Appendix E

Catalog of Data-Driven Literature from CDC Vaccine Safety Monitoring

This catalog presents a curated summary of peer-reviewed, data-driven studies supported by the CDC Immunization Safety Office (ISO) during the COVID public health emergency (PHE). These studies move beyond descriptive reporting to apply structured analytical methods—such as cohort comparisons, rapid-cycle analyses, and signal detection algorithms—to evaluate the safety of authorized COVID vaccines. They leverage surveillance systems, including the Vaccine Adverse Event Reporting System (VAERS), Vaccine Safety Datalink (VSD), and V-safe, and draw on electronic health record data, immunization registries, and patient self-reporting tools.

Grouped thematically, each summary highlights the analytic focus of the study, including the population studied, surveillance systems used, and major insights about vaccine safety during the public health response.

GENERAL SAFETY SURVEILLANCE AND SIGNAL DETECTION

• A Broad Assessment of COVID-19 Vaccine Safety Using Tree-Based Data Mining in the Vaccine Safety Datalink (Yih et al., 2023a)

Data-driven analysis of adverse events (AEs) following COVID vaccination using surveillance systems.

Included a range of adult and pediatric populations, applying broad surveillance to detect and characterize trends in AE reporting and signal strength.

• A Safety Study Evaluating Non-COVID-19 Mortality Risk Following COVID-19 Vaccination (Xu et al., 2023)

Data-driven analysis of AEs following COVID vaccination using surveillance systems.

Included a range of adult and pediatric populations, applying broad surveillance to detect and characterize trends in AE reporting and signal strength.

• Anxiety-Related Adverse Event Clusters After Janssen COVID-19—Five U.S. Mass Vaccination Sites, April 2021 (Hause, 2021a)

Data-driven analysis of AEs following COVID vaccination using surveillance systems.

Included a range of adult and pediatric populations, applying broad surveillance to detect and characterize trends in AE reporting and signal strength.

• Association Between History of SARS-CoV-2 Infection and Severe Systemic Adverse Events After mRNA COVID-19 Vaccination Among U.S. Adults (Tompkins et al., 2022)

Data-driven analysis of AEs following COVID vaccination using surveillance systems.

Included a range of adult and pediatric populations, applying broad surveillance to detect and characterize trends in AE reporting and signal strength.

• Case Series of Thrombosis With Thrombocytopenia Syndrome After COVID-19 Vaccination—United States, December 2020 to August 2021 (See et al., 2022)

Data-driven analysis of AEs following COVID vaccination using surveillance systems.

Included a range of adult and pediatric populations, applying broad surveillance to detect and characterize trends in AE reporting and signal strength.

• COVID-19 Vaccination and Non-COVID-19 Mortality Risk—Seven Integrated Health Care Organizations, United States, December 14, 2020–July 31, 2021 (Xu et al., 2021)

Data-driven analysis of AEs following COVID vaccination using surveillance systems.

Included a range of adult and pediatric populations, applying broad surveillance to detect and characterize trends in AE reporting and signal strength.

• First Month of COVID-19 Vaccine Safety Monitoring—United States, December 14, 2020–January 13, 2021 (Gee et al., 2021)

Summaries of real-world AE reporting and surveillance outcomes for COVID vaccines.

Included a range of adult and pediatric populations, applying broad surveillance to detect and characterize trends in AE reporting and signal strength.

• Guillain-Barré Syndrome After COVID-19 Vaccination in the Vaccine Safety Datalink (Hanson et al., 2021)

Data-driven analysis of AEs following COVID vaccination using surveillance systems.

Included a range of adult and pediatric populations, applying broad surveillance to detect and characterize trends in AE reporting and signal strength.

• Incidence of Guillain-Barré Syndrome After COVID-19 Vaccination in the Vaccine Safety Datalink (Hanson et al., 2022)

Data-driven analysis of AEs following COVID vaccination using surveillance systems.

Included a range of adult and pediatric populations, applying broad surveillance to detect and characterize trends in AE reporting and signal strength.

• Menstrual Irregularities and Vaginal Bleeding After COVID-19 Vaccination Reported to V-safe Active Surveillance, USA in December, 2020–January, 2022: An Observational Cohort Study (Wong et al., 2022)

Data-driven analysis of AEs following COVID vaccination using surveillance systems.

