Sex: M
Vaccine: FLUX
Symptoms: Respiratory failure, Vaccination failure
Clinical narrative: This case was reported in a literature article and described the occurrence of vaccination failure in a elderly male subject who received Flu seasonal TIV Dresden. On an unknown date, less than a year after receiving Flu seasonal TIV Dresden, the subject developed vaccination failure. Serious criteria included hospitalization and GSK medically significant. Additional event(s) included influenza with serious criteria of hospitalization. The outcome of vaccination failure was unknown. The outcome(s) of the additional event(s) included influenza (unknown). 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 unknown date. The patient's nasopharyngeal swab tests at laboratory were positive for influenza determined by rapid and/or reverse transcriptase polymerase chain reaction (RT-PCR). 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 male patient aged between 50 and 59-year who was vaccinated with unspecified trivalent inactivated seasonal influenza vaccine (manufacturer unknown). The patient was a part of a retrospective study that described the clinical characteristics and treatment outcomes of elderly patients admitted to an academic tertiary, with influenza between 1 October 2013 and 28 February 2014 influenza season. Medical electronic records were searched for all patients admitted to the Hospital with proven influenza during the 2013-2014 influenza seasons. Cohorts of vaccination and non-vaccinated patients were then compared to determine the impact of prior influenza vaccination upon respiratory-failure and mortality. (In this study, among the total 31 vaccinated patients, 18 had chronic obstructive pulmonary disease (COPD), 11 had diabetes mellitus, 7 had congestive heart failure (CHF) and 6 were immunocompromised). No information on patient's medical history or family history or concurrent condition or concomitant medication was provided. On an unspecified date between 2013 and 2014, the patient received unspecified trivalent inactivated seasonal influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). In this study, the participants were considered vaccinated if they had received greater than or equal to 1 dose of any seasonal influenza vaccine greater than or equal to 14 days before onset of illness. On an unspecified date in 2013-2014, greater than or equal to 14 days after vaccination with unspecified trivalent inactivated seasonal influenza vaccine, the patient had the onset of flu-like symptoms. Subsequently between 1 October 2013 and 28 February 2014, the patient was admitted to the Hospital with laboratory-proven influenza infection. (In this study, 12 patients were admitted to the intensive care unit (ICU) for respiratory failure. 12 patients received positive pressure ventilator (PPV) support with 7 on non-invasive ventilation and 6 were on mechanical ventilation. The median length of hospital stay for was 6 days). The patient's nasopharyngeal swab tests at laboratory were positive for influenza determined by rapid and/or reverse transcriptase polymerase chain reaction (RT-PCR). [In this study, 25 of the 31 vaccinated patients were positive for influenza A. 16 were found positive for H1N1 and 6 were found positive for influenza B. 11 patients had infiltrate on their chest x-ray (CXR)]. This case was considered as suspected vaccination failure being the time to onset was unknown. This case has been considered serious due to hospitalisation. Treatment was unknown. (In this study, 55 out of total 70 patients received oseltamivir. 24 of the 31 vaccinated patients were treated with TAMIFLU and 24 were treated with antibiotics). The outcome of the event was not reported. (In this study, 28 of the 31 vaccinated patients recovered and the 3 died due to influenza-related complications). The authors considered the event of influenza infection related to the unspecified trivalent inactivated seasonal influenza vaccine. The authors commented "our data suggest that vaccination offered no protection against severe illness in this population of patients admitted to the hospital. There was also no protection against mortality; 3 out of 4 patients in this study who died had received influenza vaccine". The authors concluded that "this study of the impact of prior influenza vaccine on severity of illness in older patients admitted with the flu found no evidence of a protective benefit from the vaccine. In fact, the prevalence of severe disease and respiratory failure was statistically higher in the vaccinated patients. These data add to the growing body of literature that raises questions about the overall efficacy of the vaccine. While even more data are awaited, we suggest a high index of suspicion in people presenting with flu-like illness, protocol-based testing to ensure rapid diagnosis, and early treatment".