Age: 33.0
Sex: F
Vaccine: UNK
Symptoms: Constipation, Delivery, Exposure during pregnancy, Placenta praevia, Subchorionic haemorrhage
Clinical narrative: Placenta previa; Subchorionic haemorrhage; Constipation; Vaccine exposure during pregnancy; This is a serious observational study case initially received on 31-May-2019, concerning a 33-year-old adult female, pregnant subject of body weight 109 lbs, height 61 inches and body mass index (BMI) 20.6, enrolled in a study.  The subject's obstetrical history noted that the subject had 11 previous pregnancies with 10 pregnancies of spontaneous abortion and 1 pregnancy of full-term live birth. No birth defects were reported. 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 subject was a cigarette smoker (used 1 pack of cigarette per day) and marijuana user. The subject's current conditions included hyperemesis since 24-Sep-2018 and adjustment anxiety disorder since 01-Oct-2018. The subject's concomitant medications included promethazine, prenatal vitamins (minerals nos, vitamins nos) and Zoloft (sertraline hydrochloride).  The subject's last menstrual period (LMP) date was 18-Jul-2018. The type of pregnancy was singleton.   On 08-Oct-2018, at approximately 11 weeks gestation, the subject was administered Flu Vaccine Cell Subunit QIV NVD (batch number: 252664, 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 after vaccination, the subject was diagnosed with subchorionic haemorrhage and placenta previa with ultrasound investigation. On the same day, the subject started treatment with Colace (docusate sodium, dose: 100 mg) three times a day (tid) as needed (prn) orally for constipation. The subject underwent ultrasound screening on the same day for which results were not reported. On 22-Oct-2018, the subject underwent ultrasound screening and no major congenital malformations were noted.  The outcome of the events was not reported.  At approximately 37.5 weeks gestation, the subject gave a live birth to a female neonate vaginally. The characteristics of the neonate included birth weight: 2722 grams, head circumference: 31.8 cm, length: 48.3 cm and appearance, pulse, grimace, activity, and respiration (APGAR) scores were 8 at one minute and 9 at five minutes. No major congenital malformations (MCMs) were identified at birth and no pregnancy complications were noted.    The subject's estimated date of delivery (EDD) was reported as 24-Apr-2019.; Reporter's Comments: A 33-year-old pregnant female with medical history of multiple spontaneous abortions, adjusted anxiety disorder, cigarette smoking and marijuana usage, was diagnosed with placenta previa, subchorionic haemorrhage and constipation, on the same day of vaccination with Flu Vaccine Cell Subunit QIV NVD. Considering the implausible temporal relationship, possible alternate aetiologies like medical conditions/ history, the causal role of suspect vaccine can be ruled out. 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 of exposure during pregnancy was assessed as not related considering the intended use of the vaccine. The company assessed the events 'placenta previa and subchorionic haemorrhage' as serious (medically significant).