Last data update: Jul 01, 2024. (Total: 47134 publications since 2009)
Records 1-14 (of 14 Records) |
Query Trace: Arana J [original query] |
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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. |
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. |
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. |
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. |
Reports of Postural Orthostatic Tachycardia Syndrome After Human Papillomavirus Vaccination in the Vaccine Adverse Event Reporting System.
Arana J , Mba-Jonas A , Jankosky C , Lewis P , Moro PL , Shimabukuro TT , Cano M . J Adolesc Health 2017 61 (5) 577-582 PURPOSE: Human papillomavirus (HPV) vaccination prevents infections with HPV strains that cause certain cancers. Reports of postural orthostatic tachycardia syndrome (POTS) following HPV vaccination have raised safety concerns. We reviewed POTS reports submitted to the Vaccine Adverse Event Reporting System (VAERS). METHODS: We searched the VAERS database for reports of POTS following any type of HPV vaccination (bivalent, quadrivalent, or nonavalent) from June 2006 to August 2015. We reviewed reports and applied established POTS diagnostic criteria. We calculated unadjusted POTS case reporting rates based on HPV vaccine doses distributed and conducted empirical Bayesian data mining to screen for disproportional reporting of POTS following HPV vaccination. RESULTS: Among 40,735 VAERS reports following HPV vaccination, we identified 29 POTS reports that fully met diagnostic criteria. Of these, 27 (93.1%) were in females and mean age was 14 years (range 12-32). Median time from vaccination to start of symptoms was 43 days (range 0-407); most (18, 75.0%) had onset between 0 and 90 days. Symptoms frequently reported concomitantly included headache (22, 75.9%) and dizziness (21, 72.4%). Twenty (68.9%) reports documented a history of pre-existing medical conditions, of which chronic fatigue (5, 17.2%), asthma (4, 13.8%), and chronic headache (3, 10.3%) were most common. Approximately one POTS case is reported for every 6.5 million HPV vaccine doses distributed in the United States. No empirical Bayesian data mining safety signals for POTS and HPV vaccination were detected. CONCLUSIONS: POTS is rarely reported following HPV vaccination. Our review did not detect any unusual or unexpected reporting patterns that would suggest a safety problem. |
Post-licensure surveillance of 13-valent pneumococcal conjugate vaccine (PCV13) in adults aged ⩾19years old in the United States, Vaccine Adverse Event Reporting System (VAERS), June 1, 2012-December 31, 2015.
Haber P , Arana J , Pilishvili T , Lewis P , Moro PL , Cano M . Vaccine 2016 34 (50) 6330-6334 BACKGROUND: The 13-valent pneumococcal conjugate vaccine (PCV13) was first recommended for use in adults aged 19years with immunocompromising conditions in June 2012. On August 2014, the Advisory Committee on Immunization Practices (ACIP) recommended routine use of PCV13 among adults aged 65 years. METHODS: We assessed adverse events (AEs) reports following PCV13 in adults aged 19 years reported to the Vaccine Adverse Event Reporting System (VAERS) from June 2012 to December 2015. VAERS is a national spontaneous reporting system for monitoring AEs following vaccination. Our assessment included automated data analysis, clinical review of all serious reports and reports of special interest. We conducted empirical Bayesian data mining to assess for disproportionate reporting. RESULTS: VAERS received 2976 US PCV13 adult reports; 2103 (71%) of these reports were from PCV13 administered alone. Fourteen percent were in persons aged 19-64 years and 86% were in persons aged 65 years. Injection site erythema (28%), injection site pain (24%) and fever (22%) were the most frequent AEs among persons aged 19-64 years; injection site erythema (30%), erythema (20%) and injection site swelling (18%) were the most frequent among persons aged 65 years who were given the vaccine alone. The most frequently reported AEs among non-death serious reports were injection site reactions and general malaise among persons 19-64 years old; injection site reactions, general malaise and Guillain-Barre syndrome among those 65 years. Data mining did not detect disproportional reporting for any unexpected AE. CONCLUSIONS: The results of this study were consistent with safety data from pre-licensure studies of PCV13. We did not detect any new or unexpected AEs. |
