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The influenza A (H1N1) 2009 monovalent vaccination programme was the largest mass vaccination initiative in recent US history. Commensurate with the size and scope of the vaccination programme, a project to monitor vaccine adverse events was undertaken, the most comprehensive safety surveillance agenda in the USA to date. The adverse event monitoring project identified an increased risk of Guillain-Barré syndrome after vaccination; however, some individual variability in results was noted. Guillain-Barré syndrome is a rare but serious health disorder in which a person's own immune system damages their nerve cells, causing muscle weakness, sometimes paralysis, and infrequently death. We did a meta-analysis of data from the adverse event monitoring project to ascertain whether influenza A (H1N1) 2009 monovalent inactivated vaccines used in the USA increased the risk of Guillain-Barré syndrome. Data were obtained from six adverse event monitoring systems. About 23 million vaccinated people were included in the analysis. The primary analysis entailed calculation of incidence rate ratios and attributable risks of excess cases of Guillain-Barré syndrome per million vaccinations. We used a self-controlled risk-interval design. Influenza A (H1N1) 2009 monovalent inactivated vaccines were associated with a small increased risk of Guillain-Barré syndrome (incidence rate ratio 2·35, 95% CI 1·42–4·01, p=0·0003). This finding translated to about 1·6 excess cases of Guillain-Barré syndrome per million people vaccinated. The modest risk of Guillain-Barré syndrome attributed to vaccination is consistent with previous estimates of the disorder after seasonal influenza vaccination. A risk of this small magnitude would be difficult to capture during routine seasonal influenza vaccine programmes, which have extensive, but comparatively less, safety monitoring. In view of the morbidity and mortality caused by 2009 H1N1 influenza and the effectiveness of the vaccine, clinicians, policy makers, and those eligible for vaccination should be assured that the benefits of inactivated pandemic vaccines greatly outweigh the risks. US Federal Government.

In preparation for pandemic vaccine safety monitoring, we assessed adverse events reported to the Vaccine Adverse Event Reporting System following receipt of trivalent inactivated influenza vaccines among adults from 1990 through 2005. We calculated reporting rates for nonserious, serious, and neurological adverse events. We reviewed reports of recurrent events and deaths, as well as reports identified through advanced signal detection. The most frequently reported events were local reactions and systemic symptoms. Guillain-Barré syndrome was the most frequently reported serious event (0.70 reports per million vaccinations). Adverse event reporting rates have been reasonably constant over time. No new safety concerns emerged after our review of 15 years of post-licensure surveillance data. These findings provide useful information if pandemic vaccine is rapidly distributed and pre-licensure data are limited.

Household contacts of persons infected with SARS-CoV-2 are at risk for infection. A single subcutaneous injection of two anti–SARS-CoV-2 monoclonal antibodies in such persons within 4 days after the detection of infection in a household contact reduced this risk by two thirds in the first 28 days after exposure.

To guide the decision-making for the case definition and guidelines, a literature search was performed by a Cochrane Collaboration professional search person for Guillain-Barré syndrome and other peripheral neuropathies in the context of immunization (MEDLINE 1976-2006; search terms included among others \"Guillain-Barré syndrome\", \"acute inflammatory demyelinating polyradiculoneuropathy\", \"peripheral neuropathy\", \"peripheral demyelination\", \"vaccine\", and \"immunization\"). First described by French neurologists Guillain, Barré, and Stohl in 1916, understanding of the disorder has increased tremendously in the past 2 decades [5]. 0 Healthy 1 Minor symptoms or signs of neuropathy but capable of manual work/capable of running 2 Able to walk without support of a stick (5m across an open space) but incapable of manual work/running 3 Able to walk with a stick, appliance, or support (5m across an open space) 4 Confined to bed or chair bound 5 Requiring assisted ventilation (for any part of the day or night) 6 Death

The HIV Prevention Trials Network (HPTN) 096 study was designed to address the markedly higher rates of HIV incidence among Black men who have sex with men (MSM) in the Southern United States (US). A cross-sectional assessment was conducted during the pilot phase of the study to determine its feasibility and collect key HIV-related metrics for the study population. Four hundred and twenty-two Black MSM, ≥ 15 years old and living in the four pilot communities (Dallas, TX; Houston, TX; Montgomery, AL; Greenville, SC), were enrolled via starfish sampling into the cross-sectional assessment. Each participant completed two questionnaires and had blood samples collected at a single study visit. Laboratory testing was performed to determine HIV status and use of oral pre-exposure prophylaxis (PrEP). HIV drug resistance and viral suppression were also assessed for two of the four pilot communities (Dallas and Houston). Categorical variables were summarized using frequency and percentage. Continuous variables were summarized using mean, standard deviation, median and interquartile range. Univariable and multivariable logistic regression models were used to assess various associations. HIV status was determined for 403 of the 422 participants (95.5%); 212 (52.6%) men were living with HIV, including one with acute HIV. For these participants, 163 (76.9%) reported that they were in HIV care. In Dallas and Houston, 71 of the 101 living with HIV (70.3%) were virally suppressed. Of the 191 not living with HIV, 57 (29.8%) reported ever taking PrEP, 41 (21.5%) reported being currently on PrEP, and eight (4.2%) reported never having heard of PrEP. PrEP use was documented through laboratory testing in 36 (19.1%) of 188 participants tested; of the 41 participants reporting current PrEP use, five did not have laboratory evidence of PrEP use. During the pilot, we successfully recruited Black MSM using starfish sampling and demonstrated the feasibility of collecting primary study outcomes using a cross-sectional assessment. We found a high burden of HIV and those living with HIV had only a moderate rate of viral suppression. In addition, PrEP use was uncommon among the men living without HIV. Reducing HIV incidence in Black MSM remains a key element to addressing the HIV epidemic in the US.

