Age: 33.0
Sex: F
Vaccine: UNK
Symptoms: Anaemia, Exposure during pregnancy, Foetal non-stress test normal, Pharyngitis, Placental disorder
Clinical narrative: Dysmature placenta; Pharyngitis; Vaccine exposure during pregnancy; Anemia; This is an observational study case, initially received from other health professional on 16-Mar-2020, concerning a 33-year-old, pregnant, female subject of body weight: 260 lbs, height: 73 inches and body mass index (BMI): 34,3, enrolled in a prospective observational safety study.  The subject's medical history included high BMI and chronic hypertension.  The subject's concomitant medications included Prenatal vitamins (unspecified vitamins and minerals) for pregnancy and labetalol for hypertension.   The subject's obstetrical history included nine previous pregnancies which included eight previous full term live birth with no birth defects and one previous ectopic pregnancy. The subject had no history of offspring with major congenital malformation (MCM) and no maternal or paternal history with MCMs. The subject did not use tobacco, illicit drugs and alcohol during pregnancy.  The subject's last menstrual period (LMP) date was 10-Apr-2019, while the estimated date of delivery (EDD) was reported on 24-Jan-2020 and corrected estimated date of delivery (CEDD) was reported on 29-Jan-2020. The type of pregnancy was singleton.   On 25-Jul-2019, the subject underwent ultrasound test and no MCMs were noted.  On 30-Jul-2019, the subject underwent spinal muscular atrophy prenatal test, cystic fibrosis mutation analysis and panorama screening test and for all no MCMs were noted.  On 21-Aug-2019, the subject underwent ultrasound test and no MCMs were noted.  On 17-Oct-2019, approximately at 27 weeks of gestation (calculated per LMP), the subject was administered Flucelvax QIV (Flu Vaccine Egg Split QIV CSL) [influenza vaccine, subunit influenza virus vaccine polyvalent; batch number: 261218, dose: 0.5 ml, route of administration, anatomical location and expiration date: not reported] for an influenza immunization (explicitly coded as 'Vaccine exposure during pregnancy') as influenza immunisation. On unspecified date, subject developed dysmature placenta as pregnancy complication.  On unspecified date in 2019, after vaccination the subject developed anemia.  On 21-Oct-2019 the subject started treatment with ferrous sulfate at a dose of 325 mg, three times a day, orally for anemia.  On 30-Oct-2019, the subject developed pharyngitis, and started a treatment with oral, amoxicilin at a dose of 1 tablet,aministered twice daily, and oral  Cetrizine (cetirizine hydrochloride) at a dose of 1 tablet, administered daily.  On 10-Nov-2019, the subject recovered from the event of pharyngitis and stopped the treatment with amoxicillin and Cetrizine (cetirizine hydrochloride).  On 11-Dec-2019, the subject underwent ultrasound and no MCMs were noted.  On 18-Dec-2019, the subject underwent ultrasound and Non-stress test and for both no MCMs were noted.  On 26-Dec-2019, the subject underwent ultrasound test and no MCMs were noted.  On 09-Jan-2020, the subject underwent ultrasound and no MCMs were noted.  On an unknown date the subject underwent Non-stress test and no MCMs were noted.  At 37,7 weeks of gestation (as reported), the patient vaginally delivered a live male neonate. The neonate's birth weight was 3495 g, head circumference 34.3 cm and length was 50,8 cm. The appearance, pulse, grimace, activity, and respiration (APGAR) scores was 9 at one minute and five minutes and no data was provided for 10 minutes. No MCM was identified at birth.   At the time of this report, the outcome of events of dysmature placenta and anemia was not reported.  The events of dysmature placenta and pharyngitis were assessed as serious due to seriousness criterion of medical significance, per company.  The reporter did not provide causality assessment to Flucelvax QIV.  Company comment: The patient experienced placental disorder (dysmature placenta) and anaemia on unspecified date. The patient also developed pharyngitis 13 days receiving Flucelvax QIV. Vaccine was administered at 27 weeks of gestation. Chronology is plausible for pharyngitis. Causal role of the suspect vaccine cannot be excluded and is assessed as possibly related for pharyngitis. For the events of placental disorder (dysmature placenta) and anaemia, causal role of the suspect vaccine is unassessable. Vaccine exposure during pregnancy is assessed as unrelated per company's conventions.; Sender's Comments: The patient experienced placental disorder (dysmature placenta) and anaemia on unspecified date. The patient also developed pharyngitis 13 days receiving Flucelvax QIV. Vaccine was administered at 27 weeks of gestation. Chronology is plausible for pharyngitis. Causal role of the suspect vaccine cannot be excluded and is assessed as possibly related for pharyngitis. For the events of placental disorder (dysmature placenta) and anaemia, causal role of the suspect vaccine is unassessable. Vaccine exposure during pregnancy is assessed as unrelated per company's conventions.