Sex: F
Vaccine: FLU3
Symptoms: Abortion spontaneous, Exposure during pregnancy, Laboratory test, Ultrasound antenatal screen abnormal
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. Previously administered products included influenza vaccine (in 2009-2010 influenza season). On an unknown date, 29 days 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. The investigator considered that there was a reasonable possibility that the spontaneous abortion may have been caused by Flu seasonal TIV Dresden. Relevant Tests: lab tests were performed on an unspecified date between 1 September 2011 and 28 April 2012. Spontaneous abortion confirmed by ultrasound or clinical diagnosis in the absence of ultrasound results. Additional information was provided. This retrospective pregnancy case was reported in a literature article and described the occurrence of spontaneous abortion (SAB) in a pregnant female between 18 and 44-year-old who was vaccinated with unspecified inactivated influenza vaccine (IIV) (manufacturer unknown) during pregnancy. The patient was part of a case-control study to determine if receipt of influenza vaccine containing pH1N1 was associated with SAB. The study included women who were pregnant during the 2010-11 or 2011-12 influenza seasons and members of 1 of 6 integrated healthcare delivery organizations in Datalink. The patient was pregnant (Pregnancy was confirmed using information from the medical record: clinic or hospital-based assay, obstetric ultrasound, patient-reported test, or physician diagnosis). The patient had continuous enrolment in the healthcare organisation for 12 months prior to last menstrual period (LMP). In 2009-2010 influenza season, the patient had received unspecified influenza vaccine (either H1N1 vaccine or seasonal vaccine. The patient's last menstrual period was on an unknown date. Estimated date of delivery was on an unknown date. In this study, out of 485 pregnant females, 2 had received concomitant IIV and Tdap vaccination before reference date. No information on patient's medical or family history or concomitant medication was provided. On an unspecified date during 2011-2012 influenza season, the patient received unspecified inactivated influenza vaccine (administration site and route unspecified; batch number not provided) during pregnancy. The age of vaccination was not provided. On an unspecified date between 1 September 2011 and 28 April 2012, 29-56 days after the vaccination, the patient had spontaneous abortion (gestational age 5 to less than 20 weeks). Spontaneous abortion confirmed by ultrasound or clinical diagnosis in the absence of ultrasound results. The Spontaneous abortion date was defined as the LMP date plus the gestational age at the time of the Spontaneous abortion. The authors commented "The associations in the other windows (29-56 and more than 56 days), regardless of prior season influenza vaccination status, were generally smaller and not statistically significant". The authors concluded "SAB was associated with influenza vaccination in the preceding 28 days. The association was significant only among women vaccinated in the previous influenza season with pH1N1-containing vaccine. This study does not and cannot establish a causal relationship between repeated influenza vaccination and SAB, but further research is warranted". This is 1 of the 2 valid cases reported in the same literature article.