Age: 29.0
Sex: F
Vaccine: UNK
Symptoms: Ultrasound antenatal screen, Ultrasound antenatal screen normal
Clinical narrative: Eclampsia; Anxiety; Vaccine exposure during pregnancy; This is a observational study case initially received from other health professional on 18-Jun-2019, concerning a 29-year-old, adult, female pregnant subject of body weight: 137.2 lbs, height: 65 inches and body mass index (BMI): 22.8, enrolled in a prospective observational safety study.  The subject's obstetrical history included two previous pregnancies which included 1 spontaneous abortion and 1 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 did not have a prior history of use of tobacco, alcohol or illicit drugs during pregnancy. The subject's current condition included hypothyroid. The subject's concomitant medications included Prenatal Vitamins [minerals NOS; vitamins NOS] for supplementation and Levothyroxine for hypothyroidism (reported as thyroid).  The subject's last menstrual period (LMP) date was 14-Oct-2018. The type of pregnancy was singleton. The subject's pregnancy status was collected and no malformations were noted.  On 10-Dec-2018, at gestational age of 8 weeks, the subject was administered Afluria QIV [Flu Vaccine Egg Split QIV CSL, batch number, dose, route of administration, expiry date and anatomical location: not reported] (explicitly coded as exposure during pregnancy) for influenza immunisation.  On 10-Dec-2018, subject underwent ultrasound and no major congenital malformations were noted.   On an unknown date, the subject experienced eclampsia.   On 08-Jan-2019, subject underwent inheritest core, sequential 1 and nuchal translucency and there was no major congenital malformations noted.   On 05-Feb-2019, subject underwent sequential 2 and no major congenital malformations were noted.  On 07-May-2019, 4 months, 3 weeks and 6 days after vaccination, subject developed anxiety and treated with Sertraline [indication: anxiety, dose 25 mg, frequency: QD, route of administration: oral, start date: 07-May-2019 and stop date: ongoing].  The outcome of the event anxiety was not resolved, while the outcome of the event of eclampsia was not reported.  The subject's estimated date of delivery (EDD) was reported as 22-Jul-2019 and corrected EDD was reported as 21-Jul-2019.  At 37 weeks of gestation, the subject delivered female neonate via caesarean method of delivery. The neonate's birth weight was 2381 grams (reported as low birth weight), body length and head circumference were not reported. The appearance, pulse, grimace, activity, and respiration (APGAR) scores were 8 (one minute) and 9 (five minutes). It was reported that there were no major congenital malformations (MCM) identified at birth.   This case is linked with case 201904399, the corresponding child case.   Follow up was received from other health professional on 05-Aug-2019: Event of eclampsia was added and accordingly case was upgraded to serious. Pregnancy outcome was provided. Indication for Afluria was added. Narrative was amended accordingly.  Company comment: The pregnant 40-years old subject experienced eclampsia and anxiety after vaccination with Flu Vaccine Egg Split QIV CSL.  Considering latency period between exposure to the product and occurrence of both events, chronology seems unsuggestive. The patient pregnancy could be the reason for eclampsia. The patient medical history of hypothyroidism, although corrected with medication, and advanced age for pregnancy (40) may have contributed in developing eclampsia. Also the use of levothyroxine (concomitant drug) could explain anxiety, especially if it used in higher amount. the level of thyroid hormone may oscillate during pregnancy which surely had an impact on developing anxiety.  With information presented, causality for both events is assessed as not related.; Reporter's Comments: The pregnant 40-years old subject experienced eclampsia and anxiety after vaccination with Flu Vaccine Egg Split QIV CSL.  Considering latency period between exposure to the product and occurrence of both events, chronology seems unsuggestive. The patient pregnancy could be the reason for eclampsia. The patient medical history of hypothyroidism, although corrected with medication, and advanced age for pregnancy (40) may have contributed in developing eclampsia. Also the use of levothyroxine (concomitant drug) could explain anxiety, especially if it used in higher amount. the level of thyroid hormone may oscillate during pregnancy which surely had an impact on developing anxiety.  With information presented, causality for both events is assessed as not related.