| AUC | Area Under the receiver-operator Curve |
| CCAE | IBM MarketScan Commercial Claims and Encounters |
| CDM | Common Data Model |
| CIOMS | Council for International Organizations of Medical Sciences |
| COVID-19 | COronaVIrus Disease 2019 |
| CPRD | Clinical Practice Research Datalink |
| CRAN | Comprehensive R Archive Network |
| EHR | Electronic Health Record |
| EMA | European Medicines Agency |
| ENCEPP | European Network of Centres for Pharmacoepidemiology and Pharmacovigilance |
| H1N1pdm | Hemagglutinin Type 1 and Neuraminidase Type 1 (2009 pandemic influenza) |
| HPV | Human PapillomaVirus |
| IRB | Institutional review board |
| JMDC | Japan Medical Data Center |
| LLR | Log Likelihood Ratio |
| MDCR | IBM MarketScan Medicare Supplemental Database |
| MDCD | IBM MarketScan Multi-State Medicaid Database |
| MSE | Mean Squared Error |
| OHDSI | Observational Health Data Science and Informatics |
| OMOP | Observational Medical Outcomes Partnership |
| MaxSPRT | MAXimized Sequential Probability Ratio Test |
| PS | Propensity score |
| RCT | Randomized controlled trial |
| SCCS | Self-Controlled Case Series |
| SCRI | Self-Controlled Risk Interval |
| WHO | World Health Organization |
| Version 2.0 Investigator | Institution/Affiliation |
|---|---|
| Fan Bu | Department of Biostatistics, University of Michigan, Ann Arbor, MI, USA |
| Shounak Chattopadhyay | Department of Biostatistics, University of California, Los Angeles, Los Angeles, CA, USA |
| George Hripcsak | Department of Biomedical Informatics, Columbia University, New York, NY, USA |
| Patrick B. Ryan | Observational Health Data Analytics, Janssen Research and Development, Titusville, NJ, USA |
| Martijn J. Schuemie | Observational Health Data Analytics, Janssen Research and Development, Titusville, NJ, USA |
| Marc A. Suchard * | Department of Biostatistics, University of California, Los Angeles, Los Angeles, CA, USA |
| * Principal Investigator |
This study is undertaken within Observational Health Data Sciences and Informatics (OHDSI), an open collaboration. GH receives grant funding from the US National Institutes of Health and the US Food & Drug Administration. PBR and MJS are employees of Janssen Research and Development and shareholders in John & Johnson. MAS receives grant funding from the US National Institutes of Health and the US Food & Drug Administration and contracts from the US Department of Veterans Affairs and Janssen Research and Development.
Background and Significance
As recently approved COVID-19 vaccines are rolled out globally, it is likely that safety signals will be identified from spontaneous reports and other data sources. Although some work has been done on the best methods for vaccine safety surveillance, there is a scarcity of information on how these perform in analyses of real-world data.
Study Aims
To study the comparative performance (bias, precision, and timeliness) of different analytical methods for the study of comparative vaccine safety.
Study Description
Table 4.1 lists any protocol amendments made over time.
| Number | Date | Section of study protocol | Amendment or update | Reason |
|---|---|---|---|---|
| 1.1.0 | 2021-04-09 | Methods to evaluate | Added historic comparator, cohort method, and SCCS variations | The historic comparator variation was based on initial EMAEUS results showing (preventable) outliers. The cohort method and SCCS variants are based on 3rd-party protocols for COVID-19 vaccine safety surveillance. |
| 1.2.0 | 2021-06-29 | Exposure-outcome pairs | Switched from synthetic to imputed positive controls | Positive control synthesis requires a minimum number of outcomes in the data, precluding many negative controls and leading to only ‘highly’ powered positive controls. This limited the ability to measure performance of methods in low-power settings. Positive control imputation is more simplistic but can be applied in low-power settings. |
| 2.0.0 | 2023-11-06 | Abstract | Added BNT162b2 and mRNA-1273 vaccines and concurrent comparator design | Second EUMAEUS study (EUMAEUS v2) to evaluate concurrent comparator design using negative and imputed positive control outcomes and myocarditis or pericarditisis real-world positive control outcome. |
| 2.0.0 | 2023-11-06 | Investigators | Updated authors | EUMAEUS v2 |
| 2.0.0 | 2023-11-06 | Milestones | Added new milestone dates | EUMAEUS v2 |
| 2.0.0 | 2023-11-06 | Exposure-outcome pairs | Added BNT1262b2 and mRNA-1273 COVID-19 vaccines | EUMAEUS v2 |
| 2.0.0 | 2023-11-06 | Real-world positive control outcome | Added myocarditisis or pericarditisis for COVID-19 vaccines | EUMAEUS v2 |
| 2.0.0 | 2023-11-06 | Methods to evaluation | Added concurrent comparator with three target/comparator design choices | EUMAEUS v2 |
| 2.0.0 | 2023-11-06 | Time-at-risk | Added concurrent comparator time-at-risk definitions for consistency with method use-cases and EUMAEUS v1 choices | EUMAEUS v2 |
| 2.0.0 | 2023-11-06 | Exposure cohort definitions | Added BNT162b2 and mRNA-1273 COVID-19 vaccine cohort definitions | EUMAEUS v2 |
| 2.0.0 | 2023-11-06 | Real-world outcome cohort definition | Added myocarditis or pericarditis outcome cohort defintion | EUMAEUS v2 |
| 2.0.0 | 2024-01-30 | Overview of analyses | Updated total number of estimates to include real-world positive control outcome | EUMAEUS v2 |
| 2.0.0 | 2024-01-30 | Appendix | Corrected age restriction for BNT162b2 and EUA date for mRNA-1273 | EUMAEUS v2 |
| 2.0.0 | 2024-02-05 | Appendix | Corrected all COVID vaccines concept set | EUMAEUS v2 |
Table 5.1 lists the study milestones.
| Milestone | Planned / actual date |
|---|---|
| EU PAS Registration | 2021-03-23 / 2021-03-23 |
| Start of analysis | 2021-03-23 / 2021-03-25 |
| End of analysis | 2021-05-01 / 2021-05-31 |
| Results presentation | 2021-05-01 / 2021-06-29 |
| Start of 2nd analysis | 2024-02-12 |
| End of 2nd analysis | 2024-04-23 |
| Results presentation | 2024-05-21 |
A total of 3 COVID-19 vaccines have been approved for clinical use in Europe, and 3 in the USA. Many more are in pipeline, and at least two more have reported to date on phase 3 efficacy data. Although safe and effective based on large randomised controlled trials, COVID-19 vaccines will be subject to post-marketing safety studies, including both analyses of spontaneous reports (pharmacovigilance) as well as longitudinal analyses in the form of post-authorisation safety studies.
The ENCEPP (European Network of Centres for Pharmacoepidemiology and Pharmacovigilance) methodological guidelines, in their 8th revision,[1] mention a few documents that set out standards for the conducting of vaccine safety studies. Specific aspects related to vaccine safety research are discussed in detail in different materials, including the Report of the CIOMS/WHO Working Group on Definition and Application of Terms for Vaccine Pharmacovigilance (2012), the CIOMS Guide to Active Vaccine Safety Surveillance (2017), the CIOMS Guide to Vaccine Safety Communication (2018), the Brighton Collaboration resources, the Module 4 (Surveillance) of the e-learning training course Vaccine Safety Basics by the World Health Organization (WHO), or the recommendations on vaccine-specific aspects of the EU pharmacovigilance system outlined in the Module P.I: Vaccines for prophylaxis against infectious diseases of the Good pharmacovigilance practices (GVP). Additionally, the Accelerated Development of VAccine beNefit-risk Collaboration in Europe (ADVANCE) project has summarized methods for vaccine safety in a bespoke report [2] covering multiple study designs, both experimental and observational in nature. The EMA (European Medicines Agency) has also issued guidances [3] and a plan [4] for pharmacovigilance of COVID-19 vaccines. Despite this plethora of literature and guidance, there is a scarcity of methodological studies on the performance of different methods for vaccine safety.
