Last data update: Apr 29, 2024. (Total: 46658 publications since 2009)
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Query Trace: Cano M [original query] |
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Adverse events after Fluzone ® Intradermal vaccine reported to the Vaccine Adverse Event Reporting System (VAERS), 2011-2013.
Moro PL , Harrington T , Shimabukuro T , Cano M , Museru OI , Menschik D , Broder K . Vaccine 2013 31 (43) 4984-7 BACKGROUND: In May 2011, the first trivalent inactivated influenza vaccine exclusively for intradermal administration (TIV-ID) was licensed in the US for adults aged 18-64 years. OBJECTIVE: To characterize adverse events (AEs) after TIV-ID reported to the US Vaccine Adverse Event Reporting System (VAERS), a spontaneous reporting surveillance system. METHODS: We searched VAERS for US reports after TIV-ID among persons vaccinated from July 1, 2011-February 28, 2013. Medical records were requested for reports coded as serious (death, hospitalization, prolonged hospitalization, disability, life-threatening-illness), and those suggesting anaphylaxis. Clinicians reviewed available information and assigned a primary clinical category to each report. Empirical Bayesian data mining was used to identify disproportional AE reporting following TIV-ID. Causality was not assessed. RESULTS: VAERS received 466 reports after TIV-ID; 9 (1.9%) were serious, including one reported fatality in an 88-year-old vaccinee. Median age was 43 years (range 4-88 years). The most common AE categories were: 218 (46.8%) injection site reactions; 89 (19.1%) other non-infectious (comprised mainly of constitutional signs and symptoms); and 74 (15.9%) allergy. Eight reports (1.7%) of anaphylaxis were verified by the Brighton criteria or a documented physician diagnosis. Disproportional reporting was identified for three AEs: 'injection site nodule', 'injection site pruritus', and 'drug administered to patient of inappropriate age'. The findings for the first two AEs were expected. Twenty-four reports of vaccinees <18 years or ≥ 65 years were reported, and 14 of 24 were coded with the AE 'drug administered to patient of inappropriate age'. CONCLUSIONS: Review of VAERS reports did not identify any new or unexpected safety concerns after TIV-ID. Injection site reactions were the most commonly reported AEs, similar to the pre-licensure clinical trials. Use of TIV-ID in younger and older individuals outside the approved age range highlights the need for education of healthcare providers regarding approved TIV-ID use. |
Development of an LC-MRM-MS-Based Candidate Reference Measurement Procedure for Standardization of Serum Apolipoprotein (a) Tests.
Ruhaak LR , Romijn Fphtm , Begcevic Brkovic I , Kuklenyik Z , Dittrich J , Ceglarek U , Hoofnagle AN , Althaus H , Angles-Cano E , Coassin S , Delatour V , Deprez L , Dikaios I , Kostner GM , Kronenberg F , Lyle A , Prinzing U , Vesper HW , Cobbaert CM . Clin Chem 2023 69 (3) 251-261 BACKGROUND: Medical results generated by European CE Marking for In Vitro Diagnostic or in-house tests should be traceable to higher order reference measurement systems (RMS), such as International Federation of Clinical Chemistry and Laboratory Medicine (IFCC)-endorsed reference measurement procedures (RMPs) and reference materials. Currently, serum apolipoprotein (a) [apo(a)] is recognized as a novel risk factor for cardiovascular risk assessment and patient management. The former RMS for serum apo(a) is no longer available; consequently, an International System of Units (SI)-traceable, ideally multiplexed, and sustainable RMS for apo(a) is needed. METHODS: A mass spectrometry (MS)-based candidate RMP (cRMP) for apo(a) was developed using quantitative bottom-up proteomics targeting 3 proteotypic peptides. The method was provisionally validated according to ISO 15193 using a single human serum based calibrator traceable to the former WHO-IFCC RMS. RESULTS: The quantitation of serum apo(a) was by design independent of its size polymorphism, was linear from 3.8 to 456 nmol/L, and had a lower limit of quantitation for apo(a) of 3.8 nmol/L using peptide LFLEPTQADIALLK. Interpeptide agreement showed Pearson Rs of 0.987 and 0.984 for peptides GISSTVTGR and TPENYPNAGLTR, and method comparison indicated good correspondence (slopes 0.977, 1.033, and 1.085 for LFLEPTQADIALLK, GISSTVTGR, and TPENYPNAGLTR). Average within-laboratory imprecision of the cRMP was 8.9%, 11.9%, and 12.8% for the 3 peptides. CONCLUSIONS: A robust, antibody-independent, MS-based cRMP was developed as higher order RMP and an essential part of the apo(a) traceability chain and future RMS. The cRMP fulfils predefined analytical performance specifications, making it a promising RMP candidate in an SI-traceable MS-based RMS for apo(a). |
Commutability Assessment of Candidate Reference Materials for Lipoprotein(a) by Comparison of a MS-based Candidate Reference Measurement Procedure with Immunoassays.
Dikaios I , Althaus H , Angles-Cano E , Ceglarek U , Coassin S , Cobbaert CM , Delatour V , Dieplinger B , Grimmler M , Hoofnagle AN , Kostner GM , Kronenberg F , Kuklenyik Z , Lyle AN , Prinzing U , Ruhaak LR , Scharnagl H , Vesper HW , Deprez L . Clin Chem 2023 69 (3) 262-272 BACKGROUND: Elevated concentrations of lipoprotein(a) [Lp(a)] are directly related to an increased risk of cardiovascular diseases, making it a relevant biomarker for clinical risk assessment. However, the lack of global standardization of current Lp(a) measurement procedures (MPs) leads to inconsistent patient care. The International Federation for Clinical Chemistry and Laboratory Medicine working group on quantitating apolipoproteins by mass spectrometry (MS) aims to develop a next-generation SI (International system of units)-traceable reference measurement system consisting of a MS-based, peptide-calibrated reference measurement procedure (RMP) and secondary serum-based reference materials (RMs) certified for their apolipoprotein(a) [apo(a)] content. To reach measurement standardization through this new measurement system, 2 essential requirements need to be fulfilled: a sufficient correlation among the MPs and appropriate commutability of future serum-based RMs. METHODS: The correlation among the candidate RMP (cRMP) and immunoassay-based MPs was assessed by measuring a panel of 39 clinical samples (CS). In addition, the commutability of 14 different candidate RMs was investigated. RESULTS: Results of the immunoassay-based MPs and the cRMPs demonstrated good linear correlations for the CS but some significant sample-specific differences were also observed. The results of the commutability study show that RMs based on unspiked human serum pools can be commutable with CS, whereas human pools spiked with recombinant apo(a) show different behavior compared to CS. CONCLUSIONS: The results of this study show that unspiked human serum pools are the preferred candidate secondary RMs in the future SI-traceable Lp(a) Reference Measurement System. |
Safety surveillance of meningococcal group B vaccine (Bexsero®), Vaccine Adverse Event Reporting System, 2015-2018.
