Age: 27.0
Sex: F
Vaccine: UNK
Symptoms: Anaemia, Exposure during pregnancy, Pre-eclampsia, Premature baby
Clinical narrative: Pre-eclampsia; Preterm birth/Gestational age at outcome (weeks): 35.3 weeks/Premature delivery; Anemia; Vaccine exposure during pregnancy; This is a serious observational study case, initially received from other health professional on 16-Jul-2019, concerning a 27-year-old, adult female pregnant subject of body weight: 198 lbs, height: 66.5 inches and body mass index (BMI): 31.5 enrolled in a prospective observational safety study.  The subject had no previous pregnancies reported. On an unknown date, the subject's family history of major congenital malformation was collected, and the subject had no maternal/paternal history with major congenital malformations. The subject's current condition included anxiety. The subject's concomitant medications included Prenatal vitamins (mineral NOS, vitamin NOS) for pregnancy and Inderal (propranolol hydrochloride) for anxiety.  The subject's last menstrual period (LMP) date was 25-Aug-2018. The type of pregnancy was singleton. The subject did not consume tobacco and illicit-drugs during pregnancy but did consume alcohol (less than 2 drinks per day) during pregnancy.  On 19-Oct-2018, at gestational age of approximately 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 12-Feb-2019, 3 months and 24 days after vaccination, the subject was noted to have anaemia. On Apr-2019, the subject had recovered from the event anaemia.  On the same day, at gestational age of 35.3 weeks the subject gave a live birth to normal female neonate (explicitly coded as premature delivery) via vaginal delivery and pre-eclampsia was observed as pregnancy complications. The birth weight of the neonate was 2296 g, head circumference was 31.8 cm and length was 48.9 cm. Appearance, pulse, grimace, activity and respiration (APGAR) score at one minute was 8, at five minutes was 9 and no data was reported for APGAR score at ten minutes. No major congenital malformation was identified at birth.  The outcome of the event pre-eclampsia was not reported.  The subject's estimated delivery date (EDD) and corrected EDD were reported as 01-Jun-2019.  This case has been linked to the case 201904148 (baby case).; Reporter's Comments: A 27-year-old female pregnant subject experienced anemia, 3 months 24 days after receipt of Flu Vaccine Cell Subunit QIV at 7 weeks of gestation (considered as vaccine exposure during pregnancy). The event anaemia assessed as not related considering the implausible temporal relationship associated with vaccine administration and also the pregnancy state of the subject provide more plausible temporal explanation rather than study vaccine.  The subject delivered at 35.3 weeks of gestational age (explicitly coded as premature delivery), 6 months 10 days after administration of study vaccine. Considering the unlikely timeframe of events with respect to vaccine administration, no evidence for a biological mechanism that could cause the events and risk factors (alcohol user and anxiety treated with propranolol hydrochloride), the event premature delivery was assessed as not related to the vaccination. The pregnancy complication of the subject was reported as pre-eclampsia, unspecified period post vaccination. Due to lack of onset latency between vaccination and reported pre-eclampsia, the causality assessed as unassessable. 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, hence the event of vaccine exposure during pregnancy was assessed as not related considering the intended use of the vaccine.  The case will be further assessed upon receipt of follow-up information. The company assessed the case as serious (medically significant).