Created at Source Raw Value Validated value
June 25, 2024, noon usa

* significant exposure to someone with sars-cov-2 infection or covid-19 in the past 14 days, as defined by the us centers for disease control and prevention (cdc) as a close contact of someone who has had covid-19. * known history of sars-cov-2 infection within 3 months prior to enrollment. * is acutely ill or febrile (temperature ≥38.0°celsius/\[100.4°fahrenheit\]) less than 72 hours prior to or at the screening visit (day 0) or day 1. * has a medical, psychiatric, or occupational condition that may pose additional risk as a result of participation, or that could interfere with safety assessments or interpretation of results according to the investigator's judgment. * has received systemic immunosuppressants or immune-modifying drugs for \>14 days in total within 6 months prior to screening (for corticosteroids ≥10 milligrams (mg)/day of prednisone equivalent) or is anticipating the need for immunosuppressive treatment at any time during participation in the study. * known or suspected allergy or history of anaphylaxis, urticaria, or other significant ar to the vaccine or its excipients. * has a documented history of myocarditis or pericarditis within 2 months prior to screening visit (day 0). * has received or plans to receive any licensed vaccine ≤28 days prior to the injection (day 1) or a licensed vaccine within 28 days before or after they study injection, with the exception of influenza vaccines, which may be given 14 days before or after receipt of a study vaccine. * has received systemic immunoglobulins or blood products within 3 months prior to the screening visit (day 0) or plans for receipt during the study. * has donated ≥450 milliliters (ml) of blood products within 28 days prior to the screening visit (day 0) or plans to donate blood products during the study. * is currently experiencing an sae in study mrna-1273-p301 (cove) at the time of screening for this study. note: other inclusion and exclusion criteria may apply.

* significant exposure to someone with sars-cov-2 infection or covid-19 in the past 14 days, as defined by the us centers for disease control and prevention (cdc) as a close contact of someone who has had covid-19. * known history of sars-cov-2 infection within 3 months prior to enrollment. * is acutely ill or febrile (temperature ≥38.0°celsius/\[100.4°fahrenheit\]) less than 72 hours prior to or at the screening visit (day 0) or day 1. * has a medical, psychiatric, or occupational condition that may pose additional risk as a result of participation, or that could interfere with safety assessments or interpretation of results according to the investigator's judgment. * has received systemic immunosuppressants or immune-modifying drugs for \>14 days in total within 6 months prior to screening (for corticosteroids ≥10 milligrams (mg)/day of prednisone equivalent) or is anticipating the need for immunosuppressive treatment at any time during participation in the study. * known or suspected allergy or history of anaphylaxis, urticaria, or other significant ar to the vaccine or its excipients. * has a documented history of myocarditis or pericarditis within 2 months prior to screening visit (day 0). * has received or plans to receive any licensed vaccine ≤28 days prior to the injection (day 1) or a licensed vaccine within 28 days before or after they study injection, with the exception of influenza vaccines, which may be given 14 days before or after receipt of a study vaccine. * has received systemic immunoglobulins or blood products within 3 months prior to the screening visit (day 0) or plans for receipt during the study. * has donated ≥450 milliliters (ml) of blood products within 28 days prior to the screening visit (day 0) or plans to donate blood products during the study. * is currently experiencing an sae in study mrna-1273-p301 (cove) at the time of screening for this study. note: other inclusion and exclusion criteria may apply.

