Reporting rates for VAERS death reports following COVID-19 vaccination, December 14, 2020-November 17, 2021.

PURPOSE: Despite widely available safety information for the COVID-19 vaccines, vaccine hesitancy remains a challenge. In some cases, vaccine hesitancy may be related to concerns about the number of reports of death to the Vaccine Adverse Event Reporting System (VAERS). We aimed to provide information and context about reports of death to VAERS following COVID-19 vaccination. METHODS: This is a descriptive study evaluating reporting rates for VAERS death reports for COVID-19 vaccine recipients in the United States between December 14, 2020, and November 17, 2021. Reporting rates were calculated as death events per million persons vaccinated and compared to expected all-cause (background) death rates. RESULTS: 9201 death events were reported for COVID-19 vaccine recipients aged 5 years and older (or age unknown). Reporting rates for death events increased with increasing age, and males generally had higher reporting rates than females. For death events within 7 days and 42 days of vaccination, respectively, observed reporting rates were lower than the expected all-cause death rates. Reporting rates for Ad26.COV2.S vaccine were generally higher than for mRNA COVID-19 vaccines, but still lower than the expected all-cause death rates. Limitations of VAERS data include potential reporting bias, missing or inaccurate information, lack of a control group, and reported diagnoses, including deaths, are not causally verified diagnoses. CONCLUSIONS: Reporting rates for death events were lower than the all-cause death rates expected in the general population. Trends in reporting rates reflected known trends in background death rates. These findings do not suggest an association between vaccination and overall increased mortality.

The risk of febrile seizures following influenza and 13-valent pneumococcal conjugate vaccines.

BACKGROUND: Evidence on the risk of febrile seizures after inactivated influenza vaccine (IIV) and 13-valent pneumococcal conjugate vaccine (PCV13) is mixed. In the FDA-sponsored Sentinel Initiative, we examined risk of febrile seizures after IIV and PCV13 in children 6-23 months of age during the 2013-14 and 2014-15 influenza seasons. METHODS: Using claims data and a self-controlled risk interval design, we compared the febrile seizure rate in a risk interval (0-1 days) versus control interval (14-20 days). In exploratory analyses, we assessed whether the effect of IIV was modified by concomitant PCV13 administration. RESULTS: Adjusted for age, calendar time and concomitant administration of the other vaccine, the incidence rate ratio (IRR) for risk of febrile seizures following IIV was 1.12 (95% CI 0.80, 1.56) and following PCV13 was 1.80 (95% CI 1.29, 2.52). The attributable risk for febrile seizures following PCV13 ranged from 0.33 to 5.16 per 100,000 doses by week of age. The age and calendar-time adjusted IRR comparing exposed to unexposed time was numerically larger for concomitant IIV and PCV13 (IRR 2.80, 95% CI 1.63, 4.83), as compared to PCV13 without concomitant IIV (IRR 1.54, 95% CI 1.04, 2.28), and the IRR for IIV without concomitant PCV13 suggested no independent effects of IIV (IRR 0.94, 95% CI 0.63, 1.42). Taken together, this suggests a possible interaction between IIV and PCV13, though our study was not sufficiently powered to provide a precise estimate of the interaction. CONCLUSIONS: We found an elevated risk of febrile seizures after PCV13 vaccine but not after IIV. The risk of febrile seizures after PCV13 is low compared to the overall risk in this population of children, and the risk should be interpreted in the context of the importance of preventing pneumococcal infections.

Meeting report narcolepsy and pandemic influenza vaccination: What we know and what we need to know before the next pandemic? A report from the 2nd IABS meeting.

A group of scientific and public health experts and key stakeholders convened to discuss the state of knowledge on the relationship between adjuvanted monovalent inactivated 2009 influenza A H1N1 vaccines used during the 2009 influenza pandemic and narcolepsy. There was consensus that an increased risk of narcolepsy was consistently observed after Pandemrix (AS03-adjuvanted) vaccine, but similar associations following Arepanrix (AS03-adjuvanted) or Focetria (MF59-adjuvanted) vaccines were not observed. Whether the differences are due to vaccine composition or other factors such as the timing of large-scale vaccination programs relative to H1N1pdm09 wild-type virus circulation in different geographic regions is not clear. The limitations of retrospective observational methodologies could also be contributing to some of the differences across studies. More basic and epidemiologic research is needed to further elucidate the association between adjuvanted influenza vaccine and narcolepsy and its mechanism and to inform planning and preparation for vaccination programs in advance of the next influenza pandemic.

