Age: 24.0
Sex: F
Vaccine: FLUX
Symptoms: Complication of pregnancy, Exposure during pregnancy, Gene mutation identification test negative, Laboratory test normal, Laparotomy
Clinical narrative: Ruptured ectopic pregnancy; Vaccine exposure during pregnancy; This is an observational study case, initially received from other health professional on 20-Jul-2020 with an additional document received on 28-Jul-2020 (being processed together), concerning a 24-year-old, pregnant, female subject of body weight 168 lbs, height 71 inches and body mass index (BMI) 23.4, enrolled in a prospective observational safety study.   The subject's relevant medical history was not reported.  The subject's concomitant medication included Prenatal vitamins (unspecified vitamins and minerals) for pregnancy.  The subject's obstetrical history noted that the subject had no previous pregnancies. The subject had no history of offspring with major congenital malformation (MCM). Also, the subject had no maternal or paternal history with MCM. The subject did not use tobacco, alcohol or illicit drugs during pregnancy.   The subject's last menstrual period (LMP) date was on 30-Sep-2019. The subject's estimated date of delivery (EDD) was reported as 07-Jul-2020, while corrected estimated date of delivery (CEDD) was not reported. The type of pregnancy was singleton.  On an unspecified date in 2019, the pregnancy status was collected, and ectopic pregnancy was noted as pregnancy complication.  On 18-Nov-2019, at approximately seven weeks of gestation (calculated per LMP), the subject was administered Flucelvax QIV (Flu Vaccine Cell Subunit QIV NVD) [influenza vaccine, subunit influenza virus vaccine polyvalent; batch number: 261218, dose: 0.5 ml, route of administration, anatomical location and expiration date: not reported] (explicitly coded as 'Vaccine exposure during pregnancy') for an influenza immunization.   On the same day, the subject underwent spinal muscular atrophy and cystic fibrosis mutation analysis and no MCMs were noted.  On 19-Nov-2019, one day after vaccination, the subject experienced ruptured of ectopic pregnancy. On the same day, the subject underwent laparotomy with removal of ectopic pregnancy.  At the time of this report, the outcome for the event of ruptured ectopic pregnancy' was not reported.  The event of ruptured ectopic pregnancy' was considered as serious due to criterion of medical significance, per company.  The reporter did not provide causality assessment.  Company comment: A pregnant subject was administered Flucelvax QIV at approximately seven weeks of gestation. On an unspecified date in 2019, the pregnancy status was collected, and ectopic pregnancy was noted as pregnancy complication. One day after vaccination, the subject experienced ruptured of ectopic pregnancy. The subject's relevant medical history was not reported. More information of diagnostic findings and medical history is needed. However, rupture is expected outcome in untreated ectopic pregnancy. Causal role of the suspect vaccine is assessed as not related due to biological implausibility. Vaccine exposure during pregnancy assessed as not related per company's conventions.; Sender's Comments: A pregnant subject was administered Flucelvax QIV at approximately seven weeks of gestation. On an unspecified date in 2019, the pregnancy status was collected, and ectopic pregnancy was noted as pregnancy complication. One day after vaccination, the subject experienced ruptured of ectopic pregnancy. The subject's relevant medical history was not reported. More information of diagnostic findings and medical history is needed. However, rupture is expected outcome in untreated ectopic pregnancy. Causal role of the suspect vaccine is assessed as not related due to biological implausibility. Vaccine exposure during pregnancy assessed as not related per company's conventions.