Age: 26.0
Sex: F
Vaccine: UNK
Symptoms: Caesarean section, Exposure during pregnancy, Laparoscopic surgery, Ultrasound antenatal screen normal, Uterine repair
Clinical narrative: Uterine rupture; Vaccine exposure during pregnancy; This is a serious observational study case, initially received on 16-Jul-2019, concerning a 26-year-old adult female pregnant subject of body weight: 130 lbs, height: 64 inches and body mass index (BMI): 22.3, enrolled in a prospective observational safety study on pregnancy outcomes in women immunized with seasonal cell culture influenza trivalent (TIVc) or quadrivalent (QIVc) vaccine during pregnancy.  The subject's obstetrical history included one previous pregnancy with one full term live birth. No birth defects were reported. The subject had no history of offspring with major congenital malformations. 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 and illicit drugs during pregnancy. The subject's medical history included previous caesarean section for gravida 1 on an unspecified date and current conditions included allergy or non-immune response to varicella vaccine. The subject's concomitant medications included Prenatal vitamins (minerals nos, vitamins nos) as vitamin supplementation and TDAP (diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid) as vaccination.  The subject's last menstrual period date (LMP) was 02-Sep-2018 and the type of pregnancy was singleton. The pregnancy status of the subject was collected, and the pregnancy complication included uterine rupture with laparoscopic repair.  On 27-Nov-2018, the subject underwent first trimester screen, Foetal nuchal translucency test and an ultrasound scan and no major congenital malformation was noted. On 26-Dec-2018, the subject underwent second trimester screening and maternal serum alpha fetoprotein (MSAFP) test and no major congenital malformation was noted.  On 14-Jan-2019, the subject underwent anatomy ultrasound scan and no major congenital malformation was noted.   On the same day at gestational age of 19 weeks, the pregnant subject was administered Flu Vaccine Cell Subunit QIV NVD [influenza vaccine, subunit influenza virus vaccine polyvalent, batch number: 252226, dose, route of administration, anatomical location and expiry date: not reported] (explicitly coded as vaccine exposure during pregnancy) for an unknown indication.  At 38.9 weeks gestation, the subject gave live birth to a normal male neonate via caesarean section. The characteristics of the neonate included birth weight: 3118 grams, appearance, pulse, grimace, activity, and respiration (APGAR) scores were 8 at one minute and 9 at five minutes. The pregnancy complication of the subject included uterine rupture with laparoscopic repair.  The subject's estimated delivery date (EDD) and corrected estimated date of delivery (CEDD) were reported as 09-Jun-2019.; Reporter's Comments: A 26-year-old pregnant subject with history (caesarean section for gravida 1) experienced uterine rupture, 4 months 18 days (38.9 weeks of gestation) after administration of study vaccine at 19 weeks of gestation (coded to Exposure during pregnancy). Considering the timeframe of event with respect to study vaccine administration, no evidence for a biological mechanism that could cause the event, the event of experienced uterine rupture was more likely associated with underlying pregnancy and was assessed as not related to the study vaccination. 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 the case as serious (medically significant).