Deaths reported to the Vaccine Adverse Event Reporting System (VAERS), United States, 1997-2013
Moro PL , Arana J , Cano M , Lewis P , Shimabukuro TT . Clin Infect Dis 2015 61 (6) 980-7 BACKGROUND: Vaccines are among the safest medical products in use today. Hundreds of millions of vaccinations are administered in the United States each year. Serious adverse reactions are uncommon. However, temporally associated deaths can occur following vaccination. To characterize main causes of death among reports submitted to the US Vaccine Adverse Event Reporting System (VAERS), a spontaneous vaccine safety surveillance system. METHODS: We searched VAERS for US reports of death after any vaccination from 7/1/1997-12/31/2013. Available medical records, autopsy reports and death certificates were reviewed to identify cause of death. RESULTS: VAERS received 2,149 death reports, most (N=1,469;68.4%) in children. Median age was 0.5 years (range 0-100 years); males accounted for 1,226 (57%) reports. The total annual number of death reports generally decreased during the latter part of the study period. Most common causes of death among 1,244 child reports with available death certificates/autopsy reports included: sudden infant death syndrome (N=544;44%), asphyxia (N=74;6.0%), septicemia (N=61;4.9%), and pneumonia (N=57;4.6%). Among 526 adult reports, most common causes of death included: diseases of the circulatory (N=247;46.9%) and respiratory systems (N=77;14.6%), certain infections and parasitic diseases (N=62;11.8%), and malignant neoplasms (N=20;3.8%). For child death reports, 79.4% received more than one vaccine on the same day. Inactivated influenza vaccine given alone was most commonly associated with death reports in adults (51.4%). CONCLUSIONS: No concerning pattern was noted among death reports submitted to VAERS during 1997-2013. The main causes of death were consistent with the most common causes of death in the US population. |
Safety of influenza A (H1N1) 2009 live attenuated monovalent vaccine in pregnant women
Moro PL , Museru OI , Broder K , Cragan J , Zheteyeva Y , Tepper N , Revzina N , Lewis P , Arana J , Barash F , Kissin D , Vellozzi C . Obstet Gynecol 2013 122 (6) 1271-8 OBJECTIVE: To characterize maternal and infant outcomes for pregnant women who received live H1N1 influenza vaccine and had no reported adverse events. METHODS: We identified Vaccine Adverse Event Reporting System reports, which described receipt of live H1N1 vaccine during pregnancy without an indication of an adverse event at the time of the report during October 2009 to June 2010. We reviewed the initial reports and obtained pregnancy outcome and infant data through 6 months of age from medical records. We reviewed the numbers and characteristics of pregnancy complications and infant outcomes including major birth defects and medically important infant conditions. Rates of spontaneous abortion, preterm birth, and major birth defects and their 95% confidence intervals were calculated. RESULTS: The Vaccine Adverse Event Reporting System received 113 reports stating receipt of live H1N1 vaccine during pregnancy with no adverse events reported. We obtained follow-up maternal records on 95 of the 113 (84%) live H1N1 reports (40.2% were vaccinated in the first trimester) and found: 87 live births (two twin pregnancies) and no maternal deaths occurred. Number and rates of pregnancy-specific adverse events included: 10 (10.5%, 5.8-18.3) spontaneous abortions; four (4.7%, 1.8-11.4) preterm deliveries at 35-36 weeks of gestation; three (3.4%, 1.2-9.7) infants had one or more major birth defects noted at birth: one cleft palate, one cleft lip, and one microtia (underdeveloped or absent external ear). Seven neonates and infants were hospitalized for medically important conditions. One infant death occurred in a 2.5-month-old boy as a result of pertussis. CONCLUSION: Rates of spontaneous abortion, preterm birth, and major birth defects in pregnant women who received live H1N1 vaccine were similar to or lower than published background rates. No concerning patterns of medical conditions in infants were identified. LEVEL OF EVIDENCE: III. |
Postlicensure safety surveillance for high-dose trivalent inactivated influenza vaccine in the Vaccine Adverse Event Reporting System, 1 July 2010-31 December 2010.
