scholarly journals Epidemiology of myocarditis and pericarditis following mRNA vaccines in Ontario, Canada: by vaccine product, schedule and interval

2021 ◽  
Author(s):  
Sarah A. Buchan ◽  
Chi Yon Seo ◽  
Caitlin Johnson ◽  
Sarah Alley ◽  
Jeffrey C. Kwong ◽  
...  
Keyword(s):  
Dose Interval ◽  
Vaccine Safety ◽  
Population Based ◽  
Reporting Rate ◽  
Case Definitions ◽  
Dose Rates ◽  
Vaccine Product ◽  
Vaccine Schedule ◽  
Dose Number ◽  
Reporting Rates

AbstractImportanceIncreased rates of myocarditis/pericarditis following COVID-19 mRNA vaccines have been observed. However, little data are available related to product-specific differences, which have important programmatic impacts.ObjectiveThe objective of this study was to estimate reporting rates of myocarditis/pericarditis following COVID-19 mRNA vaccine by product, age, sex, and dose number, as well inter-dose interval.DesignWe conducted a population-based cohort study using passive vaccine safety surveillance data. All individuals in Ontario, Canada who received at least one dose of COVID-19 mRNA vaccine between December 14, 2020 and September 4, 2021 were included.SettingThis study was conducted in Ontario, Canada (population: 14.7 million) using the provincial COVID-19 vaccine registry and provincial adverse events following immunization database.ParticipantsWe included all individuals with a reported episode of myocarditis/pericarditis following COVID-19 vaccine in the study period. We obtained information on all doses administered in the province to calculate reporting rates.ExposureReceipt of COVID-19 mRNA vaccine (mRNA-1273 [Moderna Spikevax] or BNT162b2 [Pfizer-BioNTech Comirnaty]).Main Outcome(s) and Measure(s)Reported rate of myocarditis/pericarditis meeting level 1-3 of the Brighton Collaboration case definitions.ResultsThere were 19,740,741 doses of mRNA vaccines administered and 297 reports of myocarditis/pericarditis meeting our inclusion criteria. Among these, 69.7% occurred following the second dose of COVID-19 mRNA vaccine and 76.8% occurred in males. The median age of individuals with a reported event was 24 years. The highest reporting rate of myocarditis/pericarditis was observed in males aged 18-24 years following mRNA-1273 as the second dose; the rate in this age group was 5.1 (95% CI 1.9-15.5) times higher than the rate following BNT162b2 as the second dose. Overall reporting rates were higher when the inter-dose interval was shorter (i.e., ≤30 days) for both vaccine products. Among individuals who received mRNA-1273 for the second dose, rates were higher for those who had a heterologous as opposed to homologous vaccine schedule.Conclusions and RelevanceOur results suggest that vaccine product, inter-dose interval and vaccine schedule combinations may play a role in the risk of myocarditis/pericarditis, in addition to age and sex. Certain programmatic strategies could reduce the risk of myocarditis/pericarditis following mRNA vaccines.

scholarly journals AEFI Reporting Rates in Albania During 2008-2015: A Retrospective Analysis of AEFI Reporting Forms

2016 ◽  
Vol 6 (1) ◽  
pp. 62
Author(s):  
Irsida Mehmeti ◽  
Silva Bino ◽  
Erida Nelaj ◽  
Eugena Tomini
Keyword(s):  
Public Health ◽  
Health Care Workers ◽  
Vaccine Safety ◽  
Reporting Rate ◽  
Safety Reporting ◽  
Infectious Disease Department ◽  
Care Workers ◽  
High Adherence ◽  
Central Database ◽  
Reporting Rates

In Albania, passive AEFI surveillance is conducted by Institute of Public Health, which is under the supervision of Ministry of Health. Reports of suspected adverse events following immunisation (AEFI) are reviewed by the Control of infectious disease department in the Institute of Public Health and recorded in a central database. In this study AEFI database is analysed for individual AEFI reporting forms during 2008-2015. AEFI reporting rates and their patterns were assessed. At 2003 a national standardized AEFI reporting form was introduced to the health-care workers who were obligated to report any observed AEFI. This form was changed and added more requisites in 2008 and nowadays this is the formal AEFI reporting form in Albania. Safe vaccines are essential to preserve high adherence to immunization programs¬ [1]. During the last years the reporting rate increased significantly due to implementation of enhanced vaccine safety reporting strategies but it is still low and underreporting remains one of the limits of passive surveillance. Reporting rates were calculated using as a denominator the administered doses of vaccines.

