Age: 28.0
Sex: F
Vaccine: FLUC4
Symptoms: Caesarean section, Exposure during pregnancy, Hypertension, Pre-eclampsia, Prolonged pregnancy
Clinical narrative: Pregnancy outcome at 43 week; Vaccine exposure during pregnancy; Pre-eclampsia; Hypertension; This is a spontaneous case, initially received on 27-Nov-2019 from other health care professional, concerning an 28-year-old female, pregnant patient, of body weight 149 lbs, height 64 inches and body mass index (BMI) 25.6.  The patient's medical history includ urinary tract infection (UTI). The patient's current conditions include body mass index high, constipation, nausea and vomiting. The patient's past medications included Pyridium (phenazopyridine) and Macrobid (nitrofurantoin) both for UTI. The patient's concomitant medications included Reglan (metoclopramide hydrochloride) for constipation, Diclegis (doxylamine succinate, pyridoxine hydrochloride) for nausea and vomiting, prenatal vitamins (unspecified vitamins and minerals) for pregnancy and Procardia (nifedipine) for unknown indication.  The patient's obstetrical history included one previous pregnancy with no birth defects. The patient had no history of offspring with major congenital malformation (MCM). Also, the patient had no maternal or paternal history with MCM. The patient did not use tobacco, alcohol or illicit drugs during pregnancy. Paternal age was 34-year-old.  The patient's last menstrual period (LMP) date was 31-Jan-2019. Type of pregnancy was singleton. The patient's estimated date of delivery (EDD) and corrected estimated date of delivery (CEDD) were reported as 07-Nov-2019.  On 01-Mar-2019, cystic fibrosis and spinal muscular atrophy were performed, and no MCM was noted.  On 14-Mar-2019, ultrasound was performed, and no MCM was noted.  On 28-Mar-2019, ultrasound was performed, and no MCM was noted.  On 12-Apr-2019, ultrasound was performed, and no MCM was noted.  On 29-May-2019, ultrasound and panorama were performed, and no MCM were noted.  On 16-Aug-2019, ultrasound was performed, and no MCM was noted.  On 17-Sep-2019, ultrasound was performed, and no MCM was noted.  On 04-Oct-2019, at 35 weeks of gestation, the patient was administered Flucelvax QIV [Influenza vaccine, subunit influenza virus vaccine polyvalent; batch number: 261218, dose, route of administration, anatomical location and expiration date: not reported] (explicitly coded as 'Vaccine exposure during pregnancy') for an unknown indication.  On unspecified date in 2019, the pregnancy complications were noted as hypertension and pre-eclampsia (as reported).  At gestational age 43 (reported as 38,6) weeks, the patient delivered live male neonate via caesarean method of delivery. Neonate's birth weight was 3459 grams, body length was 49.5 cm, head circumference was 34.3 cm. The appearance, pulse, grimace, activity, and respiration (Apgar) score one minute: 8, five minutes: 9 and ten minutes: not reported. There was no MCM at birth.  The events of pre-eclampsia and prolonged pregnancy were considered serious due tu medically significance per the company.  The reporter did not provide causality assessment.  This case is linked to baby case 201907080.  Company comment: Reportedly, prolonged pregnancy was associated with administration of Flucelvax QIV. The patient delivered live male neonate 1 month 24 days after vaccine administration. Chronology is plausible. On unspecified date in 2019, the patient developed hypertension and pre-eclampsia, chronology needs more clarification. The patient's medical history of high body mass index confound causality for the events. Based on provided information, causal role of the suspect product cannot be totally excluded and is assessed as related. Vaccine exposure during pregnancy is assessed as unrelated per company's conventions.; Sender's Comments: Reportedly, prolonged pregnancy was associated with administration of Flucelvax QIV. The patient delivered live male neonate 1 month 24 days after vaccine administration. Chronology is plausible. On unspecified date in 2019, the patient developed hypertension and pre-eclampsia, chronology needs more clarification. The patient's medical history of high body mass index confound causality for the events. Based on provided information, causal role of the suspect product cannot be totally excluded and is assessed as related. Vaccine exposure during pregnancy is assessed as unrelated per company's conventions.