Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Delivery, Exposure during pregnancy, Placenta praevia
Clinical narrative: Low lying placenta; Vaccine exposure during pregnancy; This is an observational study case initially received from other health professional on 31-Oct-2018, concerning a 30-year-old female, pregnant subject (race and ethnicity: not reported), with unknown body weight, height and body mass index (BMI), enrolled in a prospective observational safety study on pregnancy outcomes in women immunized with Afluria QIV, a seasonal quadrivalent vaccine, during pregnancy.  The subject's obstetrical history noted that the subject had no previous pregnancies. The subject had no history of offspring with major congenital malformation. Also, the subject had no maternal or paternal history with major congenital malformations. The father did not receive any medications prior to conception. The subject did not have a prior history of use of tobacco, alcohol or illicit drugs during pregnancy.  The subject's medical history was not reported. The subject's concomitant medications included Citra Natal Bloom as prenatal vitamin.  The subject's last menstrual period was on 03-Apr-2018 and estimated delivery date (EDD) was reported as 08-Jan-2019. The type of pregnancy was singleton.  On 28-Jun-2018, nuchal translucency and first trimester screen was performed, and no major congenital malformation was found.   On 27-Jul-2018, ultrasound was performed and no major congenital malformation was found.  On 08-Oct-2018, the pregnant subject was administered Flu Vaccine Cell Subunit QIV NVD (batch number: YF40208, expiry date, dose, route of administration, and anatomical location: not reported) for immunization for influenza virus (explicitly considered as vaccine exposure during pregnancy). The pregnancy status of the subject was collected, and pregnancy complications included Rh negative (risk factor) and low-lying placenta.  On 05-Jan-2019, 89 days after vaccination, the subject delivered a full-term male neonate at 39.6 weeks gestation. Delivery method was vaginal. The neonate's birth weight was 3560 grams and no data was provided for head circumference and body length. The appearance, pulse, grimace, activity, and respiration (APGAR) scores were 8 (one minute) and 9 (five minutes). APGAR score was not reported for 10 minutes. There were no pregnancy complications and no major congenital malformation was identified at birth.  The outcome of low lying placenta was not reported.  Significant follow up report received from other health professional on 10-Apr-2019: The delivery date (05-Jan-2019), delivery type (vaginal), birth type (live birth), fetal outcome (normal) weight (3560 grams), APGAR score (8 and 9) and delivery notes were updated in the patient tab. The narrative and case comment were amended accordingly.  Significant follow up received from other health professional on 11-Sep-2019: Laboratory data and relevant tests were updated in the relevant fields. It was provided that no major congenital malformation was identified on birth. Event of Low lying placenta was added. Therefore, the case was upgraded to serious (per medical judgement). Narrative was amended accordingly.  Company comment: A 30-year-old, pregnant female subject was administered suspect vaccine Flu Vaccine Cell Subunit QIV NVD (coded as vaccine exposure during pregnancy). The subject was diagnosed placenta previa on an unknown date after vaccination. The decision to administer a vaccine during pregnancy is related to medical decision making by the subject and her physician and is not related to any property of the medication. The event of vaccine exposure during pregnancy was assessed as not related considering the intended use of the vaccine, while for placenta previa causality is assessed as related.; Reporter's Comments: A 30-year-old, pregnant female subject was administered suspect vaccine Flu Vaccine Cell Subunit QIV NVD (coded as vaccine exposure during pregnancy). The subject was diagnosed placenta previa on an unknown date after vaccination. The decision to administer a vaccine during pregnancy is related to medical decision making by the subject and her physician and is not related to any property of the medication. The event of vaccine exposure during pregnancy was assessed as not related considering the intended use of the vaccine, while for placenta previa causality is assessed as related.