scholarly journals Assessing safety of Ontario’s publicly funded MMR and MMRV immunization programs, 2012 to 2016

2019 ◽  
Vol 25 (6) ◽  
pp. 358-364
Author(s):  
Chi Yon Seo ◽  
Mohammed Rashid ◽  
Tara Harris ◽  
Jody Stapleton ◽  
Shelley L Deeks
Keyword(s):  
Adverse Events ◽  
Vaccine Safety ◽  
Reporting Rate ◽  
Public Confidence ◽  
Publicly Funded ◽  
Systemic Reactions ◽  
Event Category ◽  
Reporting Rates ◽  
Surveillance Database ◽  
Routine Immunization Schedule

Abstract Background The combined measles, mumps, rubella (MMR) and measles, mumps, rubella, and varicella (MMRV) vaccines are part of Ontario’s routine immunization schedule. Objective To assess adverse events following immunization (AEFIs) reported in Ontario following administration of MMR and MMRV vaccines between 2012 and 2016. Methods Reports of AEFIs were extracted from the provincial surveillance database on May 9, 2017. Events were grouped by provincial surveillance definitions. Reporting rates were calculated using provincial population estimates or net doses distributed as the denominator. A serious AEFI is defined as an AEFI that resulted in an in-patient hospitalization or death. Results Overall, 289 AEFIs were reported following administration of MMR (n=246) or MMRV (n=43) vaccines, for annualized reporting rates of 16.6 and 8.8 reports per 100,000 distributed doses, respectively. The highest age-specific reporting rate was in children aged 1 to 3 years for MMR (7.7 per 100,000 population) and children aged 4 to 9 years for MMRV (0.8 per 100,000 population). Systemic reactions were the most frequently reported event category, while rash was the most frequently reported event for both vaccines. There were 22 serious AEFIs, 19 following MMR and 3 following MMRV (1.3 and 0.6 per 100,000 doses distributed, respectively). Conclusions Our assessment found a low reporting rate of adverse events following MMR and MMRV vaccines in Ontario. No safety concerns were identified. Our findings are consistent with the safety profiles of these vaccines. Continued monitoring of vaccine safety is necessary to maintain timely detection of unusual postvaccine events and public confidence in vaccine safety.

scholarly journals AEFI Reporting Rates in Albania During 2008-2015: A Retrospective Analysis of AEFI Reporting Forms

2016 ◽  
Vol 2 (4) ◽  
pp. 62
Author(s):  
Irsida Mehmeti ◽  
Silva Bino ◽  
Erida Nelaj ◽  
Eugena Tomini
Keyword(s):  
Public Health ◽  
Health Care Workers ◽  
Vaccine Safety ◽  
Reporting Rate ◽  
Safety Reporting ◽  
Infectious Disease Department ◽  
Care Workers ◽  
High Adherence ◽  
Central Database ◽  
Reporting Rates

In Albania, passive AEFI surveillance is conducted by Institute of Public Health, which is under the supervision of Ministry of Health. Reports of suspected adverse events following immunisation (AEFI) are reviewed by the Control of infectious disease department in the Institute of Public Health and recorded in a central database. In this study AEFI database is analysed for individual AEFI reporting forms during 2008-2015. AEFI reporting rates and their patterns were assessed. At 2003 a national standardized AEFI reporting form was introduced to the health-care workers who were obligated to report any observed AEFI. This form was changed and added more requisites in 2008 and nowadays this is the formal AEFI reporting form in Albania. Safe vaccines are essential to preserve high adherence to immunization programs¬ [1]. During the last years the reporting rate increased significantly due to implementation of enhanced vaccine safety reporting strategies but it is still low and underreporting remains one of the limits of passive surveillance. Reporting rates were calculated using as a denominator the administered doses of vaccines.

