Sex: U
Vaccine: FLUX
Symptoms: Congenital anomaly, Ectopic kidney, Foetal exposure during pregnancy
Clinical narrative: This retrospective pregnancy case was reported in a literature article and described the occurrence of ectopic kidney in a infant. The mother received Flu Seasonal QIV Dresden. The infant was exposed to Flu Seasonal QIV Dresden during the second trimester of pregnancy. The pregnancy resulted in a live neonate with a congenital anomaly. The infant was diagnosed with ectopic kidney. Serious criteria included congenital anomaly. Additional event(s) included maternal vaccine exposure and live birth. The outcome of ectopic kidney was unknown. The outcome(s) of the additional event(s) included maternal vaccine exposure (unknown) and live birth (unknown). The investigator considered that there was a reasonable possibility that the ectopic kidney may have been caused by Flu Seasonal QIV Dresden. Additional information was provided. This retrospective pregnancy case was reported in this literature article and described the occurrence of ectopic kidney in an infant of unspecified gender whose mother was vaccinated with unspecified seasonal inactivated influenza vaccine (IIV) (manufacturer unknown) during the second trimester of pregnancy. The patient's mother was a part of the study that assessed the safety of seasonal inactivated influenza vaccines (IIV) and live attenuated influenza vaccines (LAIVs) in pregnant women and their infants whose reports were submitted to Vaccine Adverse Event Reporting System (VAERS) during 2010-2016. No information on patient's medical history or family history or concurrent condition or concomitant medication was provided. On an unspecified date, the patient's mother received unspecified seasonal inactivated influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). Subsequently, the patient was exposed to the vaccine in utero during the second trimester of pregnancy. On an unspecified date between 1 July 2010 and 6 May 2016, an unknown period after maternal vaccine exposure, the patient had ectopic kidney. This case has been considered serious due to congenital anomaly. Treatment was unknown. The outcome of the event was not reported. The authors did not comment on the relationship between ectopic kidney and unspecified seasonal inactivated influenza vaccine. However the authors stated, "VAERS also generally cannot determine whether a vaccine caused an AE." The authors concluded that "During the study period 2010-2016, the average annual number of VAERS reports following IIV in pregnancy decreased compared with the 2009-2010 pandemic period but remained higher than prior to the pandemic. Similar to the 2009-2010 period, no new or unexpected patterns in maternal or fetal outcomes were observed during 2010-2016. Maternal influenza vaccination benefits both the mother and the infant, protecting both from influenza disease. Given that the antigenic composition of these vaccines usually changes each season, the CDC and FDA will continue to monitor the safety of influenza vaccines in pregnant women." This is 1 of the 12 valid cases reported in the same literature article.