject had delivered male neonate through caesarean delivery. The birth weight of the neonate was 2495 grams, head circumference and length: not reported. Appearance, pulse, grimace, activity and respiration (APGAR) score at one minute was 8, at five minutes was 9 and no data was reported for APGAR score at ten minutes. No major congenital malformation was identified at birth.  The reporter did not provide causality assessment to Flucelvax QIV.  Events low birth weight baby and premature birth were considered serious due to the criterion of medical significance.   This case is linked to the case 201906255 (the corresponding mother case).  Company Comment: Company Comment: The male infant subject was delivered as low birth weight baby and premature baby after foetal exposure during pregnancy (at approximately 33 weeks of gestation) with the suspect product, Flucelvax QIV. Chronology is plausible. Mother's medical history of hypertension and Crohn's disease may have contributed to development of the events in significant way. Causality was also confounded with concomitant medication, sertraline. Foetal exposure during pregnancy is assessed as not related per company's conventions. For the events low birth weight baby and premature baby, causal role of the suspect product cannot be totally excluded and is assessed as unlikely related.; Sender's Comments: Company Comment: The male infant subject was delivered as low birth weight baby and premature baby after foetal exposure during pregnancy (at approximately 33 weeks of gestation) with the suspect product, Flucelvax QIV. Chronology is plausible. Mother's medical history of hypertension and Crohn's disease may have contributed to development of the events in significant way. Causality was also confounded with concomitant medication, sertraline. Foetal exposure during pregnancy is assessed as not related per company's conventions. For the events low birth weight baby and premature baby, causal role of the suspect product cannot be totally excluded and is assessed as unlikely related.