Sex: U
Vaccine: FLUX
Symptoms: Exposure during pregnancy, Foetal disorder, Gastroschisis, Gene mutation identification test negative, Influenza
Clinical narrative: Fetal gastroschisis; Foetal exposure during pregnancy; This is an observational study case, initially received from other health professional on 18-Feb-2020, concerning a foetus subject whose mother was a 20-year-old, female of body weight: 135.5 lbs, height: 66 inches and body mass index (BMI): 21.9, enrolled in a prospective observational study.  The mother's current medical conditions included seasonal asthma and ovarian cyst.    The mother's concomitant medication included Prenatal vitamins (unspecified vitamins and minerals) for pregnancy.   The mother's obstetrical history included no previous pregnancies. Also, the subject's mother had no maternal or paternal history with major congenital malformations (MCMs). The subject's mother did not use tobacco, alcohol or illicit drugs during pregnancy.  The subject's mother last menstrual period (LMP) date was 24-Aug-2019. Estimated delivery date (EDD) and corrected estimated date of delivery (CEDD) were reported as 30-May-2020. The type of pregnancy was singleton. The subject's father was 20-year-old.  On 17-Oct-2019, the mother underwent ultrasound scan and no MCM was noted.  On 24-Oct-2019, at gestational age of 8 weeks, the subject's mother was administered Afluria QIV (Flu Vaccine Egg Split CSL) [influenza vaccine; batch number: P100126099, dose, route of administration, anatomical location and expiry date: not reported] (explicitly coded as Foetal exposure during pregnancy') for influenza immunisation.  On an unspecified date in 2019, an unknown amount of time after vaccination, the subject's mother developed flu and was treated with Tamiflu (oseltamivir).   On 23-Nov-2019, the subject's mother underwent non-invasive prenatal testing, and no MCM was noted.   On 19-Dec-2019, the mother underwent cystic fibrosis mutation analysis and no MCM was noted.   On 06-Jan-2020 and 05-Feb-2020, the subject's mother underwent ultrasound scan and MCM fetal gastroschisis was noted.   On 10-Feb-2020, the subject's mother developed erythematosus dots on inner left arm and abdomen and was treated with hydrocortisone.  At the time of this report, the outcome of the event of gastroschisis was not reported.    Per company, the event of gastroschisis was assessed as serious due to the criterion of congenital anomaly.   The reporter did not provide causality assessment to Afluria QIV.  This case is linked to 202000028, the corresponding mother case.  Company Comment: A foetus subject was diagnosed with gastroschisis after maternal receipt of Flucelvax QIV vaccine at approximately 8 weeks of gestation (considered as foetal exposure during pregnancy). Chronology seems plausible.  Mother's medical seasonal asthma and influenza infection may have contributed to development of the event. Concomitant medication Tamiflu (oseltamivir) and pregnant state may provide alternative aetiology for the event. Foetal exposure during pregnancy assessed as not related per company's conventions. Considering all the above mentioned, causality between suspect product and the event gastroschisis is assessed as unlikely related (defaults to "related" in the safety database for reporting purposes).; Sender's Comments: A foetus subject was diagnosed with gastroschisis after maternal receipt of Flucelvax QIV vaccine at approximately 8 weeks of gestation (considered as foetal exposure during pregnancy). Chronology seems plausible.  Mother's medical seasonal asthma and influenza infection may have contributed to development of the event. Concomitant medication Tamiflu (oseltamivir) and pregnant state may provide alternative aetiology for the event. Foetal exposure during pregnancy assessed as not related per company's conventions. Considering all the above mentioned, causality between suspect product and the event gastroschisis is assessed as unlikely related (defaults to "related" in the safety database for reporting purposes).