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This is VAERS ID 846437

Case Details

VAERS ID: 846437 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-11-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute respiratory distress syndrome, Cardio-respiratory arrest, Influenza, Influenza like illness, Influenza virus test positive, Intensive care, Lung infiltration, Polymerase chain reaction positive, Vaccination failure
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Interstitial lung disease (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Cardiovascular disease, unspecified
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Polymerase chain reaction; Result Unstructured Data: Test Result: see text, Test Result Unit: unknown
CDC Split Type: ESIDBIOMEDICALCORPORATION

Write-up: Suspected vaccination Failure; Influenza infection; Cardiorespiratory arrest; Flu like symptoms; pulmonary infiltrates; Acute respiratory distress syndrome; This case was reported in a literature article and described the occurrence of suspected vaccination failure in a 82-year-old male patient who received Flu unspecified (Flu vaccine) for prophylaxis. Concurrent medical conditions included cardiovascular disease, unspecified. On an unknown date, the patient received Flu vaccine at an unknown dose. On an unknown date, less than a year after receiving Flu vaccine, the patient experienced vaccination failure (serious criteria death, hospitalization and GSK medically significant), influenza (serious criteria death and hospitalization), cardiopulmonary arrest (serious criteria hospitalization and GSK medically significant), influenza-like symptoms (serious criteria hospitalization), lung infiltration (serious criteria hospitalization) and acute respiratory distress syndrome (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the vaccination failure and influenza were fatal and the outcome of the cardiopulmonary arrest, influenza-like symptoms, lung infiltration and acute respiratory distress syndrome were unknown. The reported cause of death was vaccination failure and influenza. The reporter considered the vaccination failure, influenza, cardiopulmonary arrest, influenza-like symptoms, lung infiltration and acute respiratory distress syndrome to be related to Flu vaccine. Additional details were reported as follows: This case was reported in a literature article and described the suspected vaccination failure in a 82-years-old male who was vaccinated with unspecified seasonal influenza vaccine (manufacturer unknown) for prophylaxis. This case corresponds to table 2 reported in this literature article. The patient was the part of the prospective registry that aimed to determine the incidence, presentation, and prognosis of influenza virus infections in a cardiac intensive cardiac care unit and secondary to analyze the impact of an active surveillance program for early diagnosis. [In this study, the study was performed in a university hospital with 1,550 beds serving a population of 715,000 inhabitants. The study comprises two different influenza seasons (2014 and 2015), with two differentiated phases. During the first period (baseline), influenza diagnosis was made in accordance with the attending physician''s indication, who requested tests based on clinical suspicion, and no systematic screening was performed (from November 2013 to January 2014). During the second phase (intervention), systematic influenza infection screening was performed in all patients admitted on Monday to Friday. This phase included the last weeks of the first influenza season (February 2014) and the second season period (from January to March 2015)]. The patient had the pre-existing cardiovascular disease. No information on patient family history and concomitant medications. On unspecified date, the patient had received unspecified seasonal influenza vaccine (administration route and site unspecified, dosage unknown; batch number not provided). The age of vaccination was not provided. On an unspecified date between November 2013 and March 2015), unknown period after vaccination, the patient was admitted to the cardiac ICU due to the cause of cardiorespiratory arrest. Before hospital admission (i.e previous 7 days) and at the time of admission, the patient had flu like symptoms and has been diagnosed with influenza infection by the reverse transcriptase polymerase chain reaction (RT-PCR). Also the patient was diagnosed with the pulmonary infiltrates and acute respiratory distress syndrome (ARDS). On an unspecified date, the patient died. It was unknown, whether the autopsy was performed or not. The cause of death was influenza infection.[In this study, during the study period (baseline phase from November 2013 to January 2014 and intervention phase in February 2014 and from January to March 2015), 227 patients were admitted to the cardiac ICU, and 17 were diagnosed with influenza infection. Influenza A predominated in 2014 (10 patients) and influenza B in 2015 (5 patients). During the non-screening period (Baseline phase), only 6 patients out of 90 were diagnosed with influenza infection. In contrast, during the screening phase (intervention phase), 4 patients out of 34 were diagnosed in the 2014 season and 7 patients out of 102 in 2015. The presence of flu-like symptoms throughout the admission was common in infected patients, specially fever, headache, and dyspnea. Out of 17 influenza infection, the patient had the flu like symptoms such as fever (8), cough (7), runny nose (5), headache (4), myalgias (2), dyspnea (8) and respiratory failure (7). However, 3 patients who were admitted to the coronary unit for presenting a cardiac arrest, who also were diagnosed with influenza infection, did not suffer any clear-cut influenza symptom. Patients were tested for influenza A or B. Nasopharyngeal swabs were obtained for microbiological diagnosis, but lower respiratory tract samples were also accepted if clinically indicated. A reverse transcriptase polymerase chain reaction (RT-PCR) was used. Influenza A H1N1 and influenza B were detected with real-time RTPCR (RT-PCR Flu A/B Typing Real-time Detection Anyplex)]. This case has been considered as suspected vaccination failure as time to onset was unknown. This case has been considered as serious due to suspected vaccination failure; hospitalization and death. Treatment was unknown. [In this study, improved survival in severe cases was related to early antiviral administration. Out of 17 infected patients, 6 were on mechanical ventilation, 4 patients during no screening phase, and 2 patients during systematic screening. 8 were on Inotropes/vasopressors, 2 were on renal replacement therapy, 1 patient during no screening phase, 1 patient during systematic screening and 5 were on Antimicrobials prescribed at admission) The outcome of other events cardiorespiratory arrest pulmonary infiltrates and acute respiratory distress syndrome (ARDS) were not reported. [In this study, 3 had the death during hospitalization and 2 patients during no screening phase, 1 patient during systematic screening]. The author commented, "In our study, the majority of patients infected with influenza virus did not present an ischemic event, and heart failure was the most common diagnosis of admission. The viral infection could have acted as a trigger for heart failure decompensation in these patients. In fact, patients with influenza infection suffered respiratory distress and extra-hospital cardiac arrest more frequently. It is remarkable that in our study influenza-infected patients were sicker, requiring more often advanced therapies such as respiratory, renal, or inotropic support and had a higher mortality rate, especially those admitted for a cardiac arrest. Previous studies stated that acute respiratory distress syndrome secondary to influenza-related viral pneumonia is the leading cause of mortality. We found a higher mortality among influenza-infected patients and a higher rate of respiratory complications. However, as we have stated, cardiac arrest was the primary reason of admission in deceased patients in this registry. Nevertheless, our study shows that susceptible patients admitted to a cardiac ICU still have a very low rate of influenza vaccination. This proportion is markedly low, taking into account that most of the patients admitted to our unit had factors that increased the risk of complications. Vaccination was not associated with a reduced mortality risk in our study." The author concluded, "Influenza infection is associated with increased morbidity and mortality in patients admitted to the cardiac ICU. Fever and respiratory failure are the hallmark symptoms. During the flu season, a multidisciplinary systematic surveillance program improves the early detection and management of influenza in a cardiac ICU." This is 1 of the 10 valid cases reported in this literature article. Lab Comments: On an unspecified date between November 2013 and March 2015, the patient has been diagnosed with influenza infection by the reverse transcriptase polymerase chain reaction.; Reported Cause(s) of Death: Suspected Vaccination Failure; Influenza Infection


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