Age: 23.0
Sex: F
Vaccine: UNK
Symptoms: Anaemia, Delivery, Exposure during pregnancy, Subchorionic haematoma, Ultrasound antenatal screen normal
Clinical narrative: Subchorionic hematoma; Anemia; Vaccine exposure during pregnancy; This is an observational study case, initially received from other health professional on 27-Nov-2019, concerning a 23-year-old, female pregnant subject of body weight: 114 lbs, height: 65 inches and body mass index (BMI): 19 enrolled in a prospective observational safety study.  The subject's current condition was not provided. The subject's concomitant medication included Prenatal vitamin (mineral nos, vitamin nos) for pregnancy.  The subject's obstetrical history noted that subject had two previous pregnancies with two full term live births. The subject had no history of offspring with major congenital malformation (MCM) and no relevant maternal and paternal medical history. The subject did not use tobacco, alcohol or illicit drugs during pregnancy.  The subject's last menstrual period (LMP) date was 22-Jan-2019. The subject's estimated delivery date (EDD) and corrected estimated date of delivery (CEDD) were 29-Oct-2019. The type of pregnancy was singleton. The father was 24-year old.  On 12-Mar-2019, the subject underwent ultrasound and no MCM was noted.  On 16-May, the subject underwent ultrasound and mother's serum alpha fetoprotein (MSAFP) / serum markers and no MCM was noted.  On 26-May-2019, the subject underwent ultrasound and no MCM was noted.  On 03-Jun-2019, the subject underwent spinal muscular atrophy and cystic fibrosis mutation analysis and no MCM was noted.  On 19-Sep-2019, the subject underwent ultrasound and no MCM was noted.  On 04-Oct-2019, at gestational age at 36 weeks, the subject was administered with Flu Vaccine Cell Subunit QIV NVD [influenza vaccine, subunit influenza virus vaccine polyvalent, batch number: 261218, dose: 0.5 ml, 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 07-Oct-2019, three days after vaccination, the patient developed anaemia and was treated with ferrous sulfate, 325 mg, twice a day (BID), orally (from 07-Oct-2019 to 22-Oct-2019).  On an unspecified date, after an unknown amount of time after vaccination, the patient developed subchorionic hematoma, but the details were not specified.  At gestational age of 39 weeks, the mother vaginally delivered live birth, female neonate. The neonate's birth weight was 3175 g, her head circumference was 34.3 cm and length was 48.9 cm. The appearance, pulse, grimace, activity, and respiration (APGAR) scores were 8 (one minute) and 9 (five minutes). There was no major congenital malformation identified at birth. At the time of delivery, no pregnancy complications were reported.  The outcome of the event anaemia was recovered, on 22-Oct-2019.  At the time of this report, the outcome of event subchorionic hematoma was not reported.  The event of subchorionic hematoma was assessed as serious due to criterion of medical significance per company.  The reporter did not provide causality assessment to Flucelvax QIV.  This case is linked to baby case 201907053.  Company Comment: The subject experienced subchorionic haematoma and anaemia after vaccination with the suspect product Flu Vaccine Cell Subunit QIV NVD. Reportedly, vaccination occurred during pregnancy at 36 weeks of gestation. Chronology is plausible. Pregnant state may provide alternative aetiology for the events. Vaccine exposure during pregnancy is assessed as not related per company's conventions. Considering all the above mentioned, causality between suspect product and the events subchorionic haematoma and anaemia is assessed as unlikely related.; Sender's Comments: The subject experienced subchorionic haematoma and anaemia after vaccination with the suspect product Flu Vaccine Cell Subunit QIV NVD. Reportedly, vaccination occurred during pregnancy at 36 weeks of gestation. Chronology is plausible. Pregnant state may provide alternative aetiology for the events. Vaccine exposure during pregnancy is assessed as not related per company's conventions. Considering all the above mentioned, causality between suspect product and the events subchorionic haematoma and anaemia is assessed as unlikely related.