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Australia commenced administration of the Spikevax (Moderna mRNA-1273) COVID-19 vaccine in August 2021 and Nuvaxovid (Novavax NVX-CoV2373) in January 2022. This study describes the short-term safety profile of priming doses of the Spikevax and Nuvaxovid vaccines given between September 2021 and September 2023. Online surveys were sent via AusVaxSafety, Australia's active vaccine safety surveillance system, three and eight days after vaccination. A total of 131,775 day 3 surveys were sent, with a response rate of 38.5% (N = 50,721). A total of 43,875 day 8 surveys matched with day 3 survey responses were sent, with a response rate of 71.5% (N = 31,355). Half (50.7%) of respondents reported any adverse event following immunisation (AEFI) in the 0–3 days after vaccination and 24.6% reported any AEFI 4–7 days after vaccination. Fatigue, local pain, headache, and myalgia were the most frequently reported symptoms for both vaccines in both periods. After adjusting for respondent characteristics, vaccination clinic type, jurisdiction, and medical conditions, the odds for reporting AEFI increased with age from 16–19 years to highest odds at 30–39 years, after which it declined. Females had greater odd of reporting AEFI than males across most age groups, vaccine types, and doses. Respondents with a history of anaphylaxis had greater odds of reporting any AEFI (adjusted OR range: 1.50–2.86). A total of 3.1% of respondents reported seeking medical review 0–3 days after vaccination. This study affirms the short-term safety of Spikevax and Nuvaxovid COVID-19 vaccine priming doses in a large sample in Australia. [ABSTRACT FROM AUTHOR]

Abstract The vaccination against Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) is an important public health strategy to prevent people from the pandemic. Vaccines are a game-changing tool, it is essential to understand the adverse events after COVID-19 vaccination. This study explored the adverse events of COVID-19 Vaccination Oxford–AstraZeneca, Pfizer-BioNTech, Moderna, Johnson and Johnson on Guillain–Barré Syndrome (GBS). In this study, initially 128 documents were identified from the databases, including Pub-Med, Web of Science-Clarivate Analytics, Scopus, and Google Scholar. The articles on COVID-19 vaccination and GBs were searched using the keywords “SARS-CoV-2, COVID-19, Vaccination, and Guillain Barré Syndrome, GBS”, finally, 16 documents were included in the analysis and synthesis. After administering 1,680,042,214 doses of COVID-19 vaccines, 6177 cases were identified with 10.5 cases per million vaccine doses. A significant positive risk was found between COVID-19 vaccine administration and GBS with a risk rate of RR 1.97 (95% CI 1.26–3.08, p = 0.01). The mRNA vaccines were associated with 2076 cases, and 1,237,638,401 vaccine doses were linked with 4.47 GBS events per million vaccine doses. The first dose of the m-RNA vaccine was associated with 8.83 events per million doses compared to the second dose with 02 events per million doses. The viral-vector vaccine doses 193,535,249 were linked to 1630 GBS cases with 11.01 cases per million doses. The incidence of GBS after the first dose was 17.43 compared to 1.47 cases per million in the second dose of the viral-vector vaccine. The adverse events of the Oxford–AstraZeneca vaccine were linked to 1339 cases of GBS following 167,786,902 vaccine doses, with 14.2 cases per million doses. The Oxford–AstraZeneca vaccine significantly increased the risk of GBS RR: 2.96 (95% CI 2.51–3.48, p = 0.01). For the Pfizer-BioNTech vaccine, there were 7.20 cases per million doses of the vaccine, and no significant association was identified between the Pfizer-BioNTech vaccine and GBS incidence RR: 0.99 (95% CI 0.75–1.32, p = 0.96). Moderna vaccine was related with 419 cases of GBS after administering 420,420,909 doses, with 2.26 cases per million doses. However, Johnson and Johnson's vaccination was linked to 235 GBS after 60,256,913 doses of the vaccine with 8.80 cases per million doses. A significant association was seen between the risk of GBS and Ad.26.COV2. S vaccine, RR: 2.47 (95% CI 1.30–4.69, p

Abdallah Damin Abukhalil,&ast; Raya Riyad Abushehadeh,&ast; Sireen Sultan Shatat,&ast; Ni’meh Al-Shami,&ast; Hani A Naseef,&ast; Hosniyeh Ladadweh,&ast; Raed Madia&ast; Faculty of Pharmacy, Nursing and Health Professions, Birzeit University, Birzeit, West Bank, Palestine&ast;These authors contributed equally to this workCorrespondence: Abdallah Damin Abukhalil; Hosniyeh Ladadweh, Faculty of Pharmacy, Nursing and Health Professions, Birzeit University, Birzeit, West Bank, Palestine, Email Adkhalil@birzeit.edu; hladadweh@birzeit.eduBackground: Coronavirus disease (COVID-19) vaccines play an essential role in boosting immunity, preventing severe diseases, and alleviating the Covid-19 health crisis.Objective: This study aimed to explore the type and severity of short-term adverse reactions associated with BNT162 (Pfizer-BioNTech), mRNA 1273 (Moderna), and viral vector vaccines and to compare the incidence of post-vaccination Covid-19 infection among the Birzeit University community in Palestine.Methods: This questionnaire-based retrospective cross-sectional study was conducted among individuals who were vaccinated with at least one dose of any COVID-19 vaccine offered in Palestine during the COVID-19 pandemic. The study included participants aged 18 years and older who were vaccinated with Pfizer, Moderna, Sputnik Light, or Sputnik v.Results: A total of 558 participants who were administered COVID-19 vaccine were included in the study. Sputnik (239), Pfizer vaccine recipients (236), and Moderna vaccine recipients (83). Of the viral vector vaccine recipients, 57 (23.8%) had a post-vaccination infection, compared to 30 (12.7%) for Pfizer and seven (8.4%) for Moderna. Furthermore, the reported adverse effects in the viral victor group were higher than those in the Moderna and Pfizer groups (71.7, 66.3, and 61.9%, respectively). Chills, headache, fatigue, abdominal pain, and joint pain were significantly higher in the Viral Vector vaccine group than the Moderna and Pfizer vaccine. Vomiting, tiredness, and fatigue were significantly less likely to be complained of by Pfizer vaccine recipients compared to Moderna and Viral Vector vaccine recipients (p < 0.05).Conclusions: Breakthrough infections were associated with both viral vectors and mRNA; however, the mRNA vaccine had less reported post-vaccine infection. Furthermore, the Pfizer/BioNTech COVID-19 vaccine group reported fewer commonly reported side effects (fever, chills, headache, fatigue, muscle pain, joint pain, nausea, and dizziness), followed by the Moderna and viral vector vaccines. Females and underweight participants experienced more adverse effects with both vaccines, and fewer common side effects were reported by all participants.Keywords: Covid-19 vaccine, viral vector vaccine, Sputnik, Moderna, Pfizer, breakthrough infection, adverse effects, Palestine