Included a range of adult and pediatric populations, applying broad surveillance to detect and characterize trends in AE reporting and signal strength.

• Mortality Risk After COVID-19 Vaccination: A Self-Controlled Case Series Study (Xu et al., 2024)

Data-driven analysis of AEs following COVID vaccination using surveillance systems.

Included a range of adult and pediatric populations, applying broad surveillance to detect and characterize trends in AE reporting and signal strength.

• Notes from the Field: Safety Monitoring of Novavax COVID-19 Vaccine Among Persons Aged ≥12 Years—United States, July 13, 2022–March 13, 2023 (Romanson et al., 2023)

Summaries of real-world AE reporting and surveillance outcomes for COVID vaccines.

Included a range of adult and pediatric populations, applying broad surveillance to detect and characterize trends in AE reporting and signal strength.

• Obstetric Complications and Birth Outcomes After Antenatal Coronavirus Disease 2019 (COVID-19) Vaccination (Vesco et al., 2022)

Data-driven analysis of AEs following COVID vaccination using surveillance systems.

Included a range of adult and pediatric populations, applying broad surveillance to detect and characterize trends in AE reporting and signal strength.

• Post-Authorization Safety Surveillance of Ad.26.COV2.S Vaccine: Reports to the Vaccine Adverse Event Reporting System and V-safe, February 2021–February 2022 (Woo et al., 2023)

Summaries of real-world AE reporting and surveillance outcomes for COVID-19 vaccines.

Included a range of adult and pediatric populations, applying broad surveillance to detect and characterize trends in AE reporting and signal strength.

• Post-Authorization Surveillance of Adverse Events Following COVID-19 Vaccines in Pregnant Persons in the Vaccine Adverse Event Reporting System (VAERS), December 2020–October 2021 (Moro et al., 2022a)

Summaries of real-world AE reporting and surveillance outcomes for COVID vaccines.

Included a range of adult and pediatric populations, applying broad surveillance to detect and characterize trends in AE reporting and signal strength.

• Postmenopausal Bleeding After Coronavirus Disease 2019 (COVID-19) Vaccination: Vaccine Adverse Event Reporting System (Strid et al., 2022)

Data-driven analysis of AEs following COVID vaccination using surveillance systems.

Included a range of adult and pediatric populations, applying broad surveillance to detect and characterize trends in AE reporting and signal strength.

• Preliminary Findings of mRNA COVID-19 Vaccine Safety in Pregnant Persons (Shimabukuro et al., 2021b)

Data-driven analysis of AEs following COVID vaccination using surveillance systems.

Included a range of adult and pediatric populations, applying broad surveillance to detect and characterize trends in AE reporting and signal strength.

• Reactogenicity Following Receipt of mRNA-Based COVID-19 Vaccines (Chapin-Bardales et al., 2021a)

Data-driven analysis of AEs following COVID vaccination using surveillance systems.

Included a range of adult and pediatric populations, applying broad surveillance to detect and characterize trends in AE reporting and signal strength.

• Reactogenicity Within 2 Weeks After mRNA COVID-19 Vaccines: Findings from the CDC V-safe Surveillance System (Chapin-Bardales et al., 2021b)

Data-driven analysis of AEs following COVID vaccination using surveillance systems.

Included a range of adult and pediatric populations, applying broad surveillance to detect and characterize trends in AE reporting and signal strength.

• Reporting Rates for VAERS Death Reports Following COVID-19 Vaccination, December 14, 2020–November 17, 2021 (Day et al., 2023)

Data-driven analysis of AEs following COVID vaccination using surveillance systems.

Included a range of adult and pediatric populations, applying broad surveillance to detect and characterize trends in AE reporting and signal strength.

• Reports of Anaphylaxis After Receipt of mRNA COVID-19 Vaccines in the U.S.—December 14, 2020–January 18, 2021 (Shimabukuro et al., 2021a)

Data-driven analysis of AEs following COVID vaccination using surveillance systems.

Included a range of adult and pediatric populations, applying broad surveillance to detect and characterize trends in AE reporting and signal strength.