Given the quick and increasingly global rollout of COVID-19 vaccines internationally, it is highly likely that potential safety signals will emerge, which will need a timely but robust evaluation in ‘real world’ observational studies. It is therefore urgent that we conduct large-scale evaluations of methods for vaccine safety, similar to previous work on methods for drug safety. [5] The results of this evaluation will help us understand how these methods will perform when applied to COVID-19 vaccines.
The overarching aim is to identify the best methods for the generation of evidence of vaccine safety in observational, real-world data. Specific aims:
The evaluation will center on six existing (groups of) vaccines, for specific time periods (start date to end date), as shown in Table 8.1.
| Exposure Name | Start Date | End Date | History Start Date | History End Date |
|---|---|---|---|---|
| H1N1pdm vaccination | 01-09-2009 | 31-05-2010 | 01-09-2008 | 31-05-2009 |
| Seasonal flu vaccination (Fluvirin) | 01-09-2017 | 31-05-2018 | 01-09-2016 | 31-05-2017 |
| Seasonal flu vaccination (Fluzone) | 01-09-2017 | 31-05-2018 | 01-09-2016 | 31-05-2017 |
| Seasonal flu vaccination (All) | 01-09-2017 | 31-05-2018 | 01-09-2016 | 31-05-2017 |
| Zoster vaccination (Shingrix) | 01-01-2018 | 31-12-2018 | 01-01-2017 | 31-12-2017 |
| HPV vaccination (Gardasil 9) | 01-01-2018 | 31-12-2018 | 01-01-2017 | 31-12-2017 |
| COVID-19 vaccination (BNT126b2) | 11-12-2020 | 30-06-2021 | 01-01-2019 | 30-06-2019 |
| COVID-19 vaccination (mRNA-1273) | 18-12-2020 | 30-06-2021 | 01-01-2019 | 30-06-2019 |
For some methods the period between historic start and historic end date will be used to estimate the historic incidence rate. For analyses executed on data in the southern hemisphere (if any) the flu seasons are different, and the study periods will need to be adjusted accordingly. The formal cohort definitions of each exposure can be found in Appendix A.
Negative controls are outcomes believed not to be caused by any of the vaccines, and therefore ideally would not be flagged as a signal by a safety surveillance system. Any effect size estimates for negative control ideally should be close to the null.
A single set of negative control outcomes is defined for all six vaccine groups. To identify negative control outcomes that match the severity and prevalence of suspected vaccine adverse effects, a candidate list of negative controls was generated based on similarity of prevalence and percent of diagnoses that were recorded in an inpatient setting (as a proxy for severity). Manual review of this list by clinical experts created the final list of 93 negative control outcomes. The full list of negative control outcomes can be found in Appendix C
Negative control outcomes are defined as the first occurrence of the negative control concept or any of its descendants.
Positive controls are outcomes known to be caused by vaccines, and ideally would be detected as signals by a safety surveillance system as early as possible. For various reasons, real positive controls are problematic.[6] Instead, here we will rely on imputed positive controls, created by shifting the estimated effect sizes for the negative controls. We assume the negative controls have a true effect size of 1, so to simulate the estimated effect size when the true effect size is \(\theta\) we multiply the estimate by \(\theta\). For example, if for a negative control a method produces an effect size estimate of 1.1, for a positive control with true effect size of 2 the estimated effect size becomes 1.1 x 2 = 2.2. This approach makes strong assumptions on the nature of the systematic error, most importantly that systematic error does not change as a function of the true effect size. Although this assumption is likely not to hold in the real world, imputing positive controls allows us to provide some indication of what type 2 error to expect for various true effect sizes. For each negative control we will impute positive controls with true effect sizes of 1.5, 2, and 4, so using the 93 negative controls we are able to construct 93 \(\times\) 3 = 279 positive control outcomes. This increased true effect is applied both for the first and second injection of multi-dose vaccines.
In addition to the negative control and imputed positive control outcomes, we will further investigate the risk of myocarditis or pericarditis following COVID-19 vaccination as a real-world positive control outcome [8]. Lee et al. used a historical comparator design and demonstrated an increased risk after vaccination across several administrative claims data sources. Goddard et al. used a concurrent comparator design and found an elevated risk ratio 0 - 7 days post vaccination of 3.3 (95% confidence interval, 1.5 - 7.0) summing across both BNT162b2 and mRNA-1273 vaccines. We will use this positive control to evaluate each method’s detection statistical performance and timeliness to detect an increased association. Our cohort definition (see Appendix) for myocarditis or pericarditis was developed and validated across 26 data sources [10]
We will execute EUMAEUS as an OHDSI network study. All data partners within OHDSI are encouraged to participate voluntarily and can do so conveniently, because of the community’s shared Observational Medical Outcomes Partnership (OMOP) common data model (CDM) and OHDSI tool-stack. Many OHDSI community data partners have already committed to participate and we will recruit further data partners through OHDSI’s standard recruitment process, which includes protocol publication on OHDSI’s GitHub, an announcement in OHDSI’s research forum, presentation at the weekly OHDSI all-hands-on meeting and direct requests to data holders.
Table 8.2 lists the 5 already committed data sources for EUMAEUS; these sources encompass a large variety of practice types and populations. For each data source, we report a brief description and size of the population it represents. All data sources will receive institutional review board approval or exemption for their participation before executing EUMAEUS.
| Data source | Population | Patients | History | Data capture process and short description |
|---|---|---|---|---|
| Administrative claims | ||||
| IBM MarketScan Commercial Claims and Encounters (CCAE) | Commercially insured, < 65 years | 142M | 2000 – | Adjudicated health insurance claims (e.g. inpatient, outpatient, and outpatient pharmacy) from large employers and health plans who provide private healthcare coverage to employees, their spouses and dependents. |
| IBM MarketScan Medicare Supplemental Database (MDCR) | Commercially insured, 65+ years | 10M | 2000 – | Adjudicated health insurance claims of retirees with primary or Medicare supplemental coverage through privately insured fee-for-service, point-of-service or capitated health plans. |
| IBM MarketScan Multi-State Medicaid Database (MDCD) | Medicaid enrollees, racially diverse | 26M | 2006 – | Adjudicated health insurance claims for Medicaid enrollees from multiple states and includes hospital discharge diagnoses, outpatient diagnoses and procedures, and outpatient pharmacy claims. |
| Optum Clinformatics Data Mart (Optum) | Commercially or Medicare insured | 85M | 2000 – | Inpatient and outpatient healthcare insurance claims. |
| Electronic health records (EHRs) | ||||
| Optum Electronic Health Records (OptumEHR) | US, general | 93M | 2006 – | Clinical information, prescriptions, lab results, vital signs, body measurements, diagnoses and procedures derived from clinical notes using natural language processing. |
Vaccine safety surveillance methods can be broken down in to four components: construction of a counterfactual (often referred to as the ‘expected count’), a time-at-risk, the statistic to estimate, and potentially a decision rule on the estimate to classify signals from non-signals.
Historic rates
Traditionally, vaccine surveillance methods compute an expected count based an incidence rate estimated during some historic time period, for example in the years prior to the initiation of the surveillance study. We will use the historic period indicated in Table 8.1. We will evaluate two variations:
Initial results show that this counterfactual approach is sensitive to changes in coding practices. We therefore introduce a study diagnostic: the percent change in overall incidence rate (across the entire population) between the historic and current time period. For each of the four variations listed above, we add a new variation where effect-size estimates are removed if the change in incidence rate is greater than 50%.
