Sex: U
Vaccine: FLUX
Symptoms: Death, Influenza, Influenza virus test positive, Vaccination failure
Clinical narrative: This case was reported in a literature article and described the occurrence of vaccination failure in a child subject who received Flu seasonal TIV Dresden. On an unknown date, unknown after receiving Flu seasonal TIV Dresden, the subject developed vaccination failure. Serious criteria included death and GSK medically significant. Additional event(s) included influenza with serious criteria of death. The outcome of vaccination failure was fatal. The outcome(s) of the additional event(s) included influenza (fatal). The reported cause of death was influenza. The investigator considered that there was a reasonable possibility that the vaccination failure and influenza may have been caused by Flu seasonal TIV Dresden. Relevant Tests: Lab test performed on unspecified date during influenza season 2011-2012. In this study, among the 27 Influenza-Associated Paediatric Deaths without any high-risk medical conditions, influenza A virus was found in 18 patients and influenza B found in 9 patients. Diagnostic results (unless otherwise stated, normal values were not provided): On an unknown date, Influenza virus test result was positive unknown. Additional information was provided. This case was reported in a literature article and described the occurrence of suspected vaccination failure in a patient aged between 6-month and 17-years who was vaccinated with unspecified seasonal influenza vaccine (manufacturer unknown). The patient was a part of the study that used case cohort approach comparing influenza vaccination rates among influenza associated paediatric deaths from July 2010 through June 2014 with vaccination coverage estimated for cohorts of children to estimate the effectiveness of influenza vaccination against laboratory-confirmed influenza-associated death. The patient had no high-risk medical conditions. No information on patient's family history or concomitant medication was provided. On an unspecified date during influenza season 2011-2012, the patient received unspecified seasonal influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). Age at vaccination was not provided. [In this study children were considered vaccinated (either fully or partially) if records indicated receipt of equal to or more than 1 doses of current season influenza vaccine equal to or more than 14 days before onset of illness. Partial vaccination was defined as receipt of 1 dose when health department personnel determined that 2 doses were indicated]. On an unspecified date during influenza season 2011-2012, equal to or more than 14 days after vaccination, the patient developed laboratory-confirmed influenza. Subsequently, the patient died. (In this study, among the 27 Influenza-Associated Paediatric Deaths without any high-risk medical conditions, influenza A virus was found in 18 patients and influenza B found in 9 patients). This case has been considered as suspected vaccination failure being the time to onset was unknown. This case has been considered serious due to death/suspected vaccination failure. Treatment of influenza was unknown. The authors did not comment on the relationship between influenza and unspecified seasonal influenza vaccine. The authors concluded, "Results of this study suggest that vaccination reduced the risk of influenza-associated death among children and adolescents and add to the evidence of benefits of influenza vaccination for children. Annual vaccination is an important strategy to prevent influenza and influenza-associated complications and deaths. These results support current recommendations for annual influenza vaccination for all children equal to or more than months of age".