COVID-19: AFTER TWO YEARS OF IATROGENIC AND BIOLOGIC IMMUNIZATION/ VACCINATION DO WE ACTUALLY NEED FURTHER BOOSTER IMMUNIZATION/ VACCINATION?

BackgroundThe Covid19 pandemic started in late 2019 and went through different phases by spreading from China around the whole globe. During the pandemic different mutation types got predominant from original Wuhan type through Alpha, Delta and Omicron variate BA 1/2 to BA 4/5 with different infectiousity and different potential to harm people´s health status. Immunization/ vaccination program started late 2020, first booster phase started midst of 2021, second booster phase in late 2021/ beginning of 2022 and Omicron specific booster phase midst of 2022.ObjectivesIs there a need of further iatrogenic (booster) immunization/ vaccination after 2 years of immunization/ vaccination program from efficacy driven analysis and safety issues standpoint?MethodsAnalysis of Covid-19 antibody development every three months since August 2021 with comparison of infection rates and assessment of safety parameters by assessing D-Dimers as potential endothelium damage marker in 725 patients (600 female, 125 male, age mean: 62,2 years) of a German rheumatological practice to improve the medical care.ResultsIn 99 % of the patients longstanding immune memory could be shown by analyzing the antibody curves in different exemplary shown biologic and iatrogenic immunization pathways after 2 years of immunization/ vaccination program and biologic immunization, mainly by Delta variate since late 2021 and Omicron variate since beginning of 2022. In 38.5 % of the patients the safety concerns of potential endothelium damage by analysing D-Dimers every 3 months showed a side effect potential of at least 8 months after every MRNA/ Vector immunization, but not after protein based vaccination and even not after infections in that amount.ConclusionOut of the obligation "nil nocere” no further iatrogenic Covid-19 immunization/ vaccination is of need in nearly all (99 %) already immunized people. At present only adult people with very low antibody levels (at least below 64 BAU/ml) (considering the infection or iatrogenic immunization/ vaccination status and time since last spike protein contact) and not yet immunized adult people should be forseen for iatrogenic immunization/ vaccination with protein based or attenuated viral vaccines or in rare cases one Omicron specific MRNA immunization drug. In that case D-Dimer controls for up to 8 months should be obligatory to detect endothelial damage side effect of MRNA (or Vector) technique. Intense cardiovascular monitoring (small vessels) of MRNA/ Vector immunized people in the next 10 – 20 years is necessary.Figure 1.References[1] Pohl C;SAFETY AND EFFICACY ASSESSMENT OF COVID-19 IMMUNIZATIONS/ VACCINATIONS IN PATIENTS OF A GERMAN GENERAL RHEUMATOLOGICAL PRACTICE;EULAR 2022 Poster POS1213;https://doi.org/10.1136/annrheumdis-2022-eular.1389[2] McConeghy KW et al. Effectiveness of a Second COVID-19 Vaccine Booster Dose Against Infection, Hospitalization, or Death Among Nursing Home Residents - 19 States, March 29-July 25, 2022. MMWR Morb Mortal Wkly Rep. 2022 Sep 30;71(39):1235-1238. doi: 10.15585/mmwr.mm7139a2. PMID: 36173757;PMCID: PMC9533729.[3] Bowe, B. Et al. Acute and postacute sequelae associated with SARS-CoV-2 reinfection. Nat Med 28, 2398–2405 (2022). https://doi.org/10.1038/s41591-022-02051-3[4] Hui-Lee Wong et al. Surveillance of COVID-19 vaccine safety among elderly persons aged 65 years and older, Vaccine, Volume 41, Issue 2, 2023, Pages 532-539, ISSN 0264-410X, https://doi.org/10.1016/j.vaccine.2022.11.069.[5] Maher AK et al. Transcriptional reprogramming from innate immune functions to a pro-thrombotic signature by monocytes in COVID-19. Nat Commun. 2022 Dec 26;13(1):7947. doi: 10.1038/s41467-022-35638-y. PMID: 36572683;PMCID: PMC9791976.[6] Erich Freisleben;Sie wollten alles richtig machen – Dokumentation eines verschwiegenen Leidens – Bericht eines Hausarztes über die Nebenwirkungen der Corona Impfungen;Nov 11, 2022;Cajus Verlag[7] Positive Testrate Germany – https://www.rki.de/DE/Content/InfAZ/N/Neuartiges_Coronavirus/Testzahl.htmlAcknowledgementsThanks to my fami y, all my patients and my collegues for supporting me in my research to improve my personal patient care.Disclosure of InterestsNone Declared.