Cohort method using a contemporary non-user comparator
A comparator cohort study most closely emulates a randomized clinical trial, comparing the target cohort (those vaccinated) to some comparator cohort. We define two types of non-user comparator cohort, one having an outpatient visit on the index date, and another having a random date as the index date. For both comparator variants we exclude subjects having a vaccinations for the same disease as the target vaccine on or before the index date. When doing unadjusted comparisons, the comparator cohort will be a random sample of equal size as the target cohort. When doing propensity score (PS) adjusted comparisons, the comparator cohort will be a stratified (by age and sex) random sample of four times the size of the target cohort (two times for the Seasonal Flu Vaccination (all) target cohort for computational reasons). Propensity models will use a large generic set of covariates, including demographics and covariates per drug, condition, procedure, measurement, etc., and will be fitted using large-scale regularized regression as described previously. [11] We will evaluate 10 method variations:
Anchoring the comparator on a random outpatient visit:
Anchoring the comparator on a random date:
Self-Controlled Case Series (SCCS) / Self-Controlled Risk Interval (SCRI)
The SCCS and SCRI designs are self-controlled, comparing the time-at-risk (the time shortly following the vaccination) to some other time in the same patient’s record. The SCCS design uses all patient time when not at risk as the control time. [13] The SCRI design uses a pre-specified control interval relative to the vaccination date as the control time. [14] This unexposed time can be both before or after the time at risk. We will evaluate five variations:
Case-control
The case-control design compares cases (those with the outcome) to controls (those that do not have the outcome), and looks back in time for exposures to a vaccine. We will evaluate two variants:
Concurrent comparator
Risk of confounding and biased estimation due to differences between patients who choose to receive a vaccine or when they choose to obtain the vaccine remain.
The concurrent comparator method aims to control for this bias by predefining a risk interval and designating patients in the exposure target cohort as vaccinated patients who were more recently vaccinated at the time of observation and patients in the control group as vaccinated comparators who had been vaccinated at an earlier time [15].
We will evaluate three variants that cover two different uses of the concurrent comparator method in the literature [8] and have a time-at-risk equal to our prior methods comparison [16]:
The time-at-risk is the time window, relative to the vaccination date, when outcomes will potentially be attributed to the vaccine. We define three time-at-risk windows: 1-28 days, 1-42 days, and 0-1 days after vaccination for the historical rates, cohort, SCCS and case-control methods. For the concurrent comparator method we define 0-7 days, 1-21 days and 1-28 days time-at-risk windows for greater comparability with the literature. Time-at-risk windows will be constructed both for the first and second dose. The time-at-risk for one dose will be censored at the time of the next dose.
Effect-size estimate. Each method can be used to produce an effect-size estimates such as a hazard ratio, incidence rate ratio, or odds ratio. For example, when using a historic rate we can compute the observed to expected ratio, which can be interpreted as the incidence rate ratio.
Log likelihood ratio (LLR). A common practice in vaccine safety surveillance is to computer the LLR, which is the log of the ratio between the likelihood of the alternative hypothesis (that there is an effect) and the likelihood of the null hypothesis (of no effect). The LLR is a convenient statistic when performing sequential testing, where the LLR can be compared to a pre-computed critical value, as is done in the MaxSPRT method. [17] Although typically MaxSPRT uses a historic rate as counterfactual, any counterfactual can be used to compute the LLR and can be used in MaxSPRT.
Effect-size estimates will be computed both with and without empirical calibration. [18,19] Empirical calibration will be done using leave-one-out: when calibrating the estimate for a control, the systematic error distribution will be fitted uses all controls except the one being calibrated.
To identify ‘signals’ we need a decision rule, for example in the shape of a threshold value on one of the estimates statistics.
In our experiment we will consider one decision rule, which is the critical value computed for the LLR at an alpha of 0.05.
For the historical rates method we will use a Poisson model assuming the counterfactual is known without uncertainty.
For all other methods we will use a binomial model.
All critical values will be computed using the Sequential package in CRAN.
Similar to our previous study, we will compute the following metrics based on the effect size estimates: [20]
In addition, based on the MaxSPRT decision rule, we will compute sensitivity, specificity, as well as the number of months until 80% of all positive controls exceeds the critical value (detection time). These will be stratified by true effect size of the positive controls.
To understand the time it takes for a method the identify signals, the study period for each vaccine will be divided into calendar months. For each month the methods will be executed using the data that had accumulated up to the end of that month, and the performance metrics will be reported for each month.
For the zoster and HPV vaccines requiring multiple doses separated by multiple months, metrics will be computed three times:
In total, we will evaluate:
Resulting in a total of 14 \(\times\) 3 \(\times\) [(9 + 9 + 9 + 9) \(\times\) 1 + (12 + 12) \(\times\) 3] \(\times\) (93 + 279 + 1) = 118,117,440 effect-size estimates. Each estimate will contain:
This will be computed for each database.
EUMAEUS does not involve human subjects research. The project does, however, use de-identified human data collected during routine healthcare provision. All data partners executing the EUMAEUS studies within their data sources will have received institutional review board (IRB) approval or waiver for participation in accordance to their institutional governance prior to execution (see Table 10.1). EUMAEUS executes across a federated and distributed data network, where analysis code is sent to participating data partners and only aggregate summary statistics are returned, with no sharing of patient-level data between organizations.
| Data source | Statement |
|---|---|
| IBM MarketScan Commercial Claims and Encounters (CCAE) | New England Institutional Review Board and was determined to be exempt from broad IRB approval, as this research project did not involve human subject research. |
| IBM MarketScan Medicare Supplemental Database (MDCR) | New England Institutional Review Board and was determined to be exempt from broad IRB approval, as this research project did not involve human subject research. |
| IBM MarketScan Multi-State Medicaid Database (MDCD) | New England Institutional Review Board and was determined to be exempt from broad IRB approval, as this research project did not involve human subject research. |
| Optum Clinformatics Data Mart (Optum) | New England Institutional Review Board and was determined to be exempt from broad IRB approval, as this research project did not involve human subject research. |
| Optum Electronic Health Records (OptumEHR) | New England Institutional Review Board and was determined to be exempt from broad IRB approval, as this research project did not involve human subject research. |
EUMAEUS uses coded data that already exist in electronic databases. In these types of databases, it is not possible to link (i.e., identify a potential causal association between) a particular product and medical event for any specific individual. Thus, the minimum criteria for reporting an adverse event (i.e., identifiable patient, identifiable reporter, a suspect product and event) are not available and adverse events are not reportable as individual adverse event reports. The study results will be assessed for medically important findings.
Open science aims to make scientific research, including its data process and software, and its dissemination, through publication and presentation, accessible to all levels of an inquiring society, amateur or professional [21] and is a governing principle of EUMAEUS. Open science delivers reproducible, transparent and reliable evidence. All aspects of EUMAEUS (except private patient data) will be open and we will actively encourage other interested researchers, clinicians and patients to participate. This differs fundamentally from traditional studies that rarely open their analytic tools or share all result artifacts, and inform the community about hard-to-verify conclusions at completion.
We will publicly register this protocol and announce its availability for feedback from stakeholders, the OHDSI community and within clinical professional societies. This protocol will link to open source code for all steps to generating diagnostics, effect estimates, figures and tables. Such transparency is possible because we will construct our studies on top of the OHDSI toolstack of open source software tools that are community developed and rigorously tested [20]. We will publicly host EUMAEUS source code at (https://github.com/ohdsi-studies/Eumaeus), allowing public contribution and review, and free re-use for anyone’s future research.
