Age: 34.0
Sex: F
Vaccine: UNK
Symptoms: Alpha 1 foetoprotein normal, Anaemia, Anxiety, Exposure during pregnancy, Papilloma viral infection
Clinical narrative: Anxiety; Anemia; Subchorionic hemorrhage; Vaccine exposure during pregnancy; Human papilloma virus; This is a serious observational study case, initially received on 30-May-2019, concerning a 34-year-old adult, female, pregnant subject of body weight: 217.6 lbs, height: 64 inches and body mass index (BMI): 37.3, enrolled in a prospective observational safety study on pregnancy outcomes in women immunized with Afluria QIV, a seasonal quadrivalent vaccine, during pregnancy.  The subject's obstetrical history included 3 previous pregnancies and all 3 were full term live births and no birth defects were reported. The subject had no history of offspring with major congenital malformation. Also, the subject had no maternal or paternal history with major congenital malformations. The current conditions of the subject included acid reflux (since unspecified date) and depression. The concomitant medications of the subject included Prenatal vitamins (minerals nos, vitamins nos) as supplement and omeprazole for acid reflux.   The subject's last menstrual period (LMP) date was 03-Sep-2018. The type of pregnancy was singleton. The subject did not use tobacco, alcohol or illicit drugs during pregnancy. The pregnancy status of the subject was collected, and no pregnancy complication was noted.  On 16-Nov-2018, at gestational age of 10 weeks, the 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] (explicitly coded as vaccine exposure during pregnancy) for an unknown indication.  On the same day, the subject was diagnosed with human papilloma virus. Also, the subject underwent ultrasound and there was no major congenital malformation noted.  On 30-Nov-2018, 14 days after vaccination, the subject experienced subchorionic hemorrhage. On the same day, the subject underwent nuchal translucency test and informaseq test and there were no major congenital malformations noted. On 28-Dec-2018, the subject underwent maternal serum alpha-fetoprotein (MSAFP)/ serum markers test and there was no major congenital malformation noted. On an unknown date, the subject experienced anxiety. The subject was treated with Prozac (fluoxetine hydrochloride) (dosage: 40 mg, daily (qd), orally, from 21-Feb-2019 and ongoing) for anxiety (as reported). On 25-Apr-2019, 5 months and 9 days after vaccination, the subject experienced anemia and was treated with iron [dosage: 325 mg, qd, orally from 25-Apr-2019 and ongoing].  The outcome of the events was not recovered.  Reporter's Comments: A 34-year-old female pregnant subject was diagnosed with human papilloma virus, on the same day after administered study vaccine considered as exposure during pregnancy) at 10 weeks of gestation. The subject also developed subchorionic hemorrhage, 14 days after administration of study vaccine and anaemia 5 months 9 days post vaccination. On an unspecified day post vaccination, the patient developed anxiety. Considering the timeframe of events with respect to vaccine administration, inactivated nature of the suspect vaccine and infectious aetiology of the reported event (human papilloma virus) the causal role of the suspect vaccine was assessed as not related. The events of subchorionic hemorrhage, anaemia and anxiety were assessed as not related as there is no evidence of biological mechanism that could cause the events, comorbid conditions (depression and co-administered fluoxetine hydrochloride) and underlying pregnancy which appears to be a more likely explanation rather than 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).