Moro PL , Arana J , Cano M , Menschik D , Yue X , Lewis P , Haber P , Martin D , Broder K . Clin Infect Dis 2012 54 (11) 1608-14 BACKGROUND: In December 2009, a new high-dose, trivalent, inactivated influenza vaccine (TIV-HD) was licensed for adults aged ≥65 years. We characterized clinical patterns of reports to the Vaccine Adverse Event Reporting System (VAERS) among older adults who received TIV-HD. METHODS: We searched VAERS for reports involving persons aged ≥65 years who received TIV-HD or TIV (standard dose) from 1 July 2010 through 31 December 2010. Medical records were requested for serious reports (ie, those associated with death, hospitalization or prolonged hospitalization, life-threatening illness, or disability). Clinicians reviewed information and assigned a diagnostic category to each report. Empirical Bayesian data mining was used to identify disproportional reporting following TIV-HD in VAERS. Reporting rates were calculated for reports of Guillain-Barre syndrome and anaphylaxis. RESULTS: VAERS received 606 reports after TIV-HD in persons aged ≥65 years (8.2% of reports involved serious events). The number of reports yielded by searches using the terms "ocular hyperemia" and "vomiting" exceeded the data mining threshold; >80% of these reports were nonserious. Clinical review of serious reports found that a greater proportion involving gastrointestinal events were made after TIV-HD receipt (5 of 51 [9.8%]) than after TIV receipt (1 of 123 [0.8%]). Four persons who received TIV-HD had gastroenteritis, and 1 had multiple gastrointestinal symptoms; all recovered. A higher proportion of cardiac events were noted after receipt of TIV-HD (9 of 51 [17.6%]) than after receipt of TIV (6 of 123 [4.9%]). No concerning clinical pattern was apparent. The reporting rates of Guillain-Barre syndrome and anaphylaxis after TIV-HD receipt were 1.4 and 1.0 reports per million doses distributed, respectively. CONCLUSIONS: During the first year after US licensure of TIV-HD, no new serious safety concerns were identified in VAERS. Our analyses suggested a clinically important imbalance between the reported and expected number of gastrointestinal events after TIV-HD receipt. Future studies should assess this potential association. |
Assessing the risk of international spread of yellow fever virus: a mathematical analysis of an urban outbreak in Asuncion, 2008
Johansson MA , Arana-Vizcarrondo N , Biggerstaff BJ , Gallagher N , Marano N , Staples JE . Am J Trop Med Hyg 2012 86 (2) 349-58 Yellow fever virus (YFV), a mosquito-borne virus endemic to tropical Africa and South America, is capable of causing large urban outbreaks of human disease. With the ease of international travel, urban outbreaks could lead to the rapid spread and subsequent transmission of YFV in distant locations. We designed a stochastic metapopulation model with spatiotemporally explicit transmissibility scenarios to simulate the global spread of YFV from a single urban outbreak by infected airline travelers. In simulations of a 2008 outbreak in Asuncion, Paraguay, local outbreaks occurred in 12.8% of simulations and international spread in 2.0%. Using simple probabilistic models, we found that local incidence, travel rates, and basic transmission parameters are sufficient to assess the probability of introduction and autochthonous transmission events. These models could be used to assess the risk of YFV spread during an urban outbreak and identify locations at risk for YFV introduction and subsequent autochthonous transmission. |
A cluster of nonspecific adverse events in a military reserve unit following pandemic influenza A (H1N1) 2009 vaccination - possible stimulated reporting?