May 6, 2022, 5 a.m. usa

significant exposure to someone with sars-cov-2 infection or covid-19 in the past 14 days, as defined by the us centers for disease control and prevention (cdc) as a close contact of someone who has had covid-19. known history of sars-cov-2 infection within 3 months prior to enrollment. is acutely ill or febrile (temperature ≥38.0°celsius/[100.4°fahrenheit]) less than 72 hours prior to or at the screening visit (day 0) or day 1. has a medical, psychiatric, or occupational condition that may pose additional risk as a result of participation, or that could interfere with safety assessments or interpretation of results according to the investigator's judgment. has received systemic immunosuppressants or immune-modifying drugs for >14 days in total within 6 months prior to screening (for corticosteroids ≥10 milligrams (mg)/day of prednisone equivalent) or is anticipating the need for immunosuppressive treatment at any time during participation in the study. known or suspected allergy or history of anaphylaxis, urticaria, or other significant ar to the vaccine or its excipients. has a documented history of myocarditis or pericarditis within 2 months prior to screening visit (day 0). has received or plans to receive any licensed vaccine ≤28 days prior to the injection (day 1) or a licensed vaccine within 28 days before or after they study injection, with the exception of influenza vaccines, which may be given 14 days before or after receipt of a study vaccine. has received systemic immunoglobulins or blood products within 3 months prior to the screening visit (day 0) or plans for receipt during the study. has donated ≥450 milliliters (ml) of blood products within 28 days prior to the screening visit (day 0) or plans to donate blood products during the study. is currently experiencing an sae in study mrna-1273-p301 (cove) at the time of screening for this study. note: other inclusion and exclusion criteria may apply.

significant exposure to someone with sars-cov-2 infection or covid-19 in the past 14 days, as defined by the us centers for disease control and prevention (cdc) as a close contact of someone who has had covid-19. known history of sars-cov-2 infection within 3 months prior to enrollment. is acutely ill or febrile (temperature ≥38.0°celsius/[100.4°fahrenheit]) less than 72 hours prior to or at the screening visit (day 0) or day 1. has a medical, psychiatric, or occupational condition that may pose additional risk as a result of participation, or that could interfere with safety assessments or interpretation of results according to the investigator's judgment. has received systemic immunosuppressants or immune-modifying drugs for >14 days in total within 6 months prior to screening (for corticosteroids ≥10 milligrams (mg)/day of prednisone equivalent) or is anticipating the need for immunosuppressive treatment at any time during participation in the study. known or suspected allergy or history of anaphylaxis, urticaria, or other significant ar to the vaccine or its excipients. has a documented history of myocarditis or pericarditis within 2 months prior to screening visit (day 0). has received or plans to receive any licensed vaccine ≤28 days prior to the injection (day 1) or a licensed vaccine within 28 days before or after they study injection, with the exception of influenza vaccines, which may be given 14 days before or after receipt of a study vaccine. has received systemic immunoglobulins or blood products within 3 months prior to the screening visit (day 0) or plans for receipt during the study. has donated ≥450 milliliters (ml) of blood products within 28 days prior to the screening visit (day 0) or plans to donate blood products during the study. is currently experiencing an sae in study mrna-1273-p301 (cove) at the time of screening for this study. note: other inclusion and exclusion criteria may apply.

March 3, 2022, 8:30 p.m. usa

significant exposure to someone with sars-cov-2 infection or covid-19 in the past 14 days, as defined by the us centers for disease control and prevention (cdc) as a close contact of someone who has had covid-19. known history of sars-cov-2 infection within 3 months prior to enrollment. is acutely ill or febrile (temperature ≥38.0°celsius/[100.4°fahrenheit]) less than 72 hours prior to or at the screening visit (day 0) or day 1. has a medical, psychiatric, or occupational condition that may pose additional risk as a result of participation, or that could interfere with safety assessments or interpretation of results according to the investigator's judgment. has received systemic immunosuppressants or immune-modifying drugs for >14 days in total within 6 months prior to screening (for corticosteroids ≥10 milligrams (mg)/day of prednisone equivalent) or is anticipating the need for immunosuppressive treatment at any time during participation in the study. known or suspected allergy or history of anaphylaxis, urticaria, or other significant ar to the vaccine or its excipients. has a documented history of myocarditis or pericarditis within 2 months prior to screening visit (day 0). has received or plans to receive any licensed vaccine ≤28 days prior to the injection (day 1) or a licensed vaccine within 28 days before or after they study injection, with the exception of influenza vaccines, which may be given 14 days before or after receipt of a study vaccine. has received systemic immunoglobulins or blood products within 3 months prior to the screening visit (day 0) or plans for receipt during the study. has donated ≥450 milliliters (ml) of blood products within 28 days prior to the screening visit (day 0) or plans to donate blood products during the study. is currently experiencing an sae in study mrna-1273-p301 (cove) at the time of screening for this study.

