Age: 28.0
Sex: F
Vaccine: UNK
Symptoms: Rash pruritic, Ultrasound antenatal screen, Ultrasound antenatal screen normal
Clinical narrative: Pruritic rash; Herpes simplex virus I mouth; Acute bronchitis; Nausea; Vaccine exposure during pregnancy; This is an observational pregnancy study case initially received from other health professional on 09-Dec-2019, concerning a 28-year-old, adult, female pregnant subject of body weight: 213 lbs, height: 63 inches and body mass index (BMI): 37.7, enrolled in a prospective observational study.  The subject's current medical conditions included obesity (BMI 37.7), autoimmune disease causing calcium build up on kidneys, anxiety/depression, asthma and upper respiratory tract infection.  The subject also had a history of LEEP (loop electrosurgical excision procedure).   The subject's concomitant medications included folic acid as vitamin and amoxicillin for upper respiratory infection.   The subject's obstetrical history included five previous pregnancies with two full term live births, two spontaneous abortions and one stillbirth. The subject did not have a history of offspring with major congenital malformation (MCM). Also, the subject did not have maternal or paternal history with MCMs.    The subject's last menstrual period (LMP) date was 06-Sep-2019, estimated delivery date (EDD) and corrected estimated date of delivery (CEDD) were reported as 12-Jun-2020. The subject did not use tobacco, alcohol or illicit drugs during pregnancy.   On an unknown date, the pregnancy status was collected, and no pregnancy complications were noted. The type of pregnancy was singleton.  On 01-Nov-2019, the subject underwent ultrasound scan and no MCM was noted.   On 21-Nov-2019, at 10 weeks of gestation (calculated per LMP), the subject was administered Flucelvax QIVc (Flu Vaccine Cell Subunit QIV NVD) [influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, batch number: 261223, route of administration, anatomical location and expiration date: not reported] (explicitly coded as Vaccine exposure during pregnancy') for influenza immunisation.   On the same day, an unknown amount of time after vaccination, the subject developed nausea.   On 21-Nov-2019, the subject started corrective treatment with Diclegis (doxylamine succinate, pyridoxine hydrochloride) at a dose of 10 mg, 2 tablets at every bedtime, 1 tablet every morning, 1 tablet every evening, orally.  On 02-Dec-2019, the subject underwent first trimester screen and nuchal translucency and no MCMs were noted.   On 27-Dec-2019, the subject underwent second trimester screen and no MCM was noted.   On the same date the subject underwent ultrasound cervical length (CL) check which showed CL of 4.5. No MCM was noted.   On 30-Dec-2019, the subject developed acute bronchitis and started treatment with Zithromax (azithromycin) at a dose of 250 mg, frequency: as directed, orally.   On 05-Jan-2020, the treatment with Zithromax was stopped.   On 22-Jan-2020, the subject underwent anatomy ultrasound which was incomplete and follow up was scheduled in four weeks.   On 02-Feb-2020, the subject developed herpes simplex virus I mouth, and started treatment with Valtrex (valacyclovir) at a dose of 500 mg, twice a day (bid), orally.   On 07-Feb-2020, the subject underwent ultrasound follow-up. Anatomy was within normal limits, cervical length was 3.6 and no MCM was noted.  On the same date, the subject recovered from herpes simplex virus I mouth and treatment with Valtrex was stopped.   On 21-Feb-2020, the subject underwent ultrasound follow-up, cervical length was 3.8 and no MCM was noted.   On 28-Feb-2020, the subject developed pruritic rash and started corrective treatment with hydrocortisone cream, 2.5 percent, twice a day, administered topically and Medrol Dosepak (methylprednisolone) at a dose of 4 mg, frequency: taper dose, administered orally.   On 06-Mar-2020, the treatment with Medrol Dosepak was stopped.   At the time of this report, the subject did not recover from pruritic rash and nausea. Outcome of the event acute bronchitis was not reported.   The event of acute bronchitis was assessed as serious due to the criterion of medical significance, per company.   The reporter did not provide causality assessment.   Follow up information received from other health professional on 13-Mar-2020: New adverse events (acute bronchitis, herpes simplex virus I and pruritic rash) were received. The event of acute bronchitis was assessed as medically significant; therefore, the case was upgraded to serious. Laboratory tests added in patient's tab. Zithromax, Valtrex, hydrocortisone and Medrol Dosepak added as treatment medications. Narrative was amended accordingly.  Company comment: The patient developed nausea on the same day after vaccination, experienced the event of bronchitis after more than a month after vaccination, while herpes simplex and rash pruritic occurred after approximately three months after administrating the suspect product, Flucelvax QIV. Reportedly, the patient received vaccine at gestation age of 10 weeks (explicitly coded as Vaccine exposure during pregnancy').  Causality for the event of bronchitis was confounded by medical history of asthma and upper respiratory tract infection. Considering all the above mentioned, causal relationship between the suspect product and the event of vaccine exposure during pregnancy is assessed as not related per company conventions, for nausea is assessed as possibly related, while for the events of bronchitis, herpes simplex and rash pruritic as unlikely related. (defaults to "related" in the safety database for reporting purposes).; Sender's Comments: The patient developed nausea on the same day after vaccination, experienced the event of bronchitis after more than a month after vaccination, while herpes simplex and rash pruritic occurred after approximately three months after administrating the suspect product, Flucelvax QIV. Reportedly, the patient received vaccine at gestation age of 10 weeks (explicitly coded as Vaccine exposure during pregnancy').  Causality for the event of bronchitis was confounded by medical history of asthma and upper respiratory tract infection. Considering all the above mentioned, causal relationship between the suspect product and the event of vaccine exposure during pregnancy is assessed as not related per company conventions, for nausea is assessed as possibly related, while for the events of bronchitis, herpes simplex and rash pruritic as unlikely related. (defaults to "related" in the safety database for reporting purposes).