Last data update: Sep 16, 2024. (Total: 47680 publications since 2009)
Records 1-21 (of 21 Records) |
Query Trace: Miller ER [original query] |
---|
Syncope after live attenuated influenza vaccine: Reports to the Vaccine Adverse Event Reporting System (2003-2024)
Woo EJ , Miller ER , Stroud E . Vaccine 2024 42 (24) 126290 Vasovagal syncope, or fainting, can be triggered by various stimuli, including medical procedures. Syncope after vaccination has been reported, most commonly among adolescents, and can result in injuries. Using the Vaccine Adverse Event Reporting System (VAERS), we reviewed and summarized reports of syncope after live attenuated influenza vaccine, intranasal (LAIV) administered as the sole vaccine (i.e., no concomitant injections). From June 17, 2003 (date of LAIV licensure in the US) through May 31, 2024, VAERS received 50 reports of syncope after LAIV. Nearly half (23; 46 %) pertained to individuals 10-19 years of age. While the vast majority of reports (35; 70 %) did not describe any injuries, 15 people (30 %) were injured, most commonly by falling and hitting their head or face. Twenty-two people (44 %) required evaluation in the emergency department or doctor's office, including an individual who lost consciousness while he was driving home from the vaccination appointment. He did not report any injuries, but the car was severely damaged. Nearly three-quarters of people (37; 74 %) developed syncope within 15 min after vaccination, but fewer than half of reports (24; 48 %) stated that the patient had waited in the observation area for at 15 min. Based on approximately 111.9 million doses of LAIV distributed in the US during the same time period, the reporting rate is approximately 0.4 per million doses, suggesting that syncope following LAIV is rare. The information summarized here may enable clinicians, patients, and caregivers to make a more informed decision regarding preventing injuries that may occur following LAIV-related syncope. |
COVID-19 vaccine safety inquiries to the Centers For Disease Control And Prevention Immunization Safety Office
Miller ER , Moro PL , Shimabukuro TT , Carlock G , Davis SN , Freeborn EM , Roberts AL , Gee J , Taylor AW , Gallego R , Suragh T , Su JR . Vaccine 2023 BACKGROUND: Following the authorization and recommendations for use of the U.S. COVID-19 vaccines, the Centers for Disease Control and Prevention (CDC)'s Immunization Safety Office (ISO) responded to inquiries and questions from public health officials, healthcare providers, and the general public on COVID-19 vaccine safety. METHODS: We describe COVID-19 vaccine safety inquiries, by topic, received and addressed by ISO from December 1, 2020-August 31, 2022. RESULTS: Of the 1978 COVID-19 vaccine-related inquiries received, 1655 specifically involved vaccine safety topics. The most frequently asked-about topics included deaths following vaccination, myocarditis, pregnancy, and reproductive health outcomes, understanding or interpreting data from the Vaccine Adverse Event Reporting System (VAERS), and thrombosis with thrombocytopenia syndrome. CONCLUSIONS: Inquiries about vaccine safety generally reflect issues that receive media attention. ISO will continue to monitor vaccine safety inquiries and provide accurate and timely information to healthcare providers, public health officials, and the general public. |
The reporting sensitivity of the Vaccine Adverse Event Reporting System (VAERS) for anaphylaxis and for Guillain-Barr syndrome
Miller ER , McNeil MM , Moro PL , Duffy J , Su JR . Vaccine 2020 38 (47) 7458-7463 BACKGROUND: Underreporting is a limitation common to passive surveillance systems, including the Vaccine Adverse Event Reporting System (VAERS) that monitors the safety of U.S.-licensed vaccines. Nonetheless, previous reports demonstrate substantial case capture for clinically severe adverse events (AEs), including 47% of intussusception cases after rotavirus vaccine, and 68% of vaccine associated paralytic polio after oral polio vaccine. OBJECTIVES: To determine the sensitivity of VAERS in capturing AE reports of anaphylaxis and Guillain-Barré syndrome (GBS) following vaccination and whether this is consistent with previous estimates for other severe AEs. METHODS: We estimated VAERS reporting rates following vaccination for anaphylaxis and GBS. We used data from VAERS safety reviews as the numerator, and estimated incidence rates of anaphylaxis and GBS following vaccination