Age: 21.0
Sex: F
Vaccine: UNK
Symptoms: Anaemia, Delivery, Exposure during pregnancy, Foetal non-stress test normal, Premature delivery
Clinical narrative: Pre-term labour; Anaemia; Vaccine exposure during pregnancy; This is an observational study case, reported by other health professional and initially received on 27-Nov-2019, concerning a 21-year-old pregnant, female subject of body weight 168 lbs, height 65 inches and body mass index (BMI) 28, enrolled in, a prospective observational safety study. The paternal age was 21.  The subject's current medical condition included increased BMI. The subject's concomitant medications included prenatal vitamins (unspecified vitamins and minerals) for pregnancy.  The subject's obstetrical history noted that the subject had one previous full-term, live birth pregnancies with no birth defects. 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 15-Mar-2019. The subject's estimated date of delivery (EDD) and corrected estimated date of delivery (CEDD) were reported as 20-Dec-2019. The type of pregnancy was singleton.   On 15-Apr-2019, the subject underwent fragile X carrier, cystic fibrosis mutation analysis (CF), duchenne muscular dystrophy (D/B MS), and spinal muscular atrophy (SMA). There was no MCM noted.  On 16-May-2019, the subject underwent ultrasound and no MCM was noted.  On 28-May-2019, the subject underwent panorama and no MCM was noted.  On 18-Jul-2019, the subject underwent ultrasound and no MCM was noted.  On 07-Sep-2019, the subject underwent ultrasound with no MCM noted and non-stress test with no reported data for MCM.  On 24-Oct-2019, the subject underwent ultrasound and no MCM was noted.  On 24-Oct-2019, at approximately 32 weeks of gestation, the subject was administered Flu Vaccine Cell Subunit QIV NVD (Flucelvax QIVc) [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 immunisation.   On 03-Nov-2019, the subject underwent ultrasound and non-stress test. There was no MCM noted.  On 06-Nov-2019, the subject underwent non-stress and no MCM was noted.  On 14-Nov-2019, the subject underwent non-stress and no MCM was noted.  On 16-Nov-2019, 23 days after vaccination, the subject developed anaemia and started treatment with oral ferrous sulfate, 325 mg administered twice a day via oral route.  On 17-Nov-2019, at gestation age of 35.3 weeks, the subject vaginally delivered a live birth, male neonate. The neonate's birth weight was 3620 g, length was 54.6 cm and head circumference was 33.7 cm. The appearance, pulse, grimace, activity, and respiration (APGAR) scores were 8 (one minute) and 9 (five minutes). It was reported that there were no MCM identified at birth.  At the time of initial reporting, the subject had not recovered from the event of anaemia.  The event of pre-term labour was considered serious due to the criterion of medical significance per company.  The reporter did not provide causality assessment.  This case is linked to baby case 201907048.  Company Comment: The subject experienced premature labour and anaemia after vaccination with the suspect product, Flucelvax QIV. Reportedly, vaccination occurred during pregnancy at 32 weeks of gestation. Chronology is plausible. Medical history of increased body mass index 28 may have contributed to development of the event. Vaccine exposure during pregnancy is assessed as not related per company's conventions. Considering all the above mentioned, causality between suspect product and the events premature labour and anaemia is assessed as possibly related.; Sender's Comments: The subject experienced premature labour and anaemia after vaccination with the suspect product, Flucelvax QIV. Reportedly, vaccination occurred during pregnancy at 32 weeks of gestation. Chronology is plausible. Medical history of increased body mass index 28 may have contributed to development of the event. Vaccine exposure during pregnancy is assessed as not related per company's conventions. Considering all the above mentioned, causality between suspect product and the events premature labour and anaemia is assessed as possibly related.