scholarly journals Trends of Adverse Events Following Immunization (AEFI) Reports of Human Papillomavirus Vaccine in the Valencian Community—Spain (2008–2018)

Vaccines ◽  
2020 ◽  
Vol 8 (1) ◽  
pp. 117
Author(s):  
Cecilia M. Egoavil ◽  
José Tuells ◽  
Juan José Carreras ◽  
Emilia Montagud ◽  
Eliseo Pastor-Villalba ◽  
...  
Keyword(s):  
Human Papillomavirus ◽  
Group Analysis ◽  
Vaccine Safety ◽  
Reporting Rate ◽  
Human Papillomavirus Vaccine ◽  
Annual Percent Change ◽  
Vaccination Site ◽  
Vaccination Programs ◽  
Reporting Rates ◽  
Papillomavirus Vaccine

Vaccine safety surveillance is essential in vaccination programs. We accomplished a descriptive study of surveillance AEFI-reporting rate in human papillomavirus (HPV) vaccine administered in the Valencian Community, Spain. Data were obtained from Spanish Pharmacovigilance Adverse Reactions Data (FEDRA). Reporting rates were calculated using local net doses distributed as the denominator. Trends were assessed using joinpoint regression with annual percent change (APC) reported. The AEFI-reports decreased between 2008 and 2018 in two periods, a fast decreasing rate from 2009 to 2011 (from 192.2 to 24.93 per 100000 doses; APC, −54.9%; 95%CI [−75.2; −17.7]), followed by a stable trend (−13% APC, 95%CI [−26.1; 2.4]). For the age group analysis, only the group aged 14–15 years old followed the same trend with -58.4% (95%CI [−73.9; −33.8]) APC during 2008–2011, and −8.8% (95%CI [−27.7; 15]) APC during 2011-2018. The majority of the reports (73.82%) were nonserious, involving reactions at or near the vaccination site, headache, and dizziness events. No death was reported. AEFI-reporting rates for HPV immunization in the Valencian Community have decreased considerably with two trend periods observed for girls aged 14–15 years old. Currently, the AEFI reporting rate shows a decreasing trend, perhaps following the Weber effect, and it could also be affected by media attention and coverage.

Surveillance of adverse events following immunisation in Australia annual report, 2017

2019 ◽  
Vol 43 ◽  
Author(s):  
Aditi Dey ◽  
Han Wang ◽  
Helen Quinn ◽  
Rona Hiam ◽  
Nicholas Wood ◽  
...  
Keyword(s):  
Adverse Events ◽  
Annual Report ◽  
Injection Site Reaction ◽  
Reporting Rate ◽  
Vaccination Programs ◽  
National Immunisation ◽  
National Immunisation Program ◽  
Conjugate Vaccination ◽  
Reporting Rates ◽  
To Receive

This report summarises Australian passive surveillance data for adverse events following immunisation (AEFI) for 2017 reported to the Therapeutic Goods Administration and describes reporting trends over the 18-year period 1 January 2000 to 31 December 2017. There were 3,878 AEFI records for vaccines administered in 2017; an annual AEFI reporting rate of 15.8 per 100,000 population. There was a 12% increase in the overall AEFI reporting rate in 2017 compared with 2016. This increase in reported adverse events in 2017 compared to the previous year was likely due to the introduction of the zoster vaccine (Zostavax®) provided free for people aged 70–79 years under the National Immunisation Program (NIP) and also the state- and territory-based meningococcal ACWY conjugate vaccination programs. AEFI reporting rates for most other individual vaccines in 2017 were similar to 2016. The most commonly reported reactions were injection site reaction (34%), pyrexia (17%), rash (15%), vomiting (8%) and pain (7%). The majority of AEFI reports (88%) described non-serious events. Two deaths were reported that were determined to have a causal relationship with vaccination; they occurred in immunocompromised people contraindicated to receive the vaccines.

scholarly journals Validation of a Case Definition for Pediatric Brain Injury Using Administrative Data

