Age: 19.0
Sex: F
Vaccine: FLUX
Symptoms: Bacterial vaginosis, Chromosome analysis normal, Exposure during pregnancy, Nausea, Prenatal screening test
Clinical narrative: Bacterial vaginosis; Vaccine exposure during pregnancy; Nausea; Urinary tract infection; This observational study case, initially received on 15-Dec-2020 from other health professional and concerned a 19-year-old pregnant, female subject, of body weight 106 lbs, height 62 inches and body mass index (BMI) 19.4, enrolled in a prospective observational safety study on pregnancy outcomes in women immunized with Afluria QIV, a seasonal quadrivalent vaccine, during pregnancy.   The subject's concurrent conditions included juvenile arthritis. The subject's concomitant medications included Prenatal vitamins (unspecified minerals and vitamins) for healthy pregnancy.   The subject's obstetrical history included one previous pregnancy with one elective abortion. The subject had no history of offspring with major congenital malformation (MCM). Also, the subject had no maternal or 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 reported as 23-Aug-2020. The subject's estimated delivery date (EDD) was reported as 30-May-2021 and corrected estimated date of delivery (CEDD) was not reported. The type of pregnancy was singleton.   On 01-Oct-2020, at five weeks of gestation (calculated per LMP), the subject was vaccinated with Afluria QIV (Flu Vaccine Egg Split QIV CSL) (influenza vaccine, dose, route of administration and anatomical location: not reported) (explicitly coded as 'Vaccine exposure during pregnancy') for an influenza immunisation. The batch number reported was P100239705.  On the same day, the subject experienced bacterial vaginosis. On the same day, the subject started treatment with cream Metrogel 0.75% (metronidazole), once at night, vaginally for bacterial vaginosis.  On 05-Oct-2020, treatment with Metrogel was stopped.  On an unknown date in Oct-2020, the subject experienced nausea.  On 30-Oct-2020, the subject started treatment with Zofran (ondansetron hydrochloride), at a dose of 4 mg, three times daily, orally, for nausea  On an unknown date in 2020, the subject experienced urinary tract infection (UTI).  On 06-Nov-2020, the subject started treatment with Macrobid (clarithromycin), at a dose of 100 mg, twice daily, orally, for UTI.  On 13-Nov-2020, treatments with Macrobid and Zofran were stopped.  On 16-Nov-2020, the first trimester prenatal screening test and MaterniT21 test revealed no MCM.  The outcome of the events was not reported.  The reporter did not provide causality assessment.  The event of 'urinary tract infection' was considered to be medically significant by a Physician within Seqirus' Pharmacovigilance and Risk Management Department.  Company comment: A 19-year-old pregnant, female subject experienced bacterial vaginosis  on the same day after administration of Afluria QIV, while nausea and urinary tract infection occurred on an unkown day. The subject's concurrent conditions included juvenile arthritis, while concomitant medications included unspecified minerals and vitamins for healthy pregnancy. Vaccine exposure during pregnancy is assessed as unrelated per company conventions. Causality is assessed as not related for all events due to biological implausibility, unclarified chronology (for 2 events) and presented confounder - pregnancy.; Sender's Comments: A 19-year-old pregnant, female subject experienced bacterial vaginosis  on the same day after administration of Afluria QIV, while nausea and urinary tract infection occurred on an unkown day. The subject's concurrent conditions included juvenile arthritis, while concomitant medications included unspecified minerals and vitamins for healthy pregnancy. Vaccine exposure during pregnancy is assessed as unrelated per company conventions. Causality is assessed as not related for all events due to biological implausibility, unclarified chronology (for 2 events) and presented confounder - pregnancy.