Age: 29.0
Sex: F
Vaccine: UNK
Symptoms: Caesarean section, Exposure during pregnancy, Oligohydramnios, Premature delivery, Ultrasound antenatal screen normal
Clinical narrative: Delivery at 36.9 weeks of gestation; Vaccine exposure during pregnancy; This is an observational study case, initially received from other health professional on 25-Mar-2020, concerning a 29-year-old, female pregnant subject of body weight: 286 lbs, height: 60 inches and body mass index (BMI): 55.8   (Ethnicity: not reported) 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 subject's historical condition included vaginitis/bacterial vaginosis. The subject's current condition included anaemia and obesity.  The subject's past medication included Metrogel (metronidazole) for vaginitis/bacterial vaginosis, while the the subject's concomitant medications included Prenatal vitamins (unspecified vitamins and minerals) for pregnancy and ferrous sulfate for anaemia.  The subject had two previous pregnancies with full term live births, with no birth defects. The subject had no maternal or paternal history with major congenital malformation (MCM).    The subject's last menstrual period (LMP) date was 14-Mar-2019. The type of pregnancy was singleton. The subject's estimated delivery date (EDD) and corrected estimated delivery date (CEDD) were both 19-Dec-2020. The subject did not consume tobacco, alcohol or illicit drugs during pregnancy.  On 25-Jun-2019, the subject underwent cystic fibrosis mutation analysis and spinal muscular atrophy and no MCM was noted.  On 24-Jul-2019, the subject underwent ultrasound scan and panorama, and no MCM was noted.  On 24-Oct-2019, at gestational age of 32 weeks, (calculated per LMP), the subject was administered Flucelvax QIVc (Flu Vaccine Cell Subunit QIV NVD) [influenza vaccine, subunit influenza virus vaccine polyvalent, batch number: 262218, dose, route of administration, anatomical location and expiry date: not reported) (explicitly coded as Vaccine exposure during pregnancy') for an influenza immunisation. On the same day, the subject underwent ultrasound scan and no MCM was noted.  On 13-Nov-2019 and on 26-Nov-2019, the subject underwent ultrasound scan and no MCMs were noted.  Oligohydramnios was noted. On the same day, at gestational age of 36.9 weeks (as reported), the subject gave a live birth to a male neonate via caesarean method of delivery. The birth weight of the neonate was 2552 g. Head circumference was 33 cm and length 45.7 cm. Appearance, pulse, grimace, activity and respiration (APGAR) score at one minute was 8, at five minutes was 9. No data was reported for APGAR score at ten minutes. No MCM was identified at birth.   At the time of initial reporting, the outcome of event premature delivery' was not reported.  The event of premature delivery' was considered serious due to the criterion of medical significance.  The reporter did not provide the causality assessment to Flucelvax QIV.  This case is linked to case 202002629, the corresponding child case.  Company comment: The subject was administered Flucelvax QIV at approximately 32 weeks of gestational age (explicitly considered as vaccine exposure during pregnancy).  Reportedly, at gestational age of 36.9 weeks the subject gave a live birth to a male neonate via caesarean method of delivery. (coded as premature delivery). Causality may have been confounded by medical history of obesity. Considering all the above mentioned, causal relationship between the suspect product and the event of vaccine exposure during pregnancy is assessed as not related based on company's conventions, while for premature delivery is assessed as unlikely related. (defaults to "related" in the safety database for reporting purposes).; Sender's Comments: The subject was administered Flucelvax QIV at approximately 32 weeks of gestational age (explicitly considered as vaccine exposure during pregnancy).  Reportedly, at gestational age of 36.9 weeks the subject gave a live birth to a male neonate via caesarean method of delivery. (coded as premature delivery). Causality may have been confounded by medical history of obesity. Considering all the above mentioned, causal relationship between the suspect product and the event of vaccine exposure during pregnancy is assessed as not related based on company's conventions, while for premature delivery is assessed as unlikely related. (defaults to "related" in the safety database for reporting purposes).