COVID-19 vaccine uptake and vaccine hesitancy in Indian patients with cancer: A questionnaire-based survey

Background: Patients with cancer are at a higher risk of severe forms of coronavirus disease 2019 (COVID-19) and mortality. Therefore, widespread COVID-19 vaccination is required to attain herd immunity. Objective(s): We aimed to evaluate the uptake of the COVID-19 vaccine in Indian patients with cancer and to collect information regarding vaccine hesitancy and factors that contributed to vaccine hesitancy. Material(s) and Method(s): This was a questionnaire-based survey conducted between May 7, 2021 and June 10, 2021 in patients aged 45 years and over, with solid tumors. The primary end points of the study were the proportion of Indian patients with cancer aged 45 years and older who had not received the COVID-19 vaccine, and the reasons why these patients had not received the COVID-19 vaccine. Our secondary end points were the proportion of patients with a history of COVID-19 infection, and the proportion of the patients who had vaccine hesitancy. Additionally, we attempted to assess the factors that could impact vaccine hesitancy. Result(s): A total of 435 patients were included in the study. Of these, 348 (80%) patients had not received even a single dose of the COVID-19 vaccine;66 (15.2%) patients had received the first dose, and 21 (4.8%) had received both the doses. Approximately half (47.1%) of the patients reported that they took the COVID-19 vaccine based on the advice from a doctor. The reasons for not taking the COVID-19 vaccine could be considered as vaccine hesitancy in 259 (77%) patients. The two most common reasons were fear in 124 (38%) patients (fear of side-effects and of the impact of the vaccine on the cancer/therapy) and lack of information in 87 (26.7%) patients. On the multivariate analysis, the two factors found to be significantly associated with vaccine hesitancy were a lower educational level (OR, 1.78;95% CI, 1-3.17;P = 0.048) and a lack of prior advice regarding the COVID-19 vaccine (OR, 2.80;95% CI, 1.73-4.53;P < 0.001). Conclusion(s): Vaccine hesitancy is present in over half of our patients, and the most common reasons are a fear of the vaccine impacting the cancer therapy, fear of side-effects, and lack of information. Widespread vaccination can only be attained if systematic programs for education and dissemination of information regarding the safety and efficacy of the COVID-19 vaccine are given as much importance as fortification of the vaccination supply and distribution system.Copyright © 2021 Cancer Research, Statistics, and Treatment Published by Wolters Kluwer - Medknow.

Identifying Safety Subgroups at Risk: Assessing the Agreement Between Statistical Alerting and Patient Subgroup Risk: An International Journal of Medical Toxicology and Drug Experience

Introduction Identifying individual characteristics or underlying conditions linked to adverse drug reactions (ADRs) can help optimise the benefit-risk ratio for individuals. A systematic evaluation of statistical methods to identify subgroups potentially at risk using spontaneous ADR report datasets is lacking. Objectives In this study, we aimed to assess concordance between subgroup disproportionality scores and European Medicines Agency Pharmacovigilance Risk Assessment Committee (PRAC) discussions of potential subgroup risk. Methods The subgroup disproportionality method described by Sandberg et al., and variants, were applied to statistically screen for subgroups at potential increased risk of ADRs, using data from the US FDA Adverse Event Reporting System (FAERS) cumulative from 2004 to quarter 2 2021. The reference set used to assess concordance was manually extracted from PRAC minutes from 2015 to 2019. Mentions of subgroups presenting potential differentiated risk and overlapping with the Sandberg method were included. Results Twenty-seven PRAC subgroup examples representing 1719 subgroup drug-event combinations (DECs) in FAERS were included. Using the Sandberg methodology, 2 of the 27 could be detected (one for age and one for sex). No subgroup examples for pregnancy and underlying condition were detected. With a methodological variant, 14 of 27 examples could be detected. Conclusions We observed low concordance between subgroup disproportionality scores and PRAC discussions of potential subgroup risk. Subgroup analyses performed better for age and sex, while for covariates not well-captured in FAERS, such as underlying condition and pregnancy, additional data sources should be considered.

WHAT DO USERS OF RHEUMATOID ARTHRITIS ONLINE FORUMS TALK ABOUT? APPLYING A DEEP LEARNING APPROACH TO UNCOVER COMMON THEMES