• Reports of Guillain-Barré Syndrome After COVID-19 Vaccination in the United States (Abara et al., 2023)

Data-driven analysis of AEs following COVID vaccination using surveillance systems.

Included a range of adult and pediatric populations, applying broad surveillance to detect and characterize trends in AE reporting and signal strength.

• Safety Monitoring of an Additional Dose of COVID-19 Vaccine—United States, August 12–September 19, 2021 (Hause et al., 2021d)

Summaries of real-world AE reporting and surveillance outcomes for COVID vaccines.

Included a range of adult and pediatric populations, applying broad surveillance to detect and characterize trends in AE reporting and signal strength.

• Safety Monitoring of Bivalent COVID-19 mRNA Vaccine Booster Doses Among Persons Aged ≥12 Years—United States, August 31–October 23, 2022 (Hause et al., 2022b)

Summaries of real-world AE reporting and surveillance outcomes for COVID vaccines.

Included a range of adult and pediatric populations, applying broad surveillance to detect and characterize trends in AE reporting and signal strength.

• Safety Monitoring of Bivalent mRNA COVID-19 Vaccine Among Pregnant Persons in the Vaccine Adverse Event Reporting System—United States, September 1, 2022–March 31, 2023 (Moro et al., 2024a)

Summaries of real-world AE reporting and surveillance outcomes for COVID vaccines.

Included a range of adult and pediatric populations, applying broad surveillance to detect and characterize trends in AE reporting and signal strength.

• Safety Monitoring of COVID-19 mRNA Vaccine First Booster Doses Among Persons Aged ≥12 Years with Presumed Immunocompromise Status—United States, January 12, 2022–March 28, 2022 (Hause et al., 2022c)

Summaries of real-world AE reporting and surveillance outcomes for COVID vaccines.

Included a range of adult and pediatric populations, applying broad surveillance to detect and characterize trends in AE reporting and signal strength.

• Safety Monitoring of COVID-19 mRNA Vaccine Second Booster Doses Among Adults Aged ≥50 Years—United States, March 29, 2022–July 10, 2022 (Hause et al., 2022d)

Summaries of real-world AE reporting and surveillance outcomes for COVID vaccines.

Included a range of adult and pediatric populations, applying broad surveillance to detect and characterize trends in AE reporting and signal strength.

• Safety Monitoring of COVID-19 Vaccine Booster Doses Among Adults—United States, September 22, 2021–February 6, 2022 (Hause et al., 2022e)

Summaries of real-world AE reporting and surveillance outcomes for COVID vaccines.

Included a range of adult and pediatric populations, applying broad surveillance to detect and characterize trends in AE reporting and signal strength.

• Safety Monitoring of COVID-19 Vaccine Booster Doses Among Persons Aged 12–17 Years—United States, December 9, 2021–February 20, 2022 (Hause et al., 2022f)

Summaries of real-world AE reporting and surveillance outcomes for COVID vaccines.

Included a range of adult and pediatric populations, applying broad surveillance to detect and characterize trends in AE reporting and signal strength.

• Safety Monitoring of Pfizer-BioNTech COVID-19 Vaccine Booster Doses Among Children Aged 5–11 Years—United States, May 17–July 31, 2022 (Hause et al., 2022g)

Summaries of real-world AE reporting and surveillance outcomes for COVID vaccines.

Included a range of adult and pediatric populations, applying broad surveillance to detect and characterize trends in AE reporting and signal strength.

• Safety Monitoring of the Janssen (Johnson & Johnson) COVID-19 Vaccine—United States, March–April 2021 (Shay et al., 2021)

Summaries of real-world AE reporting and surveillance outcomes for COVID vaccines.

Included a range of adult and pediatric populations, applying broad surveillance to detect and characterize trends in AE reporting and signal strength.

• Safety of Co-Administration of mRNA COVID-19 and Seasonal Inactivated Influenza Vaccines in the Vaccine Adverse Event Reporting System (VAERS) During July 1, 2021–June 30, 2022 (Moro et al., 2023a)

Data-driven analysis of AEs following COVID vaccination using surveillance systems.