from the Vaccine Safety Datalink (VSD) studies as the denominator. We defined reporting sensitivity as the VAERS reporting rate divided by the VSD incidence rate. Sensitivity was reported as either a single value, or a range if data were available from >1 study. RESULTS: VAERS sensitivity for capturing anaphylaxis after seven different vaccines ranged from 13 to 76%; sensitivity for capturing GBS after three different vaccines ranged from 12 to 64%. For anaphylaxis, VAERS captured 13-27% of cases after the pneumococcal polysaccharide vaccine, 13% of cases after influenza vaccine, 21% of cases after varicella vaccine, 24% of cases after both the live attenuated zoster and quadrivalent human papillomavirus (4vHPV) vaccines, 25% of cases after the combined measles, mumps and rubella (MMR) vaccine, and 76% of cases after the 2009 H1N1 inactivated pandemic influenza vaccine. For GBS, VAERS captured 12% of cases after the 2012-13 inactivated seasonal influenza vaccine, 15-55% of cases after the 2009 H1N1 inactivated pandemic influenza vaccine, and 64% of cases after 4vHPV vaccine. CONCLUSIONS: For anaphylaxis and GBS, VAERS sensitivity is comparable to previous estimates for detecting important AEs following vaccination. |
Adverse events following adenovirus type 4 and type 7 vaccine, live, oral in the Vaccine Adverse Event Reporting System (VAERS), United States, October 2011-July 2018
McNeil MM , Paradowska-Stankiewicz I , Miller ER , Marquez PL , Seshadri S , Collins LCJr , Cano MV . Vaccine 2019 37 (44) 6760-6767 BACKGROUND: In March 2011, the U.S. Food and Drug Administration licensed adenovirus type 4 and type 7 vaccine, live, oral (Barr Labs, Inc.) (adenovirus vaccine) for use in military personnel 17 through 50years of age. The vaccine was first universally administered to U.S. military recruits in October 2011. We investigated adverse event (AE) reports following the adenovirus vaccine submitted to the Vaccine Adverse Event Reporting System (VAERS). METHODS: We searched the VAERS database for U.S. reports among persons who received adenovirus vaccine during October 2011 through July 2018 including participants in a military observational study. We reviewed all serious reports and accompanying medical records. We compared the proportion of serious reports in a proxy military recruit population and reviewed all reports of suspected allergic reactions following adenovirus vaccination. RESULTS: During the analytic period, VAERS received 100 reports following adenovirus vaccination; 39 (39%) were classified as serious and of these, 17 (44%) were from the observational study. One death was reported. Males accounted for 72% of reports. Median age of vaccinees was 19years (range 17-32). The most frequently reported serious AEs were Guillain Barre syndrome (GBS) (n=12) and anaphylaxis (n=8); of these, two GBS and all the anaphylaxis reports were reported in the observational study. Reports documented concurrent receipt of multiple other vaccines (95%) and penicillin G (IM Pen G) or other antibiotics (50%). CONCLUSIONS: The reporting rate for serious AEs was higher than with other vaccines administered in the comparison military recruit population (39% vs 18%); however, we identified no unexpected or concerning pattern of adenovirus vaccine AEs. Co-administration of vaccines and IM Pen G was commonly reported in this military population. These exposures may have contributed to the GBS and anaphylaxis outcomes observed with the adenovirus vaccine. Future adenovirus vaccine safety studies in a population without these co-administrations would be helpful in clarifying the vaccine's safety profile. |
Adverse events following vaccination with an inactivated, Vero cell culture-derived Japanese encephalitis vaccine in the United States, 2012-2016
Walker WL , Hills SL , Miller ER , Fischer M , Rabe IB . Vaccine 2018 36 (29) 4369-4374 BACKGROUND: In March 2009, the U.S. Food and Drug Administration licensed an inactivated Vero cell culture-derived Japanese encephalitis vaccine (JE-VC [IXIARO(R)]) for use in persons aged >/=17years. In 2013, licensure was extended to include children aged >/=2months. A previous analysis reviewed adverse events reported to the U.S. Vaccine Adverse Event Reporting System (VAERS) from May 2009 through April 2012. METHODS: We reviewed adverse events reported to VAERS following JE-VC administered from May 1, 2012 through April 30, 2016. Adverse event reporting rates were calculated using 