Sex: F
Vaccine: FLUX
Symptoms: Apgar score abnormal, Caesarean section, Foetal exposure during pregnancy, Head circumference abnormal, Intensive care
Clinical narrative: Preterm birth at gestational age of 33.3 weeks/infant reported as nonvigorous/preterm; Funic presentation; APGAR score of 5 at one minute; Low birth weight of 1701 g; Intrauterine growth restriction (IUGR)/Fetal growth restriction; Head circumference (HC)/abdominal circumference ratio small for dates; Head circumference (HC)/abdominal circumference ratio small for dates; Vaccine foetal exposure during pregnancy; This is an observational study case from, initially received from other health professional on 25-Mar-2020, concerning a female foetal subject, whose mother was 23-year-old, pregnant, female subject of body weight: 250 lbs, height: 67.2 inches and body mass index (BMI): 38.9 enrolled in, a prospective observational safety study.  The subject's mother's current conditions included severely obesity, sinus infection, amenorrhea and nausea.  The subject's mother's concomitant medications included cefdinir for sinus infection, Prenatal vitamins (unspecified vitamins and minerals) as obstetrics (OB) supplement, Tdap (diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid) as vaccine and Diclegis (doxylamine succinate, pyridoxine hydrochloride) for nausea.  The subject's mother's obstetrical history included two previous pregnancies with one full term live birth and one spontaneous abortion. The subject's mother had no history of offspring with major congenital malformation (MCM) nor relevant maternal and paternal history. The subject's mother did not consume tobacco and alcohol during pregnancy, but consumed cannabis.  The mother's last menstrual period (LMP) date was not provided. The mother's estimated date of delivery (EDD) and corrected estimated date of delivery (CEDD) were both 20-Apr-2020. The type of pregnancy was singleton. The subject's father's age was 27.  On 08-Oct-2019, the subject's mother underwent first trimester screen and nuchal translucency. No MCM was noted.  On the same day, the subject's mother was administered Flucelvax QIV (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 expiry date: not reported] (explicitly coded as 'Foetal exposure during pregnancy') for influenza immunization.   On an unknown date, an unknown amount of time after vaccination, the subject's mother developed trichomoniasis which was treated with metronidazole.  On 05-Nov-2019, the subject's mother underwent second trimester screen and maternal serum alpha-fetoprotein (MSAFP/serum markers). No MCM was noted.  On 26-Nov-2019, the subject's mother underwent anatomy ultrasound, but scan was incomplete per reporter. It was unknown whether any MCM was noted.  On 23-Dec-2019, the subject's mother underwent follow up ultrasound that showed that head circumference to abdominal circumference ration was small for dates. No MCM was noted.  On 17-Jan-2020, the subject's mother underwent follow up growth ultrasound and intrauterine growth restriction (IUGR) was noted. No MCM was noted.  On 24-Jan-2020, the subject's mother underwent follow up growth ultrasound and IUGR was noted. No MCM was noted.  On 27-Jan-2020, the subject's mother started treatment with betamethasone acetate for foetal growth restriction at a dose of 6 mg per ml times 2 ml every day administered intramuscularly.  On 28-Jan-2020, the treatment for foetal growth restriction was discontinued.  On 31-Jan-2020, the subject's mother underwent follow up growth ultrasound and IUGR was noted. No MCM was noted.  On 03-Feb-2020, the subject's mother developed gestational diabetes mellitus.  On 07-Feb-2020, the subject's mother underwent follow up biophysical profile ultrasound and IUGR was noted. No MCM was noted.  On 14-Feb-2020, the subject's mother underwent ultrasound for amniotic fluid volume, biophysical profile and ultrasound age dopplers. IUGR was noted. No MCM was noted.  On 26-Feb-2019, the subject's mother underwent ultrasound for growth, biophysical profile and umbilical artery doppler. IUGR was noted. No MCM was noted.  On an unknown date, the funic presentation of foetus in uterus was noted.  On unspecified date, the cervical dilation was reported as subject's mother's pregnancy complication. On 04-Mar-2020, at gestational age of 33.3 weeks as reported, the subject's mother delivered a female neonate by caesarean method. The birth weight of subject was 1701 g. No data for head circumference and length were provided.  