Included a range of adult and pediatric populations, applying broad surveillance to detect and characterize trends in AE reporting and signal strength.

• Safety of mRNA Vaccines Administered During the Initial 6 Months of the U.S. COVID-19 Vaccination Programme: An Observational Study of Reports to the Vaccine Adverse Event Reporting System and V-safe (Rosenblum et al., 2022)

Data-driven analysis of AEs following COVID vaccination using surveillance systems.

Included a range of adult and pediatric populations, applying broad surveillance to detect and characterize trends in AE reporting and signal strength.

• Safety of Simultaneous Vaccination With COVID-19 Vaccines in the Vaccine Safety Datalink (Tat’Yana et al., 2023b)

Data-driven analysis of AEs following COVID vaccination using surveillance systems.

Included a range of adult and pediatric populations, applying broad surveillance to detect and characterize trends in AE reporting and signal strength.

• Surveillance for Adverse Events After COVID-19 mRNA Vaccination (Klein et al., 2021)

Data-driven analysis AEs following COVID vaccination using surveillance systems.

Included a range of adult and pediatric populations, applying broad surveillance to detect and characterize trends in AE reporting and signal strength.

• Tinnitus After COVID-19 Vaccination: Findings from the Vaccine Adverse Event Reporting System and the Vaccine Safety Datalink (Yih et al., 2024)

Data-driven analysis AEs following COVID vaccination using surveillance systems.

Included a range of adult and pediatric populations, applying broad surveillance to detect and characterize trends in AE reporting and signal strength.

• U.S. Case Reports of Cerebral Venous Sinus Thrombosis With Thrombocytopenia After Ad26.COV2.S Vaccination, March 2 to April 21, 2021 (See et al., 2021)

Data-driven analysis of AEs following COVID vaccination using surveillance systems.

Included a range of adult and pediatric populations, applying broad surveillance to detect and characterize trends in AE reporting and signal strength.

ALLERGIC REACTIONS AND ANAPHYLAXIS

• Allergic Reactions Including Anaphylaxis After Receipt of the First Dose of Moderna COVID-19 Vaccine—United States, December 21, 2020–January 10, 2021 (Shimabukuro, 2021)

Data-driven analysis AEs following COVID vaccination using surveillance systems.

Focused on individuals who experienced immediate hypersensitivity reactions postvaccination, with attention to those previously sensitized to PEG-containing compounds.

• Allergic Reactions Including Anaphylaxis After Receipt of the First Dose of Pfizer-BioNTech COVID-19 Vaccine—United States, December 14–23, 2020 (CDC, 2021)

Data-driven analysis of AEs following COVID vaccination using surveillance systems.

Focused on individuals who experienced immediate hypersensitivity reactions postvaccination, with attention to those previously sensitized to PEG-containing compounds.

• Allergic Reactions Including Anaphylaxis After Receipt of the First Dose of Pfizer-BioNTech COVID-19 Vaccine (Shimabukuro and Nair, 2021)

Data-driven analysis of AEs following COVID vaccination using surveillance systems.

Focused on individuals who experienced immediate hypersensitivity reactions postvaccination, with attention to those previously sensitized to PEG-containing compounds.

• Evaluation of Association of Anti-PEG Antibodies With Anaphylaxis After mRNA COVID-19 Vaccination (Zhou et al., 2023)

Evaluated potential relationship between anti-PEG antibodies and vaccine-related allergic reactions.

Focused on individuals who experienced immediate hypersensitivity reactions postvaccination, with attention to those previously sensitized to PEG-containing compounds.

BOOSTER AND BIVALENT DOSE SAFETY

• COVID-19 Booster Vaccination in Early Pregnancy and Surveillance for Spontaneous Abortion (Kharbanda et al., 2023)

Evaluated safety of booster or bivalent doses in specific populations using VAERS or VSD data.

Used VAERS and VSD to assess AEs in recipients of booster and bivalent doses, including older adults and high-risk groups.

• Reactogenicity of Simultaneous COVID-19 mRNA Booster and Influenza Vaccination in the U.S. (Hause et al., 2022h)

Evaluates safety of booster or bivalent doses in specific populations using VAERS or VSD data.