Perez-Vilar S , Dores GM , Marquez PL , Ng CS , Cano MV , Rastogi A , Lee L , Su JR , Duffy J . Vaccine 2021 40 (2) 247-254 BACKGROUND: Bexsero® (GlaxoSmithKline) is a four-component Neisseria meningitidis serogroup B vaccine (MenB-4C). It was licensed in the United States in 2015 for use among individuals ages 10-25 years. We aimed to assess the post-licensure safety profile of MenB-4C by examining reports received in the Vaccine Adverse Event Reporting System (VAERS). METHODS: VAERS is a national passive surveillance system for adverse events (AEs) following immunization that uses the Medical Dictionary for Regulatory Activities to code reported AEs and the Code of Federal Regulations to classify reports by seriousness. In this case series, we analyzed U.S. reports involving MenB-4C received between January 23, 2015 through December 31, 2018. We used Empirical Bayesian data mining to identify MenB-4C/AE combinations reported at least twice as often as expected. RESULTS: VAERS received 1,867 reports following MenB-4C administration, representing 332 reports per million doses distributed. Most reports were for females (59%), with a median age of 17 years (interquartile range: 16-18 years); 40% of reports described simultaneous administration of other vaccines. The majority of reports were classified as non-serious (96%). The most commonly reported AEs were injection site pain (22%), pyrexia (16%), and headache (16%). Data mining identified disproportionate reporting for "injected limb mobility decreased" secondary to injection site reactions, including extensive swelling of the vaccinated limb and injection site pain. CONCLUSIONS: Analysis of passive surveillance data from over 5.6 million doses of MenB-4C distributed in the United States did not reveal new safety concerns. The large majority of reports were classified as non-serious and the reported AEs were generally consistent with the safety experience described in clinical studies and the product's package insert. While our results are reassuring, continued post-marketing surveillance is warranted. |
Feasibility and acceptance of a cloud-based mobile app for antimicrobial stewardship and infection control in Colombian hospitals
Ketcherside WJ , Olson JBF , Hunt LN , Mehta JM , Gutiérrez CP , Coy LM , Pradera IP , Rivera AD , Cano JA , Saeed A , Sapiro V , Park BJ , Malpiedi P , Botero MVV . Int J Infect Control 2020 16 (3) 1-6 Infection control and antimicrobial stewardship programs (ICASPs) are essential to reduce the emergence and spread of antimicrobial resistance. The primary objective of this study was to assess the feasibility of extending a commercial off-the-shelf (COTS) software for ICASPs in low- and middle-income countries (LMICs). This project involved three hospitals in Colombia, including Centro Médico Imbanaco, Clínica San Francisco, and DIME Clínica Neurocardiovascular. A COTS platform (ILÚM Health Solutions(™) Kenilworth, NJ) was extended to function in a range of technology settings, and translatable to almost any language. ICASP features were added, including clinical practice guidelines, hand hygiene (HH) documentation, and isolation precaution (IP) documentation. The platform was delivered as a smartphone mobile application ("app") for both iOS and Android. The app was successfully implemented at all sites, however, full back-end data integration was not feasible at any site. In contrast to the United States, a suite of surveillance tools and physician-focused decision support without patient data proved to be valuable. Language translation processing occurred quickly and incurred minimal costs. HH and IP compliance tracking were the most used features among ICASP staff; treatment guidelines were most often used by physicians. Use of the app streamlined activities and reduced the time spent on ICASP tasks. Users consistently reported positive impressions including simplicity of design, ease of navigation, and improved efficiency. This ICASP app was feasible in limited-resource settings, highly acceptable to users, and represents an innovative approach to antimicrobial resistance prevention. |
Myopericarditis after vaccination, Vaccine Adverse Event Reporting System (VAERS), 1990-2018.
Su JR , McNeil MM , Welsh KJ , Marquez PL , Ng C , Yan M , Cano MV . Vaccine 2021 39 (5) 839-845 BACKGROUND: Myopericarditis after vaccination has been sporadically reported in the medical literature. Here, we present a thorough descriptive analysis of reports to a national passive vaccine safety surveillance system (VAERS) of myopericarditis after vaccines licensed for use in the United States. METHODS: We identified U.S. reports of myopericarditis received by VAERS during 1990-2018 that met a published case definition for myopericarditis or were physician-diagnosed. We stratified analysis by age group (<19, 19-49, ≥50 years), describing reports by serious/non-serious status, sex, time to symptom onset after vaccination, vaccine(s) administered, and exposure to other known causes of myopericarditis. We used Empirical Bayesian data mining to detect disproportionate reporting of myopericarditis after vaccination. RESULTS: VAERS received 620,195 reports during 1990-2018: 708 (0.1%) met the case definition or were physician-diagnosed as myopericarditis. Most (79%) myopericarditis reports described males; 69% were serious; 72% had symptom onset ≤ 2 weeks postvaccination. Overall, smallpox (59%) and anthrax (23%) vaccines were most commonly reported. By age, among persons aged < 19 years, Haemophilus influenzae type b (22, 22%) and hepatitis B (18, 18%); among persons aged 19-49 years smallpox (387, 79%); among persons aged ≥ 50 years inactivated influenza (31, 36%) and live attenuated zoster (19, 22%) vaccines were most commonly reported. The vaccines most commonly reported remained unchanged when excluding 138 reports describing other known causes of myopericarditis. Data mining revealed disproportionate reporting of myopericarditis only after smallpox vaccine. CONCLUSIONS: Despite the introduction of new vaccines over the years, myopericarditis remains rarely reported after vaccines licensed for use in the United States. In this analysis, myopericarditis was most commonly reported after smallpox vaccine, and less commonly after other vaccines. |
Safety Surveillance of Bivalent Meningococcal Group B Vaccine, Vaccine Adverse Event Reporting System, 2014-2018.
