Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Prolonged rupture of membranes, Smear cervix normal, Ultrasound antenatal screen normal
Clinical narrative: Prolonged rupture of membranes; Failure to progress; Fetal intolerance/fetal intolerance of labor; Vaccine exposure during pregnancy; This is a serious observational study case, initially received on 07-Nov-2018, concerning a 29-year-old, adult pregnant female subject ,of body mass index (BMI): 47, weight: 263.8 lbs and height: 62.8 inches, enrolled in a prospective observational safety study on pregnancy outcomes in women immunized with Afluria QIV, a seasonal quadrivalent vaccine, during pregnancy.  The subject had no maternal history with major congenital malformations. The subject had paternal history of major congenital malformation which included extra digits (toes or fingers) in the father of the baby's family. The total number of previous pregnancies were reported as 3 and the subject had elective abortions in all the previous pregnancies.  The subject's current conditions included asthma, depression and anxiety (since an unspecified date) which began prior conception. The concomitant medications included Prenatal vitamins with DHA (ascorbic acid, betacarotene, calcium carbonate, colecalciferol, docosahexaenoic acid, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, riboflavin, thiamine mononitrate, tocopheryl acetate, vitamin b12 nos, zinc oxide) for pregnancy and albuterol sulfate for asthma.  The subject's last menstrual period (LMP) date was 03-Sep-2018. The type of pregnancy was singleton. The subject did not consume tobacco, alcohol or illicit drugs during pregnancy.  On 29-Oct-2018, the subject underwent ultrasound, and no major congenital malformation was noted.  On 05-Nov-2018, approximately, at gestational age of 9 weeks, the pregnant subject was administered Flu Vaccine Egg Split QIV CSL (influenza vaccine, dose, route of administration, anatomical location, batch number and expiry date: not reported) (explicitly coded as vaccine exposure during pregnancy) for an unknown indication.  On the same day, the subject underwent prenatal bloodwork and no major congenital malformation was noted. On 15-Nov-2018, the subject had Papanicolaou test (PAP) smear test and Neisseria gonorrhoeae (GC) and chlamydia cultures were done with no major congenital malformation noted. On 26-Nov-2018, the subject underwent first trimester screen and no major congenital malformation was noted.  On 21-Jan-2019, the subject underwent ultrasound, and no major congenital malformation was noted.  The subject's pregnancy complications included spontaneous rupture of membranes, (SROM) induction of labor, prolonged rupture of membrane (ROM), foetal intolerance and failure to progress was noted.   On 30-May-2019, at gestational age of 38.4 weeks, the subject had delivered male neonate through caesarean method of delivery. The birth weight of the neonate was 2790 g, head circumference was 35.5 cm and length was 52 cm. Appearance, pulse, grimace, activity and respiration (APGAR) score at one minute was 1, at five minutes was 8 and no data was reported for APGAR score at ten minutes. No data was reported for major congenital malformation identified at birth.  The subject's estimated date of delivery (EDD) was reported as 10-Jun-2019.  This case has been linked to ARGUS case ID 201904064 (baby case).  Follow up received from the health care professional on 30-Jan-2019: The subject's race, height (62.8 inches), weight (263.8 lbs) were added in patient tab. The subject's prenatal tests (ultrasound, prenatal blood-work, PAP smear, cultures GC and chlamydia, first trimester screen) were added in relevant test of patient tab.  The narrative was amended accordingly.  Non-significant follow-up reported by other health professional on 25-Feb-2019: It was reported that the current conditions: asthma, depression and anxiety and the concomitant medications: prenatal multivitamin DHA and albuterol sulphate began started prior conception. No changes were made in the narrative.  Case re-opened for completion of full data entry: 25-Feb-2019.  Follow-up received from other health professional on 27-Jun-2019: Family history [extra digits (toes and fingers)] was added in the patient tab. Subject's delivery information was captured in the pregnancy information in the patient tab. Lab tests were added in the field in the patient tab. Events Prolonged rupture of membranes, prolonged labor, fetal distress and labor induction was added in the events tab. The case was upgraded from non-serious to serious case. Narrative and case comment was amended accordingly.; Reporter's Comments: A 29-year-old pregnant female subject experienced prolonged rupture of membrane, prolonged labour, fetal intolerance and delivered male neonate through caesarean method of delivery (at gestational age of 38.4 weeks), more than 6 months after receipt of Flu vaccine egg split QIV (considered as vaccine exposure during pregnancy). Considering the implausible temporal relationship between vaccination and reported events (prolonged rupture of membrane, prolonged labour and foetal intolerance), the causality assessed as not related to study vaccine. The event vaccine exposure during pregnancy assessed as not related considering the intended use of vaccine. The company assessed the case as serious (medically significant).