Post-licensure safety surveillance of zoster vaccine live (Zostavax®) in the United States, Vaccine Adverse Event Reporting System (VAERS), 2006-2015.

BACKGROUND: Herpes zoster (HZ), or shingles, is caused by reactivation of varicella-zoster virus in latently infected individuals. Live-attenuated HZ vaccine (zoster vaccine live, ZVL) is approved in the United States for persons aged ≥50 years and recommended by the CDC for persons ≥60 years. METHODS: We analyzed U.S. reports of adverse events (AEs) following ZVL submitted to the Vaccine Adverse Event Reporting System (VAERS), a spontaneous reporting system to monitor vaccine safety, for persons vaccinated May 1, 2006, through January 31, 2015. We conducted descriptive analysis, clinical reviews of reports with selected pre-specified conditions, and empirical Bayesian data mining. RESULTS: VAERS received 23,092 reports following ZVL, of which 22,120 (96%) were classified as non-serious. Of reports where age was documented (n = 18,817), 83% were in persons aged ≥60 years. Reporting rates of AEs were 106 and 4.4 per 100,000 ZVL doses distributed for all reports and serious reports, respectively. When ZVL was administered alone among persons aged ≥50 years, injection site erythema (27%), HZ (17%), injection site swelling (17%), and rash (14%) were the most commonly reported symptoms among non-serious reports; HZ (29%), pain (18%), and rash (16%) were the most commonly reported symptoms among serious reports. Six reports included laboratory evidence of vaccine-strain varicella-zoster virus (Oka/Merck strain) infection; AEs included HZ, HZ- or varicella-like illness, and local reaction with vesicles. In our review of reports of death with sufficient information to determine cause (n = 46, median age 75 years), the most common causes were heart disease (n = 28), sepsis (n = 4), and stroke (n = 3). Empirical Bayesian data mining did not detect new or unexpected safety signals. CONCLUSIONS: Findings from our safety review of ZVL are consistent with those from pre-licensure clinical trials and other post-licensure assessments. Transient injection-site reactions, HZ, and rashes were most frequently reported to VAERS following ZVL. Overall, our results are reassuring regarding the safety of ZVL.

Reports of Postural Orthostatic Tachycardia Syndrome After Human Papillomavirus Vaccination in the Vaccine Adverse Event Reporting System.

PURPOSE: Human papillomavirus (HPV) vaccination prevents infections with HPV strains that cause certain cancers. Reports of postural orthostatic tachycardia syndrome (POTS) following HPV vaccination have raised safety concerns. We reviewed POTS reports submitted to the Vaccine Adverse Event Reporting System (VAERS). METHODS: We searched the VAERS database for reports of POTS following any type of HPV vaccination (bivalent, quadrivalent, or nonavalent) from June 2006 to August 2015. We reviewed reports and applied established POTS diagnostic criteria. We calculated unadjusted POTS case reporting rates based on HPV vaccine doses distributed and conducted empirical Bayesian data mining to screen for disproportional reporting of POTS following HPV vaccination. RESULTS: Among 40,735 VAERS reports following HPV vaccination, we identified 29 POTS reports that fully met diagnostic criteria. Of these, 27 (93.1%) were in females and mean age was 14 years (range 12-32). Median time from vaccination to start of symptoms was 43 days (range 0-407); most (18, 75.0%) had onset between 0 and 90 days. Symptoms frequently reported concomitantly included headache (22, 75.9%) and dizziness (21, 72.4%). Twenty (68.9%) reports documented a history of pre-existing medical conditions, of which chronic fatigue (5, 17.2%), asthma (4, 13.8%), and chronic headache (3, 10.3%) were most common. Approximately one POTS case is reported for every 6.5 million HPV vaccine doses distributed in the United States. No empirical Bayesian data mining safety signals for POTS and HPV vaccination were detected. CONCLUSIONS: POTS is rarely reported following HPV vaccination. Our review did not detect any unusual or unexpected reporting patterns that would suggest a safety problem.