Duffy J , Marquez P , Dores GM , Ng C , Su J , Cano M , Perez-Vilar S . Open Forum Infect Dis 2020 7 (12) ofaa516 BACKGROUND: In October 2014, MenB-FHbp (Trumenba, Pfizer) became the first meningococcal group B vaccine licensed in the United States. It is approved for use in individuals aged 10-25 years. Our objective was to evaluate the safety of MenB-FHbp postlicensure. METHODS: The Vaccine Adverse Event Reporting System (VAERS) is a national passive vaccine safety surveillance system. We analyzed US VAERS reports for MenB-FHbp received from the date of licensure in October 2014 through December 2018. We described the characteristics of the persons and adverse events (AEs) reported and calculated reporting rates using the number of doses distributed. We used empirical Bayesian data mining to identify AEs reported at least twice as often as expected compared with all other vaccines. RESULTS: VAERS received 2106 reports involving MenB-FHbp, representing 698 reports per million doses distributed. The median age of vaccinees was 17 years, and 55% were female. MenB-FHbp was given simultaneously with other vaccines in 37% of reports. Most reports (57%) described AEs that started on the day of or day after vaccination. The most common AEs reported were pyrexia (27%), headache (25%), and pain (16%). There were 44 serious reports (2% of all reports), among which 42 reported a hospitalization. Data mining identified disproportional reporting of headache, pyrexia, chills, and myalgia. CONCLUSIONS: The AEs most commonly or disproportionately reported following MenB-FHbp were consistent with those identified in clinical trials as described in the US package insert. We did not identify any new safety issues. |
Adverse events following quadrivalent meningococcal diphtheria toxoid conjugate vaccine (Menactra®) reported to the Vaccine Adverse Event Reporting System (VAERS), 2005-2016.
Myers TR , McNeil MM , Ng CS , Li R , Marquez PL , Moro PL , Omer SB , Cano MV . Vaccine 2020 38 (40) 6291-6298 BACKGROUND: Post marketing safety evaluations of quadrivalent meningococcal diphtheria-toxoid conjugate vaccine (MenACWY-D) have focused on post-vaccination risk of Guillain Barré syndrome (GBS), adverse events (AEs) after maternal vaccination, and comparative studies with the newer quadrivalent meningococcal CRM(197) conjugate vaccine (MenACWY-CRM). To provide an updated general safety assessment, we reviewed reports of AEs following MenACWY-D submitted to the Vaccine Adverse Event Reporting System (VAERS). METHODS: VAERS is a national spontaneous reporting vaccine safety surveillance system co-administered by the Centers for Disease Control and Prevention and the U.S. Food and Drug Administration. We searched the VAERS database for U.S. reports of AEs after administration of MenACWY-D from January 2005 through June 2016. We conducted clinical reviews of serious reports after MenACWY-D administered alone, reports of MenACWY-D use during pregnancy, and reports of selected pre-specified outcomes. We screened for disproportionate reporting of AEs after MenACWY-D using empirical Bayesian data mining. RESULTS: VAERS received 13,075 U.S. reports after receipt of MenACWY-D; most (86%) described vaccination in adolescents, were classified as non-serious (94%), and described AEs consistent with pre-licensure studies. We did not find any evidence that reported deaths were related to vaccination. In serious reports, GBS and meningococcal infection were the most commonly reported medical conditions. Many reports of MenACWY-D use during pregnancy described inadvertent vaccination; most (61%) did not report any AE. CONCLUSIONS: Findings from our comprehensive review of reports to VAERS following MenACWY-D are consistent with data from pre-licensure studies and provide further reassurance on the safety of MenACWY-D. |
Monitoring the safety of high-dose, trivalent inactivated influenza vaccine in the vaccine adverse event reporting system (VAERS), 2011 - 2019
Moro PL , Woo EJ , Marquez P , Cano M . Vaccine 2020 38 (37) 5923-5926 BACKGROUND: On 12/23/2009 a new high-dose trivalent inactivated influenza vaccine (IIV3-HD) was licensed for adults aged ≥65 years. We assessed the post-licensure safety data for IIV3-HD in the Vaccine Adverse Event Reporting System (VAERS) during 2011-2019. METHODS: We searched VAERS for reports after IIV3-HD during 1/1/2011-06/30/2019 in persons aged ≥65 years. Medical records were reviewed for all death reports and for certain pre-specified conditions (e.g. Guillain Barré Syndrome [GBS], anaphylaxis). We also reviewed certain groups who received IIV3-HD erroneously (e.g. pregnant women, children). Empirical Bayesian data mining was used to identify disproportional reporting. RESULTS: VAERS received 12,320 reports after IIV3-HD;723 reports (5.9%) were serious. The most common adverse events (AEs) among serious reports were pyrexia (30.2%), asthenia (28.9%), and dyspnea (24.9%), and among non-serious reports were injection site erythema (16.8%), pain in extremity (15.8%), and injection site pain (14.2%). Among 55 death reports, the most common causes of death were diseases of the circulatory system (n = 23;41.8%). Based on medical record review, there were 61 reports of GBS and 13 of anaphylaxis. There were 13 reports of pregnant-women who inadvertently received IIV3-HD; three reports described arm pain or local reactions, and 10 did not report any AE. Among 59 reports of children who erroneously received IIV3-HD, 31 experienced an AE (most commonly injection site or constitutional reactions) and the remaining 28 reports did not describe any AE. CONCLUSIONS: Post-licensure safety data of IIV3-HD during 9 influenza seasons revealed no new or unexpected safety concerns among individuals ≥65 years. Inadvertent administration of IIV3-HD to children or pregnant women was observed, although with no serious AEs reported. Training and education of providers in vaccine recommendations and groups for whom the vaccine is indicated may help in preventing these vaccine administration errors. This review provides baseline information for future monitoring of the quadrivalent-high-dose influenza vaccine. |
Frequency of invasive fungal disease in adults: Experience of a specialized laboratory in Medellin, Colombia (2009-2015)
Valencia Y , Caceres DH , de Bedout C , Cano LE , Restrepo A . J Fungi (Basel) 2020 6 (1) Invasive fungal diseases (IFD) contribute significantly to worldwide morbidity and mortality, but their frequency is not well-described in some countries. The present work describes the frequency of IFD in a specialized laboratory in Colombia. A retrospective, descriptive study was implemented between March 2009 and December 2015. Results: 13,071 patients with clinical suspicion of IFD were referred during the study period, from which 33,516 biological samples were processed and analyzed using 14 laboratory methods. Diagnosis was confirmed in 1425 patients (11%), distributed according to the mycoses of interest analyzed here: histoplasmosis in 641/11,756 patients (6%), aspergillosis in 331/10,985 patients (3%), cryptococcosis in 239/8172 patients (3%), pneumocystosis in 111/1651 patients (7%), paracoccidioidomycosis in 60/10,178 patients (0.6%), and invasive candidiasis in 48/7525 patients (0.6%). From the first year of the study period to the last year, there was a 53% increase in the number of cases of IFD diagnosed. Our laboratory experienced a high frequency of IFD diagnosis, possibly attributable to the availability of a greater range of diagnostic tools. Frequency of IFD in this study was atypical compared with other studies, probably as a result of the single laboratory-site analysis. This demonstrates that implementing educational strategies helps to create a high index of clinical suspicion, while the availability and utilization of appropriate diagnostic assays assure greater reliability in identification of these cases. |
Erythema multiforme, Stevens Johnson syndrome, and toxic epidermal necrolysis reported after vaccination, 1999-2017.
