Allergic Reactions Including Anaphylaxis After Receipt of the First Dose of Pfizer-BioNTech COVID-19 Vaccine - United States, December 14-23, 2020
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In this article, the clinical and epidemiologic characteristics of case reports of allergic reactions after receiving the first dose of Pfizer-BioNTech COVID-19 vaccine during December 14-23, 2020, in the United States.Abstract:
As of January 3, 2021, a total of 20,346,372 cases of coronavirus disease 2019 (COVID-19) and 349,246 associated deaths have been reported in the United States. Long-term sequalae of COVID-19 over the course of a lifetime currently are unknown; however, persistent symptoms and serious complications are being reported among COVID-19 survivors, including persons who initially experience a mild acute illness.* On December 11, 2020, the Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for Pfizer-BioNTech COVID-19 vaccine to prevent COVID-19, administered as 2 doses separated by 21 days. On December 12, 2020, the Advisory Committee on Immunization Practices (ACIP) issued an interim recommendation for use of Pfizer-BioNTech COVID-19 vaccine (1); initial doses were recommended for health care personnel and long-term care facility residents (2). As of December 23, 2020, a reported 1,893,360 first doses of Pfizer-BioNTech COVID-19 vaccine had been administered in the United States, and reports of 4,393 (0.2%) adverse events after receipt of Pfizer BioNTech COVID-19 vaccine had been submitted to the Vaccine Adverse Event Reporting System (VAERS). Among these, 175 case reports were identified for further review as possible cases of severe allergic reaction, including anaphylaxis. Anaphylaxis is a life-threatening allergic reaction that does occur rarely after vaccination, with onset typically within minutes to hours (3). Twenty-one cases were determined to be anaphylaxis (a rate of 11.1 per million doses administered), including 17 in persons with a documented history of allergies or allergic reactions, seven of whom had a history of anaphylaxis. The median interval from vaccine receipt to symptom onset was 13 minutes (range = 2-150 minutes). Among 20 persons with follow-up information available, all had recovered or been discharged home. Of the remaining case reports that were determined not to be anaphylaxis, 86 were judged to be nonanaphylaxis allergic reactions, and 61 were considered nonallergic adverse events. Seven case reports were still under investigation. 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 Pfizer-BioNTech COVID-19 vaccine during December 14-23, 2020, in the United States. CDC has issued updated interim clinical considerations for use of mRNA COVID-19 vaccines currently authorized in the United States (4) and interim considerations for preparing for the potential management of anaphylaxis (5). In addition to screening for contraindications and precautions before administering COVID-19 vaccines, vaccine locations should have the necessary supplies available to manage anaphylaxis, should implement postvaccination observation periods, and should immediately treat persons experiencing anaphylaxis signs and symptoms with intramuscular injection of epinephrine (4,5).read more
Citations
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Surveillance for Adverse Events After COVID-19 mRNA Vaccination.
Nicola P. Klein,Ned Lewis,Kristin Goddard,Bruce Fireman,Ousseny Zerbo,Kayla E. Hanson,James G. Donahue,Elyse O. Kharbanda,Allison L. Naleway,Jennifer C. Nelson,Stan Xu,W. Katherine Yih,Jason M. Glanz,Jason M. Glanz,Joshua T B Williams,Simon J. Hambidge,Bruno Lewin,Tom T. Shimabukuro,Frank DeStefano,Eric Weintraub +19 more
TL;DR: In this article, the authors present an interim analysis of safety surveillance data from Vaccine Safety Datalink for COVID-19 vaccination, with a risk interval of 21 days for individuals after either vaccine dose 1 or 2 compared with an interval of 22 to 42 days for similar individuals after vaccine dose 2 or 3.
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mRNA Vaccines to Prevent COVID-19 Disease and Reported Allergic Reactions: Current Evidence and Suggested Approach.
Aleena Banerji,Paige G. Wickner,Rebecca R. Saff,Cosby A. Stone,Lacey B. Robinson,Aidan A. Long,Anna R. Wolfson,Paul D. Williams,David A. Khan,Elizabeth J. Phillips,Kimberly G. Blumenthal +10 more
TL;DR: The U.S. Food and Drug Administration (FDA) has recently issued an Emergency Use Authorization (EUA) for 2 highly effective coronavirus disease 2019 (COVID-19) vaccines from Pfizer-BioNTech and Moderna.