EUMAEUS embodies a new approach to generating evidence from healthcare data that overcome weaknesses in the current process of answering and publishing (or not) one question at a time. Generating evidence for thousands of research and control questions using a systematic process enables us to not only evaluate that process and the coherence and consistency of the evidence, but also to avoid \(p\)-hacking and publication bias [6]. We will store and openly communicate all of these results as they become available using a user-friendly web-based app that serves up all descriptive statistics, study diagnostics and effect estimates for each cohort comparison and outcome. Open access to this app will be through a general public facing EUMAEUS web-page.
We will deliver multiple presentations at scientific venues and will also prepare multiple scientific publications for clinical, informatics and statistical journals.
We believe in sharing our findings that will guide clinical care with the general public. EUMAEUS will use social-media (Twitter) to facilitate this. With dedicated support from the OHDSI communications specialist, we will deliver regular press releases at key project stages, distributed via the extensive media networks of UCLA and Columbia.
People enter the cohort when observing any of the following:
Limit cohort entry events to the earliest event per person.
The cohort end date will be offset from index event’s start date plus 0 days.
Entry events will be combined into cohort eras if they are within 0 days of each other.
| Concept ID | Concept Name | Code | Vocabulary | Excluded | Descendants | Mapped |
|---|---|---|---|---|---|---|
| 40213187 | Novel influenza-H1N1-09, all formulations | 128 | CVX | NO | YES | NO |
| 40166607 | influenza A-California-7-2009-(H1N1)v-like virus vaccine 0.03 MG/ML Injectable Suspension | 864704 | RxNorm | NO | YES | NO |
| 40166130 | 0.25 ML influenza A-California-7-2009-(H1N1)v-like virus vaccine 0.03 MG/ML Prefilled Syringe | 864781 | RxNorm | NO | YES | NO |
| 40166144 | 0.5 ML influenza A-California-7-2009-(H1N1)v-like virus vaccine 0.03 MG/ML Prefilled Syringe | 864797 | RxNorm | NO | YES | NO |
| 42902936 | influenza A-California-7-2009-(H1N1)v-like virus vaccine 0.03 MG/ML Prefilled Syringe | 1360049 | RxNorm | NO | YES | NO |
| 40240135 | influenza A-California-7-2009-(H1N1)v-like virus vaccine 0.09 MG/ML | 1111367 | RxNorm | NO | YES | NO |
| 40225009 | influenza A-California-7-2009-(H1N1)v-like virus vaccine 0.12 MG/ML | 1005949 | RxNorm | NO | YES | NO |
| 40166608 | influenza A-California-7-2009-(H1N1)v-like virus vaccine 158000000 UNT/ML | 864812 | RxNorm | NO | YES | NO |
| 45776785 | influenza A-California-7-2009-(H1N1)v-like virus vaccine 50000000 MG/ML | 1543758 | RxNorm | NO | YES | NO |
| 40166609 | influenza A-California-7-2009-(H1N1)v-like virus vaccine Injectable Suspension | 864703 | RxNorm | NO | YES | NO |
| 40166611 | influenza A-California-7-2009-(H1N1)v-like virus vaccine Prefilled Syringe | 864780 | RxNorm | NO | YES | NO |
People enter the cohort when observing any of the following:
Limit cohort entry events to the earliest event per person.
The cohort end date will be offset from index event’s start date plus 0 days.
Entry events will be combined into cohort eras if they are within 0 days of each other.
| Concept ID | Concept Name | Code | Vocabulary | Excluded | Descendants | Mapped |
|---|---|---|---|---|---|---|
| 1593906 | influenza A virus A/Hong Kong/4801/2014 (H3N2) antigen 0.03 MG/ML / influenza A virus A/Singapore/GP1908/2015 (H1N1) antigen 0.03 MG/ML / influenza B virus B/Brisbane/60/2008 antigen 0.03 MG/ML [Fluvirin 2017-2018] | 1928971 | RxNorm | NO | YES | NO |
People enter the cohort when observing any of the following:
Limit cohort entry events to the earliest event per person.
The cohort end date will be offset from index event’s start date plus 0 days.
Entry events will be combined into cohort eras if they are within 0 days of each other.
| Concept ID | Concept Name | Code | Vocabulary | Excluded | Descendants | Mapped |
|---|---|---|---|---|---|---|
| 1593354 | influenza A virus A/Hong Kong/4801/2014 (H3N2) antigen 0.12 MG/ML / influenza A virus A/Michigan/45/2015 (H1N1) antigen 0.12 MG/ML / influenza B virus B/Brisbane/60/2008 antigen 0.12 MG/ML [Fluzone 2017-2018] | 1928341 | RxNorm | NO | YES | NO |
People enter the cohort when observing any of the following:
Limit cohort entry events to the earliest event per person.
The cohort end date will be offset from index event’s start date plus 0 days.
Entry events will be combined into cohort eras if they are within 0 days of each other.
| Concept ID | Concept Name | Code | Vocabulary | Excluded | Descendants | Mapped |
|---|---|---|---|---|---|---|
| 40213145 | influenza, injectable, quadrivalent, contains preservative | 158 | CVX | NO | YES | NO |
| 42903442 | influenza B virus | 1312376 | RxNorm | NO | YES | NO |
| 40213150 | influenza, live, intranasal, quadrivalent | 149 | CVX | NO | YES | NO |
| 40213159 | influenza virus vaccine, whole virus | 16 | CVX | NO | YES | NO |
| 40225028 | influenza virus vaccine, inactivated A-Victoria-210-2009 X-187 (H3N2) (A-Perth-16-2009) strain | 1005931 | RxNorm | NO | YES | NO |
| 40213156 | influenza virus vaccine, split virus (incl. purified surface antigen)-retired CODE | 15 | CVX | NO | YES | NO |
| 40213151 | Seasonal, trivalent, recombinant, injectable influenza vaccine, preservative free | 155 | CVX | NO | YES | NO |
| 40213327 | influenza nasal, unspecified formulation | 151 | CVX | NO | YES | NO |
| 40213148 | influenza, intradermal, quadrivalent, preservative free, injectable | 166 | CVX | NO | YES | NO |
| 40213158 | influenza virus vaccine, unspecified formulation | 88 | CVX | NO | YES | NO |
| 36878713 | Influenza Virus Fragmented, Inactivated, Strain B / Phuket / 3073/2013 | OMOP989577 | RxNorm Extension | NO | YES | NO |
| 42873961 | influenza B virus vaccine, B-Wisconsin-1-2010-like virus | 1303855 | RxNorm | NO | YES | NO |
| 40225038 | influenza virus vaccine, live attenuated, A-Perth-16-2009 (H3N2) strain | 1005911 | RxNorm | NO | YES | NO |
| 40213146 | Influenza, injectable, quadrivalent, preservative free | 150 | CVX | NO | YES | NO |
| 40213143 | Influenza, injectable, Madin Darby Canine Kidney, preservative free, quadrivalent | 171 | CVX | NO | YES | NO |
| 36879025 | Influenza Virus Surface Antigens, strain A / Switzerland / 9715293/2013 H3N2 - Analogue Strain Nib-88 | OMOP991645 | RxNorm Extension | NO | YES | NO |
| 40213157 | Seasonal trivalent influenza vaccine, adjuvanted, preservative free | 168 | CVX | NO | YES | NO |
| 45776076 | influenza A virus vaccine, A-Texas-50-2012 (H3N2)-like virus | 1541617 | RxNorm | NO | YES | NO |
| 40213149 | influenza virus vaccine, live, attenuated, for intranasal use | 111 | CVX | NO | YES | NO |
| 40213147 | Influenza, injectable,quadrivalent, preservative free, pediatric | 161 | CVX | NO | YES | NO |
| 40213152 | Seasonal, quadrivalent, recombinant, injectable influenza vaccine, preservative free | 185 | CVX | NO | YES | NO |
| 42903441 | influenza A virus | 1312375 | RxNorm | NO | YES | NO |
| 40213141 | influenza, high dose seasonal, preservative-free | 135 | CVX | NO | YES | NO |
| 40213153 | Influenza, seasonal, injectable | 141 | CVX | NO | YES | NO |
| 40213144 | Influenza, injectable, Madin Darby Canine Kidney, quadrivalent with preservative | 186 | CVX | NO | YES | NO |
| 40213142 | Influenza, injectable, Madin Darby Canine Kidney, preservative free | 153 | CVX | NO | YES | NO |
| 40213155 | seasonal influenza, intradermal, preservative free | 144 | CVX | NO | YES | NO |
| 40164828 | influenza B virus vaccine B/Brisbane/60/2008 antigen | 857921 | RxNorm | NO | YES | NO |
People enter the cohort when observing any of the following:
The cohort end date will be offset from index event’s start date plus 0 days.