Used VAERS and VSD to assess AEs in recipients of booster and bivalent doses, including older adults and high-risk groups.

• Safety of Booster Doses of Coronavirus Disease 2019 (COVID-19) Vaccine in Pregnancy in the Vaccine Adverse Event Reporting System (Moro et al., 2022b)

Evaluated safety of booster or bivalent doses in specific populations using VAERS or VSD data.

Used VAERS and VSD to assess AEs in recipients of booster and bivalent doses, including older adults and high-risk groups.

• Safety of Simultaneous Administration of Bivalent mRNA COVID-19 and Influenza Vaccines in the Vaccine Adverse Event Reporting System (VAERS) (Moro et al., 2024b)

Evaluated safety of booster or bivalent doses in specific populations using VAERS or VSD data.

Used VAERS and VSD to assess AEs in recipients of booster and bivalent doses, including older adults and high-risk groups.

• Safety Signal Identification for COVID-19 Bivalent Booster Vaccination Using Tree-Based Scan Statistics in the Vaccine Safety Datalink (Yih et al., 2023c)

Evaluates safety of booster or bivalent doses in specific populations using VAERS or VSD data.

Used VAERS and VSD to assess AEs in recipients of booster and bivalent doses, including older adults and high-risk groups.

• Tree-Based Data Mining for Safety Assessment of First COVID-19 Booster Doses in the Vaccine Safety Datalink (Yih et al., 2023b)

Evaluates safety of booster or bivalent doses in specific populations using VAERS or VSD data.

Used VAERS and VSD to assess AEs in recipients of booster and bivalent doses, including older adults and high-risk groups.

Pediatric and Adolescent Safety

• COVID-19 mRNA Vaccine Safety Among Children Aged 6 Months–5 Years—United States, June 18, 2022–August 21, 2022 (Hause et al., 2022a)

Assessed COVID vaccine safety in pediatric or adolescent populations using active surveillance or EHR review.

Monitored safety among children aged 5–17 years using VSD, V-safe, and VAERS, often evaluating reactogenicity and medically attended events

• COVID-19 Vaccine Safety in Adolescents Aged 12–17 Years—United States, December 14, 2020–July 16, 2021 (Hause et al., 2021b)

Assessed COVID vaccine safety in pediatric or adolescent populations using active surveillance or EHR review.

Monitored safety among children aged 5–17 years using VSD, V-safe, and VAERS, often evaluating reactogenicity and medically attended events.

• COVID-19 Vaccine Safety in Children Aged 5–11 Years—United States, November 3–December 19, 2021 (Hause et al., 2021c)

Assessed COVID vaccine safety in pediatric or adolescent populations using active surveillance or EHR review.

Monitored safety among children aged 5–17 years using VSD, V-safe, and VAERS, often evaluating reactogenicity and medically attended events.

• Reactions Following Pfizer-BioNTech COVID-19 mRNA Vaccination and Related Health Care Encounters Among 7,077 Children Aged 5–11 Years Within an Integrated Health Care System (Malden et al., 2023)

Assessed COVID vaccine safety in pediatric or adolescent populations using active surveillance or EHR review.

Monitored safety among children aged 5–17 years using VSD, V-safe, and VAERS, often evaluating reactogenicity and medically attended events.

• Reported Cases of Multisystem Inflammatory Syndrome in Children Aged 12–20 Years in the USA Who Received a COVID-19 Vaccine, December, 2020, Through August, 2021: A Surveillance Investigation (Yousaf et al., 2022)

Assessed COVID vaccine safety in pediatric or adolescent populations using active surveillance or EHR review.

Monitored safety among children aged 5–17 years using VSD, V-safe, and VAERS, often evaluating reactogenicity and medically attended events.

• Safety of COVID-19 mRNA Vaccination Among Young Children in the Vaccine Safety Datalink (Goddard et al., 2023)

Assessed COVID vaccine safety in pediatric or adolescent populations using active surveillance or EHR review.

Monitored safety among children aged 5–17 years using VSD, V-safe, and VAERS, often evaluating reactogenicity and medically attended events.

