Analysis of the adverse events following the mRNA-1273 COVID-19 vaccine

References

• World Health Organization. Coronavirus disease (COVID-19) pandemic. WHO; 2022. [cited 2022 Dec 22]. Available from: https://www.who.int/europe/emergencies/situations/covid-19
   Google Scholar
• Shi Y, Wang G, Cai XP, et al. An overview of COVID-19. J Zhejiang Univ Sci B. 2020 May;21(5):343–360.
   PubMed Web of Science ®Google Scholar
• NHS. Coronavirus (COVID-19) symptoms in adults: crown. 2022. [updated 2022 Oct 24; cited 2022 Dec 22]. Available from: https://www.nhs.uk/conditions/coronavirus-covid-19/symptoms/main-symptoms/
   Google Scholar
• NHS. Coronavirus (COVID-19) vaccine: crown. 2022 [updated 2022 Oct 24; cited 2022 Dec 22]. Available from: https://www.nhs.uk/conditions/coronavirus-covid-19/coronavirus-vaccination/coronavirus-vaccine/
   Google Scholar
• GOV.UK. Moderna COVID-19 vaccine authorised by UK medicines regulator. Crown; 2021. [cited 2022 Dec 22]. Available from: https://www.gov.uk/government/news/moderna-covid-19-vaccine-authorised-by-uk-medicines-regulator
   Google Scholar
• Schoenmaker L, Witzigmann D, Kulkarni JA, et al. mRNA-lipid nanoparticle COVID-19 vaccines: structure and stability. Int J Pharm. 2021 May 15;601:120586.
   PubMed Web of Science ®Google Scholar
• Baden LR, El Sahly HM, Essink B, et al. Efficacy and safety of the mRNA-1273 SARS-CoV-2 vaccine. N Engl J Med. 2021 Feb 4;384(5):403–416. doi: 10.1056/NEJMoa2035389
   PubMed Web of Science ®Google Scholar
• EMA. Safety of COVID-19 vaccines: European Medicines Agency. 2022. [cited 2022 Nov 20]. Available from: https://www.ema.europa.eu/en/human-regulatory/overview/public-health-threats/coronavirus-disease-covid-19/treatments-vaccines/vaccines-covid-19/safety-covid-19-vaccines
   Google Scholar
• Mathieu E, Ritchie H, Rodés-Guirao L, et al. Coronavirus (COVID-19) vaccinations: our World in data. 2020; [updated 2022 Nov 28; cited 2022 Nov 20]. Available from: https://ourworldindata.org/covid-vaccinations
   Google Scholar
• Kricorian K, Civen R, Equils O. COVID-19 vaccine hesitancy: misinformation and perceptions of vaccine safety. Hum Vaccin Immunother. 2022 Dec 31;18(1):1950504.
   PubMed Web of Science ®Google Scholar
• Falotico JM, Desai AD, Shah A, et al. Curbing COVID-19 vaccine hesitancy from a dermatological standpoint: analysis of cutaneous reactions in the vaccine adverse event reporting system (VAERS) database. Am J Clin Dermatol. 2022 Sep;23(5):729–737. doi: 10.1007/s40257-022-00715-x
   PubMed Web of Science ®Google Scholar
• Freeman D. COVID-19 vaccine hesitancy in the. (UK): University of Oxford; 2020. Available from: https://www.ox.ac.uk/news/science-blog/covid-19-vaccine-hesitancy-uk
   Google Scholar
• Creech CB, Anderson E, Berthaud V, et al. Evaluation of mRNA-1273 covid-19 vaccine in children 6 to 11 years of age. N Engl J Med. 2022 May 26;386(21):2011–2023. doi: 10.1056/NEJMoa2203315
   PubMed Web of Science ®Google Scholar
• Masuda T, Murakami K, Sugiura K, et al. A phase 1/2 randomised placebo-controlled study of the COVID-19 vaccine mRNA-1273 in healthy Japanese adults: an interim report. Vaccine. 2022;40(13):2044–2052. doi: 10.1016/j.vaccine.2022.02.030
   PubMed Web of Science ®Google Scholar
• Chu L, McPhee R, Huang W, et al. A preliminary report of a randomized controlled phase 2 trial of the safety and immunogenicity of mRNA-1273 SARS-CoV-2 vaccine. Vaccine. 2021 May 12;39(20):2791–2799. doi: 10.1016/j.vaccine.2021.02.007
   PubMed Web of Science ®Google Scholar
• Valiathan R, Ashman M, Asthana D. Effects of ageing on the immune system: infants to elderly. Scand J Immunol. 2016 Apr;83(4):255–266. doi: 10.1111/sji.12413
   PubMed Web of Science ®Google Scholar
• Foltran D, Delmas C, Flumian C, et al. Myocarditis and pericarditis in adolescents after first and second doses of mRNA COVID-19 vaccines. Eur Heart J Qual Care Clin Outcomes. 2022 Mar 2;8(2):99–103. doi: 10.1093/ehjqcco/qcab090
   PubMed Web of Science ®Google Scholar