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Immune-Mediated Disease Flares or New-Onset Disease in 27 Subjects Following mRNA/DNA SARS-CoV-2 Vaccination
Abdulla Watad,Gabriele De Marco,Hussein Mahajna,Hussein Mahajna,Amit Druyan,Amit Druyan,Mailam Eltity,Nizar Hijazi,A. Haddad,Muna Elias,Devy Zisman,Mohammad E. Naffaa,Michal Brodavka,Michal Brodavka,Yael Cohen,Yael Cohen,Arsalan Abu-Much,Muhanad Abu Elhija,Charlie Bridgewood,Pnina Langevitz,Pnina Langevitz,Joanna McLorinan,Nicola Luigi Bragazzi,Helena Marzo-Ortega,Merav Lidar,Merav Lidar,Cassandra Calabrese,Leonard H. Calabrese,Edward M Vital,Yehuda Shoenfeld,Yehuda Shoenfeld,Howard Amital,Howard Amital,Dennis McGonagle +33 more
TL;DR: In this paper, the authors evaluated 28 cases of immune-mediated disease flare or new disease onset within 28-days of SARS-CoV-2 vaccination at five large tertiary centres in countries with early vaccination adoption, three in Israel, one in UK, and one in USA.
Journal ArticleDOI
Allergic Reactions Including Anaphylaxis After Receipt of the First Dose of Pfizer-BioNTech COVID-19 Vaccine.
Tom T. Shimabukuro,Narayan Nair +1 more
TL;DR: In the first week of use of the Pfizer-BioNTech COVID-19 vaccine in the US, December 14-23, 2020, a JAMA Insights review provides clinical details of anaphylactic reactions reported to and verified by the CDC as mentioned in this paper.
Journal ArticleDOI
Allergic Reactions Including Anaphylaxis After Receipt of the First Dose of Moderna COVID-19 Vaccine - United States, December 21, 2020-January 10, 2021.
TL;DR: In this article, the authors summarized the clinical and epidemiologic characteristics of case reports of allergic reactions, including anaphylaxis, after receiving the first dose of Moderna COVID-19 vaccine during December 21, 2020-January 10, 2021, in the United States.
References
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The Advisory Committee on Immunization Practices' Interim Recommendation for Use of Pfizer-BioNTech COVID-19 Vaccine - United States, December 2020.
Sara E. Oliver,Julia W. Gargano,Mona Marin,Megan J. Wallace,Kathryn G. Curran,Mary Chamberland,Nancy McClung,Doug Campos-Outcalt,Rebecca L. Morgan,Sarah Mbaeyi,Jose R. Romero,H. Keipp Talbot,Grace M. Lee,Beth P. Bell,Kathleen Dooling +14 more
TL;DR: The ACIP recommendation for the use of the Pfizer-BioNTech COVID-19 vaccine under EUA is interim and will be updated as additional information becomes available.
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Jens U. Ruggeberg,Michael Gold,José-María Bayas,Michael D. Blum,Jan Bonhoeffer,Sheila Fallon Friedlander,Glacus de Souza Brito,Ulrich Heininger,Babatunde Imoukhuede,Ali Khamesipour,Michel Erlewyn-Lajeunesse,Susana Martin,Mika J. Mäkelä,Patricia Nell,Vitali Pool,Nicholas Simpson +15 more
TL;DR: The Brighton Collaboration Anaphylaxis Working Group aims to provide a platform for international co-operation and co-ordination in the furtherance of knowledge and understanding of anaphylactic shock.
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Excess Deaths Associated with COVID-19, by Age and Race and Ethnicity - United States, January 26-October 3, 2020.
TL;DR: Overall, an estimated 299,028 excess deaths have occurred in the United States from late January through October 3, 2020, with two thirds of these attributed to COVID-19, and the largest percentage increases were seen among adults aged 25-44 years and among Hispanic or Latino persons.
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The Advisory Committee on Immunization Practices' Interim Recommendation for Allocating Initial Supplies of COVID-19 Vaccine - United States, 2020.
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TL;DR: ACIP recommended that, when a COVID-19 vaccine is authorized by FDA and recommended by ACIP, both health care personnel and residents of long-term care facilities should be offered vaccination in the initial phase of the CO VID-19 vaccination program (Phase 1a**).
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