Sex: M
Vaccine: UNK
Symptoms: Apgar score normal, Foetal exposure during pregnancy, Intensive care, Low birth weight baby, Premature baby
Clinical narrative: Born at 33.6 weeks of gestation; Foetal exposure during pregnancy; Low birth weight (2240 grams); This is an observational study case, initially received from other health professional on 25-Mar-2020, concerning a neonate male subject, whose mother was a 37-year-old female, of body weight 132 lbs, height 65 inches and body mass index (BMI) 22, 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 current condition included advanced maternal age.    The subject's mother's concomitant medications included multivitamin (unspecified vitamins) as a vitamin and TDAP (diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid) as a vaccine.     The mother's obstetrical history included one previous pregnancy with full term live birth. The subject's father had a history of aortic valve defect which was surgically repaired.   The mother's last menstrual period (LMP) date was 09-Jul-2019 and type of pregnancy was singleton. The estimated delivery date (EDD) and corrected estimated date of delivery (CEDD) were reported as 14-Apr-2020. The mother did not use tobacco, alcohol or illicit drugs during pregnancy. The subject's father was 35-year-old.   On 17-Sep-2019, at 10 weeks of gestation (calculated per LMP), the mother was administered Flucelvax QIV (Flu Vaccine Cell Subunit QIV NVD) [influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, batch number: 216200, route of administration, anatomical location and expiration date: not reported] (explicitly coded as Foetal exposure during pregnancy') for an influenza immunization. On the same day, the subject's mother underwent Maternit 21 and no MCM was noted.   On 15-Oct-2019, the mother underwent ultrasound scan and no MCM was noted.   On 30-Oct-2019, the mother underwent maternal serum alpha-fetoprotein screening (MSAFP) / serum markers and no MCM was noted.  On 20-Nov-2019, the mother underwent anatomy ultrasound and no MCM was noted.   At 33.6 weeks of gestation (as reported), the subject's mother gave a live birth to a male neonate via vaginal method of delivery. Pregnancy complications noted at delivery were preterm premature rupture of membranes and progression of labor. The neonate's birth weight was 2240 grams, head circumference and body length were not reported. The appearance, pulse, grimace, activity and respiration (APGAR) scores were 8 (at one minute) and 9 (at five minutes). APGAR score was not reported for 10 minutes. There was no MCM identified at birth.   On an unknown date in 2020, the neonate was admitted to neonatal intensive care unit (NICU) for prematurity.   At the time of this report, the outcome of events low birth weight baby' and premature birth' was not reported.  The of events premature birth' was assessed as serious due to criterion of hospitalisation and medical significance, while the low birth weight baby' was assessed as serious due to criterion of medical significance.  The reporter did not provide causality assessment to Flucelvax QIV.  This case is linked to 202002618 (the corresponding mother's case).  Company comment: A neonate male subject, whose mother was a 37-year-old female, developed premature baby and low birth weight baby after his mother was vaccinated with the suspect product Flucelvax QIV for an influenza immunization. Reportedly, at 33.6 weeks of gestation the subject was born. Chronology seems compatible. The mother's current condition included advanced maternal age.  The subject's mother's concomitant medications included multivitamin (unspecified vitamins) as a vitamin and TDAP (diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid) as a vaccine. With information presented, causality is assessed as unlikely related for both events considering advanced age of the mother and concomitant drugs she received during pregnancy. Foetal exposure during pregnancy is assessed as unrelated per company conventions. (''unlikely related'' defaults to "related" in the safety database for reporting purposes); Sender's Comments: A neonate male subject, whose mother was a 37-year-old female, developed premature baby and low birth weight baby after his mother was vaccinated with the suspect product Flucelvax QIV for an influenza immunization. Reportedly, at 33.6 weeks of gestation the subject was born. Chronology seems compatible. The mother's current condition included advanced maternal age.  The subject's mother's concomitant medications included multivitamin (unspecified vitamins) as a vitamin and TDAP (diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid) as a vaccine. With information presented, causality is assessed as unlikely related for both events considering advanced age of the mother and concomitant drugs she received during pregnancy. Foetal exposure during pregnancy is assessed as unrelated per company conventions. (''unlikely related'' defaults to "related" in the safety database for reporting purposes)