Su JR , Haber P , Ng CS , Marquez PL , Dores GM , Perez-Vilar S , Cano MV . Vaccine 2019 38 (7) 1746-1752 BACKGROUND: Since the last review of vaccine safety surveillance data for erythema multiforme (EM), Stevens Johnson syndrome (SJS), SJS/TEN, and toxic epidermal necrolysis (TEN) (EM/SJS/TEN), over 37 new vaccines have been introduced in the United States. We sought to describe reported EM/SJS/TEN after vaccines during 1999-2017. METHODS: We identified U.S. reports of EM/SJS/TEN received by the Vaccine Adverse Event Reporting System (VAERS) during 1999-2017. We stratified analysis by condition (EM, SJS, or TEN), and analyzed reports by serious or non-serious status, sex, age group, time from vaccination to symptom onset, exposure to known causes of EM/SJS/TEN, and vaccines administered. We used Empirical Bayesian data mining to detect vaccine-AE pairs reported more frequently than expected. RESULTS: Of 466,027 reports to VAERS during 1999-2017, we identified 984 reports of EM, 89 reports of SJS, 6 reports of SJS/TEN, and 7 reports of TEN. Few reports of EM (9%), and most reports of SJS (52%), SJS/TEN (100%), and TEN (100%) were serious. Overall, 55% of reports described males, 48% described children aged < 4 years; 58% of EM/SJS/TEN occurred </= 7 days after vaccination. Few reports (</=5%) described exposure to known causes of EM/SJS/TEN. Overall, childhood vaccines (e.g., combined measles, mumps, and rubella vaccine) were most commonly reported. We identified 6 deaths; 4 were exposed to medications associated with EM/SJS/TEN. EM after smallpox vaccine was reported disproportionately among people aged 19-49 years. CONCLUSIONS: EM/SJS/TEN were rarely reported after vaccination; data mining identified a known association between EM and smallpox vaccine. |
Safety review of tetanus toxoid, reduced diphtheria toxoid, acellular pertussis vaccines (Tdap) in adults aged ≥65 years, Vaccine Adverse Event reporting System (VAERS), United States, September 2010-December 2018.
Haber P , Moro PL , Ng C , Dores GM , Perez-Vilar S , Marquez PL , Cano M . Vaccine 2019 38 (6) 1476-1480 INTRODUCTION: The Advisory Committee on Immunization Practices (ACIP) recommends vaccination with tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine (Tdap) in persons >/=65years of age. To date, few studies have assessed the safety of Tdap in this population. We aimed to summarize reports submitted to the Vaccine Adverse Event Reporting System (VAERS) following receipt of Tdap in this age group. METHODS: We searched for and analyzed U.S. VAERS reports of Tdap among individuals >/=65years of age submitted from September 1, 2010 through December 31, 2018. We classified reports according to concurrent vaccination, seriousness, and outcome (death, non-death) and determined the frequency of reported adverse events (AEs). For serious reports, we reviewed available medical records. Data mining analyses were undertaken to detect disproportionality in reporting. RESULTS: VAERS received a total of 1,798 reports following Tdap, of which 104 (6%) were serious. The most common AEs were injection site erythema (26%; n=468), injection site pain (19%; n=335), injection site swelling (18%; n=329), and erythema (18%; n=321). We identified seven deaths; none were attributed to Tdap. Among serious non-death reports, nervous system disorders (35.1%; n=34) and infections and infestations (n=18.6%; n=18) were most commonly reported. Data mining did not identify any vaccine-AE combination reported more frequently than expected. CONCLUSIONS: We did not identify any new safety concern over nearly a decade of recommended Tdap use among adults >/=65years of age. Findings from this post-marketing review are consistent with prior post-marketing observations and pre-licensure studies. |
Reports of atypical shoulder pain and dysfunction following inactivated influenza vaccine, Vaccine Adverse Event Reporting System (VAERS), 2010-2017
Hibbs BF , Ng CS , Museru O , Moro PL , Marquez P , Woo EJ , Cano MV , Shimabukuro TT . Vaccine 2019 38 (5) 1137-1143 BACKGROUND: Vaccines administered into or too close to underlying joint structures have the potential to cause shoulder injuries. Limited data exist on the epidemiology of such events. OBJECTIVE: To describe case reports of atypical shoulder pain and dysfunction following injection of inactivated influenza vaccine (IIV). METHODS: We searched the Vaccine Adverse Event Reporting System (VAERS) database from July 2010 to June 2017 for reports of atypical shoulder pain and dysfunction following IIV. When identifying reports, we made no assumptions about true incident injury or causality with respect to vaccination. Pain had to begin <48 h after vaccination and signs and symptoms had to continue for >7 days to differentiate from self-limited local reactions. We conducted descriptive analysis. RESULTS: We identified 1220 reports that met our case definition (2.0% of all IIV reports, range 1.5%-2.5% across influenza seasons). Median age was 52 years (range 16-94) and most patients (82.6%) were female. Shoulder pain (44.1%), injected limb mobility decreased (40.8%), joint range of motion decreased (21.2%), rotator cuff syndrome (9.2%), and bursitis (9.0%) were frequently reported. In 86.6% of reports, signs and symptoms had not resolved by the time of report submission. In reports that included descriptions suggesting contributing factors (n = 266), vaccination given "too high" on the arm was cited in 81.2%. Nearly half (n = 605, 49.6%) of reports described a healthcare provider evaluation. Treatments included non-narcotic analgesics, physical therapy, and corticosteroid injection. Vaccinations were most commonly administered in a pharmacy or retail store (41.0%) or doctor's office or hospital (31.6%). CONCLUSIONS: Reports of atypical shoulder pain and dysfunction following IIV were uncommon, considering the amount of IIV use, and stable across influenza seasons. While specific etiology of cases is unknown, improperly administered vaccine, which is preventable, might be a factor. Prevention strategies include education, training, and adherence to best practices for vaccine administration. |
Safety of the 9-Valent Human Papillomavirus Vaccine.