Postmarketing safety surveillance of trivalent recombinant influenza vaccine: Reports to the Vaccine Adverse Event Reporting System.

On January 16, 2013, the Food and Drug Administration approved recombinant hemagglutinin influenza vaccine (RIV3) (Spodoptera frugiperda cell line; Flublok), which is the first completely egg-free flu vaccine licensed in the United States. To improve our understanding of the safety profile of this vaccine, we reviewed and summarized reports to the Vaccine Adverse Event Reporting System (VAERS) following RIV3. Through June 30, 2016, VAERS received 88 reports. Allergic reactions, including anaphylaxis, were the most common type of adverse event. Based on medical review, 10 cases met the Brighton Collaboration case definition of anaphylaxis, 21 reports described allergic reactions other than anaphylaxis, and 11 reports described signs and symptoms that suggested hypersensitivity. Other adverse events included injection site reactions, fatigue, myalgia, headache, and fever. The occurrence of anaphylaxis and other allergic reactions in some individuals may reflect an underlying predisposition to atopy that may manifest itself after an exposure to any drug or vaccine, and it does not necessarily suggest a causal relationship with the unique constituents that are specific to the vaccine product administered. Further research may elucidate the mechanism of allergic reactions following influenza vaccination: it is possible that egg proteins and influenza hemagglutinin play little or no role. Vaccination remains the single best defense against influenza and its complications. The information summarized here may enable policy makers, health officials, clinicians, and patients to make a more informed decision regarding vaccination strategies.

Effectiveness and Duration of Protection Provided by the Live-attenuated Herpes Zoster Vaccine in the Medicare Population Ages 65 Years and Older.

Background: Tens of millions of seniors are at risk of herpes zoster (HZ) and its complications. Live attenuated herpes zoster vaccine (HZV) reduces that risk, although questions regarding effectiveness and durability of protection in routine clinical practice remain. We used Medicare data to investigate HZV effectiveness (VE) and its durability. Methods: This retrospective cohort study included beneficiaries ages ≥65 years during January 2007 through July 2014. Multiple adjustments to account for potential bias were made. HZV-vaccinated beneficiaries were matched to unvaccinated beneficiaries (primary analysis) and to HZV-unvaccinated beneficiaries who had received pneumococcal vaccination (secondary analysis). HZ outcomes in community and hospital settings were analyzed, including ophthalmic zoster (OZ) and postherpetic neuralgia (PHN). Results: Among eligible beneficiaries (average age 77 years), the primary analysis found VE for community HZ of 33% (95% CI: 32%-35%) and 19% (95% CI: 17%-22%), for the first 3, and subsequent 4+ years postvaccination, respectively. In the secondary analysis, VE was, respectively, 37% (95% CI: 36%-39%) and 22% (95% CI: 20%-25%). In the primary analysis, VE for PHN was 57% (95% CI: 52%-61%) and 45% (95% CI: 36%-53%) in the first 3 and subsequent 4+ years, respectively; VE for hospitalized HZ was, respectively, 74% (95% CI: 67%-79%) and 55% (95% CI: 39%-67%). Differences in VE by age group were not significant. Conclusions: In both the primary and secondary analyses, HZV provided protection against HZ across all ages, but effectiveness declined over time. VE was higher and better preserved over time for PHN and HZ-associated hospitalizations than for community HZ.

Decision support environment for medical product safety surveillance.

