Age: 30.0
Sex: F
Vaccine: FLUX
Symptoms: Prenatal screening test, Type 2 diabetes mellitus, Ultrasound antenatal screen normal
Clinical narrative: Cough; Vaccine exposure during pregnancy; Type 2 diabetes mellitus aggravated; Herpes simplex aggravated; This is an observational study case, initially received from other health professional on 12-Dec-2019, concerning a 30-year-old, female pregnant subject of body weight: 317 lbs, height: 70 inches and body mass index (BMI): 45.5 enrolled in, a prospective observational safety study.  The subject's current condition included severely obesity with BMI 40 +, diabetes mellitus type 2, chronic hypertension (CHTN) and herpes simplex virus.  The subject's concomitant medication included Prometrium (progesterone) for history of miscarriage, prenatal vitamins (unspecified vitamins and minerals), vitamin D as vitamin supplementation and labetalol for chronic hypertension.   The subject's obstetrical history included two previous pregnancies with two previous spontaneous abortions. The subject had no history of offspring with major congenital malformation (MCM) and no relevant maternal and paternal medical history with MCMs. The subject did not use tobacco, alcohol or illicit drugs during pregnancy.   The subject's last menstrual period (LMP) date was 22-Jul-2019. The subject's estimated delivery date (EDD) and corrected estimated date of delivery (CEDD) were on 27-Apr-2020. The type of pregnancy was singleton.   On 06-Sep-2019, the subject underwent ultrasound and no MCM was noted.  On 14-Oct-2019, at gestational age of 12 weeks, the subject was administered with Flucelvax QIV (Flu Vaccine Cell Subunit QIV NVD) [influenza vaccine, subunit influenza virus vaccine polyvalent, batch number: 261727, dose: 0.5 ml, anatomical location, route of administration and expiration date: not reported] (explicitly coded as 'Vaccine exposure during pregnancy') for influenza immunisation. On the same day, the subject underwent Maternity 21 and no MCM was noted.  On an unspecified date in 2019, an unknown amount of time after vaccination, the subject developed aggravation of herpes simplex virus and type 2 diabetes mellitus.  On 21-Oct-2019, the subject was treated with valacyclovir at dose of 500 mg, twice a day, for 10 days as needed, orally, for aggravation of herpes simplex virus.  On 11-Nov-2019, the subject underwent second trimester screen and Maternal serum alpha-fetoprotein screening (MSAFP)/serum markers and no MCM was noted.  On 22-Nov-2019, the subject was treated with Lantus Solostar u-100 (insulin glargine) at dose of 10 units, at bedtime, subcutaneously for aggravation of type 2 diabetes mellitus.  On 04-Dec-2019, the subject underwent anatomy ultrasound and no MCM was noted.  On 26-Dec-2019, two months and 12 days after vaccination, the subject developed cough and was treated with Albuterol HFA (salbutamol), dose reported as: 2 puff, every four hours as needed, via inhalation route of administration.   At the time of this report, the outcome of the event cough was not resolved, while the outcome of the events of type 2 diabetes mellitus aggravated and herpes simplex virus aggravated was not reported.  The event of type 2 diabetes mellitus aggravated was considered serious due to the criterion of medical significance.  The reporter did not provide causality assessment.  Follow up received from other health professional on 14-Jan-2020: Type 2 diabetes mellitus aggravated, herpes simplex virus aggravated and cough were added as new events and accordingly case was upgraded from non-serious to serious. Laboratory analysis and treatments medications were added. The narrative was amended accordingly.  Company comment: The subject experienced diabetes mellitus aggravated, Herpes simplex aggravated and cough after vaccination with the suspect product, Flucelvax QIVc. Reportedly, vaccination occurred during pregnancy at 12 weeks of gestation. Chronology is plausible.  Medical history of obesity (body mass index (45.5) diabetes mellitus type 2 and herpes simplex virus may provide alternative aetiology for the events. Causality is also confounded by therapy with concomitant medication labetalol. Vaccine exposure during pregnancy is assessed as not related per company's conventions. Causality between suspect product and the events diabetes mellitus aggravated, Herpes simplex aggravated and cough is assessed as unlikely related (defaults to related for reporting purposes).; Sender's Comments: The subject experienced diabetes mellitus aggravated, Herpes simplex aggravated and cough after vaccination with the suspect product, Flucelvax QIVc. Reportedly, vaccination occurred during pregnancy at 12 weeks of gestation. Chronology is plausible.  Medical history of obesity (body mass index (45.5) diabetes mellitus type 2 and herpes simplex virus may provide alternative aetiology for the events. Causality is also confounded by therapy with concomitant medication labetalol. Vaccine exposure during pregnancy is assessed as not related per company's conventions. Causality between suspect product and the events diabetes mellitus aggravated, Herpes simplex aggravated and cough is assessed as unlikely related (defaults to related for reporting purposes).