The vaccination against Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) is an important public health strategy to prevent people from the pandemic. Vaccines are a game-changing tool, it is essential to understand the adverse events after COVID-19 vaccination. This study explored the adverse events of COVID-19 Vaccination Oxford–AstraZeneca, Pfizer-BioNTech, Moderna, Johnson and Johnson on Guillain–Barré Syndrome (GBS). In this study, initially 128 documents were identified from the databases, including Pub-Med, Web of Science-Clarivate Analytics, Scopus, and Google Scholar. The articles on COVID-19 vaccination and GBs were searched using the keywords "SARS-CoV-2, COVID-19, Vaccination, and Guillain Barré Syndrome, GBS", finally, 16 documents were included in the analysis and synthesis. After administering 1,680,042,214 doses of COVID-19 vaccines, 6177 cases were identified with 10.5 cases per million vaccine doses. A significant positive risk was found between COVID-19 vaccine administration and GBS with a risk rate of RR 1.97 (95% CI 1.26–3.08, p = 0.01). The mRNA vaccines were associated with 2076 cases, and 1,237,638,401 vaccine doses were linked with 4.47 GBS events per million vaccine doses. The first dose of the m-RNA vaccine was associated with 8.83 events per million doses compared to the second dose with 02 events per million doses. The viral-vector vaccine doses 193,535,249 were linked to 1630 GBS cases with 11.01 cases per million doses. The incidence of GBS after the first dose was 17.43 compared to 1.47 cases per million in the second dose of the viral-vector vaccine. The adverse events of the Oxford–AstraZeneca vaccine were linked to 1339 cases of GBS following 167,786,902 vaccine doses, with 14.2 cases per million doses. The Oxford–AstraZeneca vaccine significantly increased the risk of GBS RR: 2.96 (95% CI 2.51–3.48, p = 0.01). For the Pfizer-BioNTech vaccine, there were 7.20 cases per million doses of the vaccine, and no significant association was identified between the Pfizer-BioNTech vaccine and GBS incidence RR: 0.99 (95% CI 0.75–1.32, p = 0.96). Moderna vaccine was related with 419 cases of GBS after administering 420,420,909 doses, with 2.26 cases per million doses. However, Johnson and Johnson's vaccination was linked to 235 GBS after 60,256,913 doses of the vaccine with 8.80 cases per million doses. A significant association was seen between the risk of GBS and Ad.26.COV2. S vaccine, RR: 2.47 (95% CI 1.30–4.69, p < 0.01). Overall, a significant association was seen between the COVID-19 vaccines and the risk of GBS. The incidence of GBS was higher after the first dose compared to GBS cases per million in the second dose. [ABSTRACT FROM AUTHOR]

Since pregnant women were excluded from clinical trials for vaccines against SARS-CoV-2, the novel coronavirus disease 2019 (COVID-19), there is limited data on the safety and efficacy of vaccines in this population. This systematic review explored the safety and efficacy of mRNA vaccines in pregnant women. A literature search was performed using Ovid databases through November 2021 for all studies evaluated efficacy and safety of mRNA COVID-19 vaccines in pregnant women. A total of five studies including 42,782 women were included in the systematic review. Humoral immunity to COVID-19 was detected in pregnant women who received the vaccine and no differences found in spike-specific T-cell responses. Incidence of high-grade chronic villitis is higher in the unvaccinated group with adjusted odds ratio of.31 (.1-.97), P <.05. Vaccination in pregnant women resulted in 12.6% spontaneous abortions (SAB) with 92.3% occurring in the first trimester,.1% stillbirth (> 20 weeks gestation), 9.4% preterm birth (<37 weeks gestation), and 2.2% congenital abnormalities. The mRNA COVID-19 vaccines are immunogenic in pregnant women and no obvious safety concerns observed. There is no increased incidence of adverse reactions in pregnant women. Our finding supports that pregnant women should receive the vaccination at their earliest convenience regardless of trimester. [ABSTRACT FROM AUTHOR]

This descriptive study provides insights into the perceptions associated with the handling of the COVID-19 pandemic, it’s impact on degree progression, and protocols that a major R2 research university community would like to see remain in place once the pandemic ends. A Qualtrics survey was used to draw responses from the community. Our research findings conclude that: 1) Responses were mixed concerning KSU doing a good job in handling the COVID-19 pandemic, 2) The majority of student responses felt that transitioning to online course delivery did not adversely impact their degree progression, 3) Whereas vaccine availability and testing were what most impressed respondents about KSU's handling of the pandemic, the discontinuation of a mask mandate after the Summer 2020 semester is what least impressed respondents, and 4) The ability to work remotely was the most popular protocol that respondents preferred to see remain in place after the pandemic ends. [ABSTRACT FROM AUTHOR]

Background: The aim of the study was to evaluate the humoral and cellular immunity after SARS-CoV-2 infection and/or vaccination according to the type of vaccine, number of doses and combination of vaccines. Methods: Volunteer subjects were sampled between September 2021 and July 2022 in Hospital Clínico San Carlos, Madrid (Spain). Participants had different immunological status against SARS-CoV-2: vaccinated and unvaccinated, with or without previous COVID-19 infection, including healthy and immunocompromised individuals. Determination of IgG against the spike protein S1 subunit receptor-binding domain (RBD) was performed by chemiluminescence microparticle immunoassay (CMIA) using the Architect i10000sr platform (Abbott). The SARS-CoV-2-specific T-cell responses were assessed by quantification of interferon gamma release using QuantiFERON SARS-CoV-2 assay (Qiagen). Results: A total of 181 samples were collected, 170 were from vaccinated individuals and 11 from unvaccinated. Among the participants, 41 were aware of having previously been infected by SARS-CoV-2. Vaccinated people received one or two doses of the following vaccines against SARS-CoV-2: ChAdOx1-S (University of Oxford-AstraZeneca) (AZ) and/orBNT162b2 (Pfizer-BioNTech) (PZ). Subjects immunized with a third-booster dose received PZ or mRNA-1273 (Moderna-NIAID)(MD) vaccines. All vaccinees developed a positive humoral response (>7.1 BAU/ml), but the cellular response varied depending on the vaccination regimen. Only AZ/PZ combination and 3 doses of vaccination elicited a positive cellular response (median concentration of IFN-γ > 0.3 IU/ml). Regarding a two-dose vaccination regimen, AZ/PZ combination induced the highest humoral and cellular immunity. A booster with mRNA vaccine resulted in increases in median levels of IgG-Spike antibodies and IFN-γ as compared to those of two-dose of any vaccine. Humoral and cellular immunity levels were significantly higher in participants with previous infection compared to those without infection. Conclusion: Heterologous vaccination (AZ/PZ) elicited the strongest immunity among the two-dose vaccination regimens. The immunity offered by the third-booster dose of SARS-CoV-2 vaccine depends not only on the type of vaccine administered but also on previous doses and prior infection. Previous exposure to SARS-CoV-2 antigens by infection strongly affect immunity of vaccinated individuals. [ABSTRACT FROM AUTHOR]