802,229 doses distributed. RESULTS: During the 4-year period, 119 adverse event reports were received for a reporting rate of 14.8 per 100,000 doses distributed. Nine (8%) adverse events were classified as serious for a reporting rate of 1.1 per 100,000 distributed. The most commonly reported event was hypersensitivity (n=24; 20%) for a rate of 3.0 per 100,000 doses distributed; 1 anaphylaxis event was reported. Ten (8%) neurologic events were reported for a rate of 1.2 per 100,000 doses distributed; 2 events were classified as seizures. Sixty-three (53%) adverse events occurred after a first dose of JE-VC. Eighty (67%) adverse events occurred after administration of JE-VC with other vaccines. Eleven (9%) adverse events were reported in children; 1 was considered serious. CONCLUSIONS: These data continue to support the generally favorable safety profile of JE-VC. Reporting rates of adverse events were similar to those of the previous analysis. Although reporting rates of adverse events in children could not be calculated, there were low numbers of reported events in this age group. Post-licensure adverse event surveillance for this relatively new vaccine continues to be important to monitor adverse event reporting rates and identify possible rare serious events. |
Notes from the field: Vaccine administration errors involving recombinant zoster vaccine - United States, 2017-2018
Shimabukuro TT , Miller ER , Strikas RA , Hibbs BF , Dooling K , Goud R , Cano MV . MMWR Morb Mortal Wkly Rep 2018 67 (20) 585-586 Two vaccines for the prevention of herpes zoster (shingles) are licensed for use in the United States and recommended by the Advisory Committee on Immunization Practices (ACIP). Zoster vaccine live (ZVL; Zostavax, Merck), licensed in 2006,* is a live attenuated virus vaccine administered as a single subcutaneous (SQ) dose. Although the Food and Drug Administration (FDA) approved ZVL for adults aged ≥50 years, ACIP recommends ZVL for immunocompetent adults aged ≥60 years (1). Recombinant zoster vaccine (RZV; Shingrix, GlaxoSmithKline), licensed October 2017,† is also approved by the FDA for adults aged ≥50 years and is recommended by ACIP for immunocompetent adults aged ≥50 years (2). RZV is administered as a 2-dose intramuscular (IM) series, with the second dose given anytime from 2 to 6 months after the first. RZV is preferentially recommended by ACIP over ZVL (2). Furthermore, ACIP recommends that persons previously vaccinated with ZVL receive the full 2-dose RZV series (2). |
Post-licensure safety surveillance of zoster vaccine live (Zostavax®) in the United States, Vaccine Adverse Event Reporting System (VAERS), 2006-2015.
Miller ER , Lewis P , Shimabukuro TT , Su J , Moro P , Woo EJ , Jankosky C , Cano M . Hum Vaccin Immunother 2018 14 (8) 1-23 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. |
Notes from the field: Errors in administration of an excess dosage of yellow fever vaccine - United States, 2017
McNeil MM , Hibbs BF , Miller ER , Cano MV . MMWR Morb Mortal Wkly Rep 2018 67 (3) 109-110 Yellow fever vaccine (YF-VAX, Sanofi Pasteur, Swiftwater, Pennsylvania) is a live, attenuated virus vaccine recommended for persons aged ≥9 months who are traveling to or living in areas with risk for yellow fever virus transmission (1). For persons of all ages for whom vaccination is indicated, a single subcutaneous injection of 0.5 mL of reconstituted vaccine is used. Because no specific treatment for yellow fever exists, prevention through vaccination is critical to reduce yellow fever–associated morbidity and mortality (2). YF-VAX is the only yellow fever vaccine licensed in the United States, and approximately 500,000 doses are distributed annually to vaccinate military and civilian travelers. Yellow fever vaccine is supplied only to designated Yellow Fever Vaccination Centers authorized to issue certificates of yellow fever vaccination. YF-VAX is available in single-dose and 5-dose vials. Single-dose vials of lyophilized (freeze-dried) vaccine are supplied in a package of five vials of vaccine (Figure); five vials of diluent are provided separately (each vial of diluent contains 0.6 mL sodium chloride for injection USP). Five-dose vials are supplied in a package containing one vial (Figure), and diluent is supplied separately in one vial containing 3 mL sodium chloride for injection USP. The manufacturer’s instructions specify that the vaccine is to be used within 60 minutes of reconstituting either the single-dose or the 5-dose vial. |
