Sex: F
Vaccine: FLUX
Symptoms: Abortion spontaneous, Exposure during pregnancy, Foetal death, Stillbirth
Clinical narrative: This retrospective pregnancy case was reported in a literature article and described the occurrence of spontaneous abortion in a adult female subject who received Flu seasonal TIV Dresden. On an unknown date, less than a year after receiving Flu seasonal TIV Dresden, the subject developed spontaneous abortion. Serious criteria included GSK medically significant. Additional event(s) included vaccine exposure during pregnancy. The outcome of spontaneous abortion was unknown. The outcome(s) of the additional event(s) included vaccine exposure during pregnancy (unknown). The pregnancy ended in a spontaneous abortion at less than 22 weeks gestation with no apparent congenital anomaly present. It was unknown if the investigator considered the spontaneous abortion to be related to Flu seasonal TIV Dresden. Additional information was provided. This retrospective pregnancy case was reported in a literature article and described spontaneous abortion in a female aged equal to or more than 18-year who was vaccinated with unspecified inactivated trivalent influenza vaccine (IIV) during her pregnancy (manufacturer unknown). The patient was a part of the prospective observational study conducted during the 2013-2014 influenza season at a family planning clinic and three obstetrics and gynaecology practices which assessed the feasibility of recruiting pregnant women less than 20 weeks gestational age (GA) to participate in a text messaging based vaccine adverse event monitoring program after receipt of inactivated influenza vaccine (IIV) and utility of text messaging to monitor health events, including fever frequency on vaccination and next 2 days (Days 0-2), health events during pregnancy, pregnancy outcomes, and neonatal outcomes. All four sites were affiliated with hospital. The female was a pregnant woman with gestational age less than 20 weeks by last menstrual period and/or ultrasound. The patient's last menstrual period was on an unknown date. Estimated date of delivery was on an unknown date. No information on patient's medical or family history or concomitant medication was provided. On an unspecified date during the 2013-2014 influenza season, the patient received unspecified IIV (administration route and site unspecified; dosages unknown; batch number not provided) during the gestational age less than 20 weeks. Age at vaccination was unknown. (In this study, 70.5% had documented receipt of tetanus-diphtheria-pertussis vaccine during the same pregnancy). On an unspecified date at 20 weeks of gestational age, an unknown period after vaccination, the patient was reported for still birth. It was reported that the pregnancy loss was noted by text message and electronic medical records (EMR) abstraction. Treatment was unknown. The authors did not comment on relationship between stillbirth and IIV. The authors concluded, "This study demonstrated the feasibility of text messaging for influenza vaccine safety surveillance This retrospective pregnancy case was reported in a literature article and described the occurrence of spontaneous abortion in a adult female subject who received Flu seasonal TIV Dresden. On an unknown date, less than a year after receiving Flu seasonal TIV Dresden, the subject developed spontaneous abortion. Serious criteria included GSK medically significant. Additional event(s) included vaccine exposure during pregnancy. The outcome of spontaneous abortion was unknown. The outcome(s) of the additional event(s) included vaccine exposure during pregnancy (unknown). The pregnancy ended in a spontaneous abortion at less than 22 weeks gestation with no apparent congenital anomaly present. It was unknown if the investigator considered the spontaneous abortion to be related to Flu seasonal TIV Dresden. Additional information was provided. This retrospective pregnancy case was reported in a literature article and described spontaneous abortion in a female aged equal to or more than 18-year who was vaccinated with unspecified inactivated trivalent influenza vaccine (IIV) during her pregnancy (manufacturer unknown). The patient was a part of the prospective observational study conducted during the 2013-2014 influenza season at a family planning clinic and three obstetrics and gynaecology practices which assessed the feasibility of recruiting pregnant women less than 20 weeks gestational age (GA) to participate in a text messaging based vaccine adverse event monitoring program after receipt of inactivated influenza vaccine (IIV) and utility of text messaging to monitor health events, including fever frequency on vaccination and next 2 days (Days 0-2), health events during pregnancy, pregnancy outcomes, and neonatal outcomes. All four sites were affiliated with hospital. The female was a pregnant women with gestational age less than 20 weeks by last menstrual period and/or ultrasound. The patient's last menstrual period was on an unknown date. Estimated date of delivery was on an unknown date. No information on patient's medical or family history or concomitant medication was provided. On an unspecified date during the 2013-2014 influenza season, the patient received unspecified IIV (administration route and site unspecified; dosages unknown; batch number not provided) during the gestational age less than 20 weeks. Age at vaccination was unknown. (In this study, 70.5% had documented receipt of tetanus-diphtheria-pertussis vaccine during the same pregnancy). On an unspecified date at 20 weeks of gestational age, an unknown period after vaccination, the patient was reported for still birth. It was reported that the pregnancy loss was noted by text message and electronic medical records (EMR) abstraction. Treatment was unknown. The authors did not comment on relationship between stillbirth and IIV. The authors concluded, "This study demonstrated the feasibility of text messaging for influenza vaccine safety surveillance throughout pregnancy. In addition, in these women receiving IIV during pregnancy, post-vaccination fever was infrequent and a typical pattern of maternal and neonatal health outcomes for pregnancies was observed." This is 1 of the 16 valid cases in the same literature article.