moderna adverse reaction reporting phone number

The median age of persons with anaphylaxis was 47 years (range = 31–63 years). Among these, 108 case reports were identified for further review as possible cases of severe allergic reaction, including anaphylaxis, based on descriptions of signs and symptoms 10 of these reports, all describing events in females, met the Brighton Collaboration case definition criteria for anaphylaxis ( Table 1), corresponding to an initial estimated rate of 2.5 anaphylaxis cases per million first Moderna COVID-19 vaccine doses administered. During the same period, reports of 1,266 (0.03%) adverse events after receipt of the first dose of Moderna COVID-19 vaccine had been submitted to VAERS. †ĭuring December 21, 2020–January 10, 2021, the administration of 4,041,396 first doses of Moderna COVID-19 vaccine (2,465,411 to females, 1,450,966 to males, and 125,019 to persons whose sex was not recorded ) was reported to CDC. Anaphylaxis and nonanaphylaxis allergic reaction cases with symptom onset occurring later than the day after vaccination (i.e., outside the 0–1-day risk window) were also excluded because of the difficulty in clearly attributing allergic reactions with onset later than this to vaccination. Nonallergic adverse events, mostly vasovagal (e.g., fainting or the sensation of fainting) or suspected anxiety-related, were excluded from the final analyses. Physician reviewers classified all initially identified case reports as anaphylaxis or not anaphylaxis and used clinical judgment to further categorize reports that were considered not anaphylaxis as nonanaphylaxis allergic reactions or nonallergic adverse events. After initial screening, reports with sufficient evidence to suggest anaphylaxis were followed up by collecting information from medical records and through direct outreach to health care facilities and treating health care providers, and, in some cases, vaccine recipients. CDC physicians screened VAERS reports describing suspected severe allergic reactions and anaphylaxis and applied Brighton Collaboration case definition criteria for anaphylaxis* ( 7). Using methods previously described ( 5), CDC and FDA identified reports of suspected anaphylaxis in VAERS, the national passive surveillance (i.e., spontaneous reporting) system for monitoring adverse events after immunization ( 6). CDC has issued updated interim clinical considerations for use of mRNA COVID-19 vaccines currently authorized in the United States ( 3) and interim considerations for preparing for the potential management of anaphylaxis ( 4). This report summarizes the clinical and epidemiologic characteristics of case reports of allergic reactions, including anaphylaxis and nonanaphylaxis allergic reactions, after receipt of the first dose of Moderna COVID-19 vaccine during December 21, 2020–January 10, 2021, in the United States. For four case reports, investigators have been unable to obtain sufficient information to assess the likelihood of anaphylaxis. Among the remaining case reports that were determined not to be anaphylaxis, 47 were assessed to be nonanaphylaxis allergic reactions, and 47 were considered nonallergic adverse events. Among eight persons with follow-up information available, all had recovered or been discharged home. The median interval from vaccine receipt to symptom onset was 7.5 minutes (range = 1–45 minutes). Among these case reports, 10 cases were determined to be anaphylaxis (a rate of 2.5 anaphylaxis cases per million Moderna COVID-19 vaccine doses administered), including nine in persons with a documented history of allergies or allergic reactions, five of whom had a previous history of anaphylaxis. Anaphylaxis is a life-threatening allergic reaction that occurs rarely after vaccination, with onset typically within minutes to hours ( 2). Among these, 108 case reports were identified for further review as possible cases of severe allergic reaction, including anaphylaxis. As of January 10, 2021, a reported 4,041,396 first doses of Moderna COVID-19 vaccine had been administered in the United States, and reports of 1,266 (0.03%) adverse events after receipt of Moderna COVID-19 vaccine were submitted to the Vaccine Adverse Event Reporting System (VAERS). On December 19, 2020, the Advisory Committee on Immunization Practices (ACIP) issued an interim recommendation for use of Moderna COVID-19 vaccine ( 1). On December 18, 2020, the Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for Moderna COVID-19 vaccine administered as 2 doses, 1 month apart to prevent COVID-19. As of January 20, 2021, a total of 24,135,690 cases of coronavirus disease 2019 (COVID-19) and 400,306 associated deaths had been reported in the United States ( ).

Moderna adverse reaction reporting phone number