We have developed a Decision Support Environment (DSE) for medical experts at the US Food and Drug Administration (FDA). The DSE contains two integrated systems: The Event-based Text-mining of Health Electronic Records (ETHER) and the Pattern-based and Advanced Network Analyzer for Clinical Evaluation and Assessment (PANACEA). These systems assist medical experts in reviewing reports submitted to the Vaccine Adverse Event Reporting System (VAERS) and the FDA Adverse Event Reporting System (FAERS). In this manuscript, we describe the DSE architecture and key functionalities, and examine its potential contributions to the signal management process by focusing on four use cases: the identification of missing cases from a case series, the identification of duplicate case reports, retrieving cases for a case series analysis, and community detection for signal identification and characterization.

Repeated Low-Level Blast Exposure: A Descriptive Human Subjects Study.

The relationship between repeated exposure to blast overpressure and neurological function was examined in the context of breacher training at the U.S. Marine Corps Weapons Training Battalion Dynamic Entry School. During this training, Students are taught to apply explosive charges to achieve rapid ingress into secured buildings. For this study, both Students and Instructors participated in neurobehavioral testing, blood toxin screening, vestibular/auditory testing, and neuroimaging. Volunteers wore instrumentation during training to allow correlation of human response measurements and blast overpressure exposure. The key findings of this study were from high-memory demand tasks and were limited to the Instructors. Specific tests showing blast-related mean differences were California Verbal Learning Test II, Automated Neuropsychological Assessment Metrics subtests (Match-to-Sample, Code Substitution Delayed), and Delayed Matching-to-Sample 10-second delay condition. Importantly, apparent deficits were paralleled with functional magnetic resonance imaging using the n-back task. The findings of this study are suggestive, but not conclusive, owing to small sample size and effect. The observed changes yield descriptive evidence for potential neurological alterations in the subset of individuals with occupational history of repetitive blast exposure. This is the first study to integrate subject instrumentation for measurement of individual blast pressure exposure, neurocognitive testing, and neuroimaging.

Post-licensure surveillance of quadrivalent inactivated influenza (IIV4) vaccine in the United States, Vaccine Adverse Event Reporting System (VAERS), July 1, 2013-May 31, 2015.

BACKGROUND: Quadrivalent inactivated influenza vaccines (IIV4) were first available for use during 2013-14 influenza season for individuals aged ≥6 months. IIV4 is designed to protect against four different flu viruses; two influenza A viruses and two influenza B viruses. METHODS: We searched the Vaccine Adverse Event Reporting System (VAERS) for US reports after IIV4 and trivalent inactivated influenza vaccine (IIV3) from 7/1/2013-5/31/2015. Medical records were requested for non-manufacturer reports classified as serious (i.e. death, hospitalization, prolonged hospitalization, life-threatening illness, permanent disability). The review included automated data analysis, clinical review of all serious reports, reports of special interest, and empirical Bayesian data mining. RESULTS: VAERS received 1,838 IIV4 reports; 512 (28%) in persons aged 6 months-17 years of which 42 (8.2%) were serious reports; 1,265 (69%) in persons aged >18 years of which 84 (6.6%) were serious reports; two in children <6 months and 59 in persons of unknown age. Injection site erythema (24%), fever (14%) and injection site swelling (17%) were the most frequent adverse events among persons aged 6 months-17 years, while injection site pain (16%), pain (15%) and pain in extremity (13%) were the most frequent among persons aged 18-64 years given the vaccine alone. Among non-death serious reports, injection site reactions, constitutional symptoms, Guillain-Barré syndrome, seizures, and anaphylaxis were the most frequently reported adverse events. Data mining detected disproportional reporting for incorrect vaccine administration with no associated adverse events. Adverse events following IIV4 reported to VAERS were similar to those following IIV3. CONCLUSIONS: In our review of VAERS reports, IIV4 had a similar safety profile to IIV3. Most of the reported AEs were non-serious. Our findings are consistent with data from pre-licensure studies of IIV4.

Complementary use of passive surveillance and Mini-Sentinel to better characterize hemolysis after immune globulin.