Entry events will be combined into cohort eras if they are within 0 days of each other.
| Concept ID | Concept Name | Code | Vocabulary | Excluded | Descendants | Mapped |
|---|---|---|---|---|---|---|
| 36248866 | Gardasil 9 Injectable Product | 1597098 | RxNorm | NO | YES | NO |
| 45892513 | L1 protein, human papillomavirus type 11 vaccine / L1 protein, human papillomavirus type 16 vaccine / L1 protein, human papillomavirus type 18 vaccine / L1 protein, human papillomavirus type 31 vaccine / L1 protein, human papillomavirus type 33 vaccine / | 1597102 | RxNorm | NO | YES | NO |
| 45892514 | 0.5 ML L1 protein, human papillomavirus type 11 vaccine 0.08 MG/ML / L1 protein, human papillomavirus type 16 vaccine 0.12 MG/ML / L1 protein, human papillomavirus type 18 vaccine 0.08 MG/ML / L1 protein, human papillomavirus type 31 vaccine 0.04 MG/ML / | 1597103 | RxNorm | NO | YES | NO |
| 45892510 | 0.5 ML L1 protein, human papillomavirus type 11 vaccine 0.08 MG/ML / L1 protein, human papillomavirus type 16 vaccine 0.12 MG/ML / L1 protein, human papillomavirus type 18 vaccine 0.08 MG/ML / L1 protein, human papillomavirus type 31 vaccine 0.04 MG/ML / | 1597099 | RxNorm | NO | YES | NO |
| 40213322 | Human Papillomavirus 9-valent vaccine | 165 | CVX | NO | YES | NO |
People enter the cohort when observing any of the following:
The cohort end date will be offset from index event’s start date plus 0 days.
Entry events will be combined into cohort eras if they are within 0 days of each other.
| Concept ID | Concept Name | Code | Vocabulary | Excluded | Descendants | Mapped |
|---|---|---|---|---|---|---|
| 792784 | varicella zoster virus glycoprotein E Injection [Shingrix] | 1986828 | RxNorm | NO | YES | NO |
| 792783 | varicella zoster virus glycoprotein E, recombinant 0.1 MG/ML [Shingrix] | 1986827 | RxNorm | NO | YES | NO |
| 792788 | varicella zoster virus glycoprotein E, recombinant 0.1 MG/ML Injection [Shingrix] | 1986832 | RxNorm | NO | YES | NO |
| 36421491 | Varicella-Zoster Virus Vaccine Live (Oka-Merck) strain Injectable Solution [Shingrix] | OMOP4763774 | RxNorm Extension | NO | YES | NO |
| 792785 | Shingrix Injectable Product | 1986829 | RxNorm | NO | YES | NO |
| 706103 | zoster vaccine recombinant | 187 | CVX | NO | YES | NO |
People may enter the cohort when observing any of the following:
drug exposure of ‘Comirnaty Pfizer COVID-19 vaccine for initial dose adult’ for the first time in the person’s history; having no drug exposures of ‘All COVID-19 vaccines’, starting anytime prior to ‘Comirnaty Pfizer COVID-19 vaccine for initial dose adult’ start date; allow events outside observation period.
drug exposures of ‘Comirnaty Pfizer COVID-19 vaccine for initial dose adult’; with all of the following criteria:
having at least 1 drug exposure of ‘Comirnaty Pfizer COVID-19 vaccine for initial dose adult’ for the first time in the person’s history, starting between 48 days before and 14 days before ‘Comirnaty Pfizer COVID-19 vaccine for initial dose adult’ start date; having no drug exposures of ‘All COVID-19 vaccines’, starting anytime prior to ‘Comirnaty Pfizer COVID-19 vaccine for initial dose adult’ start date; allow events outside observation period.
having no drug exposures of ‘Comirnaty Pfizer COVID-19 vaccine for initial dose adult’, starting anytime prior to ‘Comirnaty Pfizer COVID-19 vaccine for initial dose adult’ start date; having at least 1 drug exposure of ‘Comirnaty Pfizer COVID-19 vaccine for initial dose adult’ for the first time in the person’s history, starting between 48 days before and 14 days before ‘Comirnaty Pfizer COVID-19 vaccine for initial dose adult’ start date.
Entry events with the following event criteria: who are >= 16 years old; starting on or after December 11, 2020.
Entry events having at least 1 observation period, starting anytime up to 365 days before cohort entry start date and ending between 0 days before and all days after cohort entry start date.
The cohort end date will be offset from index event’s start date plus 1 day.
Entry events will be combined into cohort eras if they are within 0 days of each other.
