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      Adverse reactions to mRNA coronavirus disease 2019 (COVID-19) vaccine for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in 576 medical staff

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          Abstract

          Objectives:

          Various measures have been taken to curb the COVID-19 epidemic, but their effect has been limited. Vaccines are expected to make a definite improvement. In Japan, vaccination began in February 2021. However, there are very few reports of adverse reactions to mRNA vaccines for the new coronavirus (SARS-CoV-2) in Japanese people. Therefore, adverse reactions in 576 vaccinated medical staff at the author’s hospital were investigated.

          Methods:

          The subjects were 576 medical staff who wished to receive the new coronavirus (SARS-CoV-2) vaccine. The first vaccination was performed with Pfizer’s new coronavirus mRNA vaccine (commercial name: Comirnaty intramuscular injection) from March 8 to March 15, 2021. The second vaccination was performed from March 29 to April 5, 2021, at an interval of more than 21 days from the first vaccination.

          Results:

          Adverse reactions were seen in six subjects in the first vaccination. There was dyspnea in one subject, arthralgia in one subject, fever/malaise in three subjects, and left axillary pain and lymphadenopathy in one subject. One subject had a reaction at the vaccination site that needed to be addressed. At the second vaccination, adverse reactions were observed in 64 subjects. There was fever in 58 subjects, malaise in 21 subjects, arthralgia in 12 subjects, aching pain in 11 subjects, headache in six subjects, chills in six subjects, nausea in three subjects, redness in two subjects, dizziness in two subjects, hives in two subjects, swelling in two subjects, cough in one subject, and itching in one subject (some had multiple adverse reactions). Fever was observed in the range of body temperature from 37.4 to 38.9 degrees.

          Conclusions:

          Most of the adverse reactions to the COVID-19 vaccine were mild, and no serious anaphylaxis was observed. Vaccination was considered perfectly feasible if attention is paid to adverse reactions.

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          Most cited references7

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          Clinical Characteristics of Coronavirus Disease 2019 in China

          Wei-jie Guan, Zheng-yi Ni, Yu Hu … (2020)
          Abstract Background Since December 2019, when coronavirus disease 2019 (Covid-19) emerged in Wuhan city and rapidly spread throughout China, data have been needed on the clinical characteristics of the affected patients. Methods We extracted data regarding 1099 patients with laboratory-confirmed Covid-19 from 552 hospitals in 30 provinces, autonomous regions, and municipalities in mainland China through January 29, 2020. The primary composite end point was admission to an intensive care unit (ICU), the use of mechanical ventilation, or death. Results The median age of the patients was 47 years; 41.9% of the patients were female. The primary composite end point occurred in 67 patients (6.1%), including 5.0% who were admitted to the ICU, 2.3% who underwent invasive mechanical ventilation, and 1.4% who died. Only 1.9% of the patients had a history of direct contact with wildlife. Among nonresidents of Wuhan, 72.3% had contact with residents of Wuhan, including 31.3% who had visited the city. The most common symptoms were fever (43.8% on admission and 88.7% during hospitalization) and cough (67.8%). Diarrhea was uncommon (3.8%). The median incubation period was 4 days (interquartile range, 2 to 7). On admission, ground-glass opacity was the most common radiologic finding on chest computed tomography (CT) (56.4%). No radiographic or CT abnormality was found in 157 of 877 patients (17.9%) with nonsevere disease and in 5 of 173 patients (2.9%) with severe disease. Lymphocytopenia was present in 83.2% of the patients on admission. Conclusions During the first 2 months of the current outbreak, Covid-19 spread rapidly throughout China and caused varying degrees of illness. Patients often presented without fever, and many did not have abnormal radiologic findings. (Funded by the National Health Commission of China and others.)
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            Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine

            Fernando P Polack, Stephen J. Thomas, Nicholas R.E. Kitchin … (2023)
            Abstract Background Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and the resulting coronavirus disease 2019 (Covid-19) have afflicted tens of millions of people in a worldwide pandemic. Safe and effective vaccines are needed urgently. Methods In an ongoing multinational, placebo-controlled, observer-blinded, pivotal efficacy trial, we randomly assigned persons 16 years of age or older in a 1:1 ratio to receive two doses, 21 days apart, of either placebo or the BNT162b2 vaccine candidate (30 μg per dose). BNT162b2 is a lipid nanoparticle–formulated, nucleoside-modified RNA vaccine that encodes a prefusion stabilized, membrane-anchored SARS-CoV-2 full-length spike protein. The primary end points were efficacy of the vaccine against laboratory-confirmed Covid-19 and safety. Results A total of 43,548 participants underwent randomization, of whom 43,448 received injections: 21,720 with BNT162b2 and 21,728 with placebo. There were 8 cases of Covid-19 with onset at least 7 days after the second dose among participants assigned to receive BNT162b2 and 162 cases among those assigned to placebo; BNT162b2 was 95% effective in preventing Covid-19 (95% credible interval, 90.3 to 97.6). Similar vaccine efficacy (generally 90 to 100%) was observed across subgroups defined by age, sex, race, ethnicity, baseline body-mass index, and the presence of coexisting conditions. Among 10 cases of severe Covid-19 with onset after the first dose, 9 occurred in placebo recipients and 1 in a BNT162b2 recipient. The safety profile of BNT162b2 was characterized by short-term, mild-to-moderate pain at the injection site, fatigue, and headache. The incidence of serious adverse events was low and was similar in the vaccine and placebo groups. Conclusions A two-dose regimen of BNT162b2 conferred 95% protection against Covid-19 in persons 16 years of age or older. Safety over a median of 2 months was similar to that of other viral vaccines. (Funded by BioNTech and Pfizer; ClinicalTrials.gov number, NCT04368728.)
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              Reports of Anaphylaxis After Receipt of mRNA COVID-19 Vaccines in the US—December 14, 2020-January 18, 2021

              Tom Shimabukuro, Matthew Cole, John R Su (2021)
              Article 0 comments Cited 207 times – based on 0 reviews     Review now
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                Author and article information

                Journal
                Journal ID (nlm-ta): Fujita Med J
                Journal ID (iso-abbrev): Fujita Med J
                Journal ID (publisher-id): FMJ
                Title: Fujita Medical Journal
                Publisher: Fujita Medical Society
                ISSN (Print): 2189-7247
                ISSN (Electronic): 2189-7255
                Publication date (Print): August 2022
                Publication date (Electronic): 25 November 2021
                Volume: 8
                Issue: 3
                Pages: 79-82
                Affiliations
                [1 ] Department of Internal Medicine, Division of Respiratory Medicine, Fujita Health University, School of Medicine , Okazaki, Aichi, Japan
                [2 ] Department of Respiratory Medicine I, Fujita Health University, School of Medicine , Toyoake, Aichi, Japan
                [3 ] Department of Respiratory Medicine II, Fujita Health University, School of Medicine , Nagoya, Aichi, Japan
                Author notes
                Corresponding author: Masamichi Hayashi, MD, PhD, Department of Respiratory Medicine I, Fujita Health University, School of Medicine, 1-98, Dengakugakubo, Kutsukake-cho, Toyoake, Aichi 470-1192, Japan, E-mail: michi@ 123456fujita-hu.ac.jp
                Article
                Publisher-manuscript ID: 2021-009
                DOI: 10.20407/fmj.2021-009
                PMC ID: 9358674
                PubMed ID: 35949514
                SO-VID: 527ba05e-4298-4741-8997-8ccbc2a6f3fb
                Copyright statement: Copyright @ 2022
                License:

                This is an Open access article distributed under the Terms of Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author(s) and source are credited.

                History
                Date received : 10 May 2021
                Date accepted : 6 August 2021
                Categories
                Subject: Original Article

                Keywords: sars-cov-2,covid-19,mrna vaccine,adverse reaction,anaphylaxis
                Data availability:
                Keywords: sars-cov-2, covid-19, mrna vaccine, adverse reaction, anaphylaxis

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