BACKGROUND: Hemolysis after intravenous immune globulins (IGIVs) is a known complication, but expanding indications and recent manufacturing changes warrant ongoing postmarketing surveillance. Characterization of post-IGIV hemolysis to date has been limited to small case series. STUDY DESIGN AND METHODS: We queried the Food and Drug Administration's (FDA) Adverse Event Reporting System (FAERS) from 2007 to 2014. All reported post-IGIV hemolysis cases were classified using a prespecified case definition and a case series analysis performed. We also conducted two assessments using FDA's Mini-Sentinel (MS) system to quantify the risk of hemolysis by six product indications and by IGIV formulation and evaluate the onset interval. RESULTS: A total of 109 FAERS cases met our definition. For cases with available information, 83% (66/80) received IGIV doses of at least 2 g/kg, 98.1% (51/52) had non-O blood group, and 75% (64/85) of events occurred within 4 days of IGIV exposure. We identified 313,045 treatment episodes and 337 post-IGIV hemolytic events in MS from 2006 to 2014, with 72% occurring within 2 days. Rates of hemolysis were highest among patients with Kawasaki disease (KD) and immune thrombocytopenia (ITP). The risk among patients receiving nonlyophilized products was 2.3 times higher than that in patients receiving lyophilized products. CONCLUSION: With the largest case series to date, FAERS data support that higher doses and non-O blood group are key risk factors. The incident rate of post-IGIV hemolysis is estimated at one per 1000 IGIV treatment episodes, with most occurring within 2 days of exposure. The risk is higher in patients with KD and ITP and after receipt of nonlyophilized IGIV.

Adverse events following Haemophilus influenzae type b vaccines in the Vaccine Adverse Event Reporting System, 1990-2013.

OBJECTIVE: To characterize adverse events (AEs) after Haemophilus influenzae type b (Hib) vaccines reported to the US Vaccine Adverse Event Reporting System (VAERS), a spontaneous reporting surveillance system. STUDY DESIGN: We searched VAERS for US reports after Hib vaccines among reports received from January 1, 1990, to December 1, 2013. We reviewed a random sample of reports and accompanying medical records for reports classified as serious. All reports of death were reviewed. Physicians assigned a primary clinical category to each reviewed report. We used empirical Bayesian data mining to identify AEs that were disproportionally reported after Hib vaccines. RESULTS: VAERS received 29,747 reports after Hib vaccines; 5179 (17%) were serious, including 896 reports of deaths. Median age was 6 months (range 0-1022 months). Sudden infant death syndrome was the stated cause of death in 384 (51%) of 749 death reports with autopsy/death certificate records. The most common nondeath serious AE categories were neurologic (80; 37%), other noninfectious (46; 22%) (comprising mainly constitutional signs and symptoms); and gastrointestinal (39; 18%) conditions. No new safety concerns were identified after clinical review of reports of AEs that exceeded the data mining statistical threshold. CONCLUSION: Review of VAERS reports did not identify any new or unexpected safety concerns for Hib vaccines.

Physical readiness and obesity among male U.S. Navy personnel with limited exercise availability while at sea.

OBJECTIVE: To evaluate differences in physical readiness and obesity in worksites with inherent limitations in exercise availability, utilizing data from U.S. Navy personnel assigned to submarines. METHODS: Cross-sectional study utilizing height, weight, and Physical Readiness Test (PRT) scores of 26,341 individuals assigned to small submarines (SS), large submarines (LS), and aircraft carriers (AC). RESULTS: PRT failure rates were 3.4% (AC), 1.5% (LS), and 2.9% (SS). Prevalence of obesity was 15.1% (AC), 16.9% (LS), and 17.8% (SS). The adjusted prevalence odds ratio of obesity was increased on SS and LS compared to AC, 1.25 (96% CI = 1.14, 1.31) and 1.17 (95% CI = 1.06, 1.29), respectively. CONCLUSIONS: Despite limitations in exercise availability, submarine personnel performance on the PRT was similar to that of AC personnel. Although the prevalence of obesity on submarines was slightly higher, it remains below U.S. nonmilitary comparison data. Although limited access to exercise has the potential for adverse health effects in worker populations, in our cohort of young men, the changes in both physical readiness and obesity were small. Further research on a more diverse group of workers is warranted.

