Sex: U
Vaccine: FLU3
Symptoms: Chest X-ray, Influenza, Influenza A virus test, Influenza B virus test, Influenza virus test positive
Clinical narrative: Vaccination failure; Influenza infection; respiratory disease; This case was reported in a literature article and described the occurrence of vaccination failure in a patient who received Flu Seasonal TIV Dresden (Flu trivalent vaccine) for prophylaxis.   On an unknown date, the patient received Flu trivalent vaccine at an unknown dose. On an unknown date, 6 months after receiving Flu vaccine, the patient experienced vaccination failure (serious criteria hospitalization and GSK medically significant), influenza (serious criteria hospitalization) and respiratory disorder (serious criteria hospitalization). On an unknown date, the outcome of the vaccination failure, influenza and respiratory disorder were unknown.   It was unknown if the reporter considered the vaccination failure, influenza and respiratory disorder to be related to Flu trivalent vaccine.  Additional details were provided as follows: This case was reported in a literature article and described the vaccination failure in a patient of unspecified age and gender, who was vaccinated with unspecified influenza vaccine (manufacturer unknown) for prophylaxis. This case corresponds to table 2 reported in this literature article. This patient was a part of the study that aimed was to estimate the incidence of influenza hospitalization and in-hospital deaths from PCR-proven influenza in a stable, facility-based, active surveillance platform among ethnically and geographically diverse populations and to identify risk factors associated with intensive care unit admission or death. In this study, patient who presented at one of these hospitals with any symptoms of respiratory disease were invited to undergo screening. The patient was from department. No information on patient's medical history, 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 the previous 6 months. The age at vaccination was not provided [In contrast, 68% percent had received at least one dose of the pentavalent vaccine given at 2, 4, and 6 months containing Hemophilus influenzae B, diphtheria, whole cell pertussis, tetanus and hepatitis B, and 46% had received three doses]. On an unspecified date between June 2007 to September 2012, 6 months after the vaccination, the patient presented with at least one of the following symptoms of respiratory disease: tachypnea, and/or cough, and/or sputum production, and/or hemoptysis, and/or chest pain, and/or dyspnea, and/or shortness of breath, and/or sore throat, or abnormal lung exam. [If a patient was 5 years or older, the case definition for acute respiratory infection (ARI) was: at least one of the following: documented fever (more than or equal to 38 degree Celsius) in the past 7 days; temperature less than 35.5 degree Celsius with chills; or abnormal white blood cell count (more than 11,000/cubic mm or less than 3,000/ cubic mm) or abnormal white blood cell differential. If a patient was less than 5 years old, the guideline criteria for management of pneumonia-like illness was applied in 2011: age less than 2 months with tachypnea or chest in-drawing, OR, age less than 2 months with cough or difficulty breathing and at least one of the following: cyanosis, stridor at rest, hypoxia (O2 saturation less than 90%), head nodding, or general danger signs such as not drinking or breastfeeding, vomiting all intake, convulsions, lethargy or fainting, no movement or only when stimulated, OR, age 2 to 59 months with cough or difficulty breathing and at least one of the following: tachypnea, chest in-drawing, cyanosis, head nodding, stridor at rest, hypoxia (O2 saturation less than 90%) or general danger signs such as not drinking or breastfeeding, vomiting all intake, convulsions, lethargy or fainting]. Nasopharyngeal and oropharyngeal swabs and urine samples were collected. Nasopharyngeal swab specimens were collected from the patient using a polyester swab that was placed in viral transport media, stored at 4-8 degree Celsius for about 24 hours, then frozen at -20 degree Celsius and sent for laboratory analysis where it was tested using real-time reverse transcriptase polymerase chain (rRT-PCR) reaction per standard CDC protocols for influenza A and B viruses. Chest radiographs (CXRs) were performed as part of routine clinical care. [It was examined data from the respiratory syndrome database for hospital of Department. The length of hospitalization was between 0 to 77 days. The patient was found positive for influenza. The laboratory test confirmed the influenza infection.  