Age: 29.0
Sex: F
Vaccine: TDAP, UNK
Symptoms: Exposure during pregnancy, Pre-eclampsia, Premature delivery
Clinical narrative: Delivery at 36.7 weeks of gestation; Vaccine exposure during pregnancy; Pre-eclampsia in third trimester; This is an observational study case, reported by other health professional and initially received on 20-Jan-2020, concerning a 29-year-old pregnant, female subject of body weight 190 lbs, height 65 inches and body mass index (BMI) 31.6,  enrolled in a prospective observational safety study.  The subject's medical history included obesity with BMI 31.6, anxiety, depression, nausea and intrauterine insemination.  The subject's past medication included Femara (letrozole) for an unknown indication, while the subject's concomitant medications included prenatal vitamins (unspecified vitamins and minerals) as supplement, lamotrigine for anxiety and depression, Bonjesta (doxylamine succinate, pyridoxine hydrochloride) and promethazine, both indicated for nausea.  The subject's obstetrical history included one previous spontaneous abortion. The subject had no history of offspring with major congenital malformation (MCM). Also, the subject had maternal history with MCM included mother with heart defect and no 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 28-Mar-2019. The subject's estimated date of delivery (EDD) and corrected estimated date of delivery (CEDD) were reported as 02-Jan-2020. The type of pregnancy was singleton.   On 11-Jun-2019, the subject underwent maternity 21 test and no MCM was noted.  On 22-Jul-2019, the subject underwent maternal serum alpha fetoprotein screening (MSAFP/serum markers) and second trimester screen and no MCMs were noted.  On 13-Aug-2019, the subject underwent anatomy ultrasound and no MCM was noted.  On 09-Oct-2019, at approximately 27 weeks of gestation, the subject was administered  Flucelvax QIVc (Flu Vaccine Cell Subunit QIV NVD)  [influenza vaccine, subunit influenza virus vaccine polyvalent, batch number: 261215, 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 the same day, the subject was administered  non-company co-suspect Tdap vaccine [diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid, dose: 0.5 ml; route of administration, anatomical location, batch number and expiry date: not reported] as vaccine.  On an unspecified date in 2019, in third trimester, the subject developed pre-eclampsia.  At gestation age of 36.7 weeks, the subject vaginally delivered a live birth, female neonate.The neonate's birth weight was 3402 g, length and head circumference were not reported. 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 outcome of the events of premature delivery and pre-eclampsia was not reported.  The events of pre-eclampsia and premature delivery were considered as serious due medical significance per company.  The reporter did not provide causality assessment to Flucelvax QIVc.  This case is linked to case 202000579 (the corresponding baby case).  Company Comment: The subject experienced pre-eclampsia and premature delivery after vaccination with the suspect product, Flucelvax QIV. The patient was administered vaccine at approximately 27 weeks of gestation. Chronology is plausible. Medical history of one previous spontaneous abortion, obesity (body mass index 31.6) and non-company co-suspect Tdap vaccine (diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid) may provide alternative aetiology for the events. Causality is also confounded by therapy with concomitant medication, Bonjesta (doxylamine succinate, pyridoxine hydrochloride), lamotrigine and promethazine. Causality between suspect product and the events pre-eclampsia and premature delivery is assessed as unlikely related (defaults to related for reporting purposes). Vaccine exposure during pregnancy is assessed as not related to the suspect vaccine per company's conventions.; Sender's Comments: The subject experienced pre-eclampsia and premature delivery after vaccination with the suspect product, Flucelvax QIV. The patient was administered vaccine at approximately 27 weeks of gestation. Chronology is plausible. Medical history of one previous spontaneous abortion, obesity (body mass index 31.6) and non-company co-suspect Tdap vaccine (diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid) may provide alternative aetiology for the events. Causality is also confounded by therapy with concomitant medication, Bonjesta (doxylamine succinate, pyridoxine hydrochloride), lamotrigine and promethazine. Causality between suspect product and the events pre-eclampsia and premature delivery is assessed as unlikely related (defaults to related for reporting purposes). Vaccine exposure during pregnancy is assessed as not related to the suspect vaccine per company's conventions.