We reviewed the reported imaging findings of myocarditis in the literature following COVID-19 vaccination on cardiac imaging by a literature search in online databases, including Scopus, Medline (PubMed), Web of Science, Embase (Elsevier), and Google Scholar. In total, 532 cases of myocarditis after COVID-19 vaccination were reported (462, 86.8% men and 70, 13.2% women, age range 12 to 80) with the following distribution: Pfizer-BioNTech: 367 (69%), Moderna: 137 (25.8%), AstraZeneca: 12 (2.3%), Janssen/Johnson & Johnson: 6 (1.1%), COVAXIN: 1 (0.1%), and unknown mRNA vaccine: 9 (1.7%). The distribution of patients receiving vaccine dosage was investigated. On cardiac MR Imaging, late intravenous gadolinium enhancement (LGE) was observed mainly in the epicardial/subepicardial segments (90.8%, 318 of 350 enhancing segments), with the dominance of inferolateral segment and inferior walls. Pericardial effusion was reported in 13.1% of cases. The vast majority of patients (94%, 500 of 532) were discharged from the hospital except for 4 (0.7%) cases. Post-COVID-19 myocarditis was most commonly reported in symptomatic men after the second or third dose, with CMRI findings including LGE in 90.8% of inferior and inferolateral epicardial/subepicardial segments. Most cases were self-limited.

Introduction Current safety data from Phase 3 clinical trials have concluded that apart from transient local and systemic reactions, no safety concerns were identified for the Moderna COVID-19 vaccine (mRNA-1273). However, Phase 3 studies are insufficient to detect rare adverse events (AEs). A literature search of the two major electronic databases, Embase and PubMed, was performed to enable the identification and characterization of all relevant articles from December 2020 to November 2022. Areas Covered This narrative review summarizes the key safety outcomes associated with the mRNA-1273 vaccine to inform healthcare decisions and increase public awareness of mRNA-1273 vaccine safety. The primary adverse events (AEs) reported within a diverse population, receiving the mRNA-1273 vaccine, were; localized injection site pain, fatigue, headache, myalgia, and chills. In addition, the mRNA-1273 vaccine was also associated with; less than a 1-day change in the menstrual cycle, a 10-fold higher risk of myocarditis and pericarditis within young males aged 18–29 years and increased levels of anti-polyethylene glycol (PEG) antibodies. Expert Opinion The transient nature of commonly observed AEs and the rare occurrence of severe events within mRNA-1273 recipients show no significant safety concerns which should prevent vaccination. However, large-scale epidemiological studies with longer follow-up periods are required to surveillance rare safety outcomes.

Objective This study aims to characterize the adverse events (AEs) following the administration of the mRNA-1273 COVID-19 vaccine from the Vaccine Adverse Event Reporting System (VAERS) data. Methods In this case/non-case analysis, reports between 1 January 2021, and 27 October 2022, were extracted from VAERS. AEs were defined as preferred terms (PTs) by Medical Dictionary for Regulatory Activities (MedDRA) terminology. Disproportionality analyses were conducted to calculate the reporting odds and proportional reporting ratios. The Bayesian approach was used to calculate information component (IC) values and Empirical Bayesian Geometric Mean scores for all the AEs detected. Results 186 MedDRA PTs compromising 702,495 AEs associated with the mRNA-1273 vaccine were identified. Three statistically significant signals were identified for general and systemic AEs, administration site conditions, and product issues. Cardiac disorders were rarely reported, the most common being; 489 reports for ‘myocarditis’ (19.44%), 475 for ‘acute myocardial infarction’ (18.88%), 457 for ‘myocardial infarction’ (18.16%), 290 for ‘bradycardia’ (11.53%) and 281 for ‘pericarditis’ (11.17%). Conclusions The most frequently identified AEs following mRNA-1273 vaccination agree with those listed within the Summary of Product Characteristics. In addition, disproportionality analysis did not find any statistically significant signals for myocarditis or pericarditis.

ImportanceMost healthcare institutions require employees to be vaccinated against SARS-CoV-2 and many also require at least one booster.ObjectiveWe determine the impact of vaccine type, demographics, and health conditions on COVID-19 vaccine side effects in healthcare professionals.DesignA COVID-19 immunity study was performed at the 2021 American Association for Clinical Chemistry Annual Scientific meeting. As part of this study, a REDCap survey with cascading questions was administered from September 9, 2021 to October 20, 2021. General questions included participant demographics, past and present health conditions, smoking, exercise, and medications. COVID-19 specific questions asked about SARS-CoV-2 vaccine status and type, vaccine-associated side effects after each dose including any boosters, previous infection with COVID-19, diagnostic testing performed, and type and severity symptoms of COVID-19.ResultsThere were 975 participants (47.1% male, median age of 50 years) who completed the survey. Pfizer was the most commonly administered vaccine (56.4%) followed by Moderna (32.0%) and Johnson & Johnson (7.1%). There were no significant differences in vaccine type received by age, health conditions, smoking, exercise, or type or number of prescription medications. Side effects were reported more frequently after second dose (e.g., Moderna or Pfizer) (54.1%) or single/only dose of Johnson & Johnson (47.8%). Males were significantly more likely to report no side effects (p < 0.001), while females were significantly more likely to report injection site reactions (p < 0.001), fatigue (p < 0.001), headache (p < 0.001), muscle pain (p < 0.001), chills (p = 0.001), fever (p = 0.007), and nausea (p < 0.001). There was a significant upward trend in participants reporting no side effects with increasing age (p < 0.001). There were no significant trends in side effects among different races, ethnicities, health conditions, medications, smoking status or exercise. In multivariate logistic regressions analyses, the second dose of Moderna was associated with a significantly higher risk of side effects than both the second dose of Pfizer and the single dose of Johnson & Johnson.Conclusions and relevanceYounger people, females, and those receiving the second dose of Moderna had more COVID-19 vaccine side effects that per self-report led to moderate to severe limitations. As reported in other studies, the increase in side effects from Moderna may be explained by higher viral mRNA concentrations but be associated with additional protective immunity.

