Age: 21.0
Sex: F
Vaccine: FLUX
Symptoms: Gene mutation identification test negative, Nausea, Prenatal screening test, Trichomoniasis, Ultrasound antenatal screen normal
Clinical narrative: Reflux; Nausea; Vomiting; Chlamydia; Trichomoniasis; Anemia; Vaccine exposure during pregnancy; This is a serious observational study case, initially received from other health professional on 26-Aug-2019, concerning a 21-year-old, female pregnant subject of body weight: 224 lbs, height: 71 inches and body mass index 31.2, enrolled in a prospective observational safety study.  The subject's relevant medical history was not reported.  The subject had no obstetrical history and no relevant maternal and paternal medical history. The subject did not use tobacco, alcohol or illicit drugs during pregnancy. The subject's concomitant medication included Prenatal vitamins (vitamins and minerals unspecified) as supplement.   The subject's last menstrual period date was on 21-May-2019. The type of pregnancy was singleton.   On 10-Jul-2018, the subject underwent prenatal tests spinal muscular atrophy and cystic fibrosis mutation analysis and no major congenital malformations were noted.   On 24-Jul-2018, the subject underwent ultrasound and no major congenital malformations were noted.   On 22-Aug-2018, the subject underwent ultrasound and no major congenital malformations were noted.   On 12-Sep-2018, the subject underwent ultrasound and quadscreen test and no major congenital malformations were noted.  At gestational age of approximately 20 weeks, the subject was administered Flu Vaccine Cell Subunit QIV NVD [influenza vaccine, subunit influenza virus vaccine polyvalent, batch number:252664, dose: 0.5 ml, route of administration, anatomical location, expiration date: not reported] (explicitly coded as vaccine exposure during pregnancy) for influenza prophylaxis.   On 09-Nov-2018, 30 days after vaccination, the subject developed anemia. The patient was treated with iron at a dose of 325 mg, twice a day, orally, from 09-Nov-2018 to 12-Feb-2019.   On 20-Nov-2018, one month and 10 days after vaccination, the subject developed chlamydia and trichomoniasis. The subject was treated from 20-Nov-2018 to 30-Nov-2018 with Zithromax (azithromycin), one tablet, once, orally for chlamydia and Flagyl (metronidazole), one tablet, twice a day, orally for trichomoniasis.   On 30-Nov-2018, the outcome of events chlamydia and trichomoniasis was resolved.    On 20-Jan-2019 (also reported as on 20-Jan-2018), three months and 10 days after vaccination, the patient experienced nausea, vomiting and reflux. The subject was treated from 20-Jan-2019 to 12-Feb-2019 with Zofran (ondansetron), one tablet, every eight hours, orally for nausea and vomiting and with Zantac (ranitidine hydrochloride), one tablet, twice a day as needed for reflux.    At 38.1 week of gestation, the subject vaginally delivered live birth, normal, male neonate.  The neonate's birth weight was 3175 grams, body length was 34.3 centimetres and head circumference were 52.1 centimetres. The appearance, pulse, grimace, activity, and respiration (APGAR) scores were 8 at one minute and at five minutes. APGAR score was not reported for 10 minutes. There was no major congenital malformation identified at birth.   On the same day, the outcome of events anemia, nausea, vomiting and reflux was resolved.   The subject's estimated date of delivery was reported as 25-Feb-2019.  Company Comment: The subject experienced chlamydial infection, trichomoniasis, anaemia, gastroesophageal reflux disease, nausea and vomiting with the suspect product Flu Vaccine Cell Subunit QIV NVD (influenza vaccine). Reportedly, vaccination occurred during pregnancy. Chronology is plausible. Pregnancy may have contributed to development of the events. No medical history and diagnostic findings were provided. Considering all the above mentioned, causal relationship between the suspect product and the exposure during pregnancy is assessed as not related and as related for all other events.; Reporter's Comments: The subject experienced chlamydial infection, trichomoniasis, anaemia, gastroesophageal reflux disease, nausea and vomiting with the suspect product Flu Vaccine Cell Subunit QIV NVD (influenza vaccine). Reportedly, vaccination occurred during pregnancy. Chronology is plausible. Pregnancy may have contributed to development of the events. No medical history and diagnostic findings were provided. Considering all the above mentioned, causal relationship between the suspect product and the exposure during pregnancy is assessed as not related and as related for all other events.