Age: 37.0
Sex: F
Vaccine: FLUX
Symptoms: Ultrasound antenatal screen normal, Uterine leiomyoma
Clinical narrative: Hemorrhage post-delivery; Vaccine exposure during pregnancy; Uterine leiomyoma; Endometriosis of pelvis; This is an observational study case, received from other health professional on 28-Sep-2020, and concerned a 37-year-old, female, pregnant subject of body weight: 151 lbs, height: 65 inches and body mass index (BMI): 25.1, enrolled in a prospective observational study on pregnancy outcomes in women immunized with Afluria QIV, a seasonal quadrivalent vaccine, during pregnancy.  The subject's concurrent medical history included pregnancy at advanced maternal age and BMI increased.  The subject's concomitant medication included calcium gummies and Vita Med MD Redichew RX ((6s)-5-methyltetrahydrofolate glucosamine, colecalciferol, folic acid, mecobalamin, pyridoxine hydrochloride, riboflavin), both used as supplement.  The subject's obstetrical history included no previous pregnancies. The subject had no history of offspring with major congenital malformations (MCMs) and no relevant maternal or paternal medical history with MCM. The subject did not use tobacco, alcohol or illicit drugs during pregnancy.  The subject's last menstrual period (LMP) date was 22-Dec-2019. The estimated delivery date (EDD) and corrected estimated date of delivery (CEDD) was reported as 27-Sep-2020. The type of pregnancy was singleton.  On 18-Mar-2020, at gestational age of 12 weeks (calculated per LMP), the subject was vaccinated with Afluria QIV (Flu Vaccine Egg Split QIV CSL) (influenza vaccine; dose, route of administration, anatomical location: not reported) (explicitly coded as 'Vaccine exposure during pregnancy') for an influenza immunisation. The batch number reported was P100126099 (the expiry date was not reported).  On an unknown date in 2020, unknown amount of time after vaccination, the subject developed uterine leiomyoma and endometriosis of pelvis.  On 04-Mar-2020 and 15-Apr-2020, the ultrasound scan revealed no MCMS.   On 12-May-2020, maternal serum alpha-fetoprotein screening (MSAFP) / serum markers revealed no MCM.  On 09-Sep-2020, at gestational age of 37.4 week (as reported), the subject delivered live birth, female neonate via caesarean method of delivery. The neonate's birth weight was 2807 grams, head circumference was 33 cm, and body length were 48,9 cm. The appearance, pulse, grimace, activity, and respiration (APGAR) score at one minute was 8, at five minutes was 9 and at 10 minutes was not provided. There was no MCM noted at birth. On the same day, the subject experienced post-delivery haemorrhage.  On the same day, the subject recovered from the event 'hemorrhage postpartum'.  The event of 'hemorrhage postpartum' was considered to be medically significant by a Physician within Seqirus's Pharmacovigilance and Risk Management Department.  The reporter did not provide a causality assessment to Afluria QIV.  Company comment: Postpartum haemorrhage, uterine leiomyoma and endometriosis were associated with the use of the suspect product - Afluria QIV. On an unknown date in 2020, unknown amount of time after vaccination, the subject developed uterine leiomyoma and endometriosis of pelvis making chronology unclarified. On 09-Sep-2020, approximately 6 months after vaccination, postpartum haemorrhage was reported - chronology seems unsuggestive. Several studies suggest that symptomatic endometriosis and symptomatic uterine fibroids appear together. Almost 20% of patients with symptomatic fibroids also had endometriosis. On the other hand, 26% of patients with symptomatic endometriosis also had fibroids. Both events are assessed as unrelated to the product and more likely related to pregnancy and maternal endocrine influence. Postpartum haemorrhage is a reasonable consequence of these 2 events making causality also unrelated to the product. Vaccine exposure during pregnancy is assessed as unrelated per company conventions.; Sender's Comments: Postpartum haemorrhage, uterine leiomyoma and endometriosis were associated with the use of the suspect product - Afluria QIV. On an unknown date in 2020, unknown amount of time after vaccination, the subject developed uterine leiomyoma and endometriosis of pelvis making chronology unclarified. On 09-Sep-2020, approximately 6 months after vaccination, postpartum haemorrhage was reported - chronology seems unsuggestive. Several studies suggest that symptomatic endometriosis and symptomatic uterine fibroids appear together. Almost 20% of patients with symptomatic fibroids also had endometriosis. On the other hand, 26% of patients with symptomatic endometriosis also had fibroids. Both events are assessed as unrelated to the product and more likely related to pregnancy and maternal endocrine influence. Postpartum haemorrhage is a reasonable consequence of these 2 events making causality also unrelated to the product. Vaccine exposure during pregnancy is assessed as unrelated per company conventions.