Shimabukuro TT , Su JR , Marquez PL , Mba-Jonas A , Arana JE , Cano MV . Pediatrics 2019 144 (6) BACKGROUND: The 9-valent human papillomavirus vaccine (9vHPV) was approved for females and males aged 9 to 26 years in 2014. We analyzed postlicensure surveillance reports to the Vaccine Adverse Event Reporting System (VAERS). METHODS: We searched VAERS data for US reports of adverse events (AEs) after 9vHPV from December 2014 through December 2017. We calculated reporting rates and conducted empirical Bayesian data mining to identify disproportional reporting. Physicians reviewed reports for selected prespecified conditions. RESULTS: VAERS received 7244 reports after 9vHPV: 31.2% among females, 21.6% among males, and for 47.2%, sex was not reported. Overall, 97.4% of reports were nonserious. Dizziness, syncope, headache, and injection site reactions were most commonly reported; the most commonly reported AEs were similar between females and males. Two reports of death after 9vHPV were verified; no information in autopsy reports or death certificates suggested a causal relationship with vaccination. Approximately 28 million 9vHPV doses were distributed during the study period; crude AE reporting rates were 259 reports per million 9vHPV doses distributed for all reports and 7 per million doses distributed for serious reports. Syncope (a known AE associated with human papillomavirus vaccination) and several types of vaccine administration errors (eg, administered at wrong age) exceeded the statistical threshold for empirical Bayesian data mining findings. CONCLUSIONS: No new or unexpected safety concerns or reporting patterns of 9vHPV with clinically important AEs were detected. The safety profile of 9vHPV is consistent with data from prelicensure trials and from postmarketing safety data of its predecessor, the quadrivalent human papillomavirus vaccine. |
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 purified chick embryo cell rabies vaccine in the Vaccine Adverse Event Reporting System (VAERS) in the United States, 2006-2016
Moro PL , Lewis P , Cano M . Travel Med Infect Dis 2019 29 80-81 Rabies is a life-threatening disease, and the benefits of vaccination far outweigh the risks in persons exposed to the virus [1]. Two cell culture rabies vaccines are available for use in the United States: human diploid cell vaccine (HDCV, Imovax Rabies, Sanofi Pasteur), and purified chick embryo cell vaccine (PCECV, RabAvert, Novartis Vaccines and Diagnostics) [2]. These vaccines are indicated for post- and pre-exposure prophylaxis to prevent human rabies [2]. HDCV and PCECV were licensed by the Food and Drug Administration in 1980 and 1997, respectively [2]. A study of HDCV in the Vaccine Adverse Event Reporting System (VAERS) did not find any safety issue of concern [3]. A previous post-licensure study of PCECV in VAERS during 1997–2005 did not find any safety concern but no safety study has been done since 2005 [4]. We re-assessed the safety of this vaccine in VAERS during 1/1/2006–12/31/2015. |
Notes from the field: Administration of expired injectable influenza vaccines reported to the Vaccine Adverse Event Reporting System - United States, July 2018-March 2019
Hesse EM , Hibbs BF , Cano MV . MMWR Morb Mortal Wkly Rep 2019 68 (23) 529-530 Influenza vaccination is recommended annually for persons aged ≥6 months for the prevention and control of influenza (1). Every year, injectable inactivated influenza vaccine (IIV) has a standard expiration date of June 30 for the upcoming influenza season (i.e., July 1–June 30 of the following year). Vaccination with an expired influenza vaccine might not protect against influenza infection because different influenza virus strains can be included in the vaccine each year; in addition, protection against viruses included in the vaccine could wane if vaccine potency decreases over time. During July 11, 2018–March 29, 2019 in the United States, the Vaccine Adverse Event Reporting System (VAERS) received 125 reports of 192 patients receiving expired IIV during the 2018–19 influenza season (2), during which time 169.1 million doses of seasonal influenza vaccine were distributed (3). Dates of vaccination were documented for 102 patients and ranged from July 2, 2018, to January 16, 2019. The number of expired vaccine doses administered increased in September and decreased after October, coinciding with dates when influenza vaccine is typically given (Figure). Ages were available for 103 vaccine recipients. Seventy-three recipients (70.1%) were identified as being in high-risk age groups for influenza; eight were aged <5 years, and 65 were aged >50 years (1). An additional six reports specified that the patient had been pregnant at time of vaccination; pregnancy outcomes were not reported. Adverse events after the administration of an expired IIV were rarely reported (four of 125 reports; 3.2%). None were serious, and adverse events were consistent with adverse events for seasonal IIV. |
Is there any harm in administering extra-doses of vaccine to a person Excess doses of vaccine reported to the Vaccine Adverse Event Reporting System (VAERS), 2007-2017
Moro PL , Arana J , Marquez PL , Ng C , Barash F , Hibbs BF , Cano M . Vaccine 2019 37 (28) 3730-3734 BACKGROUND: The administration of an extra dose of a vaccine may occur due to a programmatic error (e.g., vaccination error) when there is need to provide one of the antigens of a combination vaccine not readily available as a single antigen, or when there is need to provide immunization in a person with uncertain vaccination histories (e.g., refugees). There is little data available on the safety of an extra dose of vaccine. OBJECTIVE: To assess for the presence of adverse events (AEs) most commonly reported following the administration of excess doses of vaccine in the Vaccine Adverse Event Reporting System (VAERS). METHODS: We searched VAERS for US reports where an excess dose of vaccine was administered to a person received from 1/1/2007 through 1/26/2018. We reviewed medical records for all serious reports and a random sample of non-serious reports. The most common AEs among reports of excess dose of vaccine administered were compared