BackgroundSocial media platforms have become a vital resource for individuals seeking information and support regarding health issues, including rheumatoid arthritis (RA). As such, the content generated on these platforms represents a valuable source of data for gaining insight into patients' perspectives on RA. However, previous research in this area has primarily relied on qualitative analyses of small sample sizes, limiting the ability to extract meaningful insights from social media content related to RA. With the advancement of machine learning techniques, it is now possible to analyze and extract insights from large volumes of social media posts related to RA.ObjectivesThe purpose of this study was to identify the most common topics discussed in a large dataset of submissions about RA on Reddit, one of the world's largest online forums.MethodsThe data for this study was collected from the two largest Reddit forums ("subreddits”) dedicated to RA, r/rheumatoid arthritis and r/rheumatoid, which have 18.9k and 7.6k members respectively. We retrieved all submissions but excluded responses in our analyses. All deleted or duplicate submissions and those with fewer than 10 words were removed, retaining 11,094 submissions from over 5,000 users for the analysis. To identify common themes, we applied topic modeling, a technique in natural language processing that identifies underlying themes or topics in a collection of documents. We used the Bertopic Python package (Grootendorst, 2022), which employs deep learning techniques to perform the topic modeling.ResultsThe data indicates a significant increase in submissions to the two subreddits, rising from 113 in 2014 to 2892 in 2021 and 1928 in the first 8 months of 2022. Upon analysis, 65 topics were identified, with 4162 submissions (37.5%) remaining unclassified. A topic specifically dedicated to requests to participate in surveys was removed as it did not pertain to the experiences of forum users. Among the remaining topics, the top 10 accounted for 44.90% of all submissions. To better understand each topic, a sample of 10 submissions with the highest probability for that topic were examined (Table 1).Table 1.Top 10 most frequent topicsTopicn of submissionsShare of total*Side effects of methotrexate5268.02%COVID & vaccines4627.04%Mental health4386.68%RF and anti CCP test results3315.04%RA of friends, partners, and close relatives2623.99%Complaints about rheumatologist2123.23%Questions about Humira1882.87%Questions about prednisone1822.77%Diets and RA1752.67%Early symptoms of possible RA1702.59%Exercise and RA1682.56%* After excluding unclassified topicsThree of the ten topics pertained to specific medications - methotrexate, Humira, and prednisone, accounting for 12.71% of the total. The most prevalent topic, at 8.02%, focused on the side effects of methotrexate, with many submissions inquiring about symptoms such as nausea. The second most common topic, at 7.04%, primarily revolved around COVID-19 and related issues, with some pre-COVID vaccine discussions also included. In 2021, COVID-related discussions were the most prevalent topic. The third most frequent topic (6.68% of total), dealt with mental health and the emotional struggles faced by those living with RA.ConclusionThe surge in submissions on Reddit demonstrates its growing popularity as an online forum for discussing topics related to RA. Utilizing deep learning-based topic modeling has proven to be an effective method for extracting meaningful topics from the questions and experiences shared by users. The vast amount of data generated by Reddit, in combination with advanced machine learning techniques, enables both an overview of the various topics discussed and a detailed examination of specific topics. This makes the use of social media data a valuable source of insight into the concerns of RA platform users.Reference[1]Grootendorst, M. (2022). BERTopic: Neural topic modeling with a class-based TF-IDF procedure. arXiv preprint arXiv:2203.05794.Acknowledgements:NIL.Disclosure of InterestsNone Decla ed.

A case of erythema nodosum after vaccination against COVID-19.

A case report of 52-years-old male with erythema nodosum, fever and malaise that developed seven days after second dose of mRNA vaccine Comirnaty (Pfizer-BioNTech) against coronavirus SARS-CoV-2. The most common causes of erythema nodosum were ruled out and the patient was treated with systemic corticotherapy with a very good effect. Because of the time association between the development of erythema nodosum and the second dose of mRNA vaccine, findings of high titres of anti-SARS-CoV-2 IgG antibodies in the blood, the case was reported to national regulation authority (State Institute for Drug Control) as a possible side effect of the mRNA vaccine Comirnaty.Copyright © 2021, EEZY Publishing, s.r.o.. All rights reserved.

VACCINATION RATE, ADVERSE REACTIONS, AND REASONS FOR NONVACCINATION OF COVID-19 VACCINE IN PATIENTS WITH RHEUMATOID ARTHRITIS IN A JAPANESE REAL-WORLD CLINICAL PRACTICE

