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Global Translational Medicine                                        Autoimmune diseases after vaccination



            can be calculated as the background rate multiplied by the   at risk, in proportion to the strength of immune system
            number of days examined, with adjustments for reporting   stimulation (e.g., vaccine reactogenicity ). Based on
                                                                                                 [27]
            bias. The United States Vaccine Adverse Event Reporting   similar ADAE patterns observed for tozinameran (mRNA
            System (VAERS) database collects AEFI reports , which   vaccine), Moderna mRNA-1273 elasomeran (mRNA
                                                   [1]
            represent a sample (i.e., subset) of the actual number of   vaccine), and Janssen Ad26.Cov2.S (adenoviral vaccine),
            adverse events estimated by the underreporting factor   it is predicted that the frequencies of ADAE observed for
            (URF). Deviations from background population patterns   COVID-19 vaccines will be comparable across all mRNA
            in the VAERS data serve as indicators of relationships   and adenoviral vaccines and therapeutics in proportion
            between immunization and the adverse event(s).     to the level of stimulated immune system response.

              Possible  associations  between autoimmune diseases   Understanding  the  etiology  and  relationships  between
            and immunization have been reported in several     ADAE and vaccines can inform strategies for minimizing
            studies [2-4] . For example, Guillain-Barré syndrome (GBS)   the risk of ADAE occurrences. These strategies may include:
            has been linked to influenza vaccination [5-7] , narcolepsy   (i) Extending the interval between immunizations within a
            to the 2009 H1N1 influenza vaccine , and immune    dose series to at least 4 weeks (or longer), (ii) eliminating
                                            [8]
            thrombocytopenia  (ITP)  to  various  vaccinations [9-11] .   aluminum adjuvants and mercury excipients from vaccines,
            In addition, multiple  autoimmune  diseases  have been   (iii) considering lower-reactogenicity alternatives to mRNA
            reported following COVID-19 vaccination [12-21] . Some   and adenoviral platforms, and so forth.
            researchers have explored the concept of autoimmune   2. Materials and methods
            (auto-inflammatory) syndrome induced by adjuvants
            (ASIA), implicating adjuvants such as aluminum  and   2.1. VAERS data mining
                                                    [22]
            mercury. Watad  et al.  have provided an overview of   The VAERS database underwent data mining to identify
                              [23]
            thyroid autoimmunity within the ASIA framework.    autoimmune adverse events, including: Acute disseminated
            However, it is important to note that other studies have   encephalomyelitis,  alopecia,  ankylosing  spondylitis,
            found no significant associations between autoimmune   antiphospholipid  syndrome,  arthritis,  autoimmune
            diseases  and vaccinations [24-26] . Detecting  potential   disorder, autoimmune hemolytic anemia, autoimmune
            adverse events related to immunization amid a backdrop   hepatitis, autoimmune thyroiditis, Behcet’s syndrome, Bell’s
            of background adverse events can lead to observations   palsy, chronic fatigue syndrome, chronic inflammatory
            of  both correlation  and no  correlations. Distinguishing   demyelinating polyradiculoneuropathy, chronic lymphocytic
            possible adverse events triggered by immunization requires   leukemia, complex regional pain syndrome, Crohn’s disease,
            the identification of distinctive signals that set them apart   dermatomyositis, diabetes mellitus, eczema, encephalitis
            from background adverse events. Possible signals may be   autoimmune, endometriosis, erythema nodosum, giant
            overlooked  as  the  number  of  days  considered  increases,   cell arteritis, glomerulonephritis, granulomatosis with
            potentially overshadowing association signals by extending   polyangiitis, GBS, Henoch-Schonlein purpura, hidradenitis,
            the considered time frame and consequently elevating the   hypogammaglobulinaemia, idiopathic pulmonary fibrosis,
            expected number of background events.              IgA nephropathy, ITP, juvenile idiopathic fibrosis, Kawasaki’s
              In this study, VAERS data were examined to assess the   disease, Lichen planus, Lichen sclerosus, Lyme disease,
            relationships between autoimmune disease adverse events   Meniere’s disease, Miller Fisher syndrome, mixed connective
            (ADAE)  and vaccines.  Varying frequencies of  multiple   tissue disease, multiple sclerosis, multiple sclerosis relapse,
            immediate-onset autoimmune diseases were observed in   myasthenia gravis, myositis, narcolepsy, neuromyelitis optica
            response to different vaccines. These observed correlation   spectrum disorder, neutropenia, optic neuritis, pemphigus,
            patterns of immediate onset are inconsistent with the notion   polymyalgia rheumatica, polymyositis, postural orthostatic
            that these autoimmune diseases are solely background   tachycardia syndrome, psoriasis, psoriatic arthropathy,
            occurrences. Furthermore, an increase in reports of ADAE   Raynaud’s phenomenon, restless legs syndrome, rheumatoid
            was observed in association with the second dose of the   arthritis, sarcoidosis,  scleritis, scleroderma, Sjogren’s
            Pfizer-BioNTech COVID-19 mRNA vaccine (tozinameran,   syndrome,  Still’s  disease,  systemic  lupus  erythematosus,
            also known as BNT162b2/Comirnaty), occurring 3 weeks   Type 1 diabetes mellitus, Type 2 diabetes mellitus, uveitis,
            after the initial dose. Associations of vaccine platforms   vasculitis, and vitiligo. The downloaded VAERS data include
            with numerous autoimmune diseases are apparent for   all adverse events reported from 1990 to May 19, 2023. The
            both mRNA and adenoviral COVID-19 vaccines. When   Ruby program, named vaers_slice2.rb [27,28] , was used to tally
            comparing unrelated vaccines, it is predicted that the   selected reported vaccine adverse events based on vaccine
            likelihood of immediate autoimmune disease onset   type and the day of onset. The vaers_slice2.rb program takes
            exceeds a  certain  threshold, particularly in individuals   a list of one or more adverse events for characterization,


            Volume 2 Issue 3 (2023)                         2                        https://doi.org/10.36922/gtm.1455
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