with the corresponding AEs for all vaccines reported to VAERS during the same period. RESULTS: Out of 366,815 total VAERS reports received, 5067 (1.4%) reported an excess dose of vaccine was administered; 3898 (76.9%) did not describe an adverse health event (AHE). The most common vaccines reported were trivalent inactivated influenza (15.4%), varicella (13.9%), hepatitis A (11.4%), and measles, mumps, rubella, varicella (11.1%). Among reports where only AHEs were reported, the most common were pyrexia (12.8%), injection site erythema (9.7%), injection site pain (8.9%), and headache (6.6%). The percentage of AHEs among these reports was comparable to all reports submitted to VAERS during the same study period. CONCLUSION: More than three-fourths of reports of an excess dose of vaccine did not describe an AHE. Among reports where an AHE event was reported, we did not observe any unexpected conditions or clustering of AEs. |
Post-licensure surveillance of trivalent adjuvanted influenza vaccine (aIIV3; Fluad), Vaccine Adverse Event Reporting System (VAERS), United States, July 2016-June 2018.
Haber P , Moro PL , Ng C , Dores GM , Lewis P , Cano M . Vaccine 2019 37 (11) 1516-1520 BACKGROUND: Trivalent adjuvanted influenza vaccine (aIIV3; Fluad(R)) was approved in the United States (U.S.) in 2015 for adults aged >/=65years and has been in use since the 2016-17 influenza season. METHODS: We analyzed U.S. reports for aIIV3 submitted from July 1, 2016 through June 30, 2018 to the Vaccine Adverse Event Reporting System (VAERS), a national spontaneous reporting system. Medical records were reviewed for serious reports. Among individuals >/=65years of age, the relative frequency of the most commonly reported adverse events (AEs) after aIIV3 were compared with non-adjuvanted inactivated influenza vaccines given to adults aged >/=65years, high-dose trivalent influenza vaccine (IIV3-HD) and trivalent or quadrivalent vaccines (IIV3/IIV4). Data mining analyses were undertaken to identify whether AEs for aIIV3 occurred disproportionately more than expected compared to all influenza vaccines. RESULTS: VAERS received 630 reports after aIIV3, of which 521 (83%) were in adults aged >/=65years; 79 (13%) in persons <65years and in 30 (5%) reports age was missing; 19 (3%) reports were serious, including two deaths (0.4%) related to myocardial infarction and Sjogren's syndrome. The most common AEs reported in adults aged >/=65years were injection site pain (21%) and erythema (18%), with similar proportions reported for IIV3-HD (17% and 19%, respectively) and for IIV3/IIV4 (15%, each). Except for reports related to vaccination of inappropriate age (n=79) and syringe malfunction (n=6), data mining did not identify other disproportionately reported AEs. CONCLUSIONS: Although our review of aIIV3 in VAERS did not identify any unexpected health conditions of concern, we observed more than twice the expected number of reports with administration of the vaccine to persons outside of the age range for which the vaccine is approved in the U.S. Health care providers should be educated on the age groups for whom aIIV3 is recommended. |
Postlicensure safety surveillance of recombinant Zoster vaccine (Shingrix) - United States, October 2017-June 2018
Hesse EM , Shimabukuro TT , Su JR , Hibbs BF , Dooling KL , Goud R , Lewis P , Ng CS , Cano MV . MMWR Morb Mortal Wkly Rep 2019 68 (4) 91-94 Recombinant zoster vaccine (RZV; Shingrix), an adjuvanted glycoprotein vaccine, was licensed by the Food and Drug Administration (FDA) and recommended by the Advisory Committee on Immunization Practices for adults aged >/=50 years in October 2017 (1). The previously licensed live-attenuated zoster vaccine (ZVL; Zostavax) is recommended for adults aged >/=60 years. RZV is administered intramuscularly as a 2-dose series, with an interval of 2-6 months between doses. In prelicensure clinical trials, 85% of 6,773 vaccinated study participants reported local or systemic reactions after receiving RZV, with approximately 17% experiencing a grade 3 reaction (erythema or induration >3.5 inches or systemic symptoms that interfere with normal activity). However, rates of serious adverse events (i.e., hospitalization, prolongation of existing hospitalization, life-threatening illness, permanent disability, congenital anomaly or birth defect, or death) were similar in the RZV and placebo groups (2). After licensure, CDC and FDA began safety monitoring of RZV in the Vaccine Adverse Event Reporting System (VAERS) (3). During the first 8 months of use, when approximately 3.2 million RZV doses were distributed (GlaxoSmithKline, personal communication, 2018), VAERS received a total of 4,381 reports of adverse events, 130 (3.0%) of which were classified as serious. Commonly reported signs and symptoms included pyrexia (fever) (1,034; 23.6%), injection site pain (985; 22.5%), and injection site erythema (880; 20.1%). No unexpected patterns were detected in reports of adverse events or serious adverse events. Findings from early monitoring of RZV are consistent with the safety profile observed in prelicensure clinical trials. |
Anaphylaxis after vaccination reported to the Vaccine Adverse Event Reporting System, 1990-2016
Su JR , Moro PL , Ng C , Lewis PW , Said MA , Cano MV . J Allergy Clin Immunol 2019 143 (4) 1465-1473 BACKGROUND: Anaphylaxis, a rare, potentially life-threatening hypersensitivity reaction, can occur after vaccination. OBJECTIVE: Describe reports of anaphylaxis after vaccination to the Vaccine Adverse Event Reporting System (VAERS) during 1990-2016. METHODS: We identified domestic reports of anaphylaxis within VAERS using a combination of Medical Dictionary for Regulatory Activity queries and Preferred Terms. We performed descriptive analysis, including history of hypersensitivity (e.g., anaphylaxis, respiratory allergies, drug allergies), and vaccines given. We reviewed all serious reports, and all non-serious reports with available medical records, to determine if they met the Brighton Collaboration case definition (BCCD) for anaphylaxis or were diagnosed by a physician. RESULTS: During the analytic period, VAERS received 467,960 total reports; 828 met BCCD for or were physician-diagnosed as anaphylaxis: 654 (79%) were classified as serious, and 669 (81%) had medical records available. Of 478 reports in children aged <19 years, 65% were male; childhood vaccines were most commonly reported. Of 350 reports in persons aged >/=19 years, 80% were female, and influenza vaccines were most frequently reported. Overall, 41% of reports described persons with no history of hypersensitivity. We identified 8 deaths, 4 among persons with no history of hypersensitivity. CONCLUSION: Anaphylaxis after vaccination is rare in the United States, and can occur among persons with no history of hypersensitivity. Most persons recover fully with treatment, but serious complications, including death, can occur. |