BackgroundThe first coronavirus infection was confirmed in Wuhan City, People's Republic of China, in December 2019. On January 30, 2020, the World Health Organization declared the novel coronavirus disease a public health emergency of international concern. On March 11, 2020, World Health Organization announced that the new coronavirus infection can be regarded as a pandemic because of the global spread of the infection. The world's first authorization for a coronavirus disease 2019 vaccine (CV) in the UK was in December 2020. The first authorization for a CV in Japan was in February 2021. A maximum of five times of vaccination had been performed in Japanese people until January 2023. Patients with rheumatoid arthritis (RA) are generally immunocompromised because of the drugs used for RA treatment. Patients with RA are recommended to receive a CV in the 2021 update of the EULAR recommendations for the management of rheumatic and musculoskeletal diseases in the context of SARS-CoV-2 [1]. However, some patients with RA rejected CV for various reasons or reports of adverse reactions (ARs) in clinical practice. Real-world clinical information on CV is necessary for better relationships between patients with RA and their physicians.ObjectivesThis retrospective study aimed to determine the vaccination rate, ARs, and reasons for nonvaccination of CV in patients with RA in clinical practice.MethodsThe vaccination rate, ARs, and reasons for nonvaccination of CV in patients with RA on clinical records of our institute were investigated up to the third vaccination. Patients were divided into three age groups: 0–64 years old (YG), 65–74 years old (OG), and >75 years old (VOG). The association between age groups and vaccination rates was also investigated. The Cochran–Armitage test was used for statistical analysis.ResultsRegarding patient background (n = 610), the mean age was 67.8 years (YG, n = 207;OG, n = 196;VOG, n = 207;female, 75.1%;mean RA duration, 14.1 years). The vaccination rate among all patients was 8.4% for nonvaccination;91.6% for the first dose;91.3%, second dose;and 86.6%, third dose. A significant decrease over time was observed (p < 0.01). Nonvaccination was observed in 13.0%, 9.2%, and 2.9% of those in YG, OG, and VOG, respectively. A higher rate of nonvaccination was observed in the YG (p < 0.01). The results of the analysis by age group were 87.0%/90.8%/97.1% (first dose), 87.0%/90.3%/96.6% (second dose), and 77.8%/86.7%/95.2% (third dose) among the YG/OG/VOG, respectively (Figure 1). No statistically significant decrease in the vaccination rate was found over time in OG (p = 0.19) and VOG (p = 0.30) but not in VOG (p = 0.01). ARs occurred in 8.2%, 14.5%, and 16.1% of the patients receiving the first, second, and third doses, respectively. Among the reasons for nonvaccination, 35 (68.6%) patients were concerned about ARs to CV and 6 (11.8%) thought that CV was unnecessary.ConclusionCV rate in our cohort was higher than that of whole nation in Japan (81.4% for the first dose, 80.4% for the second dose, 67.8% for the third dose). CV rate has been declining steadily in patients with RA, with a stronger trend in younger age groups. Fear of ARs was the most frequent reason for nonvaccination.Reference[1]Landewé RBM et al. Ann Rheum Dis 2022.Acknowledgements:NIL.Disclosure of InterestsNone Declared.

Fiscal deficits and the socioeconomic consequences of rebalancing: Insights from a TVP‐VAR with stochastic volatility

This article connects two salient economic features: (i) Fiscal shocks have asymmetric effects across business cycle phases (Gechert, Horn, & Paetz, 2019);(ii) the unemployment‐output trade‐off is time varying and may be unstable. The intertwined dynamic behaviour of fiscal deficit shocks and the unemployment‐output trade‐off is studied in this article using a time‐varying parameter (TVP) vector autoregression (VAR) with stochastic volatility techniques applied to the analysis of data from Canada, France, Germany, Japan, Spain, Sweden, United Kingdom and the United States of America. We confirm the trade‐off heterogeneity across country, and its time‐varying nature across time, showing in addition its fluctuation around a long‐run reference value. We document significant short‐run impacts of fiscal shocks on the unemployment‐output trade‐off which, based on the experience of the Global Financial Crisis, becomes larger in periods of economic turmoil. Policy‐wise, the rebalancing of public finances may have unexpected adverse effects on job creation if implemented during slumps, precisely when the labour market sensitivity with respect to the performance of the product market is likely to be more acute. This message is particularly relevant in the aftermath of the Covid‐19 pandemic.

Side Effects of COVID-19 Vaccine in Pregnant Women: A Bibliometric Study

Introduction: Side effects related to COVID-19 vaccination are short-lived and disappear within a few days and can affect both pregnant and nonpregnant women. Aim(s): To evaluate the bibliometric profile of the worldwide scientific production on the side effects of COVID-19 vaccine in pregnant women, in Scopus. Material(s) and Method(s): A retrospective, cross-sectional, bibliometric study that analyzed metadata published in scientific journals indexed in Scopus during 2019 and 2021. The search and download of the papers were performed on May 13, 2022, and the SciVal program was used for the measurement of the bibliometric indicators. Result(s): The Lancet Infectious Diseases and International Journal of Gynecology and Obstetrics had the highest impact with 24.8 and 14.3 citations per publication, respectively. The institutions with the highest number of papers were Harvard University and National Institutes of Health, with 13 papers, respectively. Goldfarb Ilona Telefus, Kampmann Beate, and Khalil Asma were the authors with the highest number of papers, with 3 each. Only one publication on the side effects of COVID-19 vaccine in pregnant women was identified in 2019, whereas the highest scientific output was identified in 2021, with 127, of which 67 were from Q1. Conclusion(s): In Scopus, there is an increase in the production of papers on the side effects of the vaccine against COVID-19 in pregnant women, with the United States being the country with the most institutions with the highest scientific production. However, over the years, the quartile of the journals where these studies were published decreased.Copyright © The Author(s).

