Age: 35.0
Sex: F
Vaccine: FLUC4
Symptoms: Exposure during pregnancy, Prenatal screening test, Subchorionic haematoma, Subchorionic haemorrhage, Ultrasound antenatal screen normal
Clinical narrative: This is a serious observational study case, initially received from other health professional on 12-Feb-2019, concerning a 35-year-old adult female pregnant subject of body weight: 195 lbs, height: 67 inches and body mass index (BMI): 30.5 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 had no maternal and paternal history of major congenital malformations. The subject had no history of offspring with major congenital malformations. The subject had 3 previous pregnancy in which 2 were live birth and 1 was spontaneous abortion. The subject did not use tobacco, alcohol or illicit drugs during pregnancy. The subject's current conditions included nausea and vomiting. The subject's concomitant medications included Prenatal Vitamins (minerals nos, vitamins nos) for pregnancy and Diclegis (doxylamine succinate, pyridoxine hydrochloride) for nausea and vomiting. The subject's last menstrual period (LMP) date was 12-Aug-2018. The type of pregnancy was singleton. On 24-Sep-2018, the subject underwent haemoglobin electrophoresis, spinal muscular atrophy and fibrosis mutation analysis and no major congenital malformation was noted. On 02-Oct-2018, at gestational age of 7 weeks, the subject was administered Flu Vaccine Cell Subunit QIV NVD (influenza vaccine, subunit influenza virus vaccine polyvalent, batch number: 252664, dose, route of administration, anatomical location and expiry date: not reported) (explicitly coded as vaccine exposure during pregnancy) for an unknown indication. On the same day, after vaccination, the subject experienced Sub-chorionic hematoma/hemorrhage (SCH) for 3 times (reported as pregnancy complication). On 02-Oct-2018, the subject underwent ultrasound and no major congenital malformation was noted. On 30-Nov-2018, the subject underwent Q-natal (pre-natal screening) and no major congenital malformation was noted. The subject's estimated delivery date (EDD) was reported as 08-May-2019. The outcome of the event was not reported.; Reporter's Comments: A 35-year-old pregnant subject with gestational history (2 live birth and 1 spontaneous abortion) experienced sub-chorionic hematoma/hemorrhage for 3 times, on the same day after administration of study vaccine at 07 weeks of gestation (coded to Exposure during pregnancy). Considering the implausible temporal relationship between vaccination and reported event and lack of evidence for a biological mechanism that could cause the event and risk factors (advanced age and gestational history), the event was assessed as not related to the vaccination. The decision to administer a vaccine during pregnancy is related to medical decision making by the mother and her physician and is not related to any property of the medication. The event drug exposure during pregnancy was assessed as not related considering the intended use of the vaccine. The company assessed the case as serious (medically significant).