Age: 21.0
Sex: F
Vaccine: UNK
Symptoms: Complication of pregnancy, Condition aggravated, Delivery, Exposure during pregnancy, Gestational diabetes
Clinical narrative: Pre-eclampsia; Morbid obesity; Condition aggravated; Gestational hypertension in 3rd trimester; Otitis media; Gestational diabetes mellitus (GDM); Vaccine exposure during pregnancy; This is an observational study case, initially received from other health professional on 12-Dec-2019, concerning a 21-year-old, pregnant, female subject of body weight: 203 lbs, height: 64 inches and body mass index (BMI): 34.8, enrolled in a prospective observational safety study.  The subject's medical history included obesity (BMI 30+), anxiety, nausea and vomiting.   The subject's concomitant medications included promethazine, Pepcid (famotidine), Bonjesta (doxylamine succinate, pyridoxine hydrochloride), Scopolamine (hyoscine) patch, ondansetron and Prilosec (omeprazole) all for nausea, Mini Prenatal (unspecified minerals and vitamins) as vitamin supplement and TDAP (diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid) as vaccine.  The subject had no previous pregnancies. The subject had no maternal or paternal history with major congenital malformations (MCMs). Also, the subject had no history of offspring with MCM. The subject did not use alcohol, tobacco or illicit drugs during pregnancy.   The subject's last menstrual period (LMP) date was on 10-Jul-2019. The subject's estimated delivery date (EDD) and corrected estimated date of delivery (CEDD) were both reported as 15-Apr-2019. The type of pregnancy was singleton.  On 20-Sep-2019, approximately at 10 weeks of gestation (calculated per LMP), the subject was administered Flucelvax QIV (Flu Vaccine Cell Subunit QIV NVD) [influenza vaccine, subunit influenza virus vaccine polyvalent, batch number: 261200, dose: 0.5 ml, route of administration, anatomical location and expiration date: not reported] (explicitly coded as 'Vaccine exposure during pregnancy') for an influenza immunization.   On an unspecified date, the subject developed pre-eclampsia and morbid obesity, reported as pregnancy complications.  On 11-Oct-2019, the subject underwent first trimester screen and no MCM was noted.   On 05-Nov-2019, the subject underwent second trimester screen and no MCM was noted.   On 26-Nov-2019, the subject underwent an anatomy ultrasound and no MCM was noted.   On 30-Dec-2019, the subject underwent ultrasound and no MCM was noted.  On 28-Jan-2020, the subject developed gestational diabetes mellitus (GDB).  On 24-Mar-2020, the subject developed otitis media and started with treatment medications Augmentin (amoxicillin and clavulanic acid) at the dose of one tablet, consumed twice a day, orally and Flonase (fluticasone propionate) at the dose of one spray, consumed once a day, nasally.  On 29-Mar-2020, the subject stopped with treatment medication Flonase.  On 01-Apr-2020, the subject stopped with treatment medication Augmentin.  On 02-Apr-2020, the subject developed gestational hypertension.  At approximately 38.6 weeks of gestation (as reported), the subject gave live birth to a female neonate vaginally. The characteristics of the neonate included birth weight: 3799 grams, while head circumference and length were not reported. The appearance, pulse, grimace, activity, and respiration (APGAR) scores were 8 at one minute and 9 at five minutes. No data was provided for APGAR score at 10 minutes. No MCMs were identified at the time of birth.   At the time of this report, the subject did not recover from the events of gestational diabetes mellitus', otitis media' and gestational hypertension', while the outcome for the events of pre-eclampsia' , morbid obesity' and 'condition aggravated' was not reported.  The events of pre-eclampsia' and gestational diabetes mellitus' were considered as serious due to criterion of medical significance, per company.  The reporter did not provide causality assessment to Flucelvax QIVc.  Follow up information received from other health professional on 16-Jan-2020: Lab data updated. Two concomitant medications added. Narrative amended accordingly.   Follow up information received from other health professional on 15-Apr-2020: The CEDD, additional prenatal test (ultrasound) and concomitant medication (TDAP) were provided. The new events (pre-eclampsia, gestational hypertension, otitis media, morbid obesity and gestational diabetes mellitus) and treatment medications (Flonase and Augmentin) were reported as well as the pregnancy outcome. The stop date was updated for the event of vaccine exposure during pregnancy' and outcome was amended from not reported' to 'recovered'. As reported events pre-eclampsia' and gestational diabetes mellitus' were considered as serious, the case was upgraded from non-serious to serious. The narrative was amended accordingly.  Company comment: A 57-year-old female patient developed pre-clampsia, gestational diabetes, gestational hypertension, otitis media and obesity aggravated after vaccination with the suspect product Flucelvax QIV for influenza immunisation. Reportedly, on an unspecified date, the subject developed pre-eclampsia and morbid obesity making chronology plausible due to narrative information. For remaining events chronology seems compatible. The subject's medical history included obesity (BMI 30+), anxiety, nausea and vomiting. The subject's concomitant medications included promethazine, Pepcid (famotidine), Bonjesta (doxylamine succinate, pyridoxine hydrochloride), Scopolamine (hyoscine) patch, ondansetron and Prilosec (omeprazole) all for nausea, Mini Prenatal (unspecified minerals and vitamins) as vitamin supplement and TDAP (diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid) as vaccine. With information presented, causality is assessed as unlikely related for pre-clampsia, gestational diabetes, gestational hypertension and obesity aggravated due to reported confounders (BMI, advanced age and numerous concomitant drugs). For the event of otitis media causality was also assessed as unlikely related due to temporal relationship. Exposure during pregnancy is assessed as unrelated per company conventions. (''unlikely related'' defaults to "related" in the safety database for reporting purposes); Sender's Comments: A 57-year-old female patient developed pre-clampsia, gestational diabetes, gestational hypertension, otitis media and obesity aggravated after vaccination with the suspect product Flucelvax QIV for influenza immunisation. Reportedly, on an unspecified date, the subject developed pre-eclampsia and morbid obesity making chronology plausible due to narrative information. For remaining events chronology seems compatible. The subject's medical history included obesity (BMI 30+), anxiety, nausea and vomiting. The subject's concomitant medications included promethazine, Pepcid (famotidine), Bonjesta (doxylamine succinate, pyridoxine hydrochloride), Scopolamine (hyoscine) patch, ondansetron and Prilosec (omeprazole) all for nausea, Mini Prenatal (unspecified minerals and vitamins) as vitamin supplement and TDAP (diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid) as vaccine. With information presented, causality is assessed as unlikely related for pre-clampsia, gestational diabetes, gestational hypertension and obesity aggravated due to reported confounders (BMI, advanced age and numerous concomitant drugs). For the event of otitis media causality was also assessed as unlikely related due to temporal relationship. Exposure during pregnancy is assessed as unrelated per company conventions. (''unlikely related'' defaults to "related" in the safety database for reporting purposes)