Delayed hypersensitivity reactions (DHRs) have been reported in association with COVID-19 vaccines, particularly those that are mRNA-based. Classic DHRs result in induration, erythema, tenderness, and urticaria. However, soft tissue mass is an uncommon complication of a COVID-19 vaccination-associated DHR and is rarely reported in the literature. We present a case of a 49-year-old male who recognized a mildly painful, firm soft tissue mass within the biceps mimicking neoplasm six months after receiving the booster dose of the Moderna vaccine. Non-operative conservative treatment modalities, including heating pads, ice packs, acetaminophen, and ibuprofen, failed to improve the patient's mass. The mass, which proved histologically to be an inflammatory pseudo-tumor, did not recur after complete excision. While there have been many reported cases of DHRs following COVID-19 vaccinations, we present this case to raise awareness of the development of pseudo-tumors as a possible, yet rare, clinical manifestation of DHRs following vaccination. [ABSTRACT FROM AUTHOR]

Introduction: Soft tissue fillers are widely used and are commonly considered to be safe. Nonetheless, adverse events such as late inflammatory reactions (LIRs) are reported for every type of filler. As of the start of the COVID-19 pandemic, LIRs have been reported after SARS-CoV infection or vaccination. In the past, we reviewed these adverse events; however, since then, we faced a wave with the Omicron, and the vaccination programs continued with booster vaccines. We therefore aimed to perform an up-to-date review of the literature on LIRs after COVID-19 infection and vaccination with additional learned lessons from this pandemic. Material and methods: We performed a systematic review on soft tissue filler-related LIRs after SARS-CoV-2 infection or vaccination in line with the PRISMA guidelines. Eligible studies were searched in the database PubMed from 1 August 2021 until 1 June 2023. Data on patient characteristics, filler characteristics, clinical findings, and treatment options were retrieved. Results: A total of 14 papers with in total 52 patients were reported, of which 16 had adverse events after a SARS-CoV-2 infection and 36 after SARS-CoV-2 vaccination. In most cases, it concerned females who had their (mostly temporary) fillers for cosmetic purposes. Symptoms were reported in a matter of hours up to weeks after SARS-CoV-2 vaccination (22 Pfizer, 7 Moderna, 3 AstraZeneca, 3 Sputnik V, and one after Siophram), mostly after the first or second dose but sporadically after a third dose. Most patients were treated in a conservative manner. Discussion: LIRs continue to be reported after SARS-CoV-2 infection and vaccination and are currently also reported for non-mRNA vaccines, for non-temporary fillers, and also after a third dose of the vaccine. Although there are more and more papers on this matter, they remain minor and self-limiting. We therefore still advise patients with soft tissue fillers to remain participated in vaccination programs when needed. Level of evidence: Not gradable. [ABSTRACT FROM AUTHOR]

Summary: In this paper, we introduce two new randomised response models for estimating the prevalence of two sensitive characteristics and their overlap in a population by making use of a single deck of cards. The proposed models ensure the privacy of the respondents and also reduce the burden on the respondents as they require the random selection of only one card from a deck of cards each of which contains a pair of questions that are to be answered in order. The variance expressions of the proposed estimators are derived and matched to their Cramer–Rao lower bounds of variances. A simulation study has been carried out to compare the proposed models to each other for least protection. Lastly, a real survey application, related to the acceptability of the vaccines produced by Pfizer and Moderna is included. We had findings in Summer 2021 similar to those of the Harvard Study done in December 2021, which was based on a half‐million data values, that shows the cost effectiveness of the survey design. [ABSTRACT FROM AUTHOR]

This pilot study explores alterations in miRNA profiles among pregnant women and their neonates upon receiving different doses of COVID-19 vaccines. Blood samples, including maternal blood (MB) and neonatal cord blood (CB), collected from five pregnant women were scrutinized using the miRNA PanelChip Analysis System, identifying nine distinct miRNAs, including miR-451a and miR-1972, which exhibited significant downregulation with two vaccine doses in both MB and CB. When compared with women vaccinated with four doses, miR-486-5p, miR-451a, and miR-1972 in the two-dose group also showed notable downregulation. Evaluating recipients of three and four doses, miR-423-5p and miR-1972 expression were significantly reduced in both MB and CB. Further comparative analysis highlighted a decline in miR-223-3p expression with increasing vaccine doses, while miR15a-5p, miR-16-5p, and miR-423-5p showed an upward trend. Notably, miR-451a, miR-1972, and miR-423-5p levels varied across doses and were associated with pathways such as "PI3K-Akt", "neurotrophin signaling", and "cortisol synthesis", suggesting the profound influence of vaccination on diverse molecular mechanisms. Our research has uncovered that escalating vaccine dosages impact miRNA profiles, which may be associated with the immunological response mechanisms in both the mother and fetus, thus indicating a substantial impact of vaccination on various molecular processes. [ABSTRACT FROM AUTHOR]

Australia commenced administration of the Spikevax (Moderna mRNA-1273) COVID-19 vaccine in August 2021 and Nuvaxovid (Novavax NVX-CoV2373) in January 2022. This study describes the short-term safety profile of priming doses of the Spikevax and Nuvaxovid vaccines given between September 2021 and September 2023. Online surveys were sent via AusVaxSafety, Australia’s active vaccine safety surveillance system, three and eight days after vaccination. A total of 131,775 day 3 surveys were sent, with a response rate of 38.5% (N = 50,721). A total of 43,875 day 8 surveys matched with day 3 survey responses were sent, with a response rate of 71.5% (N = 31,355). Half (50.7%) of respondents reported any adverse event following immunisation (AEFI) in the 0–3 days after vaccination and 24.6% reported any AEFI 4–7 days after vaccination. Fatigue, local pain, headache, and myalgia were the most frequently reported symptoms for both vaccines in both periods. After adjusting for respondent characteristics, vaccination clinic type, jurisdiction, and medical conditions, the odds for reporting AEFI increased with age from 16–19 years to highest odds at 30–39 years, after which it declined. Females had greater odd of reporting AEFI than males across most age groups, vaccine types, and doses. Respondents with a history of anaphylaxis had greater odds of reporting any AEFI (adjusted OR range: 1.50–2.86). A total of 3.1% of respondents reported seeking medical review 0–3 days after vaccination. This study affirms the short-term safety of Spikevax and Nuvaxovid COVID-19 vaccine priming doses in a large sample in Australia.

