Age: 35.0
Sex: F
Vaccine: UNK
Symptoms: Alpha 1 foetoprotein normal, Delivery, Exposure during pregnancy, Laboratory test normal, Pre-eclampsia
Clinical narrative: Pre-eclampsia; Vaccine exposure during pregnancy; This is an observational study case, initially received from other health professional on 05-Sep-2019, concerning a 35-year-old, pregnant, female subject of body weight: 213.8 lbs, height: 59 inches and body mass index (BMI): 43.2, enrolled in a prospective observational safety study. The subject's obstetrical history noted that she had no previous pregnancies and that she was in advanced maternal age. Also, the subject had no relevant maternal and paternal medical history. The subject did not use tobacco, alcohol or illicit drugs during pregnancy. The subject's medical history included depressive disorder, left lower quadrant pain, anxiety, seasonal allergies, dyspareunia and heartburn. The concomitant medications of the subject included Prenatal gummy as health supplement, ranitidine for heartburn and fluticasone propionate for seasonal allergies.   The subject's last menstrual period date was 01-Dec-2018, the estimated delivery date and corrected delivery date were reported as 07-Sep-2019. The type of pregnancy was singleton.   On 21-Jan-2019, the subject underwent prenatal tests toxoplasma IgG and IgM and no major congenital malformations were noted.   On 04-Feb-2019, at gestational age of approximately nine weeks, the subject was administered Flu Vaccine Egg Split QIV CSL [influenza vaccine, batch number: YF41608, dose, route of administration, anatomical location and expiration date: not reported] (explicitly coded as 'vaccine exposure during pregnancy') for influenza immunisation.   On 27-Feb-2019, the subject underwent Maternal serum alfa-fetoprotein (MSAFP)/ serum markers test, Essential panel and Non-invasive prenatal test and no major congenital malformations were noted.   On 22-Apr-2019, the subject underwent ultrasound and no major congenital malformations were noted.   On 20-Aug-2019, approximately six months after vaccination, the subject experienced pre-eclampsia and was treated with labetalol at a dose of 200 mg, administered two times per day via oral route.   At 37.9 gestational week, the subject vaginally delivered live birth male neonate. The neonate's birth weight was 2841 g, length 48.9 cm and his head circumference 34.5 cm. The appearance, pulse, grimace, activity, and respiration (APGAR) scores were 8 (one minute) and 9 (five minutes). APGAR score was not reported for 10 minutes. There was no major congenital malformation identified at birth.   At the time of initial reporting, the subject had not recovered from the event of 'pre-eclampsia'.  Company Comment: The subject experienced pre-eclampsia 6 months and 16 days after vaccination with the suspect product Flu Vaccine Egg Split QIV CSL. Reportedly, vaccination occurred during pregnancy.  Chronology is unsuggestive due to long latency onset. Medical history of depressive disorder, seasonal allergies and pregnant state may have contributed to development of the event. Causality was confounded by therapy with concomitant medications ranitidine and fluticasone propionate. Considering all the above mentioned, causal relationship between the suspect product and exposure during pregnancy is assessed as not related and as related for the event pre-eclampsia.; Reporter's Comments: The subject experienced pre-eclampsia 6 months and 16 days after vaccination with the suspect product Flu Vaccine Egg Split QIV CSL. Reportedly, vaccination occurred during pregnancy.  Chronology is unsuggestive due to long latency onset. Medical history of depressive disorder, seasonal allergies and pregnant state may have contributed to development of the event. Causality was confounded by therapy with concomitant medications ranitidine and fluticasone propionate. Considering all the above mentioned, causal relationship between the suspect product and exposure during pregnancy is assessed as not related and as related for the event pre-eclampsia.