significant exposure to someone with sars-cov-2 infection or covid-19 in the past 14 days, as defined by the us centers for disease control and prevention (cdc) as a close contact of someone who has had covid-19. known history of sars-cov-2 infection within 3 months prior to enrollment. is acutely ill or febrile (temperature ≥38.0°celsius/[100.4°fahrenheit]) less than 72 hours prior to or at the screening visit (day 0) or day 1. has a medical, psychiatric, or occupational condition that may pose additional risk as a result of participation, or that could interfere with safety assessments or interpretation of results according to the investigator's judgment. has received systemic immunosuppressants or immune-modifying drugs for >14 days in total within 6 months prior to screening (for corticosteroids ≥10 milligrams (mg)/day of prednisone equivalent) or is anticipating the need for immunosuppressive treatment at any time during participation in the study. known or suspected allergy or history of anaphylaxis, urticaria, or other significant ar to the vaccine or its excipients. has a documented history of myocarditis or pericarditis within 2 months prior to screening visit (day 0). has received or plans to receive any licensed vaccine ≤28 days prior to the injection (day 1) or a licensed vaccine within 28 days before or after they study injection, with the exception of influenza vaccines, which may be given 14 days before or after receipt of a study vaccine. has received systemic immunoglobulins or blood products within 3 months prior to the screening visit (day 0) or plans for receipt during the study. has donated ≥450 milliliters (ml) of blood products within 28 days prior to the screening visit (day 0) or plans to donate blood products during the study. is currently experiencing an sae in study mrna-1273-p301 (cove) at the time of screening for this study.

Nov. 2, 2021, 12:30 p.m. usa

- significant exposure to someone with sars-cov-2 infection or covid-19 in the past 14 days, as defined by the us centers for disease control and prevention (cdc) as a close contact of someone who has had covid-19. - known history of sars-cov-2 infection including during the mrna 1273-p301 (cove) study or within the last 18 months. - is acutely ill or febrile (temperature ≥38.0°celsius/[100.4°fahrenheit]) less than 72 hours prior to or at the screening visit (day 0) or day 1. - has a medical, psychiatric, or occupational condition that may pose additional risk as a result of participation, or that could interfere with safety assessments or interpretation of results according to the investigator's judgment. - has received systemic immunosuppressants or immune-modifying drugs for >14 days in total within 6 months prior to screening (for corticosteroids ≥10 milligrams (mg)/day of prednisone equivalent) or is anticipating the need for immunosuppressive treatment at any time during participation in the study. - known or suspected allergy or history of anaphylaxis, urticaria, or other significant ar to the vaccine or its excipients. - has a medical history consistent with a protocol-specified aesi. - has received or plans to receive any licensed vaccine ≤28 days prior to the injection (day 1) or a licensed vaccine within 28 days before or after they study injection, with the exception of influenza vaccines, which may be given 14 days before or after receipt of a study vaccine. - has received systemic immunoglobulins or blood products within 3 months prior to the screening visit (day 0) or plans for receipt during the study. - has donated ≥450 milliliters (ml) of blood products within 28 days prior to the screening visit (day 0) or plans to donate blood products during the study. - is currently experiencing an sae in study mrna-1273-p301 (cove) at the time of screening for this study.