Occupational effect on the occurrence of idiopathic venous thromboembolism.

Few studies have explored the effects of various occupations on venous thromboembolism occurrence. We examined idiopathic venous thromboembolism (IVTE) occurrence by occupation, body size, and age in the U.S. military. To capture idiopathic cases, exclusion criteria included recognized venous thromboembolism risk factors. Each case was matched to three controls on branch of service, sex, rank/grade, race, and education level. Body mass index, age, and occupation were analyzed with chi2 and logistic regression. Of 2,167 cases, most were male (87%), white (69%), enlisted (78%), averaging 36 years old. IVTE odds increased with age (p < 0.001). Every occupation showed greater odds than pilots/aircrew (p < 0.001), especially infantry/artillery/combat arms, which showed twice the odds, followed by health care workers. Normal weight was protective, especially in pilots/aircrew (OR 0.52, p = 0.03) and repair/engineering (OR 0.72, p < 0.001). Our analysis found a lower risk of IVTE among pilots and aircrew compared to other military occupations. Body size had less impact than expected in aircraft and vehicle operators. Greater odds in health care workers and infantry/artillery/combat arms than in pilots/aircrew and armor/motor transport occupational groups may reflect prolonged standing. Limitations include potential miscoding of health records and potential misclassification. Future IVTE research should explore job functions and worker characteristics.

Estimated incidence of multiple sclerosis among United States Armed Forces personnel using the Defense Medical Surveillance System.

BACKGROUND: The comprehensive longitudinal medical records of the U.S. Armed Forces provide a valuable tool to study the epidemiology of multiple sclerosis (MS) in persons from a diverse demography. OBJECTIVE: This study's objectives were to estimate the frequencies, incidence rates (IRs), trends, and correlates of MS among active component U.S. military members from 2000 to 2009. METHODS: An International Classification of Diseases, 9th Revision, code algorithm was used to identify MS cases from the Defense Medical Surveillance System database. IRs were determined by dividing the number of cases of MS by the total person-time of the active component during each year. RESULTS: During the 10-year period, there were 1,827 incident cases of MS with an overall IR of 12.9 per 100,000 person-years (p-yrs). Black non-Hispanics had a higher IR: (18.3 per 100,000 p-yrs) than White non-Hispanics (12.5 per 100,000 p-yrs). The incidence of MS by birth month and geographic home did not show a clear trend of seasonality or latitudinal gradient. CONCLUSIONS: This investigation is the first longitudinal study of MS incidence in U.S. Armed Forces personnel. The study demonstrates higher IRs than seen in other populations and reveals a novel pattern of MS incidence by race.

Physician review of workers' compensation case files: can it affect decision outcomes?

OBJECTIVE: To identify common attributes of Federal workers' compensation cases referred to Navy physicians for medical opinions and to determine the impact of the review on the final case decision. METHODS: Retrospective case study and descriptive analysis of 258 opinion letters written by physicians on referred cases from 2006 to 2010. RESULTS: Navy physician opinions were considered in the outcome in some of the cases, and there was a statistically significant difference between the claim acceptance rate in the study population and the total population. Worker age was correlated with certain claim types. CONCLUSIONS: There is preliminary evidence that the opinion letters of Navy physicians influenced case decisions. Because of the selection bias in how the cases came to the study population, a prospective cohort study is warranted to establish whether this conclusion and the other results noted are valid.

Cost-minimization analysis of the U.S. Army accession screening and immunization program.

OBJECTIVES: Significant Army resources are utilized to identify nonimmune recruits for targeted vaccinations against hepatitis A, hepatitis B, measles, rubella, and varicella. Therefore, a cost-minimization analysis between the Accession Screening and Immunization Program (ASIP) and the previously utilized universal vaccination program will assist military public health policy makers in decisions that enhance force health protection. METHODS: Serological immunity data on 41,146 Fort Leonard Wood, Missouri, Army basic training recruits aged 17 to 42 years from October 1, 2007 to September 30, 2009 were utilized. Vaccination, serology, and other direct and indirect costs were determined using the Federal Supply Schedule and local base immunization data. TreeAge Pro 2009 version 1.0.2 was used for the analysis. RESULTS: The cumulative annual cost for the universal vaccination program totaled $1,504,587, whereas the cumulative costs for the ASIP totaled $1,094,025, for a cost-savings of $410,561 annually at this basic training site. CONCLUSIONS: Over $400,000 of annual savings was realized from the ASIP compared to universal vaccination at Fort Leonard Wood, thus confirming the cost-savings theorized by the implementation of the ASIP.