| Concept ID | Concept Name | Code | Vocabulary | Excluded | Descendants | Mapped |
|---|---|---|---|---|---|---|
| 702664 | SARS-COV-2 COVID-19 Non-US Vaccine, Specific Product Unknown | 500 | CVX | NO | YES | NO |
| 702665 | SARS-COV-2 COVID-19 Inactivated Virus Non-US Vaccine Product (QAZCOVID-IN) | 501 | CVX | NO | YES | NO |
| 702666 | SARS-COV-2 COVID-19 Inactivated Virus Non-US Vaccine Product (COVAXIN) | 502 | CVX | NO | YES | NO |
| 702667 | SARS-COV-2 COVID-19 Viral Vector Non-replicating Non-US Vaccine Product (Sputnik Light) | 504 | CVX | NO | YES | NO |
| 702668 | SARS-COV-2 COVID-19 Viral Vector Non-replicating Non-US Vaccine Product (Sputnik V) | 505 | CVX | NO | YES | NO |
| 702669 | SARS-COV-2 COVID-19 Viral Vector Non-replicating Non-US Vaccine Product (CanSino Biological Inc./Beijing Institute of Biotechnology) | 506 | CVX | NO | YES | NO |
| 702670 | SARS-COV-2 COVID-19 Protein Subunit Non-US Vaccine Product (Anhui Zhifei Longcom Biopharmaceutical + Institute of Microbiology, Chinese Academy of Sciences) | 507 | CVX | NO | YES | NO |
| 702671 | SARS-COV-2 COVID-19 Protein Subunit Non-US Vaccine Product (EpiVacCorona) | 509 | CVX | NO | YES | NO |
| 702672 | SARS-COV-2 COVID-19 Inactivated Virus Non-US Vaccine Product (BIBP, Sinopharm) | 510 | CVX | NO | YES | NO |
| 702673 | SARS-COV-2 COVID-19 Inactivated Virus Non-US Vaccine Product (CoronaVac, Sinovac) | 511 | CVX | NO | YES | NO |
| 702676 | SARS-COV-2 (COVID-19) vaccine, mRNA, spike protein, LNP, preservative free, 3 mcg/0.2mL dose, tris-sucrose formulation | 219 | CVX | NO | YES | NO |
| 702677 | SARS-COV-2 (COVID-19) vaccine, mRNA, spike protein, LNP, preservative free, 30 mcg/0.3mL dose, tris-sucrose formulation | 217 | CVX | NO | YES | NO |
| 702678 | SARS-COV-2 (COVID-19) vaccine, mRNA, spike protein, LNP, preservative free, 10 mcg/0.2mL dose, tris-sucrose formulation | 218 | CVX | NO | YES | NO |
| 702680 | SARS-COV-2 COVID-19 Live Attenuated Virus Non-US Vaccine Product (COVIVAC) | 503 | CVX | NO | YES | NO |
| 702681 | SARS-COV-2 COVID-19 Protein Subunit Non-US Vaccine Product (Jiangsu Province Centers for Disease Control and Prevention) | 508 | CVX | NO | YES | NO |
| 722117 | SARS-COV-2 (COVID-19) vaccine, mRNA, spike protein, LNP, bivalent booster, preservative free, 10 mcg/0.2 mL dose, tris-sucrose formulation | 301 | CVX | NO | YES | NO |
| 722118 | SARS-COV-2 (COVID-19) vaccine, mRNA, spike protein, LNP, bivalent booster, preservative free, 10 mcg/0.2 mL dose | 230 | CVX | NO | YES | NO |
| 722119 | SARS-COV-2 (COVID-19) vaccine, mRNA, spike protein, LNP, bivalent, preservative free, 3 mcg/0.2 mL dose, tris-sucrose formulation | 302 | CVX | NO | YES | NO |
| 724904 | SARS-COV-2 (COVID-19) vaccine, UNSPECIFIED | 213 | CVX | NO | YES | NO |
| 724905 | SARS-COV-2 (COVID-19) vaccine, vector non-replicating, recombinant spike protein-ChAdOx1, preservative free, 0.5 mL | 210 | CVX | NO | YES | NO |
| 739902 | SARS-COV-2 (COVID-19) vaccine, vector non-replicating | 2479831 | RxNorm | NO | YES | NO |
| 778259 | SARS-COV-2 COVID-19 Virus Like Particle (VLP) Non-US Vaccine Product (Medicago, Covifenz) | 512 | CVX | NO | YES | NO |
| 778260 | SARS-COV-2 COVID-19 Protein Subunit Non-US Vaccine Product (Anhui Zhifei Longcom, Zifivax) | 513 | CVX | NO | YES | NO |
| 778261 | SARS-COV-2 COVID-19 DNA Non-US Vaccine Product (Zydus Cadila, ZyCoV-D) | 514 | CVX | NO | YES | NO |
| 778262 | SARS-COV-2 COVID-19 Protein Subunit Non-US Vaccine Product (Medigen, MVC-COV1901) | 515 | CVX | NO | YES | NO |
| 778263 | SARS-COV-2 COVID-19 Inactivated Non-US Vaccine Product (Minhai Biotechnology Co, KCONVAC) | 516 | CVX | NO | YES | NO |
| 778264 | SARS-COV-2 COVID-19 Protein Subunit Non-US Vaccine Product (Biological E Limited, Corbevax) | 517 | CVX | NO | YES | NO |
| 780152 | SARS-COV-2 (COVID-19) vaccine, subunit, recombinant spike protein | 2606074 | RxNorm | NO | YES | NO |
| 905418 | SARS-COV-2 (COVID-19) vaccine, D614, prefusion spike recombinant protein subunit (CoV2 preS dTM), AS03 adjuvant added, preservative free, 5mcg/0.5mL dose | 225 | CVX | NO | YES | NO |
| 905419 | SARS-COV-2 (COVID-19) vaccine, D614, prefusion spike recombinant protein subunit (CoV2 preS dTM), AS03 adjuvant added, preservative free, 10mcg/0.5mL dose | 226 | CVX | NO | YES | NO |
| 35894915 | COVID-19 vaccine | OMOP5042939 | RxNorm Extension | NO | YES | NO |
| 36118948 | COVID-19 vaccine, whole virus, inactivated, adjuvanted with Alum and CpG 1018 | OMOP5051441 | RxNorm Extension | NO | YES | NO |
| 36118949 | COVID-19 vaccine, recombinant, full-length nanoparticle spike (S) protein, adjuvanted with Matrix-M | OMOP5051442 | RxNorm Extension | NO | YES | NO |
| 36126197 | COVID-19 vaccine, recombinant, plant-derived Virus-Like Particle (VLP) spike (S) protein, adjuvanted with AS03 | OMOP5051443 | RxNorm Extension | NO | YES | NO |
| 37003432 | SARS-CoV-2 (COVID-19) vaccine, mRNA spike protein | 2468231 | RxNorm | NO | YES | NO |
| 739902 | SARS-COV-2 (COVID-19) vaccine, vector non-replicating | 2479831 | RxNorm | NO | YES | NO |
| 780152 | SARS-COV-2 (COVID-19) vaccine, subunit, recombinant spike protein | 2606074 | RxNorm | NO | YES | NO |
| Concept ID | Concept Name | Code | Vocabulary | Excluded | Descendants | Mapped |
|---|---|---|---|---|---|---|
| 37003433 | SARS-CoV-2 (COVID-19) vaccine, mRNA-BNT162b2 0.1 MG/ML | 2468232 | RxNorm | NO | YES | NO |
| 702117 | SARS-CoV-2 (COVID-19) vaccine, mRNA-BNT162b2 0.05 MG/ML | 2583742 | RxNorm | YES | YES | NO |
| 742039 | SARS-CoV-2 (COVID-19) vaccine, mRNA-BNT162b2 0.0075 MG/ML | 2623380 | RxNorm | YES | YES | NO |
| 779947 | SARS-CoV-2 (COVID-19) vaccine, mRNA-BNT162b2 0.015 MG/ML | 2603832 | RxNorm | YES | YES | NO |
| 742008 | SARS-CoV-2 (COVID-19) vaccine, mRNA-BNT162b2 0.025 MG/ML | 2621899 | RxNorm | YES | YES | NO |
| 742040 | SARS-CoV-2 (COVID-19) vaccine, mRNA-BNT162b2 OMICRON (BA.4/BA.5) 0.0075 MG/ML | 2623381 | RxNorm | YES | YES | NO |
| 1525544 | SARS-CoV-2 (COVID-19) vaccine, mRNA-BNT162b2 OMICRON (BA.4/BA.5) 0.05 MG/ML | 2610346 | RxNorm | YES | YES | NO |
| 742007 | SARS-CoV-2 (COVID-19) vaccine, mRNA-BNT162b2 OMICRON (BA.4/BA.5) 0.025 MG/ML | 2621898 | RxNorm | YES | YES | NO |
People may enter the cohort when observing any of the following:
drug exposure of ‘Spikevax Moderna COVID-19 vaccine for initial dose adult’ for the first time in the person’s history; having no drug exposures of ‘All COVID-19 vaccines’, starting anytime prior to ‘Spikevax Moderna COVID-19 vaccine for initial dose adult’ start date; allow events outside observation period.
drug exposures of ‘Spikevax Moderna COVID-19 vaccine for initial dose adult’; with all of the following criteria:
having at least 1 drug exposure of ‘Spikevax Moderna COVID-19 vaccine for initial dose adult’ for the first time in the person’s history, starting between 48 days before and 14 days before ‘Spikevax Moderna COVID-19 vaccine for initial dose adult’ start date; having no drug exposures of ‘All COVID-19 vaccines’, starting anytime prior to ‘Spikevax Moderna COVID-19 vaccine for initial dose adult’ start date; allow events outside observation period.
having no drug exposures of ‘Spikevax Moderna COVID-19 vaccine for initial dose adult’, starting anytime prior to ‘Spikevax Moderna COVID-19 vaccine for initial dose adult’ start date; having at least 1 drug exposure of ‘Spikevax Moderna COVID-19 vaccine for initial dose adult’ for the first time in the person’s history, starting between 48 days before and 14 days before ‘Spikevax Moderna COVID-19 vaccine for initial dose adult’ start date.