En la localidad de Valdealcón se encuentra una construcción hidráulica abovedada similar a otras muchas de la Península Ibérica, abundantes en la provincia de León. Su principal peculiaridad consiste en una entrada de agua de mayores dimensiones y mejor factura técnica de lo habitual. Por esta razón se realizó una intervención arqueológica, cuyo fin era documentar el abastecimiento de agua de la estructura y, sobre todo, avanzar en la datación de este tipo de construcciones, a menudo tenidas por romanas. Actualmente son muy escasas las excavaciones arqueológicas acometidas en ellas, y aún más las dataciones. En el caso de Valdealcón, la secuencia estratigráfica y la datación radiocarbónica confirmaron su pertenencia a un periodo comprendido entre finales de la Edad Media y principios de época Moderna. El resultado pone a esta construcción, y a otras similares localizadas en el valle medio del Esla, en relación con importantes cambios políticos, sociales y económicos, vinculados con el auge de la ganadería. ABSTRACT: In the village of Valdealcón (León) there is a vaulted hydraulic construction, which has a deposit under its arch, and belongs to a morphology similar to that of a large number of structures present throughout the Iberian Peninsula, which are also numerous in the province of León. However, its main peculiarity is to have a side water inlet of greater dimensions and better technical invoice than usual. This issue favored that it was selected for the realization of an archaeological intervention, whose purpose was not only to understand the water supply of the structure, documenting both its deposit and the channel that supplies it, but also and above all, to advance in the dating of this morphology of vaulted constructions. In fact, until now there are very few archaeological excavations undertaken in this type of hydraulic buildings, and even more the dating made from these. In the case of Valdealcón, the stratigraphy associated with his intervention, as well as the sample selected for radiocarbon dating, confirmed its belonging to a chronological period between the late Middle Ages and early modern periods. This result puts both this construction, and other similar ones located in the middle valley of the Esla, in relation to important political, social and economic changes, closely linked to the rise of livestock, widespread throughout the Iberian territory, and exemplified in this specific area of the leonese territory.

Several COVID-19 vaccines have been developed and authorized for emergency use by various regulatory agencies worldwide. Objective: to compare the adverse effects and safety of confirmed COVID-19 vaccines in Saudi Arabia and provide a centralized database of suspected adverse reactions and safety profiles to these vaccines. In this cross-sectional study, the study was conducted among the 633 vaccinated participants living in Saudi Arabia through an online questionnaire. Their age group was between 15-85 years old. The study indicated that 55% of the participants were infected with COVID-19, and 33% were infected before vaccination. 10% of our study participants had two or more related comorbidities, commonly hypertension, respiratory problems, and diabetes mellitus. The most frequent side effects of these vaccines are fatigue, headaches, fever, myalgia, arthralgia, pain, tenderness, and swelling at the injection site, especially after the first dose. Commonly systemic side effects presented in young female participants, 15-30 years old. This study postulates a database about the possibility of developing COVID-19 vaccine adverse effects based on age, gender, comorbidities, and vaccine type. More research must be done to understand more clearly the association between developing adverse effects and risk factors. [ABSTRACT FROM AUTHOR]

Most Australian adults now have hybrid immunity to the SARS-CoV-2 virus, referring to a combination of protection from previous vaccine doses and past infection. Protection from both vaccination and past infection wanes over time. Booster doses are recommended to ensure that those who are at increased risk of severe COVID-19 remain protected. The optimal timing of future booster doses to maintain adequate protection against severe illness is not yet known. Older age remains the most important risk factor for severe COVID-19, including in the current Omicron variant era. The original COVID-19 vaccines are monovalent vaccines based on the ancestral strain of the SARS-CoV-2 virus. Bivalent vaccines have been developed based on earlier Omicron subvariants (BA.1 or BA.4-5) and the ancestral strain. These provide enhanced protection against severe illness from Omicron compared with the original monovalent vaccines. Updated monovalent vaccines based on a more recent Omicron subvariant (XBB.1.5) have been developed. COVID-19 vaccines have an excellent safety record, and serious adverse events are extremely rare. [ABSTRACT FROM AUTHOR]

Purpose: To assess the incidence of axillary lymphadenopathy over established time ranges after COVID-19 vaccination and lymph node pathologic features (i.e. size increase and qualitative characteristics) in subjects undergoing axillary evaluation during a breast imaging examination. Methods and materials: The institutional review board approved this prospective study. Inclusion criteria: women undergoing mammography and breast ultrasound between July and October 2021; information about the COVID-19 vaccine and infection, if any. Exclusion criteria: known metastatic lymphadenopathy. Participants were divided into 5 subgroups according to time between vaccine and imaging: < 6 weeks; 7–8 weeks; 9–10 weeks; 11–12 weeks; > 12 weeks. Evaluation of axillary lymph nodes was performed with ultrasound. Descriptive statistical analysis was performed. p < 0.05 was considered significant. Results: A total of 285 women were included. Most of the patients underwent Moderna vaccine (n = 175, 61.4%). 63/285 patients had a previous history of breast cancer (22.1%). 13/17 (76.5%) patients with previous COVID-19 infection had no previous history of cancer, whereas 4/17 had a previous history of cancer (p <.001). 41/285 (14.4%) women showed lymphadenopathy, and they were significantly younger (46.9 ± 11.6 years) than women with borderline (54.0 ± 11.9 years) or no lymphadenopathy (57.3 ± 11.9 years) (p <.001). Lymphadenopathy and borderline lymphadenopathy were more frequently observed in the Moderna-vaccinated women and in the subgroup of patients evaluated < 6 weeks after vaccination (p < 0.001). The most common pathologic feature was cortical thickening, followed by complete or partial effacement of fatty hilum. Conclusion: A lymphadenopathy within 12 weeks after vaccination is a common finding particularly in younger women and after Moderna vaccine and no further assessment should be required. [ABSTRACT FROM AUTHOR]

SARS-CoV-2 causes Coronavirus Disease 2019 (COVID-19), an infectious condition that can present none or one or more of these symptoms: fever, cough, headache, sore throat, loss of taste and smell, aches, fatigue and musculoskeletal pain. For the prevention of COVID-19, there are vaccines available including those developed by Pfizer, Moderna, Sinovac, Janssen, and AstraZeneca. Recent evidence has shown that some COVID-19-vaccinated individuals can occasionally develop as a potential side effect Guillain-Barre syndrome (GBS), a severe neurological autoimmune condition in which the immune response against the peripheral nerve system (PNS) can result in significant morbidity. GBS had been linked previously to several viral or bacterial infections, and the finding of GBS after vaccination with certain COVID-19, while rare, should alert medical practitioners for an early diagnosis and targeted treatment. Here we review five cases of GBS that developed in different countries after COVID-19 vaccination.