The Most Common Side Effects of AstraZeneca COVID-19 Vaccine among Saudi Arabian Population: A Systematic Review

In order to fight the coronavirus disease 2019 (COVID-19) pandemic, the AstraZeneca vaccine was introduced in the Saudi Arabian vaccination campaign. AstraZeneca was rapidly developed, and side effects have been reported following vaccination. This review aims to evaluate the adverse side effects of the AstraZeneca vaccine within the Saudi population. A literature search of the national and international databases PubMed, Scopus, Google Scholar, Embase databases, and Cochrane Library using the search terms "COVID-19 vaccine”, "AstraZeneca post-vaccination,” and "COVID-19 vaccine Saudi Arabia” in combination with the terms "side effects,” "adverse effects,” and "COVID-19 AstraZeneca” was performed. Articles published before 12 January 2022 were eligible for screening. A total of seven articles met the inclusion criteria, totalling 4838 participants. The most common side effects were fever and either pain or redness at the site of the injection. Furthermore, systemic reactions to AstraZeneca accounted for approximately 80% of adverse effects following vaccination. In sum, AstraZeneca appears to have mild to moderate side effects. [ FROM AUTHOR] Copyright of Journal of Pure & Applied Microbiology is the property of Dr. M. N. Khan and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full . (Copyright applies to all s.)

STUDY OF ADVERSE REACTIONS TO COVID-19 VACCINATION IN PATIENTS WITH RHEUMATIC DISEASES

BackgroundVaccination has been recommended in the midst of the COVID-19 pandemic, but some patients are not vaccinated due to concerns about adverse reactions.ObjectivesThe purpose of this study is to investigate the adverse reactions in rheumatic diseases and to guide the decision-making of patients and physicians.MethodsA questionnaire was sent to patients with rheumatic diseases, and patients who could be counted as of September 2021, when they consented to this study, were surveyed.ResultsThe subjects were 123 (male:female=10:113), 84 with rheumatoid arthritis and 39 with other immune diseases. The therapeutic agents used were PSL 31(25.2%), MTX 65(52.8%), NSAID/COX inhibitors 28(22.8%), bDMARDs 42(34.1%). adverse reactions after the first and second vaccination were fever 17(13.8%)/50(40.7%), joint symptoms 7(5.7%)/22(17.9%), local injection reactions (pain/irritation) 22(17.9%), local injection reactions (pain/erythema) 93(75.6)/98(79.7), systemic skin symptoms 0(0%)/2(1.6%), other symptoms (malaise, myalgia, etc.) 59(48.0%)/85(69.1%), and treatment intensification 5(4.1%)/12(9.7%). These responses differed in occurrence only for fever with and without PSL medication (22.5%: 47.3% (p=0.02)).The odds ratio for disease worsening after the first dose of vaccine and again after the second dose was 33.5 (p<0.01).ConclusionNo specific adverse reactions other than the commonly known ones were observed, but some patients experienced worsening of symptoms after vaccination, requiring intensified treatment. Based on the results of this study, we believe that adverse reactions to vaccination are acceptable. We plan to accumulate more cases and analyze them in the future.The exacerbation of disease after the first vaccination would predict the exacerbation after the second vaccination.REFERENCES:NIL.Acknowledgements:NIL.Disclosure of InterestsNone Declared.

Discussed Poster Abstracts – PM1

B PM1-030 b B Adverse drug reaction profile of drug interactions involving a protein kinase inhibitor indicated in chronic myeloid leukemia from pharmacovigilance databases b M. C. Pajiep, M. Lapeyre-Mestre and F. Despas I Centre Hospitalier Universitaire (CHU) de Toulouse, France i B Introduction: b The introduction of protein kinase inhibitors (PKIs) for chronic myeloid leukemia (CML) has considerably improved prognosis of the disease but has also demonstrated a great potential for drug-drug interactions. Service de Médecine Interne et Infectiologie, Groupe Hospitalier Diaconesses-Croix Saint-Simon, Paris, France i B Introduction: b Despite an important drug-drug interaction, it was previously suggested the clindamycin-rifampicin combination could be used in patients with bone and joints infections (BJIs) provided clindamycin is administered by continuous infusion. Most of eligible patients to the antiviral drug can benefit from it despite the risk of drug-drug interaction. Twenty patients received clindamycin without rifampicin, 19 patients received clindamycin concomitantly with rifampicin and the remaining 85 received clindamycin successively without and with rifampicin. B Results: b Among 957 patients treated with anti-PD-1/PD-L1 during the data collection period, 686 patients were included: 430 new users of a SD regimen, 161 patients who started with SD and switched to ED regimen during follow-up, and 95 new users of an ED regimen. [Extracted from the article] Copyright of Fundamental & Clinical Pharmacology is the property of Wiley-Blackwell and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full . (Copyright applies to all s.)

Herbal medicine use in Republic of Korea to alleviate side effects of COVID-19 vaccines: A cross-sectional study.