Entry events with the following event criteria: who are >= 18 years old; starting on or after December 18, 2020.
Entry events having at least 1 observation period, starting anytime up to 365 days before cohort entry start date and ending between 0 days before and all days after cohort entry start date.
The cohort end date will be offset from index event’s start date plus 1 day.
Entry events will be combined into cohort eras if they are within 0 days of each other.
| Concept ID | Concept Name | Code | Vocabulary | Excluded | Descendants | Mapped |
|---|---|---|---|---|---|---|
| 702664 | SARS-COV-2 COVID-19 Non-US Vaccine, Specific Product Unknown | 500 | CVX | NO | YES | NO |
| 702665 | SARS-COV-2 COVID-19 Inactivated Virus Non-US Vaccine Product (QAZCOVID-IN) | 501 | CVX | NO | YES | NO |
| 702666 | SARS-COV-2 COVID-19 Inactivated Virus Non-US Vaccine Product (COVAXIN) | 502 | CVX | NO | YES | NO |
| 702667 | SARS-COV-2 COVID-19 Viral Vector Non-replicating Non-US Vaccine Product (Sputnik Light) | 504 | CVX | NO | YES | NO |
| 702668 | SARS-COV-2 COVID-19 Viral Vector Non-replicating Non-US Vaccine Product (Sputnik V) | 505 | CVX | NO | YES | NO |
| 702669 | SARS-COV-2 COVID-19 Viral Vector Non-replicating Non-US Vaccine Product (CanSino Biological Inc./Beijing Institute of Biotechnology) | 506 | CVX | NO | YES | NO |
| 702670 | SARS-COV-2 COVID-19 Protein Subunit Non-US Vaccine Product (Anhui Zhifei Longcom Biopharmaceutical + Institute of Microbiology, Chinese Academy of Sciences) | 507 | CVX | NO | YES | NO |
| 702671 | SARS-COV-2 COVID-19 Protein Subunit Non-US Vaccine Product (EpiVacCorona) | 509 | CVX | NO | YES | NO |
| 702672 | SARS-COV-2 COVID-19 Inactivated Virus Non-US Vaccine Product (BIBP, Sinopharm) | 510 | CVX | NO | YES | NO |
| 702673 | SARS-COV-2 COVID-19 Inactivated Virus Non-US Vaccine Product (CoronaVac, Sinovac) | 511 | CVX | NO | YES | NO |
| 702676 | SARS-COV-2 (COVID-19) vaccine, mRNA, spike protein, LNP, preservative free, 3 mcg/0.2mL dose, tris-sucrose formulation | 219 | CVX | NO | YES | NO |
| 702677 | SARS-COV-2 (COVID-19) vaccine, mRNA, spike protein, LNP, preservative free, 30 mcg/0.3mL dose, tris-sucrose formulation | 217 | CVX | NO | YES | NO |
| 702678 | SARS-COV-2 (COVID-19) vaccine, mRNA, spike protein, LNP, preservative free, 10 mcg/0.2mL dose, tris-sucrose formulation | 218 | CVX | NO | YES | NO |
| 702680 | SARS-COV-2 COVID-19 Live Attenuated Virus Non-US Vaccine Product (COVIVAC) | 503 | CVX | NO | YES | NO |
| 702681 | SARS-COV-2 COVID-19 Protein Subunit Non-US Vaccine Product (Jiangsu Province Centers for Disease Control and Prevention) | 508 | CVX | NO | YES | NO |
| 722117 | SARS-COV-2 (COVID-19) vaccine, mRNA, spike protein, LNP, bivalent booster, preservative free, 10 mcg/0.2 mL dose, tris-sucrose formulation | 301 | CVX | NO | YES | NO |
| 722118 | SARS-COV-2 (COVID-19) vaccine, mRNA, spike protein, LNP, bivalent booster, preservative free, 10 mcg/0.2 mL dose | 230 | CVX | NO | YES | NO |
| 722119 | SARS-COV-2 (COVID-19) vaccine, mRNA, spike protein, LNP, bivalent, preservative free, 3 mcg/0.2 mL dose, tris-sucrose formulation | 302 | CVX | NO | YES | NO |
| 724904 | SARS-COV-2 (COVID-19) vaccine, UNSPECIFIED | 213 | CVX | NO | YES | NO |
| 724905 | SARS-COV-2 (COVID-19) vaccine, vector non-replicating, recombinant spike protein-ChAdOx1, preservative free, 0.5 mL | 210 | CVX | NO | YES | NO |
| 739902 | SARS-COV-2 (COVID-19) vaccine, vector non-replicating | 2479831 | RxNorm | NO | YES | NO |
| 778259 | SARS-COV-2 COVID-19 Virus Like Particle (VLP) Non-US Vaccine Product (Medicago, Covifenz) | 512 | CVX | NO | YES | NO |
| 778260 | SARS-COV-2 COVID-19 Protein Subunit Non-US Vaccine Product (Anhui Zhifei Longcom, Zifivax) | 513 | CVX | NO | YES | NO |
| 778261 | SARS-COV-2 COVID-19 DNA Non-US Vaccine Product (Zydus Cadila, ZyCoV-D) | 514 | CVX | NO | YES | NO |
| 778262 | SARS-COV-2 COVID-19 Protein Subunit Non-US Vaccine Product (Medigen, MVC-COV1901) | 515 | CVX | NO | YES | NO |
| 778263 | SARS-COV-2 COVID-19 Inactivated Non-US Vaccine Product (Minhai Biotechnology Co, KCONVAC) | 516 | CVX | NO | YES | NO |
| 778264 | SARS-COV-2 COVID-19 Protein Subunit Non-US Vaccine Product (Biological E Limited, Corbevax) | 517 | CVX | NO | YES | NO |
| 780152 | SARS-COV-2 (COVID-19) vaccine, subunit, recombinant spike protein | 2606074 | RxNorm | NO | YES | NO |
| 905418 | SARS-COV-2 (COVID-19) vaccine, D614, prefusion spike recombinant protein subunit (CoV2 preS dTM), AS03 adjuvant added, preservative free, 5mcg/0.5mL dose | 225 | CVX | NO | YES | NO |
| 905419 | SARS-COV-2 (COVID-19) vaccine, D614, prefusion spike recombinant protein subunit (CoV2 preS dTM), AS03 adjuvant added, preservative free, 10mcg/0.5mL dose | 226 | CVX | NO | YES | NO |
| 35894915 | COVID-19 vaccine | OMOP5042939 | RxNorm Extension | NO | YES | NO |
| 36118948 | COVID-19 vaccine, whole virus, inactivated, adjuvanted with Alum and CpG 1018 | OMOP5051441 | RxNorm Extension | NO | YES | NO |
| 36118949 | COVID-19 vaccine, recombinant, full-length nanoparticle spike (S) protein, adjuvanted with Matrix-M | OMOP5051442 | RxNorm Extension | NO | YES | NO |
| 36126197 | COVID-19 vaccine, recombinant, plant-derived Virus-Like Particle (VLP) spike (S) protein, adjuvanted with AS03 | OMOP5051443 | RxNorm Extension | NO | YES | NO |
| 37003432 | SARS-CoV-2 (COVID-19) vaccine, mRNA spike protein | 2468231 | RxNorm | NO | YES | NO |
| 739902 | SARS-COV-2 (COVID-19) vaccine, vector non-replicating | 2479831 | RxNorm | NO | YES | NO |
| 780152 | SARS-COV-2 (COVID-19) vaccine, subunit, recombinant spike protein | 2606074 | RxNorm | NO | YES | NO |
| Concept ID | Concept Name | Code | Vocabulary | Excluded | Descendants | Mapped |
|---|---|---|---|---|---|---|
| 1525542 | SARS-CoV-2 (COVID-19) vaccine, mRNA-1273 OMICRON (BA.4/BA.5) 0.05 MG/ML | 2610327 | RxNorm | YES | YES | NO |
| 37003517 | SARS-CoV-2 (COVID-19) vaccine, mRNA-1273 0.2 MG/ML | 2470233 | RxNorm | NO | YES | NO |
| 779678 | SARS-CoV-2 (COVID-19) vaccine, mRNA spike protein Injectable Suspension [Spikevax] | 2601551 | RxNorm | NO | YES | NO |
| 779413 | SARS-CoV-2 (COVID-19) vaccine, mRNA-1273 0.1 MG/ML | 2598699 | RxNorm | YES | YES | NO |
| 1525540 | SARS-CoV-2 (COVID-19) vaccine, mRNA-1273 0.05 MG/ML | 2610324 | RxNorm | YES | YES | NO |
| 742037 | SARS-CoV-2 (COVID-19) vaccine, mRNA-1273 OMICRON (BA.4/BA.5) 0.025 MG/ML | 2623377 | RxNorm | YES | YES | NO |
| 742036 | SARS-CoV-2 (COVID-19) vaccine, mRNA-1273 0.025 MG/ML | 2623376 | RxNorm | YES | YES | NO |
People may enter the cohort when observing any of the following:
Entry events having no condition occurrences of ‘Myocarditis Pericarditis’, starting in the 365 days prior to cohort entry start date; allow events outside observation period.
