Safety Monitoring of the Janssen (Johnson & Johnson) COVID-19 Vaccine — United States, March–April 2021
David K. Shay, Julianne Gee, John R. Su, Tanya R. Myers, Paige Marquez, Ruiling Liu, Bicheng Zhang, Charles Licata, Thomas A. Clark, Tom T. Shimabukuro
Abstract
Fatigue and pain were commonly reported symptoms in both VAERS and v-safe. The overall safety profile is consistent with preauthorization clinical trials data. Prompt review of U.S. vaccine safety data detected three additional cases of non-CVST TTS, in addition to the previously recognized CVST cases that initiated the pause in use of the Janssen COVID-19 vaccine. Ongoing monitoring of adverse events after COVID-19 vaccination, including vaccination with the Janssen single-dose vaccine, is essential for evaluating the risks and benefits of each vaccine.
Topics & Concepts
MedicineVaccinationAdverse effectInterimInfluenza vaccineVirologyTrivalent influenza vaccineImmunizationPediatricsFamily medicineImmunologyInternal medicineAntibodyHistoryArchaeologyHeparin-Induced Thrombocytopenia and ThrombosisPlatelet Disorders and TreatmentsBlood groups and transfusion