Age: 27.0
Sex: F
Vaccine: FLUX
Symptoms: Exposure during pregnancy, Premature delivery, Premature rupture of membranes, Prenatal screening test, Ultrasound antenatal screen normal
Clinical narrative: Premature rupture of membranes; Delivery at 34 weeks of gestation; Vaccine exposure during pregnancy; This is an observational study case from, initially received from other health professional on 06-May-2020, concerning a 27-year-old, pregnant female subject (Race:, Ethnicity:) (Subject ID:), of body weight: 161.2 lbs, height: 67 inches and body mass index (BMI): 25.2, enrolled in, a prospective observational safety study.  The subject's medical history included anxiety and high BMI.  The subject's concomitant medications included escitalopram for anxiety.  The subject's obstetrical history noted that the subject had two previous full-term live births. The subject had no history of offspring with major congenital malformation (MCM). The subject had no relevant maternal or paternal medical history. The subject did not use tobacco, illicit drugs or alcohol during pregnancy.  The subject's last menstrual period (LMP) date was 26-Aug-2019. The subject's estimated delivery date (EDD) was 31-May-2020 and corrected estimated date of delivery (CEDD) was 21-May-2020. The type of pregnancy was singleton.   On 28-Oct-2019, at approximately 9 weeks of gestation (calculated per LMP), the subject was administered Flucelvax QIVc (Flu Vaccine Cell Subunit QIV NVD) [influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, batch number: 261207, anatomical location, route of administration and expiration date: not reported] (explicitly coded as Vaccine exposure during pregnancy') for influenza immunisation.   On the same day, the subject underwent ultrasound and no MCM was noted.  On 21-Nov-2019, the subject underwent prenatal labs and no MCM was noted.  On 16-Dec-2019, the subject underwent ultrasound and no MCM was noted.  On an unspecified date, an unknown amount of time after vaccination, the subject experienced premature rupture of membranes.  On 09-Apr-2020, at gestational age of 34 weeks (as reported), the subject vaginally delivered premature live birth female neonate. The neonate's birth weight was 2450 g, while head circumference and length were not provided. The appearance, pulse, grimace, activity and respiration (APGAR) scores were 8 (one minute), 9 (five minutes), and APGAR score for ten minutes was not reported. There were no major MCMs identified at birth.  At the time of this report, the outcome of the events preterm delivery' and 'preterm premature rupture of membranes' was not reported.  The events of 'preterm delivery' and 'preterm premature rupture of membranes' were assessed as serious due to criteria of medical significance, per company.   The reporter did not provide causality assessment.  This case is linked to the case 202003313, the corresponding baby case.  Company comment: A 27-year-old pregnant female subject developed premature rupture of membranes and premature delivery after vaccination with the suspect product Flucelvax QIVc (Flu Vaccine Cell Subunit QIV NVD) for influenza immunisation. Reportedly, on an unspecified date an unknown amount of time after vaccination, the subject experienced premature rupture of membranes. Chronology needs more clarification. There were no major MCMs identified at birth. The subject's medical history included anxiety and high BMI. The subject's concomitant medications included escitalopram for anxiety. The subject's obstetrical history noted that the subject had two previous full-term live births. The subject had no history of offspring with major congenital malformation (MCM). The subject had no relevant maternal or paternal medical history. Reported anxiety may have contributed in developing premature rupture which subsequently resulted in premature birth. With information presented, causality is assessed as unlikely related for premature rupture of membranes and unrelated for premature delivery. 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 27-year-old pregnant female subject developed premature rupture of membranes and premature delivery after vaccination with the suspect product Flucelvax QIVc (Flu Vaccine Cell Subunit QIV NVD) for influenza immunisation. Reportedly, on an unspecified date an unknown amount of time after vaccination, the subject experienced premature rupture of membranes. Chronology needs more clarification. There were no major MCMs identified at birth. The subject's medical history included anxiety and high BMI. The subject's concomitant medications included escitalopram for anxiety. The subject's obstetrical history noted that the subject had two previous full-term live births. The subject had no history of offspring with major congenital malformation (MCM). The subject had no relevant maternal or paternal medical history. Reported anxiety may have contributed in developing premature rupture which subsequently resulted in premature birth. With information presented, causality is assessed as unlikely related for premature rupture of membranes and unrelated for premature delivery. Exposure during pregnancy is assessed as unrelated per company conventions. (''unlikely related'' defaults to "related" in the safety database for reporting purposes)