- significant exposure to someone with sars-cov-2 infection or covid-19 in the past 14 days, as defined by the us centers for disease control and prevention (cdc) as a close contact of someone who has had covid-19. - known history of sars-cov-2 infection including during the mrna 1273-p301 (cove) study or within the last 18 months. - is acutely ill or febrile (temperature ≥38.0°celsius/[100.4°fahrenheit]) less than 72 hours prior to or at the screening visit (day 0) or day 1. - has a medical, psychiatric, or occupational condition that may pose additional risk as a result of participation, or that could interfere with safety assessments or interpretation of results according to the investigator's judgment. - has received systemic immunosuppressants or immune-modifying drugs for >14 days in total within 6 months prior to screening (for corticosteroids ≥10 milligrams (mg)/day of prednisone equivalent) or is anticipating the need for immunosuppressive treatment at any time during participation in the study. - known or suspected allergy or history of anaphylaxis, urticaria, or other significant ar to the vaccine or its excipients. - has a medical history consistent with a protocol-specified aesi. - has received or plans to receive any licensed vaccine ≤28 days prior to the injection (day 1) or a licensed vaccine within 28 days before or after they study injection, with the exception of influenza vaccines, which may be given 14 days before or after receipt of a study vaccine. - has received systemic immunoglobulins or blood products within 3 months prior to the screening visit (day 0) or plans for receipt during the study. - has donated ≥450 milliliters (ml) of blood products within 28 days prior to the screening visit (day 0) or plans to donate blood products during the study. - is currently experiencing an sae in study mrna-1273-p301 (cove) at the time of screening for this study.

June 17, 2021, 12:32 a.m. usa

- significant exposure to someone with sars-cov-2 infection or covid-19 in the past 14 days, as defined by the us centers for disease control and prevention (cdc) as a close contact of someone who has had covid-19. - known history of sars-cov-2 infection including during the mrna 1273-p301 (cove) study. - is acutely ill or febrile (temperature ≥38.0°celsius/[100.4°fahrenheit]) less than 72 hours prior to or at the screening visit (day 0) or day 1. - has a medical, psychiatric, or occupational condition that may pose additional risk as a result of participation, or that could interfere with safety assessments or interpretation of results according to the investigator's judgment. - has received systemic immunosuppressants or immune-modifying drugs for >14 days in total within 6 months prior to screening (for corticosteroids ≥10 milligrams (mg)/day of prednisone equivalent) or is anticipating the need for immunosuppressive treatment at any time during participation in the study. - known or suspected allergy or history of anaphylaxis, urticaria, or other significant ar to the vaccine or its excipients. - has a medical history consistent with a protocol-specified aesi. - has received or plans to receive any licensed vaccine ≤28 days prior to the injection (day 1) or a licensed vaccine within 28 days before or after they study injection, with the exception of influenza vaccines, which may be given 14 days before or after receipt of a study vaccine. - has received systemic immunoglobulins or blood products within 3 months prior to the screening visit (day 0) or plans for receipt during the study. - has donated ≥450 milliliters (ml) of blood products within 28 days prior to the screening visit (day 0) or plans to donate blood products during the study. - is currently experiencing an sae in study mrna-1273-p301 (cove) at the time of screening for this study.

- significant exposure to someone with sars-cov-2 infection or covid-19 in the past 14 days, as defined by the us centers for disease control and prevention (cdc) as a close contact of someone who has had covid-19. - known history of sars-cov-2 infection including during the mrna 1273-p301 (cove) study. - is acutely ill or febrile (temperature ≥38.0°celsius/[100.4°fahrenheit]) less than 72 hours prior to or at the screening visit (day 0) or day 1. - has a medical, psychiatric, or occupational condition that may pose additional risk as a result of participation, or that could interfere with safety assessments or interpretation of results according to the investigator's judgment. - has received systemic immunosuppressants or immune-modifying drugs for >14 days in total within 6 months prior to screening (for corticosteroids ≥10 milligrams (mg)/day of prednisone equivalent) or is anticipating the need for immunosuppressive treatment at any time during participation in the study. - known or suspected allergy or history of anaphylaxis, urticaria, or other significant ar to the vaccine or its excipients. - has a medical history consistent with a protocol-specified aesi. - has received or plans to receive any licensed vaccine ≤28 days prior to the injection (day 1) or a licensed vaccine within 28 days before or after they study injection, with the exception of influenza vaccines, which may be given 14 days before or after receipt of a study vaccine. - has received systemic immunoglobulins or blood products within 3 months prior to the screening visit (day 0) or plans for receipt during the study. - has donated ≥450 milliliters (ml) of blood products within 28 days prior to the screening visit (day 0) or plans to donate blood products during the study. - is currently experiencing an sae in study mrna-1273-p301 (cove) at the time of screening for this study.