Outbreaks of postoperative surgical-site infections or bloodstream infections are usually thought to be related to the surgeon or the surgical procedure. In May and June 1990, the Centers for Disease Control (CDC) were notified of the simultaneous and sudden onset of postoperative infections of the bloodstream, surgical sites, or other sites involving a variety of organisms at hospitals in four states. These outbreaks were investigated and traced to the use of a newly introduced anesthetic agent, propofol (Diprivan, Stuart Pharmaceuticals, Wilmington, Del.). 1 Propofol is a sterile, white, nonpyrogenic, oil-based anesthetic agent that is given intravenously; approved by the Food and . . .

Vaccines against Salmonella enterica serotype Typhi are used for prophylaxis of international travelers and have potential use as counterbioterrorism agents. The Vaccine Adverse Event Reporting System (VAERS) cannot usually establish causal relationships between vaccines and reported adverse events without further research but has successfully detected unrecognized side effects of vaccine. We reviewed reports to VAERS for US-licensed typhoid fever vaccines for the period of July 1990 through June 2002. We received 321 reports for parenteral Vi capsular polysaccharide vaccine and 345 reports for live, oral, attenuated Ty21a vaccine, with 7.5% and 5.5%, respectively, describing death, hospitalization, permanent disability, or life-threatening illness. Unexpected frequently reported symptoms included dizziness and pruritus for Vi vaccine and fatigue and myalgia for Ty21a vaccine. Gastroenteritis-like illness after receipt of Ty21a vaccine and abdominal pain after receipt of Vi vaccine, which are previously recognized events, occasionally required hospitalization. Nonfatal anaphylaxis was reported after both vaccines. VAERS reports do not indicate any unexpected serious side effects that compromise these vaccines' use for travelers' prophylaxis.

Extensive limb swelling (ELS) has been reported after vaccination with a limited number of vaccine types. We sought to describe vaccine types involved in and the clinical characteristics of ELS cases reported to the Vaccine Adverse Event Reporting System (VAERS). A case of ELS was defined as any report of edema extending at least to the elbow or knee of a vaccinated extremity. Four hundred ninety-seven cases were identified, with some describing swelling from the shoulder to the hand or the hip to the foot. Patient age ranged from 0.1 to 91 years. The proportion of reports of ELS associated with a given vaccine, among all VAERS reports received for that vaccine, varied substantially among vaccines. Most reactions began within 1 day after vaccination and involved other signs of inflammation. Postvaccination ELS can involve both the proximal and distal segments of the extremity, affects all age groups, and occurs after vaccination with a broad range of vaccines.

Objectives. We implemented active surveillance for Guillain–Barré syndrome (GBS) following seasonal or H1N1 influenza vaccination among the Medicare population during the 2009-2010 influenza season. Methods. We used weekly Medicare claims data to monitor vaccinations and subsequent hospitalizations with principal diagnosis code for GBS within 42 days. Group sequential testing assessed whether the observed GBS rate exceeded a critical limit based on the expected rate from 5 previous years adjusted for claims delay. We evaluated the lag between date of service and date of claims availability and used it for adjustment. Results. By July 30, 2010 (after 26 interim surveillance tests), 14.0 million seasonal and 3.3 million H1N1 vaccinations had accrued. Taking into account claims delay appropriately lowered the critical limit during early monitoring. The observed GBS rate was below the critical limit throughout the surveillance. Conclusions. Medicare data contributed rapid safety monitoring among millions of 2009–2010 influenza vaccine recipients. Adjustment for claims delay facilitates early detection of potential safety issues. Although limited by lack of medical record review to confirm cases, this claims-based surveillance did not indicate a statistically significant elevated GBS rate following seasonal or H1N1 influenza vaccination.

Background: Vaccines are administered differentially according to age and sex, and disease patterns also vary among people of different age and sex groups. Estimates of disproportionality should be calculated based on comparisons of groups that have a similar likelihood of receiving similar vaccines and experiencing similar adverse events, to prevent false disproportionality from occurring. Stratified empirical Bayesian (EB) methods have been compared with crude, but not stratified, proportional reporting ratios (PRRs) in their performance on adverse event data. Objectives: (i) to implement stratification of PRR; (ii) to quantify and compare vaccine-event pairs that are highlighted by PRR and EB05 (the lower bound of the 90% CI of the EB geometric mean), for both crude and stratified; and (iii) to evaluate the effects of stratification by age and sex, in identifying adverse events that are accepted to be caused by vaccines. Methods: We applied EB and PRR data mining methods to data from the US Vaccine Adverse Event Reporting System (VAERS). We stratified PRR and EB05 by age and sex. To study the effects of stratification, we compared the crude PRR and stratified PRR. We also assessed the crude EB05 and stratified EB05, and then compared the effects of stratification on EB05 and PRR. Results: Stratification not only changed the number of vaccine-event pairs that were highlighted, but also changed which pairs were highlighted. There were 283 vaccine-event pairs that were highlighted by the crude EB05, but not the stratified; 12 that were highlighted by the stratified EB05, but not the crude; and 162 that were highlighted by both. Similarly, there were 701 vaccine-event pairs that were highlighted by the crude PRR, but not the stratified; 139 that were highlighted by the stratified PRR, but not the crude; and 895 that were highlighted by both. There were 1466 vaccine-event pairs in which the effect of stratification was different for EB05 and PRR. Conclusion: To our knowledge, this is the first published analysis using stratified PRRs. In this analysis of passive surveillance data, stratification revealed and reduced confounding in EB and PRR, and also unmasked some vaccine-event pairs that the crude values did not highlight. Stratification should be applied if confounding is suspected. By decreasing the total number of highlighted vaccine-event pairs, stratification is likely to increase efficiency and therefore might reduce workload.