• Massari M, Spila Alegiani S, Morciano C, et al. Postmarketing active surveillance of myocarditis and pericarditis following vaccination with COVID-19 mRNA vaccines in persons aged 12 to 39 years in Italy: a multi-database, self-controlled case series study. PLOS Med. 2022 Jul;19(7):e1004056. doi: 10.1371/journal.pmed.1004056
   PubMed Web of Science ®Google Scholar
• Oster ME, Shay DK, Su JR, et al. Myocarditis cases reported after mRNA-based COVID-19 vaccination in the US from December 2020 to August 2021. JAMA. 2022 Jan 25;327(4):331–340. doi: 10.1001/jama.2021.24110
   PubMed Web of Science ®Google Scholar
• VAERS. About VAERS. https://vaers.hhs.gov/about.html
   Google Scholar
• VAERS. VAERS data. https://vaers.hhs.gov/data.html
   Google Scholar
• Medical Dictionary for Regulatory Activities. Introductory Guide MedDRA version 23.1: MedDRA. 2020. [cited 2023 Jan 3]. Available from: https://admin.new.meddra.org/sites/default/files/guidance/file/intguide_%2023_1_English.pdf
   Google Scholar
• Team RC. R: the R project for Statistical computing. The R Foundation; 2020. https://www.r-project.org/
   Google Scholar
• Bate A, Evans SJ. Quantitative signal detection using spontaneous ADR reporting. Pharmacoepidemiol Drug Saf. 2009 Jun;18(6):427–436. doi: 10.1002/pds.1742
   PubMed Web of Science ®Google Scholar
• Activities MDfR. Introductory Guide MedDRA version 23.1: MedDRA. 2020. https://admin.new.meddra.org/sites/default/files/guidance/file/intguide_%2023_1_English.pdf
   Google Scholar
• Amanzio M, Mitsikostas DD, Giovannelli F, et al. Adverse events of active and placebo groups in SARS-CoV-2 vaccine randomized trials: a systematic review. Lancet Reg Health Eur. 2022 Jan;12:100253.
   PubMedGoogle Scholar
• Ali K, Berman G, Zhou H, et al. Evaluation of mRNA-1273 SARS-CoV-2 vaccine in adolescents. N Engl J Med. 2021 Dec 9;385(24):2241–2251. doi: 10.1056/NEJMoa2109522
   PubMed Web of Science ®Google Scholar
• Anderson EJ, Creech CB, Berthaud V, et al. Evaluation of mRNA-1273 vaccine in children 6 months to 5 years of age. N Engl J Med. 2022 Nov 3;387(18):1673–1687. doi: 10.1056/NEJMoa2209367
   PubMed Web of Science ®Google Scholar
• Kadali RAK, Janagama R, Peruru S, et al. Non-life-threatening adverse effects with COVID-19 mRNA-1273 vaccine: a randomized, cross-sectional study on healthcare workers with detailed self-reported symptoms. J Med Virol. 2021 Jul;93(7):4420–4429. doi: 10.1002/jmv.26996
   PubMed Web of Science ®Google Scholar
• Kabisch M, Ruckes C, Seibert-Grafe M, et al. Randomized controlled trials: part 17 of a series on evaluation of scientific publications. Dtsch Arztebl Int. 2011 Sep;108(39):663–668. doi: 10.3238/arztebl.2011.0663
   PubMed Web of Science ®Google Scholar
• NHS. Coronavirus (COVID-19) symptoms in adults: crown. 2022. [updated 2022 Oct 24; cited 2022 Nov 15]. Available from: https://www.nhs.uk/conditions/coronavirus-covid-19/symptoms/main-symptoms/
   Google Scholar
• Moderna Biotech UK Ltd. Spikevax dispersion for injection COVID-19 mRNA vaccine (nucleoside modified). 2021 [cited 2022 Dec 23]. Available from: https://www.medicines.org.uk/emc/product/13982/pil
   Google Scholar
• Hause AM, Gee J, Johnson T, et al. Anxiety-related adverse event clusters after Janssen COVID-19 vaccination - five U.S. Mass vaccination sites, April 2021. MMWR Morb Mortal Wkly Rep. 2021 May 7;70(18):685–688. doi: 10.15585/mmwr.mm7018e3
   PubMed Web of Science ®Google Scholar
• Geers AL, Clemens KS, Faasse K, et al. Psychosocial factors predict COVID-19 vaccine side effects. Psychother Psychosom. 2022;91(2):136–138. doi: 10.1159/000519853
   PubMed Web of Science ®Google Scholar
• Galan N. When to call your healthcare provider about an injection side effect: Dotdash media, Inc. [cited 2022 Nov 6th]. Available from: https://www.verywellhealth.com/injection-side-effects-call-doctor-2616542#:~:text=An%20injection%20site%20reaction%20is%20your%20body%27s%20response,response%20to%20the%20needle%2C%20vaccine%2C%20or%20other%20medicine