Cognitive testing to evaluate revisions to the Vaccine Adverse Event Reporting System (VAERS) reporting form
Suragh TA , Miller ER , Hibbs BF , Winiecki SK , Zinderman C , Shimabukuro TT . Vaccine 2017 35 (18) 2295-2297 INTRODUCTION: The Vaccine Adverse Event Reporting System (VAERS) is the spontaneous (passive) reporting system CDC and FDA use to monitor vaccine safety. We used cognitive testing to evaluate proposed revisions to the current VAERS form. METHODS: We conducted in-person cognitive interviews with 22 volunteers to evaluate proposed revisions in a prototype VAERS 2.0 form (new VAERS form). We analyzed data using thematic analysis. RESULTS: Repeating themes included preferences for: brevity, simplicity and clarity; features to minimize time requirements and facilitate ease of completion; logical ordering of questions by topic and importance; and visual cues like color-coded highlighting. Interviews identified instances of discordance between the intended meaning questions (from the perspective of CDC and FDA) and interpretation by volunteers. CONCLUSIONS: Cognitive testing yielded useful information to guide further revisions of the VAERS form. Cognitive testing can be an effective tool for public health programs interested in developing surveys and reporting forms. |
Research needs to improve hypertension treatment and control in African Americans
Whelton PK , Einhorn PT , Muntner P , Appel LJ , Cushman WC , Diez Roux AV , Ferdinand KC , Rahman M , Taylor HA , Ard J , Arnett DK , Carter BL , Davis BR , Freedman BI , Cooper LA , Cooper R , Desvigne-Nickens P , Gavini N , Go AS , Hyman DJ , Kimmel PL , Margolis KL , Miller ER 3rd , Mills KT , Mensah GA , Navar AM , Ogedegbe G , Rakotz MK , Thomas G , Tobin JN , Wright JT , Yoon SS , Cutler JA . Hypertension 2016 Additional targeted research and customized training programs could spearhead strategies for elimination of the disparities in prevalence and control of high BP between African Americans and the remainder of the US general population. | This report presents findings of an ad hoc working group assembled by the National Heart, Lung, and Blood Institute (NHLBI) to assess research needs to improve prevention, treatment and control of hypertension among African Americans. Non-Hispanic Blacks (African American and Black will be used for US and international studies, respectively) tend to have an earlier onset, higher prevalence, and disproportionately high risk of complications for hypertension compared to non-Hispanic Whites and Mexican Americans.1 |
Adverse event reports following yellow fever vaccination, 2007-13
Lindsey NP , Rabe IB , Miller ER , Fischer M , Staples JE . J Travel Med 2016 23 (5) BACKGROUND: Yellow fever (YF) vaccines have been available since the 1930s and are generally considered safe and effective. However, rare reports of serious adverse events (SAE) following vaccination have prompted the Advisory Committee for Immunization Practices to periodically expand the list of conditions considered contraindications and precautions to vaccination. METHODS: We describe adverse events following YF vaccination reported to the U.S. Vaccine Adverse Event Reporting System (VAERS) from 2007 through 2013 and calculate age- and sex-specific reporting rates of all SAE, anaphylaxis, YF vaccine-associated neurologic disease (YEL-AND) and YF vaccine-associated viscerotropic disease (YEL-AVD). RESULTS: There were 938 adverse events following YF vaccination reported to VAERS from 2007 through 2013. Of these, 84 (9%) were classified as SAEs for a rate of 3.8 per 100 000 doses distributed. Reporting rates of SAEs increased with increasing age with a rate of 6.5 per 100 000 in persons aged 60-69 years and 10.3 for ≥70 years. The reporting rate for anaphylaxis was 1.3 per 100 000 doses distributed and was highest in persons ≤18 years (2.7 per 100 000). Reporting rates of YEL-AND and YEL-AVD were 0.8 and 0.3 per 100 000 doses distributed, respectively; both rates increased with increasing age. CONCLUSIONS: These findings reinforce the generally acceptable safety profile of YF vaccine, but highlight the importance of continued physician and traveller education regarding the risks and benefits of YF vaccination, particularly for older travellers. |
Post-licensure safety surveillance of 23-valent pneumococcal polysaccharide vaccine in the Vaccine Adverse Event Reporting System (VAERS), 1990-2013.