This case has been considered as serious due to vaccination failure and hospitalization. Treatment was unknown. The outcome of the event was not reported. The author commented, "In this study, we identified three characteristics of patients with severe disease or death: study site, ethnicity, and presumed bacterial pneumonia. Pre-existing heart, lung, and metabolic conditions were prominent in hospitalized patients. In addition, few patients presenting to all three hospitals seemed to have been vaccinated against influenza. Interventions to prevent infection and minimize serious outcomes should target these factors. In addition, although common risk factors for illness attributed to influenza requiring hospitalization have been established, little is known about risk factors associated with poor outcomes among hospitalized cases, especially in Coountry. Other risks associated with hospitalization for influenza include pre-existing cardiac or neurologic and neuromuscular disease among children especially those aged less than 2 years. Among adults, increased risk of complications include obesity, especially body mass index (BMI) more than 40; age more than 65 years, chronic medical problems such as diabetes and asthma, and pregnancy and infection during the two weeks post-partum. The present study clearly indicate children aged less than 5 years and persons 65 years and older have the highest incidence rates of influenza hospitalization. A strength of the present study is that cases were sought actively by study nurses and influenza virus was detected by sensitive PCR. The active surveillance in the present study highlights the importance of influenza prevention in this older age group which can be underestimated through the multiplier method. In addition, our findings suggest that some patients had not been fully vaccinated with the Penta vaccine, introduced in Country in 2005, that provides protection against three respiratory pathogens: (H. influenzae, diphtheria and pertussis). Immunization cards may need to be updated to include specific locations for recording more recently recommended vaccines such as influenza and conjugated pneumococcal vaccine. Vaccination against S. pneumonia with 13 valent conjugated vaccine was introduced in late 2012. This vaccine is expected to have an impact on one of the major determinates of severe disease, pneumonia. This study has several limitations. First, we did not collect detailed information about outpatient illness and/or care received at health posts and centers prior to hospitalization; therefore, we were not able to investigate the risk factors for hospitalization itself. Second, the data are further limited by the denominator population estimates from Agency, and we lacked a population data estimate incidence for City. Although the healthcare utilization data provided additional precision to the incidence estimate, these were conducted in 2006 and in the first half of 2009, before the major number of cases of the 2009 influenza A(H1N1)pdm09 pandemic occurred. Therefore, the reported utilization might have imprecisely estimated the actual use of facilities from 2009 through the present, after the pandemic." The author concluded, "This study demonstrates high rates of influenza-associated morbidity and mortality in Country. Consistent with current global recommendations, this study highlights the potential value of vaccinating high risk groups, such as pregnant women, children aged more than 6 months, persons aged more than 60 years, those with pre-existing health conditions, and health care workers. Our data suggest the value of exploring the impact and cost effectiveness of influenza vaccination among target groups including ethnic minorities in Country. Utilization of quadrivalent vaccines, high dose or adjuvant vaccines might also be useful in tropical middle income settings like Country, but the main emphasis should be on increasing vaccine coverage. Vaccine coverage surveys need to be completed periodically to monitor and improve influenza immunization rates. Furthermore, influenza vaccinations can prevent illnesses that may lead to unwarranted antibiotic use and bacterial resistance among persons with viral infections. Because we identified pneumonia on chest X-ray as an independent risk factor for severe illness, the effects of introduction of conjugated pneumococcal vaccine in Country in 2012 against S. pneumoniae the major cause of bacterial superinfection of influenza should be monitored. Specific treatment of influenza with neuraminidase inhibitors early in severe illness should become standard. Future health education and vaccination efforts should be tailored to fit the different epidemiologic, ethnic, and geographic profiles found across the country. Influenza is a major contributor of hospitalization and death due to respiratory diseases in Country. Further application of proven influenza prevention and treatment strategies is warranted."   Follow up information received from the author on 6th May 2020: The author stated, "Author did not have full vaccination records for the participants and cannot confirm if they were vaccinated."  Upon internal quality review following corrections were done for the data received on 28th April 2020: Suspect vaccine was updated to Flu trivalent vaccine. Seriousness criteria "hospitalization" was captured for events vaccination failure, influenza and respiratory disorder. As reported causality was updated to unknown for events vaccination failure, influenza and respiratory disorder. This case has been considered as vaccination failure.  Upon internal review the GSK receipt date for error correction was updated to 28th April 2020.