• Safety of COVID-19 Vaccination in United States Children Ages 5 to 11 Years (Hause et al., 2022i)

Assessed COVID vaccine safety in pediatric or adolescent populations using active surveillance or EHR review.

Monitored safety among children aged 5–17 years using VSD, V-safe, and VAERS, often evaluating reactogenicity and medically attended events.

• Surveillance for Multisystem Inflammatory Syndrome in U.S. Children Aged 5–11 Years Who Received Pfizer-BioNTech COVID-19 Vaccine, November 2021 through March 2022 (Cortese et al., 2023)

Assessed COVID vaccine safety in pediatric or adolescent populations using active surveillance or EHR review.

Monitored safety among children aged 5–17 years using VSD, V-safe, and VAERS, often evaluating reactogenicity and medically attended events.

Pregnancy Outcomes

• COVID-19 Vaccine Safety Surveillance in Early Pregnancy in the United States: Design Factors Affecting the Association Between Vaccine and Spontaneous Abortion (Vazquez-Benitez et al., 2023)

Presented data-driven analysis of vaccine safety outcomes during pregnancy using registry or linked data.

Examined pregnant individuals enrolled in V-safe or VSD, with outcomes including spontaneous abortion, stillbirth, and major birth defects.

• Evaluation of Acute Adverse Events After COVID-19 Vaccination During Pregnancy (DeSilva et al., 2022)

Presented data-driven analysis of vaccine safety outcomes during pregnancy using registry or linked data.

Examined pregnant individuals enrolled in V-safe or VSD, with outcomes including spontaneous abortion, stillbirth, and major birth defects.

• Receipt of COVID-19 Vaccine During Pregnancy and Preterm or Small-for-Gestational-Age at Birth—Eight Integrated Health Care Organizations, United States, December 15, 2020–July 22, 2021 (Lipkind et al., 2022)

Presented data-driven analysis of vaccine safety outcomes during pregnancy using registry or linked data.

Examined pregnant individuals enrolled in V-safe or VSD, with outcomes including spontaneous abortion, stillbirth, and major birth defects.

• Spontaneous Abortion Following COVID-19 Vaccination During Pregnancy (Kharbanda et al., 2021a)

Presented data-driven analysis of vaccine safety outcomes during pregnancy using registry or linked data.

Examined pregnant individuals enrolled in V-safe or VSD, with outcomes including spontaneous abortion, stillbirth, and major birth defects.

MYOCARDITIS RISK EVALUATION

• Incidence of Myocarditis/Pericarditis Following mRNA COVID-19 Vaccination Among Children and Younger Adults in the United States (Goddard et al., 2022a)

Analyzed risk or incidence of myocarditis following mRNA COVID vaccination using postauthorization safety data.

Focused primarily on adolescents and young adults, particularly male recipients, and evaluated risk after the second dose of mRNA vaccines using VAERS and VSD data.

• Myocarditis Cases Reported After mRNA-Based COVID-19 Vaccination in the U.S. from December 2020 to August 2021 (Oster et al., 2022)

Analyzed risk or incidence of myocarditis following mRNA COVID vaccination using postauthorization safety data.

Focused primarily on adolescents and young adults, particularly male recipients, and evaluated risk after the second dose of mRNA vaccines using VAERS and VSD data.

• Myocarditis or Pericarditis Following mRNA COVID-19 Vaccination (Weintraub et al., 2022)

Analyzed risk or incidence of myocarditis following mRNA COVID vaccination using postauthorization safety data.

Focused primarily on adolescents and young adults, particularly male recipients, and evaluated risk after the second dose of mRNA vaccines using VAERS and VSD data.

• Outcomes at Least 90 Days Since Onset of Myocarditis After mRNA COVID-19 Vaccination in Adolescents and Young Adults in the USA: A Follow-Up Surveillance Study (Kracalik et al., 2022)

Analyzed risk or incidence of myocarditis following mRNA COVID vaccination using postauthorization safety data.

Focused primarily on adolescents and young adults, particularly male recipients, and evaluated risk after the second dose of mRNA vaccines using VAERS and VSD data.

• Risk of Myocarditis and Pericarditis Following BNT162b2 and mRNA-1273 COVID-19 Vaccination (Goddard et al., 2022b)

Analyzed risk or incidence of myocarditis following mRNA COVID vaccination using postauthorization safety data.