In December 2019, Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) appeared and spread worldwide, triggering a pandemic of respiratory illness. So, there was an urgent need for vaccines worldwide. The mRNA-based vaccines are undergoing an accelerated phase of development during this pandemic. WHO has issued interim guidelines for administering the Moderna mRNA-1273 vaccine against COVID-19 based on advice given by the Strategic Advisory Group of Experts on Immunization (SAGE). The significant future directions for study would be comparing and elucidating the immune processes triggered by mRNA vaccine platforms, developing existing methods focused on these mechanisms, and introducing new clinical trials of these vaccines against additional disease targets. This study aims to reveal the important role and contribution of the Moderna mRNA-1273 vaccine to COVID-19 vaccinology. Moderna mRNA-1273 vaccine could be the keystone of modern vaccinology in the context of the COVID-19 pandemic.

Recent studies regarding COVID-19 show a growing tendency to talk about the COVID-19 Pandemic on online channels. With the recent release of the Pfizer vaccine of COVID-19, people keep posting many rumors regarding the safety concerns of the Vaccine, especially among older people. Due to the rapid spread of the COVID-19 virus and the worldwide Pandemic developed, the rush to develop the COVID-19 Vaccine has become an alarming priority in health care services worldwide. In this research work, we have systematically evaluated people’s views towards the COVID-19 Vaccine, and shreds of evidence are supported empirically. The study mainly focuses on the empirical evidence and intensive discussions on what is currently known about the mechanism of action, efficacy, and toxicity of the most promising vaccines (Moderna), (Pfizer/BioNtech), (Astrazenac/Oxford), and (Sputnik V) against COVID-19. Our study’s primary objective is to provide an analysis of the questionnaire regarding people’s opinions, preferences, and acceptance of the COVID-19 vaccines. We have created an online questionnaire using a google form to collect data from various countries supposed to employ COVID-19 vaccines. The questionnaires were distributed to people in many Arab and foreign countries such as Egypt, Saudi Arabia, India, England, China, and Japan. A total of 516 responses were returned and analyzed using statistical, and Seasonal Autoregressive Integrated Moving Average (SARIMA) approaches. The SARIMA model is used to predict the total number of vaccines in the next few days. To attain the most accurate forecast and prediction, the SARIMA model parameters are investigated with a grid search method. Finally, the combination of the parameters (1,0,1)×(1,0,0,1) is considered to be the best SARIMA model because it has the lowest AIC values of −4100.11 and the best Correlation coefficients of 0.984.

Studies for vaccine development have been completed in an unprecedented time to prevent further outbreak of the dangerous and potentially fatal coronavirus disease-2019 (COVID-19) caused by severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2). Some of these vaccines have been approved by various authorities and made available worldwide. While vaccine applications continue globally, the number of dermatological side effects reported after vaccination is increasing daily. Many cutaneous reactions have been reported in the literature, such as injection site reactions, pernio lesions, pityriasis rosacea, herpes zoster, and exacerbations of chronic inflammatory dermatoses such as atopic dermatitis and psoriasis. Most COVID-19 vaccines require two doses and a booster dose, and considering the new variants of the coronavirus, vaccination is estimated to continue for a while. In this context, dermatologists are more likely to encounter vaccine-related dermatological side effects in their daily practice. Dermatologists play an essential role in many issues such as diagnosis and treatment of cutaneous reactions after COVID-19 vaccination, informing patients and providing necessary counseling. This perspective will also provide helpful information for the future in terms of vaccination strategies to be developed for repeated doses. In this study, most of the cutaneous reactions reported after COVID-19 vaccination in the current literature are reviewed.

SARS-CoV-2 causes the highly contagious coronavirus disease (COVID-19), first discovered in Wuhan, China, in December of 2019. As of August 21, 2021, over 211 million people have been diagnosed with COVID-19 and 4.42 million people have died from the disease worldwide. The COVID-19 pandemic has adversely affected world economies, global public health infrastructure, and social behaviors. Despite physical distancing and the advent of symptomatic and monoclonal antibody therapies, perhaps the most effective method to combat COVID-19 remains the creation of immunity through vaccines. Scientific communities globally have been diligently working to develop vaccines since the start of the pandemic. Though a few have been authorized for use, the Pfizer vaccine was the first to be given full approval in the United States in August 2021 – being the quickest vaccine to ever be developed. Although several vaccines produced via different approaches are in use, no mortality has been reported thus far from vaccine use. Here, we highlight the latest advances in the development of the COVID-19 vaccines, specifically the lead candidates that are in late-stage clinical trials or authorized for emergency use. As SARS-CoV-2 uses its spike protein to enter a host cell and cause infection, most vaccine candidates target this protein. This review describes the various COVID-19 vaccines - authorized and/or under development - and their composition, advantages, and potential limitations as the world continues to fight this devastating pandemic. [ABSTRACT FROM AUTHOR]

