CAMP Study


About This Study

Low-Interventional cohort study of Myocarditis/Pericarditis associated with COMIRNATY in persons less than 21 years of age  (Phase 4 Cohort Study) -  The reason for this research study is to learn more about myocarditis and pericarditis either following vaccination with any Pfizer-BioNTech COVID-19 Vaccine (COMIRNATY®) or following a COVID-19 infection, including Multi-Inflammatory System in Children (MIS-C). Myocarditis is inflammation of the muscle of the heart, and pericarditis is inflammation of the tissue that forms a sac around the heart. Sponsor: Pfizer

Study Locations

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Post-marketing data for mRNA COVID-19 vaccines suggest increased risks of myocarditis/pericarditis, particularly within 7 days following a second dose of the vaccine. However, there are currently limited data on possible long-term outcomes associated with post-vaccine myocarditis/pericarditis.

The purpose of this cohort study is to improve our understanding of the potential long-term health outcomes associated with myocarditis/pericarditis following vaccination with COMIRNATY® and how those outcomes compare to those of COVID-19 or MIS-C related myocarditis/pericarditis.

Males or Females between the ages of 0 years to 21 years who either:

  • Received either a 1st, 2nd, 3rd or booster dose of any Pfizer-BioNTech COVID-19 vaccine (COMIRNATY®) within 21 days of experiencing symptoms, and meets the criteria for a case of definite or probable post-vaccine myocarditis or isolated pericarditis, or
  • Had COVID-19 or Multi-system Inflammatory Syndrome in Children Associated with COVID-19 (MIS-C)-related myocarditis and meets the criteria for a case of definite or probable myocarditis.

This study will be explained to you and/or your parent/guardian in detail by one of the study investigators. Once your questions have been answered, you and/or your parent/guardian will be asked to sign an assent form/informed consent form to enter the study.

The study team will collect information that your doctors have performed as part of your regular care, including laboratory test results and cardiac testing reports, such as echocardiograms (echo), electrocardiograms (ECG), cardiac MRIs, exercise stress tests, ambulatory monitoring, and troponin values. You may also have certain tests, procedures and assessments that are required by the study.

You will also be asked to complete simple questionnaires called Patient-Reported Outcomes Measures (PROMs) during some of your visits. These PROMs will ask about your physical, mental, and social health.

The study team will contact you to conduct a brief annual medical history once a year for up to 5 years. We will ask about any operations, tests or times that you/your child was in the hospital, any medications they are taking, and if they have developed any health problems.

If you are enrolled after you came to the hospital with your symptoms, the schedule of tests will begin when you are enrolled. Your doctor will tell you which specific tests will be required.

You will be in the study for up to 5 years following your myocarditis/pericarditis diagnosis.

For most participants in this study, there will be no direct benefit. However, the results of the study may improve our understanding of the long-term outcomes after myocarditis/pericarditis temporally associated with the COMIRNATY® vaccine. It may also serve to help improve care of children, adolescents, and young adults with similar problems in the future.

You may experience risks or discomforts from the procedures that are required by the study:

  • Attending study visits: You may be asked to see the study doctor in person. Without appropriate distancing and personal protective equipment (PPE), there is a potential for increased exposure to SARS-CoV-2.
  • Possible loss of privacy (confidentiality): When we share your information, there is a small risk that people may get to see it who are not supposed to.
  • Risk of blood draw: Blood will be drawn through a needle placed into a vein in your arm. Having blood taken may be uncomfortable or make you feel dizzy or faint (pass out). Redness, pain, bruising, bleeding, or infection may also happen where the needle goes into the skin during blood collection.
  • Risk of echo: The sticky pads (electrodes) that are placed on the chest may feel uncomfortable, and cause redness or itching. You may feel slight pressure from the part of the machine that is used to rub across your chest. You may be asked to breathe, hold their breath or to lie in a way that may be uncomfortable during the test.
  • Risk of ECG: The sticky pads (electrodes) that are placed on the chest may be uncomfortable, and cause skin redness or itching.
  • Risk of exercise stress testing: Exercise can make you feel tired and out of breath. Rare and not common possible risks of testing include changes in the rhythm of the heart (the way the heart beats) and possible big changes in blood pressure.
  • Risk of ambulatory monitor: The sticky pads (electrodes) that are placed on the chest may be uncomfortable, and cause skin redness or itching. Also, given that this monitor is worn for 3-7 days, you may feel embarrassed.
  • Risk of doing survey questions: Answering the survey questions can take a long time. This may make you tired, uncomfortable, or frustrated. You can stop or take a break if you need to.


You will not have to pay for any research tests, procedures or visits that are required by the study.