Focused primarily on adolescents and young adults, particularly male recipients, and evaluated risk after the second dose of mRNA vaccines using VAERS and VSD data.

MULTISYSTEM INFLAMMATORY SYNDROME (MIS-C)

• Multiple MIS-C Readmissions and Giant Coronary Aneurysm After COVID-19 Illness and Vaccination: A Case Report (Haq et al., 2023)

Surveillance and outcome characterization for MIS-C cases post-COVID or postvaccination.

Evaluated incidence and severity of MIS-C in vaccinated versus unvaccinated children using linked hospital and vaccine records.

• Multisystem Inflammatory Syndrome in Adults After Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection and Coronavirus Disease 2019 (COVID-19) Vaccination (Belay et al., 2022)

Surveillance and outcome characterization for MIS-C cases post-COVID or postvaccination.

Evaluated incidence and severity of MIS-C in vaccinated versus unvaccinated children using linked hospital and vaccine records.

CATALOG OF DESCRIPTIVE LITERATURE FROM CDC VACCINE SAFETY MONITORING

During the COVID PHE, the ISO and its partners rapidly published a range of descriptive studies that laid the foundation for subsequent safety evaluations. These papers primarily focused on characterizing vaccine uptake, describing the function and reach of monitoring systems, and establishing the epidemiological context needed for safety signal interpretation. This body of literature did not always test hypotheses or conduct

comparative risk analyses but was critical in documenting population patterns, system design, and baseline expectations—especially in the early and uncertain phases of vaccine rollout.

Pregnancy Surveillance and Uptake Monitoring

Papers in this group focused on vaccine coverage, safety system implementation, and registry development for pregnant individuals—an initially excluded population in clinical trials. They leveraged VSD, VAERS, and V-safe (including the pregnancy registry) to capture postmarketing data.

• COVID-19 Vaccination Coverage Among Pregnant Women During Pregnancy (Razzaghi et al., 2021)

Described early vaccine uptake among pregnant individuals across VSD sites, identifying demographic disparities.

• Monitoring the Safety of COVID-19 Vaccines in Pregnancy in the U.S. (Moro et al., 2021)

Synthesized preliminary safety data from VAERS, VSD, and the V-safe Pregnancy Registry. No unexpected signals were noted.

• Receipt of COVID-19 Booster Dose Among Fully Vaccinated Pregnant Individuals (Razzaghi et al., 2022)

Provided demographic breakdowns of booster uptake in pregnant individuals, informing equity and outreach efforts.

• CDC COVID-19 Vaccine Pregnancy Registry (Madni et al., 2024)

Detailed design, enrollment methods, and response rates. Demonstrated feasibility of rapid registry creation during a PHE.

Equity, Demographics, and Population Coverage

These studies examined vaccine uptake and data quality across different sociodemographic groups, often using VSD infrastructure. Their value lies in identifying coverage disparities and highlighting data limitations that could bias safety signal interpretation.

• COVID-19 Vaccination Coverage Among Insured Persons Aged ≥16 Years by Race/Ethnicity (Pingali et al., 2021)

Tracked uptake disparities and identified subgroups with lower vaccine coverage, shaping later equity-focused communications.

• Reporting of Race and Ethnicity in the Vaccine Safety Datalink, 2011–2022 (Kurlandsky et al., 2022)

Assessed the completeness and trends in race/ethnicity data, critical for interpreting subgroup safety signals.

• Association Between Vaccine Exemption Policy Change in California and Adverse Event Reporting (Hause et al., 2020)

Provided contextual insight into how policy changes affect reporting behaviors, potentially influencing VAERS data interpretation.

Signal Detection and AE Characterization

These papers described methods and results related to identifying or contextualizing AEs of interest. While many were foundational rather than comparative, they helped build the landscape for signal evaluation.

• Surveillance for Adverse Events After COVID-19 mRNA Vaccination (Klein et al., 2021)

Offered early signal tracking data; documented myocarditis as a safety concern in younger males.