   Google Scholar
• Washrawirul C, Triwatcharikorn J, Phannajit J, et al. Global prevalence and clinical manifestations of cutaneous adverse reactions following COVID-19 vaccination: a systematic review and meta-analysis. J Eur Acad Dermatol Venereol. 2022 Nov;36(11):1947–1968. doi: 10.1111/jdv.18294
   PubMed Web of Science ®Google Scholar
• Solimani F, Mansour Y, Didona D, et al. Development of severe pemphigus vulgaris following SARS-CoV-2 vaccination with BNT162b2. J Eur Acad Dermatol Venereol. 2021 Oct;35(10):e649–e651. doi: 10.1111/jdv.17480
   PubMed Web of Science ®Google Scholar
• Potestio L, Villani A, Fabbrocini G, et al. Cutaneous reactions following booster dose of COVID-19 mRNA vaccination: what we should know? J Cosmet Dermatol. 2022 Nov;21(11):5339–5340. doi: 10.1111/jocd.15331
   PubMed Web of Science ®Google Scholar
• Carreño JM, Singh G, Tcheou J, et al. mRNA-1273 but not BNT162b2 induces antibodies against polyethylene glycol (PEG) contained in mRNA-based vaccine formulations. Vaccine. 2022 Oct 6;40(42):6114–6124. doi: 10.1016/j.vaccine.2022.08.024
   PubMed Web of Science ®Google Scholar
• Stone CA Jr., Liu Y, Relling MV, et al. Immediate hypersensitivity to polyethylene glycols and polysorbates: more common than We have recognized. J Allergy Clin Immunol Pract. 2019 May;7(5):1533–1540.e8. doi: 10.1016/j.jaip.2018.12.003
   PubMed Web of Science ®Google Scholar
• Richter AW, Akerblom E. Polyethylene glycol reactive antibodies in man: titer distribution in allergic patients treated with monomethoxy polyethylene glycol modified allergens or placebo, and in healthy blood donors. Int Arch Allergy Appl Immunol. 1984;74(1):36–39. doi: 10.1159/000233512
   PubMedGoogle Scholar
• CDC. Storage & handling: centers for disease control and prevention 2022. https://www.cdc.gov/vaccines/covid-19/info-by-product/moderna/storage.html
   Google Scholar
• CDC. Vaccine preparation and administration summary: centers for Disease Control and Prevention. 2022 https://www.cdc.gov/vaccines/covid-19/info-by-product/moderna/downloads/prep-and-admin-summary.pdf
   Google Scholar
• Schulz JB, Berlit P, Diener HC, et al. COVID-19 vaccine-associated cerebral venous thrombosis in Germany. Ann Neurol. 2021 Oct;90(4):627–639. doi: 10.1002/ana.26172
   PubMed Web of Science ®Google Scholar
• EMA. COVID-19 vaccines safety update: European Medicines Agency. 2022. [cited 2022 Nov 20]. Available from: https://www.ema.europa.eu/en/documents/covid-19-vaccine-safety-update/covid-19-vaccines-safety-update-10-november-2022_en.pdf
   Google Scholar
• OASH. Your menstrual cycle: office on women’s health. 2021. [updated 2022 Feb 21; cited 2022 Nov22]. Available from: https://www.womenshealth.gov/menstrual-cycle/your-menstrual-cycle
   Google Scholar
• Leon R, Richard J, Galea L. Menstrual irregularities and the COVID-19 vaccine. The University of British Columbia; 2021. [cited 2022 Nov 22]. Available from: https://womenshealthresearch.ubc.ca/blog/menstrual-irregularities-and-covid-19-vaccine#
   Google Scholar
• Wong KK, Heilig CM, Hause A, et al. Menstrual irregularities and vaginal bleeding after COVID-19 vaccination reported to v-safe active surveillance, USA in December, 2020-January, 2022: an observational cohort study. Lancet Digit Health. 2022 Sep;4(9):e667–e675. doi: 10.1016/S2589-7500(22)00125-X
   PubMedGoogle Scholar
• VAERS. Guide to interpreting VAERS data. https://vaers.hhs.gov/data/dataguide.html
   Google Scholar
• Wu KC, Deshpande SR Myocarditis: BMJ. 2022. [cited 2022 Nov 26]. Available from: https://bestpractice.bmj.com/topics/en-gb/244
   Google Scholar
• Gilotra NA. Myocarditis: Johns Hopkins 2022 [cited 2022 Nov 26]. Available from: https://www.hopkinsmedicine.org/health/conditions-and-diseases/myocarditis
   Google Scholar
• VAERS. Vaccine adverse event reporting system (VAERS): CDC; 2022. Available from: https://www.cdc.gov/vaccinesafety/ensuringsafety/monitoring/vaers/index.html
   Google Scholar