Age: 31.0
Sex: F
Vaccine: FLUX
Symptoms: Ultrasound antenatal screen normal
Clinical narrative: HELLP syndrome; Delivery at 32 weeks of gestational age; Vaccine exposure during pregnancy; This is an observational study case, initially received from other health professional, on 16-Oct-2019, concerning a 31-year-old female, pregnant subject of body weight: 195 lbs, height: 63 inches and body mass index (BMI): 34.5, who was enrolled in, a prospective observational safety study.  The subject's medical history included seasonal allergies, anxiety, hypothyroidism and acid reflux.  The subject's concomitant medications included Prenatal vitamins (unspecified minerals and vitamins) for pregnancy; Flonase (fluticasone furoate) and Claritin (oxymetazoline hydrochloride) for allergies; Lexapro (escitalopram oxalate) for anxiety, levothyroxine for hypothyroidism and Prilosec (omeprazole) for acid reflux.    The subject had one previous spontaneous abortion. The subject had no history of offspring with major congenital malformation (MCM). The subject had no maternal or paternal history with MCMs. The subject did not have a prior history of use of tobacco, alcohol or illicit drugs during pregnancy.  The subject's last menstrual period (LMP) was on 22-Apr-2019. The type of pregnancy was singleton and was complicated with hypertension associated disorders of pregnancy (HELLP) syndrome. The subject's estimated delivery date (EDD) was reported as 27-Jan-2020 and corrected EDD (CEDD) was reported as 29-Jan-2020.   On 28-Aug-2019 and 25-Sep-2019, ultrasound was performed, and no MCM was noted.  On 25-Sep-2019, at approximately 22 weeks of gestation, the subject received Flu Vaccine Egg Split QIV CSL [influenza vaccine, batch number: P100118566, dose, route of administration, anatomical location and expiry date: not reported] (explicitly coded as Vaccine exposure during pregnancy') for influenza immunisation.  at the gestational age of 32.0 weeks, the subject delivered male neonate via caesarean method of delivery. The neonate's body weight was 1531 grams, head circumference: 28.5 cm and length: 41.3 cm. The appearance, pulse, grimace, activity, and respiration (APGAR) score one minute: 5, five minutes: 7 and ten minutes: not reported. There was no MCM identified at birth.  The outcome of event HELLP syndrome was not reported.  The event of HELLP syndrome was assessed as serious due to criterion of medical significance.   The reporter did not provide causality assessment.  The case is linked with 202000507 (baby case).   Follow-up received from other health professional on 17-Jan-2020: Classification removed. Pregnancy outcome updated. New events HELLP syndrome and premature labour added. Narrative updated accordingly.  Company comment: A 31-year-old pregnant subject experienced premature labour and HELLP syndrome after vaccination with the suspect product, Flu Vaccine Egg Split QIV CSL. The vaccine was administered at 22 weeks of gestation. Medical history of obesity (body mass index 34.5) and hypothyroidism may provide alternative aetiology for the events. Causality was also confounded by use of multiple concomitant drugs. Vaccine exposure during pregnancy assessed as unrelated per company's conventions. Considering all the above mentioned, causality between suspect product and the events premature labour and HELLP syndrome is assessed as unlikely related (defaults to related for reporting purposes).; Sender's Comments: A 31-year-old pregnant subject experienced premature labour and HELLP syndrome after vaccination with the suspect product, Flu Vaccine Egg Split QIV CSL. The vaccine was administered at 22 weeks of gestation. Medical history of obesity (body mass index 34.5) and hypothyroidism may provide alternative aetiology for the events. Causality was also confounded by use of multiple concomitant drugs. Vaccine exposure during pregnancy assessed as unrelated per company's conventions. Considering all the above mentioned, causality between suspect product and the events premature labour and HELLP syndrome is assessed as unlikely related (defaults to related for reporting purposes).