Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy, Haemorrhoids, Subchorionic haematoma, Ultrasound antenatal screen normal
Clinical narrative: Vaccine exposure during pregnancy; Subchorionic hematoma; Hemorrhoids; This is an observational pregnancy study case, initially received from other health professional on 20-Dec-2019, concerning a 35-year-old, adult, female pregnant subject of body weight: 156.6 lbs, height: 64.8 inches and body mass index (BMI): 26.2, enrolled in, a prospective observational study.  The subject's current medical conditions included migraines, body mass index high (BMI: 26.2) and pregnancy with advanced maternal age.   The subject's concomitant medications included Butalbital (butalbital, caffeine, paracetamol) for migraines, vitamins as OB (obstetrical) supplement and TDAP (diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid) as a vaccine.   The subject's obstetrical history included two previous pregnancies with two live births. The subject did not have a history of offspring with major congenital malformation (MCM). Also, the subject had no maternal or paternal history with major congenital malformations.   The subject's last menstrual period (LMP) date was 18-Apr-2019, estimated delivery date (EDD) and corrected estimated date of delivery (CEDD) were reported as 23-Jan-2020. The subject did not use tobacco, alcohol or illicit drugs during pregnancy. The type of pregnancy was singleton. The subject's partner was 43 years old.  On 26-Jun-2019, the subject underwent ultrasound (initial) and no MCM was noted.   On 09-Sep-2019, at 20 weeks of gestation, the subject was administered Flu Vaccine Cell Subunit QIV NVD (influenza vaccine, subunit influenza virus vaccine polyvalent; batch number: 261200, dose: 0.5 ml, route of administration, expiry date and anatomical location: not reported] (explicitly coded as Vaccine exposure during pregnancy') for influenza immunisation.   On the same day, the subject underwent ultrasound  anatomy and no MCM was noted.   On unspecified dates in 2019, unknown amount of time after vaccination, the subject developed subchorionic hematoma and haemorrhoids.    On 02-Dec-2019 subject started treatment with topical, hydrocortisone, at dose 2.5 percent administered once daily for haemorrhoids.  At the time of initial report, the subject did not recover from the events.      The event of subchorionic hematoma' was assessed as serious due to the criterion of medical significance (IME event).   The causality assessment was not provided.  Company comment: The subject experienced subchorionic haematoma and haemorrhoids associated with administration of Afluria QIV. The patient was administered vaccine at approximately 20 weeks of gestation and developed mentioned events on unspecified dates in 2019. Chronology needs more clarification. For the event of haemorrhoids, causality was highly confounded by pregnant state. Medical history of body mass index high and advanced maternal age may have contributed to development of the events as well. Causal role of the suspect vaccine cannot be totally excluded and is assessed as unlikely related for the event of subchorionic haematoma. Vaccine exposure during pregnancy and haemorrhoids are assessed as not related to the suspect vaccine.; Sender's Comments: The subject experienced subchorionic haematoma and haemorrhoids associated with administration of Afluria QIV. The patient was administered vaccine at approximately 20 weeks of gestation and developed mentioned events on unspecified dates in 2019. Chronology needs more clarification. For the event of haemorrhoids, causality was highly confounded by pregnant state. Medical history of body mass index high and advanced maternal age may have contributed to development of the events as well. Causal role of the suspect vaccine cannot be totally excluded and is assessed as unlikely related for the event of subchorionic haematoma. Vaccine exposure during pregnancy and haemorrhoids are assessed as not related to the suspect vaccine.