Age: 19.0
Sex: F
Vaccine: FLU4
Symptoms: Anaemia, Delivery, Exposure during pregnancy, Foetal disorder, Premature delivery
Clinical narrative: Delivery at 36.9 weeks of gestation; Anemia; Vaccine exposure during pregnancy; This is an observational study case, initially received from other health professional on 05-Mar-2020, concerning a 19-year-old, pregnant, female subject of body weight: 147 lbs, height: 63 inches and body mass index (BMI): 26, 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 current condition included increased BMI and adolescent pregnancy.   The subject's concomitant medications 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 maternal or paternal history with major congenital malformations (MCMs). Also, the subject had no history of offspring with MCM. The subject did not use tobacco, alcohol or illicit drugs during pregnancy.   The subject's last menstrual period (LMP) date was on 15-Jul-2019. The subject's estimated delivery date (EDD) was reported as 20-Apr-2020, while corrected estimated date of delivery (CEDD) was reported as 11-Apr-2020. The type of pregnancy was singleton.   On 16-Sep-2019, the subject underwent ultrasound and no MCMs were noted.   On 01-Oct-2019, the subject underwent first sequential and nuchal translucency. No MCMs were noted.  On 29-Oct-2019, the subject underwent second sequential and no MCMs were noted.  On 26-Nov-2019, the subject underwent 20 weeks anatomy ultrasound and no MCMs were noted.  On 08-Jan-2020, at approximately 25 weeks of gestation (calculated per LMP), the subject was administered Afluria QIV (Flu Vaccine Egg Split QIV CSL) [influenza vaccine; batch number: P100112488, dose, route of administration, anatomical location and expiration date: not reported] (explicitly coded as Vaccine exposure during pregnancy') for an influenza immunisation.   On the same day, after vaccination, the subject developed anaemia.  On 13-Jan-2020, the subject started treatment medication ferrous sulphate at the dose of 325 mg, administered via oral route, once per day.   On 25-Feb-2020, the subject stopped with treatment medication ferrous sulphate.  At gestational age of 36.9 weeks (reported as), the subject vaginally delivered live birth, female neonate. The neonate's birth weight was 3204 g, her head circumference and length were not provided. The appearance, pulse, grimace, activity, and respiration (APGAR) scores were 8 (one minute) and 9 (five minutes) and for ten minutes not reported. No MCM was noted on birth. Pregnancy complications included anemia and fetal pylectasis.  At the time of this report, the subject did not recover from the event of anaemia, while the outcome of the event 'premature delivery' was not reported.  The event of 'premature delivery' was assessed as serious due to criterion of medical significance, per company.  The reporter did not provide causality assessment to Afluria QIV.  The case is linked to 202003815, the corresponding baby case.  Follow up received from other health professional on 15-Jun-2020: Pregnancy details updated [date and type of delivery, birth type and foetal outcome populated]. Details regarding neonate added [body weight and APGAR scores added]. The event of vaccine exposure during pregnancy updated [stop date added, outcome changed from 'not reported' to 'recovered']. The narrative was amended accordingly.  Company comment: A pregnant patient was administered Afluria QIV and anaemia was noted on the same day. Temporal relationship is implausible. Anaemia is common during pregnancy. Causal role of the suspect vaccine is assessed as not related. The neonate was delivered pre-term, however considering unsuggestive temporal relationship causality is assessed as not related as well. Vaccine exposure during pregnancy is assessed as unrelated per company's conventions.; Sender's Comments: A pregnant patient was administered Afluria QIV and anaemia was noted on the same day. Temporal relationship is implausible. Anaemia is common during pregnancy. Causal role of the suspect vaccine is assessed as not related. The neonate was delivered pre-term, however considering unsuggestive temporal relationship causality is assessed as not related as well. Vaccine exposure during pregnancy is assessed as unrelated per company's conventions.