Background Postural tachycardia syndrome (POTS) is characterized by orthostatic intolerance and heart rate increase in an upright position without orthostatic hypotension. It has been described after coronavirus disease-19 (COVID-19) as well as after COVID-19 vaccination. Case summary A 54-year-old female patient presented with a 9-months history of severe orthostatic intolerance since COVID-19 vaccination with messenger RNA (mRNA)-1273 (Spikevax, Moderna). Except for diet-controlled coeliac disease, the patient was healthy, had no allergies, and did not take regular medication. Tilt table testing revealed a significant heart rate increase to 168 bpm without orthostatic hypotension accompanied by light-headedness, nausea, and syncope, findings consistent with POTS. Potential underlying causes including anaemia, thyroid dysfunction, adrenal insufficiency, pheochromocytoma, (auto)-immune disease, chronic inflammation as well as neurological causes were ruled out. Echocardiography and cardiac stress magnetic resonance imaging (MRI) did not detect structural or functional heart disease or myocardial ischaemia. Forty-eight-hour-electrocardiogram (ECG) showed no tachycardias other than sinus tachycardia. Finally, genomic analysis did not detect an inherited arrhythmia syndrome. Serologic analysis revealed adequate immune response to mRNA-1273 vaccination without signs of previous severe acute respiratory syndrome-coronavirus-2 infection. While ivabradine was not tolerated and metoprolol extended release only slightly improved symptoms, physical exercise reduced orthostatic intolerance moderately. At a 5-months follow-up, the patient remained dependant on assistance for activities of daily living. Discussion The temporal association of POTS with the COVID-19 vaccination in a previously healthy patient and the lack of evidence of an alternative aetiology suggests COVID-19 vaccination is the potential cause of POTS in this patient. To our knowledge, this is the first case reporting severe, long-term, and treatment-refractory POTS following COVID-19 vaccination with mRNA1273. [ABSTRACT FROM AUTHOR]

With the introduction of large‐scale COVID‐19 vaccination programs, a variety of cutaneous manifestations have been described. We present two girls (ages 12 and 5 years) who developed erythema nodosum (EN) 3 and 14 days after Pfizer‐BioNTech COVID‐19 vaccination, respectively. While EN after COVID‐19 vaccination has been reported in adults, it is can also occur in children. [ABSTRACT FROM AUTHOR]

The emergence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) prompted accelerated vaccine development of novel messenger RNA (mRNA)-based vaccines by Moderna and Pfizer, which received FDA Emergency Use Authorization in December 2020. The purpose of this study was to examine trends in primary series administration and multi-dose completion rates with Moderna's mRNA-1273 vaccine administered at a United States retail pharmacy. Walgreens pharmacy data were joined to publicly available data sets to examine trends in mRNA-1273 primary series and multi-dose completion across patient race/ethnicity, age, gender, distance to first vaccination, and community characteristics. Eligible patients received their first dose of mRNA-1273 administered by Walgreens between December 18, 2020 and February 28, 2022. Variables significantly associated with on-time second dose (all patients) and third dose (immunocompromised patients) in univariate analyses were included in linear regression models. A subset of patients in selected states were studied to identify differences in early and late vaccine adoption. Patients (N = 4,870,915) who received ≥ 1 dose of mRNA-1273 were 57.0% White, 52.6% female, and averaged 49.4 years old. Approximately 85% of patients received a second dose during the study period. Factors associated with on-time second dose administration included older age, race/ethnicity, traveling ≤ 10 miles for the first dose, higher community-level health insurance, and residing in areas with low social vulnerability. Only 51.0% of immunocompromised patients received the third dose as recommended. Factors associated with third dose administration included older age, race/ethnicity, and small-town residence. Early adopters accounted for 60.6% of patients. Factors associated with early adoption included older age, race/ethnicity, and metropolitan residence. Over 80% of patients received their on-time second dose of mRNA-1273 vaccine per CDC recommendations. Patient demographics and community characteristics were associated with vaccine receipt and series completion. Novel approaches to facilitate series completion during a pandemic should be further studied. [ABSTRACT FROM AUTHOR]

Introduction: As an endeavor to control SARS-CoV-2 infection, the Moderna vaccine booster was given to healthcare workers to prevent reinfection and reduce the risk of complications from COVID-19. A heterologous booster vaccine is also thought to provide better protection against the current SARS-CoV-2 variants of concern. However, research that evaluates the effectiveness of the Moderna vaccine booster and the resulting SARS-CoV-2 antibody concentration is needed. Objective: To evaluate the concentration of SARS-CoV-2 antibodies after the Moderna vaccine booster and the severity of SARS-CoV-2 infection before and after the Moderna vaccine booster. Results: A total of 93 healthcare providers who received Moderna vaccine booster were included in the study. Examination of antibody concentration 3 months after the booster showed an average concentration of 10081.65 U/mL. There was an increase in antibody concentration before the booster and 3 months after, from a median of 1.7 U/mL to 9540 U/mL. Every subject showed a statistically significant increment of antibody concentration 3 months after the booster (p < 0.01). Thirty-seven (39.8%) subjects received two doses of the Sinovac vaccine and were confirmed to have COVID-19 with the Delta variant. After the booster, 26 (28%) subjects were infected with the Omicron Variant. Among the subjects who received two doses of the Sinovac vaccine and were confirmed with COVID-19, 36 (30.1%) had mild symptoms, and 1 (1.1%) was asymptomatic. Conclusions: Heterologous Moderna vaccine booster effectively increases antibody response against SARS-CoV-2 variants and shows mild symptoms of COVID-19 infection. [ABSTRACT FROM AUTHOR]

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Copyright of Social Sciences & Humanities Studies / Društvene i Humanističke Studije (DHS) is the property of Faculty of Humanities & Social Sciences, University of Tuzla 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 abstract 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 abstract. (Copyright applies to all Abstracts.)

Millions of people have died as a result of SARS-CoV-2, which was first discovered in China and has since spread globally. Patients with SARS-CoV-2 infection may show a range of symptoms, including fever, coughing, and shortness of breath, or they may show no symptoms at all. To treat COVID-19 symptoms and avoid serious infections, many medications and vaccinations have been employed. However, to entirely eradicate COVID-19 from the world, next-generation vaccine research is required because of the devastating consequences it is having for humanity and every nation's economy. Scientists are working hard to eradicate this dangerous virus across the world. SARS-CoV-2 has also undergone significant mutation, leading to distinct viral types such as the alpha, beta, gamma, delta, and omicron variants. This has sparked discussion about the effectiveness of current vaccines for the newly formed variants. A proper comparison of these vaccinations is required to compare their efficacy as the number of people immunized against SARS-CoV-2 globally increases. Population-level statistics evaluating the capacity of these vaccines to reduce infection are therefore being developed. In this paper, we analyze the many vaccines on the market in terms of their production process, price, dosage needed, and efficacy. This article also discusses the challenges of achieving herd immunity, the likelihood of reinfection, and the importance of convalescent plasma therapy in reducing infection. [ABSTRACT FROM AUTHOR]

