Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: Alpha 1 foetoprotein normal, Cholestasis, Exposure during pregnancy, Genital herpes simplex, Ultrasound antenatal screen normal
Clinical narrative: This is a serious observational study case, initially received from other health professional on 13-May-2019, concerning a 24-year-old adult female pregnant subject of weight 131.6 lbs, 67.5 inches height and body mass index (BMI) 20.3, enrolled in prospective observational safety study on pregnancy outcomes in women immunized with seasonal cell culture influenza trivalent (TIVc) or quadrivalent (QIVc) vaccine during pregnancy. The current conditions of the subject included Rh D negative. The subject's obstetrical history was collected in which no previous pregnancies were reported. The concomitant medication of the subject included Prenatal Vitamins (unspecified) as a supplement. 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 did not use tobacco, alcohol or illicit drugs during pregnancy. The subject's last menstrual period date was 05-Sep-2018. The type of pregnancy was singleton. On an unknown date, the pregnancy status of the subject was collected, and no pregnancy complications were noted. On 09-Nov-2018, at 9 weeks of gestation, the pregnant subject was administered Flu Vaccine Egg Split QIV CSL [influenza vaccine, batch number: YF42609, dose, route of administration, expiry date and anatomical location: not reported] for an unknown indication (explicitly coded as vaccine exposure during pregnancy). On the same day, the subject underwent ultrasound scan and no major congenital malformation was noted. On 06-Dec-2018, the subject underwent maternal serum alpha-fetoprotein (MSAFP)/ serum markers test and no major congenital malformation was detected. On 22-Feb-2019, 3 months and 13 days after vaccination, the subject experienced genital herpes simplex type 2. On 10-Apr-2019, 5 months and 1 day after vaccination, the subject experienced cholestasis. The subject was treated with Ursodiol (ursodeoxycholic acid) (dosage: 300mg, qd, orally, start date: 12-Apr-2019 and was ongoing) for cholestasis. The outcome of the events was not recovered. The subject's estimated date of delivery was reported as 12-Jun-2019 and corrected estimated date of delivery was reported as 18-Jun-2019.; Reporter's Comments: A 24-year-old pregnant subject experienced genital herpes simplex, 3 months 13 days after administration of study vaccine and cholestasis approximately 5 months post vaccination, at 9 weeks of gestation (coded to Exposure during pregnancy). Considering the implausible temporal relationship between vaccination and reported events and no evidence for a biological mechanism that could cause the events, the events were assessed as not related to the 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 this case as serious (medically significant).