Miller ER , Moro PL , Cano M , Lewis P , Bryant-Genevier M , Shimabukuro T . Vaccine 2016 34 (25) 2841-6 BACKGROUND: 23-Valent pneumococcal polysaccharide vaccine, trade name Pneumovax(R)23 (PPSV23), has been used for decades in the Unites States and has an extensive clinical record. However, limited post-licensure safety assessment has been conducted. OBJECTIVE: To analyze reports submitted to the Vaccine Adverse Event Reporting System (VAERS) following PPSV23 from 1990 to 2013 in order to characterize its safety profile. METHODS: We searched the VAERS database for US reports following PPSV23 for persons vaccinated from 1990 to 2013. We assessed safety through: automated analysis of VAERS data, crude adverse event (AE) reporting rates based on PPSV23 doses distributed in the US market, clinical review of death reports and reports involving vaccine administered to pregnant women, and empirical Bayesian data mining to assess for disproportional reporting. RESULTS: During the study period, VAERS received 25,168 PPSV23 reports; 92% were non-serious, 67% were in females and 86% were in adults aged ≥19 years. When PPSV23 was administered alone, fever (43%), injection site erythema (28%) and injection site pain (25%) were the most commonly reported non-serious AEs in children. Injection site erythema (32%), injection site pain (27%) and injection site swelling (23%) were the most commonly reported non-serious AEs in adults. Of serious reports (2129, 8% of total), fever was most commonly reported in both children (69%) and adults (39%). There were 66 reports of death, four in children and 62 in adults. Clinical review of death reports did not reveal any concerning patterns that would suggest a causal association with PPSV23. No disproportional reporting of unexpected AEs was observed in empirical Bayesian data mining. CONCLUSIONS: We did not identify any new or unexpected safety concerns for PPSV23. The VAERS data are consistent with safety data from pre-licensure clinical trials and other post-licensure studies. |
Notes from the field: Administration error involving a meningococcal conjugate vaccine - United States, March 1, 2010-September 22, 2015
Su JR , Miller ER , Duffy J , Baer BM , Cano MV . MMWR Morb Mortal Wkly Rep 2016 65 (6) 161-162 Menveo (GlaxoSmithKline, previously Novartis AG) is a conjugate vaccine that was recommended in October 2010 for routine use in adolescents (preferably aged 11 or 12 years, with a booster at 16 years), and among persons aged 2 through 54 years with certain immunosuppressive conditions, to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y, and W-135. These recommendations have since been update. Menveo is supplied in two vials that must be combined before administration. The MenA lyophilized (freeze-dried) component must be reconstituted with the MenCYW-135 liquid component. To administer the vaccine, the liquid component is drawn into a syringe, and used to reconstitute the lyophilized component. The resulting solution is administered by intramuscular injection. Failure to prepare Menveo as directed by the manufacturer's instructions can lead to lack of protection against the intended pathogens (N. meningitidis serogroups A, C, Y, and/or W-135). Recently, an immunization provider administered only the lyophilized component of Menveo, subsequently administered a properly prepared dose of Menveo to the same patient, and asked CDC if this practice was safe. This question prompted CDC to search the Vaccine Adverse Event Reporting System (VAERS) database for reports during March 1, 2010-September 22, 2015, of only one component of Menveo being administered. Additionally, to more broadly identify disproportional reporting of adverse events in general following Menveo immunization compared with other vaccines in VAERS (including errors in vaccine preparation and administration), the Food and Drug Administration performed data mining with empiric Bayesian methods. |
Vaccine safety resources for nurses
Miller ER , Shimabukuro TT , Hibbs BF , Moro PL , Broder KR , Vellozzi C . Am J Nurs 2015 115 (8) 55-8 Nurses are on the front lines of health care delivery, and many of them routinely administer immunizations. The authors describe the Centers for Disease Control and Prevention's (CDC) vaccine safety monitoring systems, explaining how nurses can access inquiry channels and other immunization information resources. Examples of recent vaccine safety inquiries are also provided. |
Deaths following vaccination: what does the evidence show?