Concordance analysis between different methodologies used for identification of oral isolates of Candida species
Zuluaga A , Arango-Bustamante K , Caceres DH , Sanchez-Quitian ZA , Velasquez V , Gomez BL , Parra-Giraldo CM , Maldonado N , Cano LE , de Bedout C , Rivera RE . Colomb Med (Cali) 2018 49 (3) 193-200 Background: The yeasts species determination is fundamental not only for an accurate diagnosis but also for establishing a suitable patient treatment. We performed a concordance study of five methodologies for the species identification of oral isolates of Candida in Colombia. Methods: Sixty-seven Candida isolates were tested by; API(R) 20C-AUX, Vitek(R)2 Compact, Vitek(R)MS, Microflex(R) and a molecular test (panfungal PCR and sequencing). The commercial cost and processing time of the samples was done by graphical analysis. Results: Panfungal PCR differentiated 12 species of Candida, Vitek(R)MS and Microflex(R) methods identified 9 species, and API(R) 20C-AUX and Vitek(R)2 Compact methods identified 8 species each. Weighted Kappa (wK) showed a high agreement between Panfungal PCR, Vitek(R)MS, Microflex(R) and API(R) 20C-AUX (wK 0.62-0.93). The wK that involved the Vitek(R)2 Compact method presented moderate or good concordances compared with the other methods (wK 0.56-0.73). Methodologies based on MALDI TOF MS required 4 minutes to generate results and the Microflex(R) method had the lowest selling price. Conclusion: The methods evaluated showed high concordance in their results, being higher for the molecular methods and the methodologies based on MALDI TOF. The latter are faster and cheaper, presenting as promising alternatives for the routine identification of yeast species of the genus Candida. |
Safety of bivalent human papillomavirus vaccine in the US vaccine adverse event reporting system (VAERS), 2009-2017.
Suragh TA , Lewis P , Arana J , Mba-Jonas A , Li R , Stewart B , Shimabukuro TT , Cano M . Br J Clin Pharmacol 2018 84 (12) 2928-2932 BACKGROUND: Human papillomavirus (HPV) vaccines prevent infection with oncogenic virus types. We analyzed reports to the U.S. Vaccine Adverse Event Reporting System (VAERS) of adverse events (AE) following bivalent HPV vaccine (2vHPV). METHODS: We conducted descriptive analysis of 2vHPV reports, reviewed individual reports, calculated crude AE reporting rates, and conducted empirical Bayesian data mining. RESULTS: Of 241 2vHPV reports, 158 were in females, 64 in males (2vHPV is approved for females only), and 19 with unknown sex; 95.8% were classified as non-serious. Dizziness, headache, nausea and injection site reactions were the most common symptoms. Crude AE reporting rates were 33.3 reports per 100,000 doses distributed overall, and 1.4 per 100,000 for serious reports. Empirical Bayesian data mining identified disproportional reporting for three types of medical errors; assessment indicated findings were likely driven by inadvertent 2vHPV use in males. CONCLUSIONS: We did not identify any new or unexpected safety concerns in our review of 2vHPV reports to VAERS. |
Adverse events after vaccination among HIV-positive persons, 1990-2016
Su JR , Ng C , Lewis PW , Cano MV . PLoS One 2018 13 (6) e0199229 Human immunodeficiency virus (HIV) causes immune dysregulation, potentially affecting response to vaccines in infected persons. We investigated if unexpected adverse events (AEs) or unusual patterns of AEs after vaccination were reported among HIV-positive persons. We searched for domestic reports among HIV-positive persons to the Vaccine Adverse Event Reporting System (VAERS) during 1990-2016. We analyzed reports by age group (<19 and >/=19 years), sex, serious or non-serious status, live vaccine type (live versus inactivated), AEs reported, and CD4 counts. Of 532,235 reports received, 353 (0.07%) described HIV-positive persons, of whom 67% were aged >/=19 years, and 57% were male; most reports (75%) were non-serious. The most commonly reported inactivated vaccines were pneumococcal polysaccharide (27%) and inactivated influenza (27%); the mostly reported common live virus vaccines were combination measles, mumps, and rubella (8%) and varicella (6%). Injection site reactions were commonly reported (39%). Of 67 reports with CD4 counts available, 41 (61%) described persons immunocompromised at time of vaccination (CD4 count <500 cells/mm3), and differed from overall reports only in that varicella was the most common live virus vaccine (4 reports). Of 22 reports describing failure to protect against infection, 6 described persons immunocompromised at time of vaccination, among whom varicella vaccine was most common (3 reports). Of 66 reports describing live virus vaccines, 7 described persons with disseminated infection: 6 had disseminated varicella, 3 of whom had vaccine strain varicella-zoster virus. Of 18 reported deaths, 7 resulted from disseminated infection: 6 were among immunocompromised persons, 1 of whom had vaccine strain varicella-zoster virus. We identified no unexpected or unusual patterns of AEs among HIV-positive persons. These data reinforce current vaccine recommendations for this risk group. However, healthcare providers should know their HIV-positive patients' immune status because immunocompromising conditions can potentially increase the risk of rare, but severe, AEs following vaccination with live virus vaccines. |
Safety Surveillance of Diphtheria and Tetanus Toxoids and Acellular Pertussis (DTaP) Vaccines.
