Sex: U
Vaccine: FLUX
Symptoms: Foetal exposure during pregnancy, Premature baby
Clinical narrative: Preterm birth (birth prior to 37 weeks of gestation); Foetal exposure during pregnancy; This is a literature case, initially received on 19-Feb-2020, concerning a neonate patient of unspecified gender.   The Project was a multi-site, prospective cohort study of pregnant women who were members of agency during the 20102011 influenza season. Women and their newborns were followed until six months post-delivery. Potential participants were pregnant women identified through agency's electronic health records (EHR) and were contacted for recruitment between Dec-2010 and May-2011.  The maternal demographics, behavioural characteristics and medical conditions included: maternal race/ethnicity, age (less than 30, 3034, more than 35 years), education (high school or less, some college/college graduate, Master's degree or higher), prenatal vitamin use (unspecified minerals and vitamins) (yes/no), alcohol use during pregnancy (yes/no), smoking during pregnancy (yes/no), parity (0, 1+), and month of conception during typical wintertime flu season (Nov-Mar) or not during flu season (Apr-Oct). Influenza vaccination status in the year prior to pregnancy was also ascertained from the EHR.  On an unspecified date, during 2010-2011 influenza season, the patient's mother was administered trivalent inactivated influenza vaccine (IIV3) [influenza virus vaccine polyvalent; dose, route od administration, anatomical location, batch number and expiry date: not reported] (explicitly coded as Foetal exposure during pregnancy') for influenza vaccination.   On an unspecified date, the patient was born prior to 37 weeks of gestation.  The outcome of 'premature birth' was not reported.   The event of 'premature birth' was assessed as serious due to the criterion of medical significance.   The reporter did not provide causality assessment to influenza vaccine.  The study results found no association between IIV3 exposure during pregnancy and infant development at six months.  This case is linked to cases: 202001895, 202001904, 202001915, 202001916, 202001917, 202001918, 202001919, 202001920, 202001921, 202001922, 202001923, 202001924, 202001925, 202001926, 202001927, 202001928, 202001929, 202001930, 202001931, 202001932, 202001933, 202001935, 202001936, 202001937 and 202001938 (same literature article).   Company comment: A neonate subject was delivered as premature baby after foetal exposure to the suspect product trivalent inactivated influenza vaccine (IIV3). Multiple pregnant patients were administered vaccine during pregnancy. Of these women, 40% received the IIV3 during the first trimester, 44% in the second trimester and 16% in the third trimester. Chronology needs more clarification. Some of these patients had medical history of advanced maternal age, smoking and alcohol use during pregnancy which may have contributed to development of the event. Causal role of the suspect vaccine cannot be totally excluded and is assessed as unlikely related (defaults to "related" in the safety database for reporting purposes). Foetal exposure during pregnancy is assessed as unrelated per company's conventions.; Sender's Comments: A neonate subject was delivered as premature baby after foetal exposure to the suspect product trivalent inactivated influenza vaccine (IIV3). Multiple pregnant patients were administered vaccine during pregnancy. Of these women, 40% received the IIV3 during the first trimester, 44% in the second trimester and 16% in the third trimester. Chronology needs more clarification. Some of these patients had medical history of advanced maternal age, smoking and alcohol use during pregnancy which may have contributed to development of the event. Causal role of the suspect vaccine cannot be totally excluded and is assessed as unlikely related (defaults to "related" in the safety database for reporting purposes). Foetal exposure during pregnancy is assessed as unrelated per company's conventions.