OBJECTIVE: Coronavirus disease 2019 (COVID-19) has spread worldwide, and several virus variants have emerged. Vaccines are administered to help prevent the infection. In Republic of Korea, most people take herbal medicine. This study investigated the use of herbal medicine to counter the side effects of COVID-19 vaccines. METHODS: This cross-sectional study was conducted using an online survey. Chi-square tests were used to determine differences in the use of herbal medication according to sociodemographic characteristics. Independent two-sample and paired t-tests were performed to examine the effect and satisfaction of herbal medicine use for countering the side effects of COVID-19 vaccines. One-way analysis of variance was used to determine vaccine-related differences. RESULTS: A total of 233 and 181 participants received the first and second doses of COVID-19 vaccines, respectively. The majority of herbal medicine users were in their thirties, had a bachelor's degree, suffered from side effects of vaccination, and received Vaxzevria for their first COVID-19 vaccine dose and Comirnaty for their second dose. The herbal medicine group had a higher satisfaction level of post-vaccination side effects than the non-herbal medicine group (P < 0.0001). The numeric rating scale scores for vaccination side effects were lower among participants who took herbal medication to alleviate those symptoms (P < 0.0001). The most commonly used herbal formula was Shuanghetang. CONCLUSION: A third of participants receiving COVID-19 vaccines used herbal medication to counter the side effects of vaccination. The use of herbal medicine was associated with age, education level, vaccine brand, and whether side effects of vaccination occurred. Herbal medication use was associated with greater satisfaction compared to vaccine recipients not using herbal medication. Please cite this article as: Yoon HC. Herbal medicine use in Republic of Korea to alleviate side effects of COVID-19 vaccines: A cross-sectional study. J Integr Med. 2023; 21(4):361-368.

A Nationwide Survey of mRNA COVID-19 Vaccinee's Experiences on Adverse Events and Its Associated Factors.

BACKGROUND: Although coronavirus disease 2019 (COVID-19) vaccines have been distributed worldwide under emergency use authorization, the real-world safety profiles of mRNA vaccines still need to be clearly defined. We aimed to identify the overall incidence and factors associated with adverse events (AEs) following mRNA COVID-19 vaccination. METHODS: We conducted web-based survey from December 2 to 10 in 2021 with a 2,849 nationwide sampled panel. Study participants were individuals who had elapsed at least two-weeks after completing two dosing schedules of COVID-19 vaccination aged between 18-49 years. We weighted the participants to represent the Korean population. The outcome was the overall incidence of AEs following mRNA COVID-19 vaccination and associated factors. We estimated the weighted odds ratios (ORs) using multivariable logistic regression models to identify the factors associated with AEs. RESULTS: Of the 2,849 participants (median [interquartile range] age, 35 [27-42] years; 51.6% male), 90.8% (n = 2,582) for the first dose and 88.7% (n = 2,849) for the second dose reported AEs, and 3.3% and 4.3% reported severe AEs, respectively. Occurrence of AEs was more prevalent in mRNA-1273 (OR, 2.06; 95% confidence interval [CI], 1.59-2.67 vs. BNT162b2), female sex (1.88; 1.52-2.32), and those with dermatologic diseases (2.51; 1.32-4.77). History of serious allergic reactions (1.96; 1.06-3.64) and anticoagulant medication use (4.72; 1.92-11.6) were associated with severe AEs. CONCLUSION: Approximately 90% of participants reported AEs following mRNA COVID-19 vaccination. Substantial factors, including vaccine type (mRNA-1273), female sex, and dermatologic diseases were associated with AEs. Our findings could aid policymakers in establishing vaccination strategies tailored to those potentially susceptible to AEs.

Ocular Adverse Events after Coronavirus Disease 2019 mRNA Vaccination: Matched Cohort and Self-Controlled Case Series Studies Using a Large Database.

PURPOSE: To investigate the risk of ocular adverse events after Coronavirus Disease 2019 (COVID-19) mRNA vaccination. DESIGN: Matched cohort and self-controlled case series (SCCS) studies. PARTICIPANTS: We used a population-based database of medical claims and vaccination records in a large Japanese city. In the matched cohort study, we identified individuals who received COVID-19 vaccination (BNT162b2) from February 2021 to September 2021. One control was selected from nonvaccinated individuals by matching time, date of birth, sex, Charlson comorbidity index, and the enrollment period for health insurance. In the SCCS study, we analyzed individuals who developed ocular adverse events. METHODS: In the matched cohort study, we applied the Kaplan-Meier estimator to estimate the cumulative incidence of ocular adverse events over 21 days after the first dose and 84 days after the second dose. In the SCCS method, we used conditional Poisson regression to estimate the incidence rate ratio (IRR) of ocular adverse events during the risk periods (0-21 days after the first dose and 0-84 days after the second dose) compared with the remaining periods. MAIN OUTCOME MEASURES: Composite outcome of uveitis, scleritis, retinal vein occlusion (RVO), and optic neuritis. RESULTS: There were 99 718 pairs eligible for the matched cohort study after the first dose (mean age, 69.3 years; male, 44%). The vaccinated and control groups developed 29 and 21 events, respectively, over 21 days after the first dose, and 79 and 28 events, respectively, over 84 days after the second dose. The differences in cumulative incidence (reference, the control group) were 2.9 (95% confidence interval, -14.5 to 19.1) events/100 000 persons and 51.3 (16.2-84.3) events/100 000 persons, respectively, for the first and second doses. The SCCS study showed the IRRs of 0.89 (0.62-1.28) and 0.89 (0.71-1.11) for the first and second doses, respectively. CONCLUSIONS: The matched cohort analysis found an increased risk for the composite outcome after the second dose; however, the SCCS analysis showed no increased risk. Considering that the SCCS can cancel out time-invariant confounders, the current results suggest that COVID-19 vaccination is unlikely to causally increase the risk of ocular adverse events. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found after the references.