The cohort end date will be offset from index event’s start date plus 1 day.
Entry events will be combined into cohort eras if they are within 0 days of each other.
| Concept ID | Concept Name | Code | Vocabulary | Excluded | Descendants | Mapped |
|---|---|---|---|---|---|---|
| 4231274 | Viral myocarditis | 89141000 | SNOMED | NO | YES | NO |
| 4289908 | Viral pericarditis | 70189005 | SNOMED | NO | YES | NO |
| 4138837 | Pericarditis | 3238004 | SNOMED | NO | YES | NO |
| 314383 | Myocarditis | 50920009 | SNOMED | NO | YES | NO |
| 4149913 | Systemic lupus erythematosus with pericarditis | 309762007 | SNOMED | NO | YES | NO |
| 318072 | Histoplasmosis with pericarditis | 187059008 | SNOMED | NO | YES | NO |
| 44782774 | Chest pain due to pericarditis | 34791000119103 | SNOMED | NO | YES | NO |
| Outcome Id | Outcome Name |
|---|---|
| 438945 | Accidental poisoning by benzodiazepine-based tranquilizer |
| 434455 | Acquired claw toes |
| 316211 | Acquired spondylolisthesis |
| 201612 | Alcoholic liver damage |
| 438730 | Alkalosis |
| 441258 | Anemia in neoplastic disease |
| 432513 | Animal bite wound |
| 4171556 | Ankle ulcer |
| 4098292 | Antiphospholipid syndrome |
| 77650 | Aseptic necrosis of bone |
| 4239873 | Benign neoplasm of ciliary body |
| 23731 | Benign neoplasm of larynx |
| 199764 | Benign neoplasm of ovary |
| 195500 | Benign neoplasm of uterus |
| 4145627 | Biliary calculus |
| 4108471 | Burn of digit of hand |
| 75121 | Burn of lower leg |
| 4284982 | Calculus of bile duct without obstruction |
| 434327 | Cannabis abuse |
| 78497 | Cellulitis and abscess of toe |
| 4001454 | Cervical spine ankylosis |
| 4068241 | Chronic instability of knee |
| 195596 | Chronic pancreatitis |
| 4206338 | Chronic salpingitis |
| 4058397 | Claustrophobia |
| 74816 | Contusion of toe |
| 73302 | Curvature of spine |
| 4151134 | Cyst of pancreas |
| 77638 | Displacement of intervertebral disc without myelopathy |
| 195864 | Diverticulum of bladder |
| 201346 | Edema of penis |
| 200461 | Endometriosis of uterus |
| 377877 | Esotropia |
| 193530 | Follicular cyst of ovary |
| 4094822 | Foreign body in respiratory tract |
| 443421 | Gallbladder and bile duct calculi |
| 4299408 | Gouty tophus |
| 135215 | Hashimoto thyroiditis |
| 442190 | Hemorrhage of colon |
| 43020475 | High risk heterosexual behavior |
| 194149 | Hirschsprung’s disease |
| 443204 | Human ehrlichiosis |
| 4226238 | Hyperosmolar coma due to diabetes mellitus |
| 4032787 | Hyperosmolarity |
| 197032 | Hyperplasia of prostate |
| 140362 | Hypoparathyroidism |
| 435371 | Hypothermia |
| 138690 | Infestation by Pediculus |
| 4152376 | Intentional self poisoning |
| 192953 | Intestinal adhesions with obstruction |
| 196347 | Intestinal parasitism |
| 137977 | Jaundice |
| 317510 | Leukemia |
| 765053 | Lump in right breast |
| 378165 | Nystagmus |
| 434085 | Obstruction of duodenum |
| 4147016 | Open wound of buttock |
| 4129404 | Open wound of upper arm |
| 438120 | Opioid dependence |
| 75924 | Osteodystrophy |
| 432594 | Osteomalacia |
| 30365 | Panhypopituitarism |
| 4108371 | Peripheral gangrene |
| 440367 | Plasmacytosis |
| 439233 | Poisoning by antidiabetic agent |
| 442149 | Poisoning by bee sting |
| 4314086 | Poisoning due to sting of ant |
| 4147660 | Postural kyphosis |
| 434319 | Premature ejaculation |
| 199754 | Primary malignant neoplasm of pancreas |
| 4311499 | Primary malignant neoplasm of respiratory tract |
| 436635 | Primary malignant neoplasm of sigmoid colon |
| 196044 | Primary malignant neoplasm of stomach |
| 433716 | Primary malignant neoplasm of testis |
| 133424 | Primary malignant neoplasm of thyroid gland |
| 194997 | Prostatitis |
| 80286 | Prosthetic joint loosening |
| 443274 | Psychostimulant dependence |
| 314962 | Raynaud’s disease |
| 37018294 | Residual osteitis |
| 4288241 | Salmonella enterica subspecies arizonae infection |
| 45757269 | Sclerosing mesenteritis |
| 74722 | Secondary localized osteoarthrosis of pelvic region |
| 200348 | Secondary malignant neoplasm of large intestine |
| 43020446 | Sedative withdrawal |
| 74194 | Sprain of spinal ligament |
| 4194207 | Tailor’s bunion |
| 193521 | Tropical sprue |
| 40482801 | Type II diabetes mellitus uncontrolled |
| 74719 | Ulcer of foot |
| 196625 | Viral hepatitis A without hepatic coma |
| 197494 | Viral hepatitis C |
| 4284533 | Vitamin D-dependent rickets |