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      Side effects of BNT162b2 mRNA COVID-19 vaccine: A randomized, cross-sectional study with detailed self-reported symptoms from healthcare workers

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          Graphical abstract

          Abstract

          Introduction

          Concerns are prevailing about the safety and side effects from BNT162b2 mRNA COVID-19 vaccine.

          Methods

          A randomized, cross-sectional study was performed to investigate the side effects of BNT162b2 vaccine using an independent online questionnaire gathering responses from healthcare workers (HCWs) with detailed review of organ systems.

          Results

          Of all HCWs, 87.98% (1245/1415) completed the survey. Of them, 64.5 % (803/1245) received BNT162b2 mRNA vaccine and reported at-least one or more symptoms (classified based on organ systems and occurrence rate) post-vaccination. Of these, 640/803 (79.7%) were able to continue activities of daily living (ADL), 103/803 (12.83%) were temporarily unable to perform ADL, 99/803 (12.33%) temporarily took off from work, only 20/803 (2.49%) required help from an outpatient provider, 5/803 (0.62%) required help from emergency department, and 2/803 (0.25%) required hospitalization. Despite, 97.61% had no intention to skip the second dose and 92.9% had already received it.

          Conclusions

          The commonly reported symptoms (occurrence in the descending order) include soreness, fatigue, myalgia, headache, chills, fever, joint pain, nausea, muscle spasm, sweating, dizziness, flushing, feelings of relief, brain fogging, anorexia, localized swelling, decreased sleep quality, itching, tingling, diarrhea, nasal stuffiness, and palpitations. Despite, there is remarkable acceptance for the second dose among HCWs.

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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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            Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine

            Lindsey Baden, Hana El Sahly, Brandon Essink … (2020)
            Abstract Background Vaccines are needed to prevent coronavirus disease 2019 (Covid-19) and to protect persons who are at high risk for complications. The mRNA-1273 vaccine is a lipid nanoparticle–encapsulated mRNA-based vaccine that encodes the prefusion stabilized full-length spike protein of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes Covid-19. Methods This phase 3 randomized, observer-blinded, placebo-controlled trial was conducted at 99 centers across the United States. Persons at high risk for SARS-CoV-2 infection or its complications were randomly assigned in a 1:1 ratio to receive two intramuscular injections of mRNA-1273 (100 μg) or placebo 28 days apart. The primary end point was prevention of Covid-19 illness with onset at least 14 days after the second injection in participants who had not previously been infected with SARS-CoV-2. Results The trial enrolled 30,420 volunteers who were randomly assigned in a 1:1 ratio to receive either vaccine or placebo (15,210 participants in each group). More than 96% of participants received both injections, and 2.2% had evidence (serologic, virologic, or both) of SARS-CoV-2 infection at baseline. Symptomatic Covid-19 illness was confirmed in 185 participants in the placebo group (56.5 per 1000 person-years; 95% confidence interval [CI], 48.7 to 65.3) and in 11 participants in the mRNA-1273 group (3.3 per 1000 person-years; 95% CI, 1.7 to 6.0); vaccine efficacy was 94.1% (95% CI, 89.3 to 96.8%; P<0.001). Efficacy was similar across key secondary analyses, including assessment 14 days after the first dose, analyses that included participants who had evidence of SARS-CoV-2 infection at baseline, and analyses in participants 65 years of age or older. Severe Covid-19 occurred in 30 participants, with one fatality; all 30 were in the placebo group. Moderate, transient reactogenicity after vaccination occurred more frequently in the mRNA-1273 group. Serious adverse events were rare, and the incidence was similar in the two groups. Conclusions The mRNA-1273 vaccine showed 94.1% efficacy at preventing Covid-19 illness, including severe disease. Aside from transient local and systemic reactions, no safety concerns were identified. (Funded by the Biomedical Advanced Research and Development Authority and the National Institute of Allergy and Infectious Diseases; COVE ClinicalTrials.gov number, NCT04470427.)
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              Neurologic Manifestations of Hospitalized Patients With Coronavirus Disease 2019 in Wuhan, China

              Ling Mao, Huijuan Jin, Mengdie Wang … (2020)
              The outbreak of coronavirus disease 2019 (COVID-19) in Wuhan, China, is serious and has the potential to become an epidemic worldwide. Several studies have described typical clinical manifestations including fever, cough, diarrhea, and fatigue. However, to our knowledge, it has not been reported that patients with COVID-19 had any neurologic manifestations.
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                Author and article information

                Journal
                Journal ID (nlm-ta): Int J Infect Dis
                Journal ID (iso-abbrev): Int J Infect Dis
                Title: International Journal of Infectious Diseases
                Publisher: The Author(s). Published by Elsevier Ltd on behalf of International Society for Infectious Diseases.
                ISSN (Print): 1201-9712
                ISSN (Electronic): 1878-3511
                Publication date PMC-release: 15 April 2021
                Publication date (Electronic): 15 April 2021
                Affiliations
                [a ]Department of Internal Medicine, Central Harnett Hospital (affiliated with Cape Fear Valley Health System), Lillington, NC, USA
                [b ]Department of Internal Medicine, Campbell University Jerry M. Wallace School of Osteopathic Medicine, Lillington, NC, USA
                [c ]Department of Pediatrics, Kidzcare Pediatrics, Sanford, NC, USA
                [d ]Department of Statistics, North Carolina State University, Raleigh, NC, USA
                [e ]Internal Medicine, Temple University Hospital, Philadelphia, PA, USA
                Author notes
                [* ]Corresponding author at: Department of Internal Medicine, Central Harnett Hospital, Address: 215 Brightwater Dr, Lillington, NC 27546.
                [** ]Corresponding authors at: 145 W Main St, Sanford, NC 27332.
                [1]

                Both are first authors who have contributed equally.

                Article
                Publisher Item ID: S1201-9712(21)00358-1
                DOI: 10.1016/j.ijid.2021.04.047
                PMC ID: 8049195
                PubMed ID: 33866000
                SO-VID: e7993007-f5cc-4422-a2a4-39b424f80e2c
                Copyright © © 2021 The Author(s). Published by Elsevier Ltd on behalf of International Society for Infectious Diseases.
                License:

                Since January 2020 Elsevier has created a COVID-19 resource centre with free information in English and Mandarin on the novel coronavirus COVID-19. The COVID-19 resource centre is hosted on Elsevier Connect, the company's public news and information website. Elsevier hereby grants permission to make all its COVID-19-related research that is available on the COVID-19 resource centre - including this research content - immediately available in PubMed Central and other publicly funded repositories, such as the WHO COVID database with rights for unrestricted research re-use and analyses in any form or by any means with acknowledgement of the original source. These permissions are granted for free by Elsevier for as long as the COVID-19 resource centre remains active.

                History
                Date received : 11 March 2021
                Date revision received : 13 April 2021
                Date accepted : 13 April 2021
                Categories
                Subject: Article

                ScienceOpen disciplines: Infectious disease & Microbiology
                Keywords: side effect,adverse event,sars-cov-2,covid-19,mrna vaccine,acceptance,pfizer biontech,bnt162b2
                Data availability:
                ScienceOpen disciplines: Infectious disease & Microbiology
                Keywords: side effect, adverse event, sars-cov-2, covid-19, mrna vaccine, acceptance, pfizer biontech, bnt162b2

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