Age: 33.0
Sex: F
Vaccine: FLUC4
Symptoms: Hypertension, Prenatal screening test, Ultrasound antenatal screen abnormal
Clinical narrative: This is a serious observational study case, initially received from other health professional on 15-Mar-2019, concerning a 33-year-old, adult female pregnant subject of body weight: 98 lbs, height: 57 inches and body mass index (BMI): 21.2 enrolled in a prospective observational safety study. The subject had 4 previous pregnancy reported with 1 full-term live birth, 1 preterm live birth and 2 spontaneous abortions. There was no history of maternal or paternal congenital malformation. The subject had not used tobacco, alcohol or illicit drugs during pregnancy. The subject's historical condition included vaginitis and the historical drug included Metrogel for vaginitis. The subject's current condition included nausea. The subject's concomitant medications included Prenatal vitamins (minerals nos, vitamins nos) indicated for pregnancy and promethazine for nausea. The subject's last menstrual period (LMP) date was 26-Jun-2018 and the type of pregnancy was singleton. On 09-Aug-2018, the subject underwent spinal muscular atrophy and cystic fibrosis mutation analysis and the results was normal as no major congenital malformation was noted. On 15-Aug-2018, the subject underwent an ultrasound and the result was normal as no major congenital malformation was noted. On 18-Oct-2018, at gestational age of 16 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, the subject underwent ultrasound scan and congenital malformation was noted (identified: club feet). On the same day quadruple screen was also performed and no major congenital malformation was noted. On 09-Nov-2018, 22 days after vaccination, the subject developed hypertension and was treated with labetalol (200 mg, bid, oral, ongoing). On 14-Dec-2018, 1 month 26 days after vaccination, the subject developed anaemia and was treated with ferrous sulfate (325 mg, bid, oral, ongoing). On 10-Jan-2019, ultrasound scan was performed, and congenital malformation was noted (identified: club feet). On 04-Feb-2019, 11-Feb-2019 and 18-Feb-2019, ultrasound scan was performed, and no major congenital malformation was noted.  The pregnancy complications were asymmetrical growth, mild cardiomegaly and myocardial hypertrophy in the foetus. On an unspecified date, the subject gave live birth to an infant of an unspecified gender. The subject had not recovered from the events. The estimated delivery date was 01-Apr-2019. This case was linked to case: 201902747 (baby case).; Reporter's Comments: A 33-year-old pregnant patient with history (vaginitis treated with Metrogel) and gestational history (4 previous pregnancy reported with 1 full-term live birth, 1 preterm live birth and 2 spontaneous abortions) experienced hypertension, 22 days after administration of study vaccine and anaemia one month 26 days post vaccination at 16 weeks of gestation (coded to Exposure during pregnancy).  Considering the clinical course of events and lack of evidence suggesting any causal role of vaccine, the underlying pregnancy associated with significant gestational history appears as a more possible explanation rather than study vaccine and events (hypertension and anaemia) were assessed as not related to study vaccine. 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 reported event of ultrasound foetal abnormal as not related due to implausible temporal relationship between vaccination and reported investigation (reported as on the same day) and biological implausibility. The gestational history should be considered as confounding factor in this case. The company assessed the event hypertension as serious (medically significant).