Sex: M
Vaccine: FLUX
Symptoms: Congenital anomaly, Foetal exposure during pregnancy, Heterotaxia, Hypospadias
Clinical narrative: This retrospective pregnancy case was reported in a literature article and described the occurrence of situs inversus in a male infant. The mother received Flu seasonal TIV Dresden. The pregnancy resulted in a live neonate with a congenital anomaly. The infant was diagnosed with situs inversus. Serious criteria included GSK medically significant and congenital anomaly. Additional event(s) included hypospadias (serious criteria GSK medically significant and congenital anomaly) and maternal vaccine exposure. The outcome of situs inversus was unknown. The outcome(s) of the additional event(s) included hypospadias (unknown) and maternal vaccine exposure (unknown). It was unknown if the investigator considered the situs inversus and hypospadias to be related to Flu seasonal TIV Dresden. Additional information was provided. This retrospective pregnancy case was reported in a literature article and described situs inversus/hypospadias in a male infant who was exposed to unspecified inactivated trivalent influenza vaccine (IIV) in utero (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 patient's mother was a pregnant woman with gestational age less than 20 weeks by last menstrual period and/or ultrasound at the time of enrollment. No information on patient's medical or family history or concomitant medication or concurrent condition was provided. On an unspecified date during the 2013-2014 influenza season, the patient's mother 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). The infant was exposed to unspecified IIV in utero. On an unspecified date, an unknown period after vaccination, the patient had situs inversus/hypospadias (major birth defect). The birth defect was reported via text message with electronic medical records (EMR) confirmation. Treatment was unknown. The outcome of the event was not reported. The authors did not comment on relationship between situs inversus/hypospadias 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.