2017 ◽  
Vol 44 (2) ◽  
pp. 161-169 ◽  
Author(s):  
Jane McChesney-Corbeil ◽  
Karen Barlow ◽  
Hude Quan ◽  
Guanmin Chen ◽  
Samuel Wiebe ◽  
...  
Keyword(s):  
Brain Injury ◽  
Administrative Data ◽  
Predictive Value ◽  
External Validation ◽  
Secondary Data ◽  
Population Based ◽  
Case Definition ◽  
Case Definitions ◽  
Icd 10 ◽  
Pediatric Tbi

AbstractBackground: Health administrative data are a common population-based data source for traumatic brain injury (TBI) surveillance and research; however, before using these data for surveillance, it is important to develop a validated case definition. The objective of this study was to identify the optimal International Classification of Disease , edition 10 (ICD-10), case definition to ascertain children with TBI in emergency room (ER) or hospital administrative data. We tested multiple case definitions. Methods: Children who visited the ER were identified from the Regional Emergency Department Information System at Alberta Children’s Hospital. Secondary data were collected for children with trauma, musculoskeletal, or central nervous system complaints who visited the ER between October 5, 2005, and June 6, 2007. TBI status was determined based on chart review. Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) were calculated for each case definition. Results: Of 6639 patients, 1343 had a TBI. The best case definition was, “1 hospital or 1 ER encounter coded with an ICD-10 code for TBI in 1 year” (sensitivity 69.8% [95% confidence interval (CI), 67.3-72.2], specificity 96.7% [95% CI, 96.2-97.2], PPV 84.2% [95% CI 82.0-86.3], NPV 92.7% [95% CI, 92.0-93.3]). The nonspecific code S09.9 identified >80% of TBI cases in our study. Conclusions: The optimal ICD-10–based case definition for pediatric TBI in this study is valid and should be considered for future pediatric TBI surveillance studies. However, external validation is recommended before use in other jurisdictions, particularly because it is plausible that a larger proportion of patients in our cohort had milder injuries.

scholarly journals SARS-CoV-2 Post Vaccinated Adverse Effects and Efficacy in the Egyptian Population

Vaccines ◽  
2021 ◽  
Vol 10 (1) ◽  
pp. 18
Author(s):  
Marwa O. Elgendy ◽  
Ahmed O. El-Gendy ◽  
Abdulaziz Ibrahim Alzarea ◽  
Sarah Mahmoud ◽  
Saad S. Alqahtani ◽  
...  
Keyword(s):  
Adverse Effects ◽  
Laboratory Tests ◽  
Dose Interval ◽  
Vaccine Safety ◽  
Spike Protein ◽  
Post Vaccination ◽  
The Third ◽  
Antibody Titers ◽  
Administration Methods ◽  
Structured Questionnaire

Vaccines are the solution to overcome SARS-CoV-2. This study aimed to determine the post-Sinopharm vaccine safety-profile and immunity through antibody titers. Data were collected using a structured questionnaire from Egyptian participants who received two doses of Sinopharm vaccine. Data were divided into three parts, the first and second parts were to detect participants’ post-first and second dose symptoms and practices, and the third for the results of IgG anti spike protein antibodies test and laboratory tests. Pain, redness, swelling at the injection site, headache, fatigue, and lethargy were the most common post-vaccine symptoms for both first and second doses. Most of the participants felt mild or no symptoms after vaccination. The symptoms started mostly during the first day post-vaccination and lasted for no more than two days. Forty-nine percent of the participants resulted in positive antibodies tests on day 18 post-vaccination. The average antibody level for vaccinated participants with past SARS-CoV-2 infection was much higher than that for non-past infected participants. These vaccines’ administration methods need to be reevaluated by changing the dose, dose interval, adding a third dose, or mixing it with other vaccines with different techniques to improve their protection rates. Further studies are required to validate this finding.

scholarly journals Existing comorbidities in people with osteoarthritis: a retrospective analysis of a population-based cohort in Alberta, Canada

BMJ Open ◽  
2019 ◽  
Vol 9 (11) ◽  
pp. e033334 ◽  
Author(s):  
Deborah A Marshall ◽  
Xiaoxiao Liu ◽  
Cheryl Barnabe ◽  
Karen Yee ◽  
Peter D Faris ◽  
...  
Keyword(s):  
Cohort Analysis ◽  
Age Groups ◽  
Population Based ◽  
Case Definition ◽  
Chronic Obstructive ◽  
Age Group ◽  
Case Definitions ◽  
Obstructive Pulmonary Disease ◽  
Physician Visits ◽  
Significant Difference

