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Global Translational Medicine Autoimmune diseases after vaccination

summarizing them from the yearly VAERS Symptoms, Vax, of common adverse events in the clinical trial(s) to the
Data files spanning from 1990 to 2023, and NonDomestic. frequency of VAERS reports, valuable insights into the
The output generated by vaers_slice2.rb consists of six reports: values of reporting bias (r ) can be gained.
i
Summaries categorized by vaccine, annual summaries,
summaries based on the age of vaccinees, summaries 2.3. VAERS URF estimate
categorized by day of symptom onset, which is further By June 1, 2023, COVID-19 vaccine doses administered
divided by (i) dose and gender and (ii) vaccine name/type, included 366,979,906 tozinameran, 232,147,784
and two summaries covering additional reported symptoms elasomeran, and 19,007,537 Ad26.Cov2.S. Considering
(selected symptoms and all other symptoms). For tables and 898,860 common adverse events reported in VAERS,
figures, adverse events associated with diphtheria, tetanus, with an average of 35% (combining averages of 47.4%
and pertussis vaccines are combined under “DTAP/TDAP,” and 22.8% for fatigue after doses 1 and 2) of vaccinees
influenza vaccines are consolidated as “FLU,” hepatitis A and experiencing headache, fatigue, pyrexia, chills, and/or pain,
B vaccines are represented as “HEP,” human papillomavirus the estimation of VAERS underreporting is represented in
(HPV) vaccines are grouped as “HPV,” and pneumococcal Equation VII and subsequently applied in Equation VIII:
vaccines are consolidated as “PNC.” Microsoft Excel was UDF
used for creating figures. common AEs %
= Vaccine doses *(faction common adverse events) (VII)
2.2. AEFI VAERS common adverse events
AEFI can be represented as the sum of two components: 617,135,227 doses *0.35
Immunization-associated adverse events (if any) and UDF 35% = = 241 (VIII)
background occurrences of adverse events. These 898,860
adverse events diminish due to reporting bias as the time
since immunization increases. This relationship can be 3. Results
represented mathematically for a group of vaccinated 3.1. VAERS data mining results
th
people (P) by considering reporting bias (r ) for the i
i
day post-immunization, the vaccine-associated adverse Reports from Vaers_slice2.rb were generated for selected
autoimmune diseases in VAERS, and Figures 1 and 2
events reported on the i day post-immunization (v ), and illustrate ADAEs for vaccines with the highest reported
th
i
the background rate of adverse events (b ) for a single day cases by day of onset.
X
(Equations I–III).
The vaccine types associated with the highest
Adverse events ( ) = X AE X = V X + B X (I) number of multiple ADAE reported are summarized
in Table S1. Comparisons of the frequency of vaccine-
n days
r v P
V X = ∑ i X i (II) associated ADAE to background rate estimates are found
i =0 in Table S2. Regarding COVID-19 ADAEs, VAERS
includes reports of ADAE for two different types of
n days
B X = ∑ i i X (III) vaccines: mRNA (elasomeran and tozinameran) and
rb P
i =0 adenoviral (Ad26.Cov2.S). The contributions of ADAE by
individual COVID-19 vaccines are illustrated in Table 1.
If immunization does not lead to any autoimmune For GBS, Ad26.Cov2.S represents 3.1% of the vaccine
adverse events (X), this simplifies to Equation IV: doses administered but accounts for 16.2% of the GBS-
n days related adverse events reported — 91 expected based on
X
Adverse events ( ) =X B X = ∑ i rb P (IV) elasomeran and tozinameran ([657 + 2,200]/0.97 = 91)
i =0 but 554 GBS ADAEs were reported (Table 1). The initial
immunization of COVID-19 mRNA vaccines involved a
The first 24 h following vaccination can be examined to two-dose series, with 3 weeks (tozinameran) and 4 weeks
derive the term v (Equations V and VI):
X
0 (elasomeran) between doses. The ratio of autoimmune
Adverse events (X within 24 h ) = AE 0 X = (r v X 0 +b X )P (V) adverse events when comparing dose 2 to dose 1 for these
0
COVID-19 vaccines is presented in Figure 3.
Immunization-associated adverse events (X) become
detectable when v 0 X > 0 (when the number of adverse 4. Discussion
events exceeds the background rate within the first 24 h Numerous articles have suggested potential associations
of immunization). By comparing the frequency of reports between immunization and autoimmune diseases [2-21] ,

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