Miller ER , Moro PL , Cano M , Shimabukuro T . Vaccine 2015 33 (29) 3288-92 Vaccines are rigorously tested and monitored and are among the safest medical products we use. Millions of vaccinations are given to children and adults in the United States each year. Serious adverse reactions are rare. However, because of the high volume of use, coincidental adverse events including deaths, that are temporally associated with vaccination, do occur. When death occurs shortly following vaccination, loved ones and others might naturally question whether it was related to vaccination. A large body of evidence supports the safety of vaccines, and multiple studies and scientific reviews have found no association between vaccination and deaths except in rare cases. During the US multi-state measles outbreak of 2014-2015, unsubstantiated claims of deaths caused by measles, mumps, and rubella (MMR) vaccine began circulating on the Internet, prompting responses by public health officials to address common misinterpretations and misuses of vaccine safety surveillance data, particularly around spontaneous reports submitted to the US Vaccine Adverse Event Reporting System (VAERS). We summarize epidemiologic data on deaths following vaccination, including examples where reasonable scientific evidence exists to support that vaccination caused or contributed to deaths. Rare cases where a known or plausible theoretical risk of death following vaccination exists include anaphylaxis, vaccine-strain systemic infection after administration of live vaccines to severely immunocompromised persons, intussusception after rotavirus vaccine, Guillain-Barre syndrome after inactivated influenza vaccine, fall-related injuries associated with syncope after vaccination, yellow fever vaccine-associated viscerotropic disease or associated neurologic disease, serious complications from smallpox vaccine including eczema vaccinatum, progressive vaccinia, postvaccinal encephalitis, myocarditis, and dilated cardiomyopathy, and vaccine-associated paralytic poliomyelitis from oral poliovirus vaccine. However, making general assumptions and drawing conclusions about vaccinations causing deaths based on spontaneous reports to VAERS - some of which might be anecdotal or second-hand - or case reports in the media, is not a scientifically valid practice. |
Vaccination errors reported to the Vaccine Adverse Event Reporting System, United States, 2000-2013
Hibbs BF , Moro PL , Lewis P , Miller ER , Shimabukuro T . Vaccine 2015 33 (28) 3171-8 IMPORTANCE: Vaccination errors are preventable events. Errors can have impacts including inadequate immunological protection, possible injury, cost, inconvenience, and reduced confidence in the healthcare delivery system. OBJECTIVES: To describe vaccination error reports submitted to the vaccine adverse event reporting system (VAERS) and identify opportunities for prevention. METHODS: We conducted descriptive analyses using data from VAERS, the U.S. spontaneous surveillance system for adverse events following immunization. The VAERS database was searched from 2000 through 2013 for U.S. reports describing vaccination errors and categorized reports into 11 error groups. We analyzed numbers and types of vaccination error reports, vaccines involved, reporting trends over time, and descriptions of errors for selected reports. RESULTS: We identified 20,585 vaccination error reports documenting 21,843 errors. Annual reports increased from 10 in 2000 to 4324 in 2013. The most common error group was "Inappropriate Schedule" (5947; 27%); human papillomavirus (quadrivalent) (1516) and rotavirus (880) vaccines were most frequently involved. "Storage and Dispensing" errors (4983; 23%) included mostly expired vaccine administered (2746) and incorrect storage of vaccine (2202). "Wrong Vaccine Administered" errors (3372; 15%) included mix-ups between vaccines with similar antigens such as varicella/herpes zoster (shingles), DTaP/Tdap, and pneumococcal conjugate/polysaccharide. For error reports with an adverse health event (5204; 25% of total), 92% were classified as non-serious. We also identified 936 vaccination error clusters (i.e., same error, multiple patients, in a common setting) involving over 6141 patients. The most common error in clusters was incorrect storage of vaccine (582 clusters and more than 1715 patients). CONCLUSIONS: Vaccination error reports to VAERS have increased substantially. Contributing factors might include changes in reporting practices, increasing complexity of the immunization schedule, availability of products with similar sounding names or acronyms, and increased attention to storage and temperature lapses. Prevention strategies should be considered. |
