Age: 27.0
Sex: F
Vaccine: UNK
Symptoms: Alpha 1 foetoprotein normal, COVID-19, Delivery, Exposure during pregnancy, SARS-CoV-2 test positive
Clinical narrative: COVID-19 positive; Vaccine exposure during pregnancy; This is an observational study case, initially received from other health professional on 22-Jun-2020, concerning a 27-year-old female, pregnant subject of body weight: 174 lbs, height: 61.5 in and body mass index (BMI) 32.3, enrolled in a prospective observational safety study.  The subject's medical history included body mass index increased.    The subject's concomitant medications included: Prenatal vitamins (minerals nos, vitamins nos) for pregnancy.  The subject had one previous ectopic pregnancy. The subject had no history of offspring with major congenital malformation (MCM) and 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 06-Sep-2019. The subject's estimated delivery date (EDD) and corrected estimated date of delivery (CEDD) were reported as 12-Jun-2020. The type of pregnancy was singleton.  On 07-Nov-2020, the subject underwent ultrasound scan and no MCM was noted.   On 19-Nov-2019, at approximately ten weeks of gestation (calculated per LMP), the subject was administered Afluria QIV (Flu Vaccine Egg Split QIV CSL) [influenza vaccine, batch number: P100126099, dose, expiration date, route of administration and anatomical location: not reported] (explicitly coded as 'Vaccine exposure during pregnancy') for an influenza immunization.  On 23-Dec-2019, the subject underwent maternal serum alpha-fetoprotein (MSAFP)/ serum markers test and no MCM was noted.  On 22-Jan-2020, the subject underwent ultrasound scan and no MCM was noted.  On 12-May-2020, five months and 23 days after vaccination, the subject was COVID-19 positive.  On 26-May-2020, the subject recovered from COVID-19.   At gestational age of 38.1 weeks (as reported), the subject vaginally delivered a live birth, female neonate. The neonate's birth weight was 3005 g, head circumference was 33 cm and length was 49.5 cm. The appearance, pulse, grimace, activity, and respiration (APGAR) scores were 8 at one minute and 9 at five minutes. No date for APGAR score at 10 minutes was provided. No MCM was identified at birth.   The event of 'COVID-19' was considered serious due to the criterion of medical significance.   The reporter did not provide causality assessment to Afluria QIV.  Company comment: The pregnant subject developed COVID-19, five months and 23 days after vaccination with the suspect product, Afluria QIV. (explicitly coded as 'Vaccine exposure during pregnancy'). Chronology is unsuggestive. The subject had one previous ectopic pregnancy. Considering a lack of biological mechanism, infectious etiology of event  as well as unsuggestive chronology, causality for the event of COVID-19 is assessed as not related. Vaccine exposure during pregnancy is assessed as not related per company conventions.; Sender's Comments: The pregnant subject developed COVID-19, five months and 23 days after vaccination with the suspect product, Afluria QIV. (explicitly coded as 'Vaccine exposure during pregnancy'). Chronology is unsuggestive. The subject had one previous ectopic pregnancy. Considering a lack of biological mechanism, infectious etiology of event  as well as unsuggestive chronology, causality for the event of COVID-19 is assessed as not related. Vaccine exposure during pregnancy is assessed as not related per company conventions.