![]() ![]() Systemic reactions, including fatigue, headache, myalgia, chills, fever, and joint pain, occurred in participants after the first dose, although they were more frequently reported after the second dose among both Pfizer-BioNTech and Moderna vaccine recipients. 4, 5 Data from millions of v-safe participants indicate that injection site pain is common after both the first and second doses of either mRNA-based vaccine. The frequency of reported reactions was generally consistent with results observed in clinical trials. For both doses of both vaccines, the percentage of v-safe participants who reported local and systemic reactions was highest on day 1 after vaccination and declined markedly through day 7. Local and systemic reactions were less commonly reported by v-safe participants 65 years and older compared with those younger than 65 years, but greater reactogenicity after the second dose was observed for both age groups (eFigure in the Supplement). When stratified by age (<65 vs ≥65 years), differences in reactogenicity by vaccine remained consistent with overall findings (data not shown). Reactogenicity was substantially greater after the second dose for both vaccines, particularly for systemic reactions, including fatigue (53.9%), headache (46.7%), myalgia (44.0%), chills (31.3%), fever (29.5%), and joint pain (25.6%).Ī greater percentage of participants who received the Moderna vaccine, compared with the Pfizer-BioNTech vaccine, reported reactogenicity this pattern was more pronounced after the second dose ( Table). The most frequently reported solicited local and systemic reactions after the first dose of COVID-19 vaccine were injection site pain (67.8%), fatigue (30.9%), headache (25.9%), and myalgia (19.4%). Most v-safe participants reported an injection site reaction (dose 1: 70.0% dose 2: 75.2%) or a systemic reaction (dose 1: 50.0% dose 2: 69.4%) during days 0 to 7 after vaccination ( Table). ![]() Solicited local and systemic reactions during days 0 to 7 after each dose were assessed. 8 A total of 3 643 918 persons were enrolled in v-safe and completed at least 1 health survey within 7 days following their first vaccine dose 1 920 872 v-safe participants reported receiving a second vaccine dose and completed at least 1 daily health survey within 7 days following the second dose. Self-reported Local and Systemic Reactions Among V-safe Participantsīy February 21, 2021, more than 46 million persons received at least 1 dose of an mRNA-based COVID-19 vaccine. 7 This activity was reviewed by the CDC and was conducted consistent with applicable federal law and CDC policy (see Additional Information). Preliminary data from v-safe through January 13, 2021, have been previously reported. Responses were limited to individuals who were vaccinated by February 21, 2021, to allow a 7-day reporting period after the day of vaccination. This report describes information on solicited local and systemic reactogenicity reported to v-safe on days 0 to 7 after each dose of vaccine from December 14, 2020, through February 28, 2021. ![]() Medically attended events are followed up on through active telephone outreach future analyses will address these adverse vaccine experiences. These solicited reactions do not include allergic reactions or anaphylaxis however, v-safe does allow participants to enter free-text information about their postvaccination experience and asks about adverse health events (eg, received medical care). 6 From day 0 through day 7 after each vaccine dose, participants are asked questions about solicited local and systemic reactions (eg, injection site pain, fatigue, headache). V-safe participants voluntarily self-enroll and receive periodic smartphone text messages to initiate web-based health surveys from the day of vaccination (day 0) through 12 months after the final dose of a COVID-19 vaccine. To facilitate rapid assessment of COVID-19 vaccines, in 2020, the Centers for Disease Control and Prevention (CDC) established v-safe, a new active surveillance system for collecting near–real-time data from COVID-19 vaccine recipients in the US.
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