Notes from the field: rotavirus vaccine administration errors - United States, 2006-2013
Hibbs BF , Miller ER , Shimabukuro T . MMWR Morb Mortal Wkly Rep 2014 63 (4) 81 Two live rotavirus oral vaccines, RotaTeq (RV5) (Merck & Co., Inc.) and Rotarix (RV1) (GlaxoSmithKline Biologicals), are approved for prevention of rotavirus gastroenteritis and recommended at ages 2, 4 (RV5/RV1), and 6 (RV5) months by the Advisory Committee on Immunization Practices. Because most childhood vaccines are injectable, vaccination providers might have less experience administering oral vaccines. To assess that hypothesis, CDC searched for reports to the Vaccine Adverse Event Reporting System (VAERS) of rotavirus vaccine administration errors involving injection and eye splashes in the United States during the period January 1, 2006-August 1, 2013. A total of 66 reports were found. |
Adverse event reports following Japanese encephalitis vaccination in the United States, 1999-2009
Lindsey NP , Staples JE , Jones JF , Sevjar JJ , Griggs A , Iskander J , Miller ER , Fischer M . Vaccine 2010 29 (1) 58-64 We reviewed adverse events following receipt of inactivated mouse brain-derived Japanese encephalitis (JE) vaccine reported to the U.S. Vaccine Adverse Event Reporting System (VAERS) from 1999 to 2009. During this period, VAERS received 300 adverse event reports following JE vaccination (24 per 100,000 doses distributed); 106 (35%) were classified as hypersensitivity reactions (8.4 per 100,000 doses) and four (1%) were classified as neurologic events (0.3 per 100,000 doses). Twenty-three (8%) reports described serious adverse events (1.8 per 100,000 doses distributed). There were no reports of encephalitis, meningitis, or Guillain-Barre syndrome. As reported previously, hypersensitivity reactions were common among persons receiving inactivated mouse brain-derived JE vaccine. |
Prevalence of chronic kidney disease in US adults with undiagnosed diabetes or prediabetes
Plantinga LC , Crews DC , Coresh J , Miller ER 3rd , Saran R , Yee J , Hedgeman E , Pavkov M , Eberhardt MS , Williams DE , Powe NR . Clin J Am Soc Nephrol 2010 5 (4) 673-82 BACKGROUND AND OBJECTIVES: Prevalence of chronic kidney disease (CKD) in people with diagnosed diabetes is known to be high, but little is known about the prevalence of CKD in those with undiagnosed diabetes or prediabetes. We aimed to estimate and compare the community prevalence of CKD among people with diagnosed diabetes, undiagnosed diabetes, prediabetes, or no diabetes. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: The 1999 through 2006 National Health and Nutrition Examination Survey is a representative survey of the civilian, noninstitutionalized US population. Participants who were aged ≥20 years; responded to the diabetes questionnaire; and had fasting plasma glucose (FPG), serum creatinine, and urinary albumin-creatinine ratio measurements were included (N = 8188). Diabetes status was defined as follows: Diagnosed diabetes, self-reported provider diagnosis (n = 826); undiagnosed diabetes, FPG ≥126 mg/dl without self-reported diagnosis (n = 299); prediabetes, FPG ≥100 and <126 mg/dl (n = 2272); and no diabetes, FPG <100 mg/dl (n = 4791). Prevalence of CKD was defined by estimated GFR 15 to 59 ml/min per 1.73 m(2) or albumin-creatinine ratio ≥30 mg/g; adjustment was performed with multivariable logistic regression. RESULTS: Fully 39.6% of people with diagnosed and 41.7% with undiagnosed diabetes had CKD; 17.7% with prediabetes and 10.6% without diabetes had CKD. Age-, gender-, and race/ethnicity-adjusted prevalence of CKD was 32.9, 24.2, 17.1, and 11.8%, for diagnosed, undiagnosed, pre-, and no diabetes, respectively. Among those with CKD, 39.1% had undiagnosed or prediabetes. CONCLUSIONS: CKD prevalence is high among people with undiagnosed diabetes and prediabetes. These individuals might benefit from interventions aimed at preventing development and/or progression of both CKD and diabetes. |
Safety assessment of recalled Haemophilus influenzae type b (Hib) conjugate vaccines-United States, 2007-2008