An Analysis of SARS-CoV-2 Vaccine Reactogenicity: Variation by Type, Dose, and History, Severity, and Recency of Prior SARS-CoV-2 Infection.

Background: There is limited information on the functional consequences of coronavirus disease 2019 (COVID-19) vaccine side effects. To support patient counseling and public health messaging, we describe the risk and correlates of COVID-19 vaccine side effects sufficient to prevent work or usual activities and/or lead to medical care ("severe" side effects). Methods: The EPICC study is a longitudinal cohort study of Military Healthcare System beneficiaries including active duty service members, dependents, and retirees. We studied 2789 adults who were vaccinated between December 2020 and December 2021. Results: Severe side effects were most common with the Ad26.COV2.S (Janssen/Johnson and Johnson) vaccine, followed by mRNA-1273 (Moderna) then BNT162b2 (Pfizer/BioNTech). Severe side effects were more common after the second than first dose (11% vs 4%; P < .001). First (but not second) dose side effects were more common in those with vs without prior severe acute respiratory syndrome coronavirus 2 infection (9% vs 2%; adjusted odds ratio [aOR], 5.84; 95% CI, 3.8-9.1), particularly if the prior illness was severe or critical (13% vs 2%; aOR, 10.57; 95% CI, 5.5-20.1) or resulted in inpatient care (17% vs 2%; aOR, 19.3; 95% CI, 5.1-72.5). Side effects were more common in women than men but not otherwise related to demographic factors. Conclusions: Vaccine side effects sufficient to prevent usual activities were more common after the second than first dose and varied by vaccine type. First dose side effects were more likely in those with a history of COVID-19-particularly if that prior illness was severe or associated with inpatient care. These findings may assist clinicians and patients by providing a real-world evaluation of the likelihood of experiencing impactful postvaccine symptoms.

Comparison of Adverse Effects of Two SARS-CoV-2 Vaccines Administered in Workers of the University of Padova.

Introduction: In Italy, on December 2020, workers in the education sector were identified as a priority population to be vaccinated against COVID-19. The first authorised vaccines were the Pfizer-BioNTech mRNA (BNT162b2) and the Oxford-AstraZeneca adenovirus vectored (ChAdOx1 nCoV-19) vaccines. Aim: To investigate the adverse effects of two SARS-CoV-2 vaccines in a real-life preventive setting at the University of Padova. Methods: Vaccination was offered to 10116 people. Vaccinated workers were asked to voluntarily report symptoms via online questionnaires sent to them 3 weeks after the first and the second shot. Results: 7482 subjects adhered to the vaccination campaign and 6681 subjects were vaccinated with ChAdOx1 nCoV-19 vaccine and 137 (fragile subjects) with the BNT162b2 vaccine. The response rate for both questionnaires was high (i.e., >75%). After the first shot, the ChAdOx1 nCoV-19 vaccine caused more fatigue (p < 0.001), headache (p < 0.001), myalgia (p < 0.001), tingles (p = 0.046), fever (p < 0.001), chills (p < 0.001), and insomnia (p = 0.016) than the BNT162b2 vaccine. After the second dose of the BNT162b2 vaccine, more myalgia (p = 0.033), tingles (p = 0.022), and shivers (p < 0.001) than the ChAdOx1 nCoV-19 vaccine were elicited. The side effects were nearly always transient. Severe adverse effects were rare and mostly reported after the first dose of the ChAdOx1 nCoV-19 vaccine. They were dyspnoea (2.3%), blurred vision (2.1%), urticaria (1.3%), and angioedema (0.4%). Conclusions: The adverse effects of both vaccines were transient and, overall, mild in severity.

The Prevalence of Side Effects of Sinopharm COVID-19 Vaccine: An Experience From Pakistan.