ObjectivesThe purpose of this study is to estimate the prevalence of comorbidities among people with osteoarthritis (OA) using administrative health data.DesignRetrospective cohort analysis.SettingAll residents in the province of Alberta, Canada registered with the Alberta Health Care Insurance Plan population registry.Participants497 362 people with OA as defined by ‘having at least one OA-related hospitalization, or at least two OA-related physician visits or two ambulatory care visits within two years’.Primary outcome measuresWe selected eight comorbidities based on literature review, clinical consultation and the availability of validated case definitions to estimate their frequencies at the time of diagnosis of OA. Sex-stratified age-standardised prevalence rates per 1000 population of eight clinically relevant comorbidities were calculated using direct standardisation with 95% CIs. We applied χ2 tests of independence with a Bonferroni correction to compare the percentage of comorbid conditions in each age group.Results54.6% (n=2 71 794) of people meeting the OA case definition had at least one of the eight selected comorbidities. Females had a significantly higher rate of comorbidities compared with males (standardised rates ratio=1.26, 95% CI 1.25 to 1.28). Depression, chronic obstructive pulmonary disease (COPD) and hypertension were the most prevalent in both females and males after age-standardisation, with 40% of all cases having any combination of these comorbidities. We observed a significant difference in the percentage of comorbidities among age groups, illustrated by the youngest age group (<45 years) having the highest percentage of cases with depression (24.6%), compared with a frequency of 16.1% in those >65 years.ConclusionsOur findings highlight the high frequency of comorbidity in people with OA, with depression having the highest age-standardised prevalence rate. Comorbidities differentially affect females, and vary by age. These factors should inform healthcare programme and delivery.

Definitions of medication-overuse headache in population-based studies and their implications on prevalence estimates: A systematic review

Cephalalgia ◽  
2013 ◽  
Vol 34 (6) ◽  
pp. 409-425 ◽  
Author(s):  
Maria L Westergaard ◽  
Ebba Holme Hansen ◽  
Charlotte Glümer ◽  
Jes Olesen ◽  
Rigmor H Jensen
Keyword(s):  
Medication Overuse ◽  
Medication Overuse Headache ◽  
Large Population ◽  
Population Based ◽  
Case Definition ◽  
Practical Case ◽  
Case Definitions ◽  
Wide Range ◽  
Concurrent Medication ◽  
Over Time

Background Case definitions of medication-overuse headache (MOH) in population-based research have changed over time. This study aims to review MOH prevalence reports with respect to these changes, and to propose a practical case definition for future studies based on the ICHD-3 beta. Methods A systematic literature search was conducted to identify MOH prevalence studies. Findings were summarized according to diagnostic criteria. Results Twenty-seven studies were included. The commonly used case definition for MOH was headache ≥15 days/month with concurrent medication overuse ≥3 months. There were varying definitions for what was considered as overuse. Studies that all used ICHD-2 criteria showed a wide range of prevalence among adults: 0.5%–7.2%. Conclusions There are limits to comparing prevalence of MOH across studies and over time. The wide range of reported prevalence might not only be due to changing criteria, but also the diversity of countries now publishing data. The criterion “headache occurring on ≥15 days per month” with concurrent medication overuse can be applied in population-based studies. However, the new requirement that a respondent must have “a preexisting headache disorder” has not been previously validated. Exclusion of other headache diagnoses by expert evaluation and ancillary examinations is not feasible in large population-based studies.

scholarly journals Update of the Case Definitions for Population-Based Surveillance of Periodontitis

2012 ◽  
Vol 83 (12) ◽  
pp. 1449-1454 ◽  
Author(s):  
Paul I. Eke ◽  
Roy C. Page ◽  
Liang Wei ◽  
Gina Thornton-Evans ◽  
Robert J. Genco
Keyword(s):  
Population Based ◽  
Case Definitions
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