McNeil MM , Arana J , Stewart B , Hartshorn M , Hrncir D , Wang H , Lamias M , Locke M , Stamper J , Tokars JI , Engler RJ . Vaccine 2012 30 (14) 2421-6 BACKGROUND: On February 20, 2010, a 23 year old male Army Reservist (index case) with symptom onset 4h after receiving inactivated monovalent pandemic 2009 (H1N1) vaccine (MIV) was hospitalized with possible Guillain-Barre syndrome (GBS). Within 1-2 days, 13 reservists from the same unit presented to the emergency department and 14 filed Vaccine Adverse Event Reporting System (VAERS) reports of nonspecific symptoms following MIV. OBJECTIVES: To describe the spectrum of adverse events (AE) among reservists in the unit after MIV and to identify factors contributing to this cluster of reports. METHODS: We reviewed the reservists' VAERS reports and hospital records for demographics, influenza vaccination status, diagnostic results and outcome. All VAERS reports after vaccination from the same MIV lot were also screened. We conducted a survey of unit reservists to identify contributing factors for this cluster. RESULTS: The presumptive diagnosis of GBS in the index case was not confirmed. All other reservists demonstrated normal exam findings and laboratory investigations. VAERS reports following vaccination from the same MIV lot revealed no consistent pattern. Our survey of factors contributing to the cluster was returned by 55 reservists (response rate 28%). AEs following MIV were significantly more often reported by female and black reservists. There was a tendency for concern about the safety of the 2010-2011 seasonal influenza vaccine to be higher for reservists that reported an AE to MIV (p=0.13) or that sought medical attention for their symptoms (p=0.08). CONCLUSIONS: This cluster represents possible stimulated reporting following receipt of inactivated pandemic 2009 (H1N1) vaccine among service personnel. |
On the treatment of airline travelers in mathematical models
Johansson MA , Arana-Vizcarrondo N , Biggerstaff BJ , Staples JE , Gallagher N , Marano N . PLoS One 2011 6 (7) e22151 The global spread of infectious diseases is facilitated by the ability of infected humans to travel thousands of miles in short time spans, rapidly transporting pathogens to distant locations. Mathematical models of the actual and potential spread of specific pathogens can assist public health planning in the case of such an event. Models should generally be parsimonious, but must consider all potentially important components of the system to the greatest extent possible. We demonstrate and discuss important assumptions relative to the parameterization and structural treatment of airline travel in mathematical models. Among other findings, we show that the most common structural treatment of travelers leads to underestimation of the speed of spread and that connecting travel is critical to a realistic spread pattern. Models involving travelers can be improved significantly by relatively simple structural changes but also may require further attention to details of parameterization. |
Incubation periods of yellow fever virus
Johansson MA , Arana-Vizcarrondo N , Biggerstaff BJ , Staples JE . Am J Trop Med Hyg 2010 83 (1) 183-8 Yellow fever virus is a global health threat due to its endemicity in parts of Africa and South America where human infections occur in residents and travelers. To understand yellow fever dynamics, it is critical to characterize the incubation periods of the virus in vector mosquitoes and humans. Here, we compare four statistical models of the yellow fever incubation periods fitted with historical data. The extrinsic incubation period in the urban vector Aedes aegypti was best characterized with a temperature-dependent Weibull model with a median of 10 days at 25 degrees C (middle 95% = 2.0-37 days). The intrinsic incubation period, fitted with a log-normal model, had a median of 4.3 days (middle 95% = 2.3-8.6 days). These estimates and their associated statistical models provide a quantitative basis to assist in exposure assessments, model potential outbreaks, and evaluate the effectiveness of public health interventions. |
Exposure of seasonal migrant workers to Onchocerca volvulus on coffee plantations in Guatemala
Lindblade KA , Richards M , Richards J , Gonzalez RJ , Cruz-Ortiz N , Zea-Flores G , Morales AL , Sauerbrey M , Castro J , Catu E , Arana B , Richards FO Jr , Klein RE . Am J Trop Med Hyg 2009 81 (3) 438-42 Onchocerciasis (river blindness), which is close to being eliminated from Guatemala through semiannual administration of ivermectin, is still transmitted in one area of the country that coincidentally receives an annual influx of migrant workers to harvest coffee. Migrant workers generally are not included in semiannual ivermectin treatments, but if infected could serve as a reservoir. We report on two studies undertaken to measure the exposure to onchocerciasis (presence of IgG4 antibodies to a recombinant Onchocerca volvulus antigen, OV-16) among migrant workers. During two coffee harvest seasons, 170 migrant workers with a history of working in the disease-endemic area were tested and 1 (0.6%, 95% confidence interval = 0-3.2%) was seropositive. This low rate of exposure in migrant workers indicates that they are unlikely to play a significant role in transmission of onchocerciasis and may indicate that transmission in the last remaining disease-endemic area of Guatemala is decreasing significantly. |
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