Viruses and vitamin D in the etiology of type 1 diabetes mellitus and multiple sclerosis.

Although specific viruses have been associated with autoimmune diseases, none fulfill Koch's criteria of causation. The etiologies of such diseases appear to be complex and multifactorial. For example, one might propose that the etiology of type 1 diabetes mellitus results from a toxic metabolite of nitrosamines during an enteroviral infection. Multiple sclerosis might result from a cascade of events involving several herpes virus infections activated during periods of vitamin D deficiency. We encourage investigators to consider Rotman's sufficient-component causal model when developing hypotheses for testing for the etiology of chronic diseases. Delineating the web of causation may lead to additional strategies for prevention and treatment of several autoimmune diseases.

Headache disorders in the millennium cohort: epidemiology and relations with combat deployment.

OBJECTIVE: Characterize migraine and other headache disorders within a large population-based US military cohort, with an emphasis on the temporal association between military deployment and exposure to combat. BACKGROUND: Little research has been published on the prevalence of headache disorders in the US military population, especially in relation to overseas deployments and exposure to combat. A higher than expected prevalence of migraine has previously been reported among deployed US soldiers in Iraq, suggesting an association. Headache disorders, including migraine, could have important effects on the performance of service members. METHODS: A total of 77,047 US active-duty, Reserve, and National Guard members completed a baseline questionnaire between July 2001 to June 2003 for the Millennium Cohort Study. Headache disorders were assessed using the following survey-based measures: self-reported history of provider-diagnosed migraine, recurrent severe headache within the past year, and recent headaches/bothered a lot within the past 4 weeks. Follow-up surveys were completed on average 3 years after baseline (mean=2.7 years; range=11.4 months to 4.5 years). RESULTS: The overall male and female prevalence of self-reported headache conditions at baseline were: provider-diagnosed migraine, 6.9% and 20.9%, respectively; recurrent severe headache, 9.4% and 22.3%, respectively; and bothered a lot by headaches, 3.4% and 10.4%, respectively. Combat deployers had significantly higher odds of any new-onset headache disorders than non-deployers (adjusted odds ratios=1.72 for men, 1.84 for women; 95% confidence intervals, 1.55-1.90 for men, 1.55-2.18 for women), while deployers without combat exposure did not. CONCLUSIONS: Deployed personnel with reported combat exposure appear to represent a higher risk group for new-onset headache disorders. The identification of populations at higher risk of development of headache provides support for targeted interventions.

Systematic review of military motor vehicle crash-related injuries.

CONTEXT: Motor vehicle crashes account for nearly one third of U.S. military fatalities annually. The objective of this review is to summarize the published evidence on injuries due specifically to military motor vehicle (MMV) crashes. EVIDENCE ACQUISITION: A search of 18 electronic databases identified English language publications addressing MMV crash-related injuries between 1970 and 2006 that were available to the general public. Documents limited in distribution to military or government personnel were not evaluated. Relevant articles were categorized by study design. EVIDENCE SYNTHESIS: The search identified only 13 studies related specifically to MMV crashes. Most were case reports or case series (n=8); only one could be classified as an intervention study. Nine of the studies were based solely on data from service-specific military safety centers. CONCLUSIONS: Few studies exist on injuries resulting from crashes of military motor vehicles. Epidemiologic studies that assess injury rates, type, severity, and risk factors are needed, followed by studies to evaluate targeted interventions and prevention strategies. Interventions currently underway should be evaluated for effectiveness, and those proven effective in the civilian community, such as graduated driver licensing, should be considered for implementation and evaluation in military populations.