Huang WT , Chang S , Miller ER , Woo EJ , Hoffmaster AR , Gee JE , Clark TA , Iskander JK , Ball R , Broder KR . Pharmacoepidemiol Drug Saf 2010 19 (3) 306-10 PURPOSE: On 13 December 2007, Merck & Co., Inc. voluntarily recalled 1.2 million doses of Haemophilus influenzae type b (Hib) vaccines that had been distributed since April 2007 for concerns regarding potential Bacillus cereus contamination. Enhanced postrecall surveillance was conducted to detect vaccine-associated B. cereus infections. METHODS: We reviewed reports involving recalled Hib vaccines received by the Vaccine Adverse Event Reporting System (VAERS) during 1 April 2007-29 February 2008. For each reported death, autopsy review sought evidence of B. cereus infections. For each specified outcome, the proportional reporting ratios (PRRs) were calculated to compare the recalled Hib vaccines with the manufacturer's nonrecalled Hib vaccines in the VAERS databases. On 20 December 2007, we used the Epidemic Information Exchange (Epi-X) to solicit nongastrointestinal vaccine-associated B. cereus infections, and requested B. cereus isolates for genotyping to compare with the manufacturing facility isolate. RESULTS: VAERS received 75 reports involving recalled Hib vaccines; none described a confirmed B. cereus infection. Comparative analyses did not reveal disproportionate reporting of specified outcomes for recalled Hib vaccines. The Epi-X posting triggered one report of vaccine-associated B. cereus bacteremia from a child who received a nonrecalled Hib vaccine manufactured by Merck; the genotypes of isolates from the patient and the manufacturing facility differed. CONCLUSIONS: No evidence of vaccine-associated B. cereus infection had been found in recipients of recalled Hib vaccines. Conducting laboratory surveillance through Epi-X was feasible and may enhance public health response capacities for future vaccine safety emergencies. Published in 2010 by John Wiley & Sons, Ltd. |
Blood pressure control among persons without and with chronic kidney disease: US trends and risk factors 1999-2006
Plantinga LC , Miller ER 3rd , Stevens LA , Saran R , Messer K , Flowers N , Geiss L , Powe NR , Centers for Disease Control and Prevention Chronic Kidney Disease Surveillance Team . Hypertension 2009 54 (1) 47-56 Recent guidelines recommending more aggressive blood pressure control in patients with chronic kidney disease have unknown impact. We assessed trends in and predictors of blood pressure control in 8829 adult National Health and Nutrition Examination Survey 1999-2006 participants with hypertension (self-report, measured blood pressure, or use of antihypertensive medications), without (n=7178) and with (n=1651) chronic kidney disease. Uncontrolled blood pressure was defined as follows: general definition, systolic blood pressure > or =140 mm Hg and diastolic blood pressure > or =90 mm Hg, and disease-specific definition, systolic blood pressure > or =130 mm Hg and diastolic blood pressure > or =85 mm Hg (1999-2002) and systolic blood pressure > or =130 mm Hg and diastolic blood pressure > or =80 mm Hg (2003-2006) for those with chronic kidney disease (estimated glomerular filtration rate: <60 mL/min per 1.73 m(2)) or diabetes mellitus (self-report). Proportions with uncontrolled blood pressure in 1999-2006 were greater in those with chronic kidney disease versus those without chronic kidney disease (51.5% versus 48.7% [general definition: P=0.122] and 68.8% versus 51.7% [disease-specific definition: P<0.001]). In those with chronic kidney disease, there were significant decreases in uncontrolled blood pressure over time (55.9% to 47.8% [general definition: P=0.011]). With adjustment for demographic, socioeconomic, and clinical variables, older age (P<0.001) and lack of antihypertensive treatment (P<0.001) were associated with uncontrolled blood pressure, regardless of chronic kidney disease status; nonwhite race (P=0.002) was associated in those without chronic kidney disease, whereas female sex (P=0.030) was associated in those with chronic kidney disease. Multiple medications (P<0.001) and angiotensin-converting enzyme inhibitors/angiotensin II receptor blockers (P=0.001) were associated with less uncontrolled blood pressure. Although some improvement has occurred over time, uncontrolled blood pressure remains highly prevalent, especially in subjects with chronic kidney disease and in nonwhites, older persons, and women. Therapy appears suboptimal. |
- Page last reviewed:Feb 1, 2024
- Page last updated:Sep 16, 2024
- Content source:
- Powered by CDC PHGKB Infrastructure