Introduction Vaccination for coronavirus disease 2019 (COVID-19) helps develop protective immunity against COVID-19 without experiencing potentially severe illness. Many vaccines are used worldwide, but there is little data on the efficacy and side effects of the Sinopharm vaccine. Therefore, this study aimed to investigate the reported adverse effects of the Sinopharm vaccine among participants. Methods This prospective cross-sectional study was conducted in multiple hospitals in Karachi, Pakistan. The study was eight months, from April 1, 2022, to November 30, 2022. A total of 600 participants who gave informed consent and had received their first and second doses of the Sinopharm vaccine were included in the study. As hypertension and diabetes mellitus (DM) are common prevalent conditions in our population, the duration of DM and hypertension were documented as means and standard deviations apart from age, height, and weight. Side effects of the Sinopharm vaccine were reported as frequencies and percentages. Results The study findings showed that out of 600 participants, 376 (62.7%) were males and 224 (37.3%) were females; their mean age was 42.79±14.44 years. Among them, 130 (21.7%) had hypertension, and 138 (23.0%) had DM. All participants received the Sinopharm vaccine. Fever was the most frequently reported adverse effect following the first dose of the Sinopharm vaccine in 308 (51.3% of participants), followed by burning at the injection site in 244 (40.7% of participants) and pain at the injection site in 228 (38.0% of participants). Following the second dose of the Sinopharm vaccine, fever was the most frequently reported side effect in 254 (42.3%) participants, followed by pain at the injection site in 236 (39.5%) participants and burning at the site of injection in 210 (35.0%) participants. Moreover, joint pain in 194 (32.3%), shortness of breath in 170 (28.3%), swelling of glands in 168 (28.0%), chest pain in 164 (27.3%), and muscle pain were reported by 140 (23.3%) participants. The level of satisfaction showed that the majority of the participants, 334 (55.7%), were satisfied, 132 (22.0%) were very satisfied with their vaccination, and only 12 (2.0%) were dissatisfied. Conclusion This study concluded that fever was the most frequent side effect after both doses of the Sinopharm vaccine. Pain and burning at the injection site and joint pain were among the other common side effects reported by most participants. The Sinopharm COVID-19 vaccine had mild, predictable, and non-life-threatening side effects after the first and second doses.

The role of blood groups, vaccine type and gender in predicting the severity of side effects among university students receiving COVID-19 vaccines.

On March 11th, 2020, the World Health Organization (WHO) declared the coronavirus disease 2019 (COVID-19) a pandemic. To control the pandemic, billions of vaccine doses have been administered worldwide. Predictors of COVID-19 vaccine-related side effects are inconsistently described in the literature. This study aimed to identify the predictors of side effects' severity after COVID-19 vaccination among young adult students at Taif University (TU) in Saudi Arabia. An online, anonymous questionnaire was used. Descriptive statistics were calculated for numerical and categorical variables. Possible correlations with other characteristics were identified using the chi-square test. The study included 760 young adult participants from TU. Pain at the injection site (54.7%), headache (45.0%), lethargy and fatigue (43.3%), and fever (37.5%) were the most frequently reported COVID-19 vaccine-related side effects after the first dose. The most frequent side effects were reported among the 20-25-year-old age group for all doses of all vaccines. Females experienced remarkably more side effects after the second (p < 0.001) and third doses (p = 0.002). Moreover, ABO blood groups significantly correlated with vaccine-related side effects after the second dose (p = 0.020). The participants' general health status correlated with the side effects after the first and second doses (p < 0.001 and 0.022, respectively). The predictors of COVID-19 vaccine-related side effects in young, vaccinated people were blood group B, female gender, vaccine type, and poor health status.

Association between reactogenicity and immunogenicity after BNT162b2 booster vaccination: a secondary analysis of a prospective cohort study.

OBJECTIVES: A weak correlation between symptom severity and antibody levels after primary immunization against COVID-19 has already been shown. This study aimed to describe the association between reactogenicity and immunogenicity after booster vaccination. METHODS: This secondary analysis of a prospective cohort study included 484 healthcare workers who received a booster vaccination with BNT162b2. Anti-receptor binding domain (RBD) antibodies were assessed at baseline and 28 days after booster vaccination. Side effects were graded (none, mild, moderate, or severe) and reported daily for 7 days after booster vaccination. Spearman correlation coefficient (rho) was used to determine the correlations between the severity of each symptom and anti-RBD levels before vaccination and 28 days after. The Bonferroni method was used to adjust p values for multiple comparisons. RESULTS: Most of the 484 participants reported at least one local (451 [93.2%]) or systemic (437 [90.3%]) post-booster symptom. No correlations between the severity of local symptoms and antibody levels were found. Except for nausea, systemic symptoms showed weak but statistically significant correlations with 28-day anti-RBD levels (fatigue [rho = 0.23, p < 0.01], fever [rho = 22, p < 0.01], headache [rho = 0.15, p 0.03], arthralgia [rho = 0.2, p < 0.01], myalgia [rho = 0.17, p < 0.01]). There was no association between post-booster symptoms and pre-booster antibody levels. DISCUSSION: This study showed only a weak correlation between the severity of systemic post-booster symptoms and anti-SARS-CoV-2 antibody levels at 28 days. Therefore, self-reported symptom severity cannot be used to predict immunogenicity after booster vaccination.