Age: 38.0
Sex: F
Vaccine: UNK
Symptoms: Caesarean section, Exposure during pregnancy, Neonatal disorder, Pre-eclampsia, Premature delivery
Clinical narrative: Delivery at 32.7 weeks of gestation; Superimposed pre-eclampsia; Vaccine exposure during pregnancy; This is an observational study case, reported by other health professional and initially received on 12-Feb-2020, concerning a 38-year-old, pregnant, female subject of body weight 263 lbs, height 67 inches and body mass index (BMI) 41.2, enrolled in a prospective observational safety study.  The subject's medical history included increased BMI, hypertension, pain and pregnancy with advanced maternal age.   The subject's concomitant medications included prenatal vitamins (unspecified vitamins and minerals) for pregnancy, Tylenol (paracetamol) for pain, labetalol and Procardia (nifedipine) both for hypertension.  The subject's obstetrical history noted that the subject had one previous preterm, live birth pregnancy 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 30-May-2019, the estimated delivery date (EDD) and corrected estimated date of delivery (CEDD) were reported as 06-Mar-2020. The type of pregnancy was singleton.   On 12-Aug-2019, the subject had an ultrasound scan and no MCMs were noted.  On 24-Sep-2019, at approximately 16 weeks of gestation, the subject was administered Afluria QIV (Flu Vaccine Egg Split) [influenza vaccine, batch number: P100118566, dose, route of administration, anatomical location and expiration date: not reported] (explicitly coded as 'Vaccine exposure during pregnancy') for an influenza immunisation.   On 13-Jan-2020, 3 months and 20 days after vaccination, the subject developed superimposed pre-eclampsia reported as pregnancy complication.  At gestation age of 32.7 weeks, the subject delivered a preterm live birth, male neonate by caesarean method. The neonate's birth weight was 2693 g, length was 48.3 cm and head circumference was 32.5 cm. The appearance, pulse, grimace, activity, and respiration (APGAR) scores were 5 (one minute), 6 (five minutes) and 9 (ten minutes). It was reported that there were no MCM identified at birth.  On 16-Jan-2020, three days after the onset, the subject recovered from the event of 'pre-eclampsia'.   At the time of this report, the outcome of the events 'premature delivery' was not reported.  The events of 'pre-eclampsia' and 'premature delivery' were assessed as serious due to the criterion of medical significance, per company.  The reporter did not provide causality assessment.  This case is linked to the case 202001709, the corresponding baby case.  Company comment: The subject experienced pre-eclampsia and premature delivery three months and 20 days after vaccination with the suspect product, Afluria QIV. Reportedly, vaccination occurred during pregnancy at gestational age of 32.7 weeks. Chronology is incompatible due to very long onset latency over three months. Medical history of obesity (body mass index 41.2), hypertension and pregnancy with advanced maternal age may provide more plausible alternative aetiology. Causality was also confounded by therapy with Tylenol (paracetamol), labetalol and Procardia (nifedipine). Vaccine exposure during pregnancy is assessed as unrelated per company's conventions. Considering all the above mentioned, causality between suspect product and the events pre-eclampsia and premature delivery are assessed as not related.; Sender's Comments: The subject experienced pre-eclampsia and premature delivery three months and 20 days after vaccination with the suspect product, Afluria QIV. Reportedly, vaccination occurred during pregnancy at gestational age of 32.7 weeks. Chronology is incompatible due to very long onset latency over three months. Medical history of obesity (body mass index 41.2), hypertension and pregnancy with advanced maternal age may provide more plausible alternative aetiology. Causality was also confounded by therapy with Tylenol (paracetamol), labetalol and Procardia (nifedipine). Vaccine exposure during pregnancy is assessed as unrelated per company's conventions. Considering all the above mentioned, causality between suspect product and the events pre-eclampsia and premature delivery are assessed as not related.