Appearance, pulse, grimace, activity and respiration (APGAR) score at one minute was 5 and at five minutes was 8 and APGAR score for 10 minutes was not provided., and on the same day the outcome of 'APGAR score low' was resolved. It was reported that subject's mother's labour was complicated with progression of labour. The subject was sent to neonatal intensive care unit (NICU) since she was non-vigorous/preterm baby.  At the time of initial reporting, the outcome of 'premature baby', ' head circumference abnormal ', ' waist circumference decreased',' fetal growth restriction', 'umbilical cord prolapse' and ' low birth weight baby was not reported.  Per company, the events of 'premature baby', 'APGAR score low', ' head circumference abnormal ', ' waist circumference decreased',' fetal growth restriction', 'umbilical cord prolapse' and ' low birth weight baby' were considered serious due to the criterion of medical significance. The event of premature baby' had additional criterion of hospitalization.  This reporter did not provide the causality assessment to Flucelvax QIV.  This case is linked to case 201907301 (the corresponding mother case).  Company comment: A female foetal subject, whose mother was 23-year-old pregnant female, developed premature baby, head circumference abnormal, waist circumference decreased, foetal growth restriction, umbilical cord prolapse, Apgar score low and low birth weight baby after her mother was vaccinated with the suspect product Flucelvax QIV for influenza immunization. Two and a half months later ultrasound showed that head circumference to abdominal circumference ration was small for dates. No MCM was noted.  three and a half months after vaccination mother underwent follow up growth ultrasound and IUGR was noted. No MCM was noted. After that the events started to emerge one by one. At gestational age of 33.3 weeks as reported, the subject's mother delivered a female neonate by caesarean method. Chronology seems plausible. The subject's mother's obstetrical history included two previous pregnancies with one full term live birth and one spontaneous abortion. The subject's mother's current conditions included severely obesity, sinus infection, amenorrhea and nausea. The subject's mother's concomitant medications included cefdinir for sinus infection, Prenatal vitamins (unspecified vitamins and minerals) as obstetrics (OB) supplement, Tdap (diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid) as vaccine and Diclegis (doxylamine succinate, pyridoxine hydrochloride) for nausea. With information presented, causality is assessed as unlikely related for all events considering medical history of the mother and concomitant drugs reported. Causal role cannot be entirely excluded due to temporal relationship. 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 female foetal subject, whose mother was 23-year-old pregnant female, developed premature baby, head circumference abnormal, waist circumference decreased, foetal growth restriction, umbilical cord prolapse, Apgar score low and low birth weight baby after her mother was vaccinated with the suspect product Flucelvax QIV for influenza immunization. Two and a half months later ultrasound showed that head circumference to abdominal circumference ration was small for dates. No MCM was noted.  three and a half months after vaccination mother underwent follow up growth ultrasound and IUGR was noted. No MCM was noted. After that the events started to emerge one by one. At gestational age of 33.3 weeks as reported, the subject's mother delivered a female neonate by caesarean method. Chronology seems plausible. The subject's mother's obstetrical history included two previous pregnancies with one full term live birth and one spontaneous abortion. The subject's mother's current conditions included severely obesity, sinus infection, amenorrhea and nausea. The subject's mother's concomitant medications included cefdinir for sinus infection, Prenatal vitamins (unspecified vitamins and minerals) as obstetrics (OB) supplement, Tdap (diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid) as vaccine and Diclegis (doxylamine succinate, pyridoxine hydrochloride) for nausea. With information presented, causality is assessed as unlikely related for all events considering medical history of the mother and concomitant drugs reported. Causal role cannot be entirely excluded due to temporal relationship. Foetal exposure during pregnancy is assessed as unrelated per company conventions. (''unlikely related'' defaults to "related" in the safety database for reporting purposes)