Age: 23.0
Sex: F
Vaccine: FLUX
Symptoms: Alpha 1 foetoprotein normal, Amniotic fluid volume, Caesarean section, Cervical dilatation, Exposure during pregnancy
Clinical narrative: Delivery at 33.3 weeks of gestation; Progression of labour; Gestational diabetes mellitus; Vaccine exposure during pregnancy; Trichomoniasis; This is an observational study case, initially received from other health professional on 12-Dec-2019, concerning a 23-year-old, female pregnant subject of body weight: 250 lbs, height: 67,2 inches and body mass index (BMI): 38,9, enrolled in a prospective observational safety study.   The subject's current condition included sinus infection, nausea, amenorrhea, cannabis abuse and severe obesity.   The subject's concomitant medication t included prenatal vitamins (minerals nos; vitamins nos) as OB (obstetrical) supplement, Diclegis (doxylamine succinate, pyridoxine hydrochloride) for nausea and cefdinir for sinus infection.  The subject's obstetrical history included two previous pregnancies with one full term live birth and one spontaneous abortus. The subject had no history of offspring with major congenital malformation (MCM) and no relevant maternal and paternal medical history. The subject used cannabis during pregnancy but did not use tobacco and alcohol.   The subject's last menstrual period (LMP) was not reported, the subject's estimated date of delivery (EDD) and corrected estimated date of delivery (CEDD) were reported as 20-Apr-2020. The type of pregnancy was singleton.   On 08-Oct-20019, at unknown week of gestation, the subject was administered Flucelvax (Flu Vaccine Cell Subunit QIV NVD) [ influenza vaccine, subunit influenza virus vaccine polyvalent; batch number: 261207; dose: 0.5 ml; route of administration, anatomical location and expiry date: not reported] (explicitly coded as Vaccine exposure during pregnancy) for influenza immunisation.  On unspecified date, after vaccination, the funic presentation and intrauterine cervical dilation were noted.  On the same day, the subject underwent nuchal translucency and first trimester screen. No MCMs were noted.  On an unknown date in 2019, the subject developed trichomoniasis.  On 15-Oct-2019, the patient started treatment with metronidazole at dose of four tablets, administered daily.  On 17-Oct-2019, treatment with metronidazole was stopped.  On 23-Oct-2019 subject started treatment with oral cefdinir, one tablet administered twice daily for sinus infection.  On 02-Nov-2019 treatment with cefdinir was stopped.  On 05-Nov-2019, the subject underwent second trimester screen and MSAFP/serum markers analysis and no MCM was noted.   On 26-Nov-2019, the subject underwent anatomy ultrasound scan, and it was reported that scan was incomplete and follow up needed in four weeks, so results were unknown.   On 23-Dec-2019, the subject underwent ultrasound/follow up head circumference to abdominal circumference ratio was small for dates. No MCMs were noted.  On 17-Jan-2020, 24-Jan-2020 and 31-Jan-2020, the subject underwent ultrasound/follow up growth ultrasound and intrauterine growth was noted. No MCMs were noted.  On 24-Jan-2020 the subject was administered intramuscular TDAP (diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid), at dose of 0,5 mg as vaccine.  On 27-Jan-2020, the subject started concomitant therapy with betamethasone acetate for fetal growth restriction, 6 mg per mL times 2 mL administered intramuscular one day only.  On 03-Feb-2020, the patient developed gestational diabetes mellitus.  On 07-Feb-2020, the subject underwent ultrasound/follow up ultrasound biophysical profile and intrauterine growth was noted. No MCMs were noted.  On 14-Feb-2020, the subject underwent amniotic fluid volume; biophysical profile; ultrasound age dopplers intrauterine growth was noted. No MCMs were noted.  On 26-Feb-2020, the subject underwent ultrasound for growth; biophysical profile and umbilical artery doppler and intrauterine growth was noted. No MCMs were noted.  At gestation age of 33.3 weeks, the subject delivered a live birth, female neonate via Caesarean method. On the same day progression of labour was noted. The neonate's birth weight was 1701 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).  The APGAR score for ten minutes was not reported. It was reported that there were no MCM identified at birth.  At the time of this report, the patient had not recovered from gestational diabetes mellitus while the outcome for all other events was not reported.  The events of 'premature delivery' and 'gestational diabetes mellitus' were considered serious due criterion of medical significance.  The causality assessment was not provided. This case is linked with 202002621(corresponding baby's case).  Follow up information received from other health professional on 25-Mar-2020: The corrected EDD, and additional laboratory tests provided. The outcome of pregnancy reported and changed from not reported to resolved. New concomitant medications provided: Tdap, diclegis and betamethasone acetate. New event of gestational diabetes mellitus was provided, with start date. Events of 'premature delivery' and 'percipitate labour' were provided. Pregnancy information were updated in patient tab and narrative amended accordingly. Nausea added in medical history.  Company comment:The subject developed trichomoniasis on an unknown date after vaccination, while gestational diabetes, premature delivery and precipitate labour occurred approximately five months after vaccination with the suspect product, Flu Vaccine Cell Subunit QIV NVD. Chronology is unclear for the event of trichomoniasis, while unsuggestive for other events. Reportedly, the subject was administered Flucelvax on an unknown week of gestation (explicitly coded as Vaccine exposure during pregnancy). Causality was confounded by medical history of spontaneous abortus, cannabis abuse and severe obesity. Vaccine exposure during pregnancy is assessed as not related per company's conventions. Causal relationship between the suspect product and all other events is assessed as unlikely related (defaults to "related" in the safety database for reporting purposes).; Sender's Comments: The subject developed trichomoniasis on an unknown date after vaccination, while gestational diabetes, premature delivery and precipitate labour occurred approximately five months after vaccination with the suspect product, Flu Vaccine Cell Subunit QIV NVD. Chronology is unclear for the event of trichomoniasis, while unsuggestive for other events. Reportedly, the subject was administered Flucelvax on an unknown week of gestation (explicitly coded as Vaccine exposure during pregnancy). Causality was confounded by medical history of spontaneous abortus, cannabis abuse and severe obesity. Vaccine exposure during pregnancy is assessed as not related per company's conventions. Causal relationship between the suspect product and all other events is assessed as unlikely related (defaults to "related" in the safety database for reporting purposes).