Sex: M
Vaccine: FLUX
Symptoms: H1N1 influenza, Influenza A virus test positive, Lung assist device therapy, Renal failure, Renal replacement therapy
Clinical narrative: suspected vaccination failure; Influenza A H1N1 infection; acute respiratory distress syndrome; renal failure; dyspnea; cough; This case was reported in a literature article and described the occurrence of suspected vaccination failure in a 56-year-old male patient who received Flu unspecified (Influenza vaccine) for prophylaxis.   The patient's past medical history included coronary artery disease.   On an unknown date, the patient received Influenza vaccine at an unknown dose. On an unknown date, less than a year after receiving Influenza vaccine, the patient experienced vaccination failure (serious criteria hospitalization and GSK medically significant), h1n1 influenza (serious criteria hospitalization), dyspnea (serious criteria hospitalization), cough (serious criteria hospitalization), acute respiratory distress syndrome (serious criteria hospitalization and GSK medically significant) and renal failure (serious criteria hospitalization and GSK medically significant). The patient was treated with cardiovascular system drugs (Vasopressors (Nos)), baloxavir marboxil and oseltamivir. On an unknown date, the outcome of the vaccination failure and renal failure were unknown and the outcome of the h1n1 influenza, dyspnea, cough and acute respiratory distress syndrome were recovered/resolved.   It was unknown if the reporter considered the vaccination failure, h1n1 influenza, dyspnea, cough, acute respiratory distress syndrome and renal failure to be related to Influenza vaccine.  Additional details were provided as follows: This case was reported in a literature article and described the suspected vaccination failure in a 56-year-old male patient, who was vaccinated with unspecified influenza vaccine (manufacturer unknown) for prophylaxis. This case corresponds to case 1 reported in this literature article. The patient had a history of coronary artery disease. No information on patient's family history, concurrent condition or concomitant medication was provided. On an unspecified date, the patient received unspecified influenza vaccine (administration route and site unspecified, dosage unknown; batch number not provided) in this season. The age of vaccination was not provided. On an unspecified date, an unknown period after the vaccination, the patient presented with 5 days of cough and dyspnea and required cannulation for veno-venous extracorporeal membrane oxygenation (VV-ECMO) due to severe acute respiratory distress syndrome (ARDS). The patient was placed on continuous renal replacement therapy (CRRT) for renal failure as well as vasopressor and inotropic support. Bronchoalveolar lavage (BAL) polymerase chain reaction (PCR) was positive for Influenza A H1N1 2009 strain. The patient was diagnosed to Influenza A H1N1 infection. The patient received a dose of baloxavir marboxil 80 mg on day 1 and a 7-day course of oseltamivir which was started on Day 0. Influenza PCR testing obtained 5 days after receipt of baloxavir marboxil was negative. The patient was decannulated on hospital day 7 and extubated at 14 days. This case has been considered as suspected vaccination failure being the time to onset was unknown. This case has been considered as serious due to suspected vaccination failure and hospitalization. The author did not comment on the relationship between the event of influenza A H1N1 infection, acute respiratory distress syndrome (ARDS) and unspecified influenza vaccine. The author stated, "We present the first reported use of baloxavir marboxil in combination with oseltamivir in two critically ill patients requiring veno-venous extracorporeal membrane oxygenation (VV-ECMO) support due to severe acute respiratory distress syndrome (ARDS) caused by influenza A H1N1 2009." The author concluded, "We describe the first reported clinical use of baloxavir in combination with oseltamivir for influenza A H1N1 infection in two critically ill patients with respiratory failure requiring VV ECMO. Further pharmacokinetic/pharmacodynamics analysis is needed to determine optimal dosing in critically ill patients, and those requiring CRRT. Baloxavir synergy with the neuraminidase inhibitors may be of benefit in critically ill patients, and additional prospective clinical study is needed." This article corresponding to this case is not available for regulatory submission due to copyright restriction.  It was unknown if the reporter considered the vaccination failure, influenza a virus infection, dyspnea, cough, acute respiratory distress syndrome and renal failure to be related to Influenza vaccine.      Lab Comments: On an unspecified date lab test were performed. Influenza PCR testing obtained 5 days after receipt of baloxavir marboxil was negative.