• Myopericarditis After Vaccination (VAERS, 1990–2018) (Su et al., 2021)

Placed myocarditis reports in historical context and informed comparisons to mRNA vaccine-associated rates.

• Use of mRNA COVID-19 Vaccine After Reports of Myocarditis (ACIP Update) (Gargano et al., 2021)

Informed risk–benefit decisions by ACIP in response to myocarditis data.

• Tree-Based Data Mining for First Booster Doses (Yih et al., 2023b)

Employed high-throughput signal detection methods in VSD to scan for unexpected AEs postbooster.

• Safety Signal Identification for Bivalent Booster Vaccination (Yih et al., 2023c)

Used tree scan methods to monitor safety in bivalent booster recipients; no new signals were observed.

• Simultaneous Administration of Bivalent Booster and Influenza Vaccines (Tat’Yana et al., 2023a)

Evaluated safety of coadministration; important for fall campaign planning.

• Updated Recommendations for Janssen Vaccine After TTS Reports (MacNeil et al., 2021)

Summarized evidence on thrombosis with thrombocytopenia syndrome and associated policy response.

• Causality Assessment of Adverse Events Reported to VAERS (Loughlin et al., 2012)

Described approaches for interpreting spontaneous reports, laying groundwork for postmarketing review methodology.

• Algorithm to Assess Causality After Individual Adverse Events Following Immunizations (Halsey et al., 2012)

Outlined systematic methods for determining vaccine-attributable events using structured criteria.

System Infrastructure and Data Tools

These publications described the design, function, and capabilities of CDC’s vaccine safety surveillance systems, such as VAERS, VSD, V-safe, and CISA. While not evaluative of safety itself, they were essential for understanding system architecture and integration during the COVID response.

• Overview of U.S. COVID-19 Vaccine Safety Surveillance Systems (Gee et al., 2024)

Summarized the scope, coordination, and role of each system in the national safety monitoring strategy.

• The V-safe After Vaccination Health Checker (Moro et al., 2023b)

Provided early operational results from V-safe, including enrollment and symptom reporting patterns.

• Impact of the COVID-19 Pandemic on Health Care Utilization in the Vaccine Safety Datalink (Qian et al., 2024)

Described changes in data quality and patterns that could affect VSD-based analyses.

• Dashboard Development for Real-Time Visualization of VSD Safety Data (Tat’Yana et al., 2022)

Highlighted innovations in visualizing vaccine safety data for internal and external stakeholders.

• Overview of the Clinical Consult Case Review Network (CISA) (Williams et al., 2011)

Provided historical and operational background on CISA’s role in managing complex clinical safety consultations.

• A Decade of Data: Adolescent Vaccination in VSD (Irving et al., 2022)

While pre-COVID, this paper demonstrated VSD’s capacity for long-term safety monitoring in a specific population.

• Reporting Sensitivity of VAERS for Anaphylaxis and Guillain-Barré Syndrome (Miller et al., 2020)

Quantified the underreporting in VAERS for two serious AEs, helping contextualize COVID signal detection sensitivity.

• Understanding the Role of Human Variation in Vaccine Adverse Events (CISA) (LaRussa et al., 2011)

Offered insights into host-specific factors that could contribute to AE risk—relevant to interpreting heterogeneity in COVID AE patterns.

Methodological Tools and Epidemiologic Context

These studies supported vaccine safety interpretation by developing background incidence rates, refining analytic techniques, and highlighting future methodological needs.

• Novel Vaccine Safety Issues and Areas for Further Research (Salmon et al., 2021)

Outlined thematic gaps in safety knowledge and future directions, including long-term and rare event monitoring.

• Expected Rates of Select Adverse Events Following Immunization (Abara et al., 2022)

Provided critical baseline rates to assess observed-to-expected event ratios—central for VAERS signal evaluation.

• Developing Algorithms for Birth Defect Detection Using EHR Data (Kharbanda et al., 2021b)

Demonstrated a scalable approach to detecting structural birth defects—a key outcome of interest for pregnancy safety monitoring.

• COVID-19 Vaccine Safety Inquiries to the CDC ISO (Miller et al., 2023)

Catalogued inquiries and communication trends received by ISO, helping shape transparency and messaging strategies.

REFERENCES

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