Age: 34.0
Sex: F
Vaccine: FLUC4
Symptoms: Exposure during pregnancy, Premature delivery, Premature labour, Preterm premature rupture of membranes, Skin candida
Clinical narrative: Preterm labor at gestational age of 35.1 weeks/Progression of labor (POL); Preterm premature rupture of membranes (PPROM); Candidiasis of skin; Vaccine exposure during pregnancy; This is an observational study case initially received on 09-Dec-2019, concerning a 34-year-old female pregnant subject of body weight 148 lbs, height 63 inches and body mass index (BMI) 26.2, enrolled in, a prospective observational safety study on pregnancy outcomes in women immunized with seasonal cell culture influenza trivalent (TIVc) or quadrivalent (QIVc) vaccine during pregnancy.   The subject's medical history included dysuria, nausea, exposure to influenza virus and advanced maternal age. The subject was Rh negative.   The subject's concomitant medications included Macrobid (nitrofurantoin) for dysuria, Prenatal vitamins (unspecified vitamins and minerals) as vitamin, Diclegis (doxylamine succinate and pyridoxine hydrochloride) for nausea, Tamiflu (oseltamivir phosphate) for exposure to flu virus, TDAP (diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid) as vaccine and Rhogam (anti-D immunoglobulin) for RhD negative.  The subject's obstetrical history noted that the subject had two previous pregnancies of full-term live birth. The subject had no history of offspring with major congenital malformation (MCM), nor relevant maternal history. The subject's partner (father of a baby) had haemophilia. The subject did not use tobacco, alcohol or illicit drugs during pregnancy.   The subject's last menstrual period (LMP) date was 15-May-2019. The subject's estimated date of delivery (EDD) and corrected estimated date of delivery (CEDD) were both 19-Feb-2020. The type of pregnancy was singleton.  On 16-Jul-2019, the subject underwent initial ultrasound and no MCM was noted.  On 26-Jul-2019, the subject underwent MaterniT21 and no MCM was noted.  On 04-Sep-2019, the subject underwent maternal serum alpha fetoprotein (MSAFP/serum markers) and second trimester screen. No MCM was noted.  On 27-Sep-2019, at gestational age of  19 weeks, the subject was administered Flucelvax QIVc (Flu Vaccine Cell Subunit QIV NVD) [influenza vaccine, subunit influenza virus vaccine polyvalent; batch number: 261207, dose: 0.5 mg, 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, the subject underwent anatomy ultrasound and no MCM was noted.  On 23-Oct-2019, the subject developed candidiasis of skin. The subject started treatment with nystatin cream at the dose of  0.1 %, twice  a day, topically.  On 16-Jan-2020, at gestational age of 35.1 weeks, the subject vaginally delivered male neonate. The labor was complicated with preterm premature rupture of membranes (PPROM) for which no details were provided. The birth weight of the neonate was 2580 g. No data was provided for head circumference and length. Appearance, pulse, grimace, activity and respiration (APGAR) score at one minute was 7, at five minutes was 8. No data was reported for APGAR score at ten minutes. No MCM was identified at birth. The newborn was admitted to neonatal intensive care unit.  At the time of this reporting, the outcome of skin candida was not resolved while the outcome of premature labor/progression of labor (POL), premature rupture of membranes (PPROM) and was not reported.  The events of premature labor/progression of labor (POL) and premature rupture of membranes were considered serious due to the criterion of medical significance per company.  The reporter did not provide causality assessment to Flucelvax QIVc.  This case is linked to 202001873, the corresponding child case.  Follow up received on 24-Jan-2020: The outcome of pregnancy provided. Formulation for Macrobid updated. The events of premature labor/progression of labor (POL) and premature rupture of membranes added and event assessment for these events added. The case updated from non-serious to serious. The stop date and outcome for the event of vaccine exposure during pregnancy updated. Narrative amended accordingly.  Company Comment: The subject experienced premature labour, preterm premature rupture of membranes and skin candida after vaccination with the suspect product, Flucelvax QIV. Reportedly, vaccination occurred during pregnancy at 19 weeks of gestation. Chronology is plausible. Pregnant state and advanced maternal age may provide alternative aetiology for the event. Causality is also confounded with multiple concomitant medications and non-company vaccine TDAP (diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid).  Vaccine exposure during pregnancy is assessed as not related per company's conventions. Causality between suspect product and the events premature labour, preterm premature rupture of membranes and skin candida is assessed as unlikely related (defaults to related for reporting purposes).; Sender's Comments: The subject experienced premature labour, preterm premature rupture of membranes and skin candida after vaccination with the suspect product, Flucelvax QIV. Reportedly, vaccination occurred during pregnancy at 19 weeks of gestation. Chronology is plausible. Pregnant state and advanced maternal age may provide alternative aetiology for the event. Causality is also confounded with multiple concomitant medications and non-company vaccine TDAP (diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid).  Vaccine exposure during pregnancy is assessed as not related per company's conventions. Causality between suspect product and the events premature labour, preterm premature rupture of membranes and skin candida is assessed as unlikely related (defaults to related for reporting purposes).