Age: 26.0
Sex: F
Vaccine: FLUX
Symptoms: Mixed anxiety and depressive disorder, Nausea, Ultrasound antenatal screen, Ultrasound antenatal screen normal, Urinary tract infection
Clinical narrative: Mixed anxiety and depression; Urinary tract infection; Lower back pain; Migraine; Anemia; Nausea; Vomiting; Vaccine exposure during pregnancy; This is an observational study case from, initially received on 17-Jan-2020, concerning a 26-year-old, pregnant female subject, of body weight 119.8 lbs, height 61.2 inches and body mass index (BMI) 22.5, enrolled in, a prospective observational safety study.   The subject's current medical conditions included scoliosis (deformity of the spine) and anxiety. The subject was rubella non-immune.  The subject's concomitant medication included unspecified vitamins as obstetrical (OB) supplement and Vistaril (hydroxyzine hydrochloride) for anxiety.  The subject's obstetrical history noted that the subject had no previous pregnancies. 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 30-Sep-2019, estimated delivery date (EDD) was reported as 06-Jul-2020, while corrected estimated date of delivery (CEDD) was not reported. The type of pregnancy was singleton.   On 12-Dec-2019, at gestational age of 10 weeks (calculated per LMP), the subject was administered Flucelvax QIV (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 an influenza immunisation.   On the same day, after vaccination, the subject experienced nausea and vomiting due to which started treatment with Bonjesta (doxylamine succinate, pyridoxine hydrochloride, one tablet, orally, two times per day). On the same day, the subject also experienced anaemia and started treatment with CitraNatal Bloom with iron (vitamin C, calcium, iron, vitamin D3, vitamin E, thiamin, riboflavin, niacinamide, vitamin B6, folic acid, iodine, zinc, copper, docusate sodium, one tablet, orally, once per day) as OB supplementation.  On 30-Dec-2019, the subject underwent first trimester screen, initial ultrasound and nuchal translucency and no MCMs were noted.  On 30-Jan-2020, the subject underwent second trimester screen and maternal serum alpha-fetoprotein screening (MSAFP)/serum markers and no MCMs were noted.  On an unspecified date, after vaccination, the patient experienced mixed anxiety and depression.  On 31-Jan-2020, one month and 19 days after vaccination, the subject experienced lower back pain, urinary tract infection (UTI) and migraine. On the same day, the subject started treatment with Macrobid (nitrofurantoin, 100 mg, every 12 hours, orally, until 07-Feb-2020) for UTI and Fioricet (butalbital, caffeine, paracetamol, one tablet, every four hours as needed, orally) for migraine.  On 07-Feb-2020, the outcome of the event UTI was resolved.  On 13-Feb-2020, the subject underwent anatomy ultrasound and no MCM was noted.  On 05-Mar-2020, the subject started treatment with fluoxetine (10 mg, every day, orally) for mixed anxiety and depression.  At the time of this report, the outcome of the events nausea, vomiting, anaemia, lower back pain, migraine and mixed anxiety and depression was not resolved.  Per company, the event of urinary tract infection was assessed as serious due to the criterion of medical significance.   The reporter did not provide causality assessment.  Follow up information received from other health professional on 25-Mar-2020: Laboratory data (initial/anatomy ultrasound, nuclear translucency, MSAFP/serum markers, the second trimester screen) added, subject's medical history updated (rubella non-immune added as current condition), Vistaril added as concomitant medication, Macrobid, Fioricet and Fluoxetine added as treatment medications. UTI, migraine, lower back pain, and mixed anxiety and depression added as events. The narrative was amended accordingly.  Company comment: A 26-year-old pregnant female subject developed anaemia, nausea, vomiting, UTI, migraine, lower back pain, mixed anxiety and depression after vaccination with the suspect product Flucelvax QIV for influenza immunisation. For anaemia, nausea, vomiting chronology seems suggestive, while for all other reported events chronology seems plausible. The subject's current medical conditions included scoliosis (deformity of the spine) and anxiety, while concomitant medication included unspecified vitamins as obstetrical (OB) supplement. Considering that the subject was pregnant anaemia, nausea and vomiting can be confounded with reported pregnancy however, temporal relationship is too suggestive since events occurred the same day after product was given. With information provided, causality is assessed as unlikely related for anaemia and nausea and not related for vomiting (since nausea occurred) and exposure during pregnancy (per company conventions). For other events there are no suggestions that they developed due to vaccination and pregnancy might be a more plausible explanation however causal role cannot be entirely excluded, making them unlikely related as well. (''unlikely related'' defaults to "related" in the safety database for reporting purposes); Sender's Comments: A 26-year-old pregnant female subject developed anaemia, nausea, vomiting, UTI, migraine, lower back pain, mixed anxiety and depression after vaccination with the suspect product Flucelvax QIV for influenza immunisation. For anaemia, nausea, vomiting chronology seems suggestive, while for all other reported events chronology seems plausible. The subject's current medical conditions included scoliosis (deformity of the spine) and anxiety, while concomitant medication included unspecified vitamins as obstetrical (OB) supplement. Considering that the subject was pregnant anaemia, nausea and vomiting can be confounded with reported pregnancy however, temporal relationship is too suggestive since events occurred the same day after product was given. With information provided, causality is assessed as unlikely related for anaemia and nausea and not related for vomiting (since nausea occurred) and exposure during pregnancy (per company conventions). For other events there are no suggestions that they developed due to vaccination and pregnancy might be a more plausible explanation however causal role cannot be entirely excluded, making them unlikely related as well. (''unlikely related'' defaults to "related" in the safety database for reporting purposes)