Moro PL , Perez-Vilar S , Lewis P , Bryant-Genevier M , Kamiya H , Cano M . Pediatrics 2018 142 (1) OBJECTIVE: To assess the safety of currently licensed diphtheria-tetanus-acellular pertussis (DTaP) vaccines in the United States by using data from the Vaccine Adverse Event Reporting System (VAERS), a spontaneous reporting surveillance system. METHODS: We searched VAERS for US reports of DTaP vaccinations occurring from January 1, 1991, through December 31, 2016, and received by March 17, 2017. We reviewed available medical records for all death reports and a random sample of reports classified as nondeath serious. We used Empirical Bayesian data mining to identify adverse events that were disproportionally reported after DTaP vaccination. RESULTS: VAERS received 50 157 reports after DTaP vaccination; 43 984 (87.7%) of them reported concomitant administration of other vaccines, and 5627 (11.2%) were serious. Median age at vaccination was 19 months (interquartile range 35 months). The most frequently reported events were injection site erythema (12 695; 25.3%), pyrexia (9913; 19.8%), injection site swelling (7542; 15.0%), erythema (5599; 11.2%), and injection site warmth (4793; 9.6%). For 3 of the DTaP vaccines, we identified elevated values for vaccination errors using Empirical Bayesian data mining. CONCLUSIONS: No new or unexpected adverse events were detected. The observed disproportionate reporting for some nonserious vaccination errors calls for better education of vaccine providers on the specific indications for each of the DTaP vaccines. |
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. |
Post-licensure safety monitoring of quadrivalent human papillomavirus vaccine in the Vaccine Adverse Event Reporting System (VAERS), 2009-2015.
Arana JE , Harrington T , Cano M , Lewis P , Mba-Jonas A , Rongxia L , Stewart B , Markowitz LE , Shimabukuro TT . Vaccine 2018 36 (13) 1781-1788 BACKGROUND: The Food and Drug Administration (FDA) approved quadrivalent human papillomavirus vaccine (4vHPV) for use in females and males aged 9-26years, since 2006 and 2009 respectively. We characterized reports to the Vaccine Adverse Event Reporting System (VAERS), a US spontaneous reporting system, in females and males who received 4vHPV vaccination. METHODS: We searched VAERS for US reports of adverse events (AEs) following 4vHPV from January 2009 through December 2015. Signs and symptoms were coded using Medical Dictionary for Regulatory Activities (MedDRA). We calculated reporting rates and conducted empirical Bayesian data mining to identify disproportional reports. Clinicians reviewed available information, including medical records, and reports of selected pre-specified conditions. FINDINGS: VAERS received 19,760 reports following 4vHPV; 60.2% in females, 17.2% in males, and in 22.6% sex was missing. Overall, 94.2% of reports were non-serious; dizziness, syncope and injection site reactions were commonly reported in both males and females. Headache, fatigue and nausea were commonly reported serious AEs. More than 60 million 4vHPV doses were distributed during the study period. Crude AE reporting rates were 327 reports per million 4vHPV doses distributed for all reports, and 19 per million for serious reports. Among 29 verified reports of death, there was no pattern of clustering of deaths by diagnosis, co-morbidities, age, or interval from vaccination to death. INTERPRETATION: No new or unexpected safety concerns or reporting patterns of 4vHPV with clinically important AEs were detected. Safety profile of 4vHPV is consistent with data from pre-licensure trials and postmarketing safety data. |
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. |
Safety of currently licensed hepatitis B surface antigen vaccines in the United States, Vaccine Adverse Event Reporting System (VAERS), 2005-2015.
Haber P , Moro PL , Ng C , Lewis PW , Hibbs B , Schillie SF , Nelson NP , Li R , Stewart B , Cano MV . Vaccine 2017 36 (4) 559-564 INTRODUCTION: Currently four recombinant hepatitis B (HepB) vaccines are in use in the United States. HepB vaccines are recommended for infants, children and adults. We assessed adverse events (AEs) following HepB vaccines reported to the Vaccine Adverse Event Reporting System (VAERS), a national spontaneous reporting system. METHODS: We searched VAERS for reports of AEs following single antigen HepB vaccine and HepB-containing vaccines (either given alone or with other vaccines), from January 2005 - December 2015. We conducted descriptive analyses and performed empirical Bayesian data mining to assess disproportionate reporting. We reviewed serious reports including reports of special interest. RESULTS: VAERS received 20,231 reports following HepB or HepB-containing vaccines: 10,291 (51%) in persons <2years of age; 2588 (13%) in persons 2-18years and 5867 (29%) in persons >18years; for 1485 (7.3%) age was missing. Dizziness and nausea (8.4% each) were the most frequently reported AEs following a single antigen HepB vaccine: fever (23%) and injection site erythema (11%) were most frequent following Hep-containing vaccines. Of the 4444 (22%) reports after single antigen HepB vaccine, 303 (6.8%) were serious, including 45 deaths. Most commonly reported cause of death was Sudden Infant Death Syndrome (197). Most common non-death serious reports following single antigen HepB vaccines among infants aged <1month, were nervous system disorders (15) among children aged 1-23months; infections and infestation (8) among persons age 2-18years blood and lymphatic systemic disorders; and general disorders and administration site conditions among persons age >18years. Most common vaccination error following single antigen HepB was incorrect product storage. CONCLUSIONS: Review current U.S.-licensed HepB vaccines administered alone or in combination with other vaccines did not reveal new or unexpected safety concerns. Vaccination errors were identified which indicate the need for training and education of providers on HepB vaccine indications and recommendations. |
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