Abstract Background To prevent the spread of the novel coronavirus disease 2019 (COVID-19) infection, various vaccines have been developed and used in a large number of people worldwide. One of the most commonly used vaccines is the mRNA vaccine developed by Moderna. Although several studies have shown this vaccine to be safe, the full extent of its side effects has not yet been known. Miller-Fisher syndrome (MFS) is a rare condition that manifests ophthalmoplegia, ataxia, and loss of tendon reflexes. It is a subtype of Guillain–Barré syndrome and an immune-mediated disease related to serum IgG anti-GQ1b antibodies. Several vaccines including those for COVID-19 have been reported to induce MFS. However, there have been no reports of MFS following Moderna COVID-19 vaccine administration. Case presentation A 70-year-old man was referred to our hospital due to diplopia that manifested 1 week after receiving the second Moderna vaccine dose. The patient presented with restricted abduction of both eyes, mild ataxia, and loss of tendon reflexes. He was diagnosed with MFS based on his neurological findings and detection of serum anti-GQ1b antibodies. The patient was administered intravenous immunoglobulin, and his symptoms gradually improved. Five days after admission, the patient showed peripheral facial paralysis on the right side. This symptom was suggested to be a delayed onset of peripheral facial nerve palsy following MFS that gradually improved by administration of steroids and antiviral drugs. Conclusion There have been no previous reports of MFS after Moderna COVID-19 vaccination. This case may provide new information about the possible neurological side effects of COVID-19 vaccines.

Abstract Background Due to a rising number of COVID-19 cases, the Indonesian government implemented public health programs to lower the rate. Since January 2021, one of the government’s primary policies has been the COVID-19 immunization program. Recently, the Moderna messenger ribonucleic acid (mRNA) vaccine is one of the COVID-19 vaccines used in Indonesia. Based on some research, Moderna has possible side effects throughout the body, including neurological symptoms. Case presentation We describe a 39-year-old female with uncontrolled hypertension who showed behavioral change, communication difficulty, social withdrawal, and a confused state within 7 days from getting her first dose of the Moderna vaccine. The patient had a history of febrile convulsion in childhood. An increase of neutrophil-to-lymphocyte ratio (16.9) and C-reactive protein level (31.75 mg/L) indicates ongoing inflammation. Head CT scan shows no abnormalities. She received ceftriaxone, citicoline, and methylprednisolone. The patient was discharged on the seventh day and completely recovered 1 week later. This study is the first case report of encephalopathy following the administration of the Moderna COVID-19 vaccine reported in Indonesia up to our knowledge. Conclusion Encephalopathy related to the Moderna COVID-19 vaccine should be acknowledged as an adverse effect of the Moderna COVID-19 vaccine.

We reviewed the reported imaging findings of myocarditis in the literature following COVID-19 vaccination on cardiac imaging by a literature search in online databases, including Scopus, Medline (PubMed), Web of Science, Embase (Elsevier), and Google Scholar. In total, 532 cases of myocarditis after COVID-19 vaccination were reported (462, 86.8% men and 70, 13.2% women, age range 12 to 80) with the following distribution: Pfizer-BioNTech: 367 (69%), Moderna: 137 (25.8%), AstraZeneca: 12 (2.3%), Janssen/Johnson & Johnson: 6 (1.1%), COVAXIN: 1 (0.1%), and unknown mRNA vaccine: 9 (1.7%). The distribution of patients receiving vaccine dosage was investigated. On cardiac MR Imaging, late intravenous gadolinium enhancement (LGE) was observed mainly in the epicardial/subepicardial segments (90.8%, 318 of 350 enhancing segments), with the dominance of inferolateral segment and inferior walls. Pericardial effusion was reported in 13.1% of cases. The vast majority of patients (94%, 500 of 532) were discharged from the hospital except for 4 (0.7%) cases. Post-COVID-19 myocarditis was most commonly reported in symptomatic men after the second or third dose, with CMRI findings including LGE in 90.8% of inferior and inferolateral epicardial/subepicardial segments. Most cases were self-limited.

A spectrum of cutaneous reactions to SARs-CoV-2 (COVID-19) vaccines have been reported in the literature. We present a case of a pityriasis rosea-like rash occurring after Pfizer COVID-19 vaccination and review cases of pityriasis rosea (PR)/PR-like eruption (PR-LE) after mRNA COVID-19 vaccine published in the medical literature. Of the 30 cases found, none experienced severe adverse effects and the rash resolved in an average of 5.6 weeks. It is important for physicians to be aware of this self-limited reaction so they can reassure and appropriately counsel patients that it is safe to receive subsequent vaccine doses despite the cutaneous eruption. Additionally, differences in incidence of this reaction after Pfizer and Moderna vaccination may suggest a differing host immune response incited by these vaccines which warrants further investigation.

Delayed hypersensitivity reactions (DHRs) have been reported in association with COVID-19 vaccines, particularly those that are mRNA-based. Classic DHRs result in induration, erythema, tenderness, and urticaria. However, soft tissue mass is an uncommon complication of a COVID-19 vaccination-associated DHR and is rarely reported in the literature. We present a case of a 49-year-old male who recognized a mildly painful, firm soft tissue mass within the biceps mimicking neoplasm six months after receiving the booster dose of the Moderna vaccine. Non-operative conservative treatment modalities, including heating pads, ice packs, acetaminophen, and ibuprofen, failed to improve the patient’s mass. The mass, which proved histologically to be an inflammatory pseudo-tumor, did not recur after complete excision. While there have been many reported cases of DHRs following COVID-19 vaccinations, we present this case to raise awareness of the development of pseudo-tumors as a possible, yet rare, clinical manifestation of DHRs following vaccination.

Abstract Background In late 2019, Coronavirus disease 2019 has been declared as a global emergency by World Health Organization. Hopefully, recent reports of effective and safe vaccines were welcomed, and approved on emergency base. Millions of recipients had received one of the approved COVID 19 vaccines, with lots of adverse events recorded global wide. Objective To assess post-COVID vaccination immune-mediated adverse events and evaluate its association to specific type of vaccine global wide. Methods Systematic literature review and meta-analysis of published reports (since December 2020 till December 2021) on immune-mediated adverse events post-COVID vaccination. Results We evaluated 34 published studies; 460 cases with various adverse events post-COVID vaccination. Studies in current literature are primarily retrospective case series, isolated case reports or narrative studies. Different COVID vaccines were involved. Results’ data was subcategorized according to associated vaccine. Adverse effects of COVID-19 vaccinations included thrombotic, neurological, myocarditis, ocular, dermatological, renal, hematological events timely linked to inoculation. Each vaccine type was linked to adverse profile that differ from others. Conclusion High suspicion of post-vaccination adverse events is mandatory to provoke earlier detection, better understanding, optimum prevention, and management. Specific vaccine/patient risk profile is needed to selectively categorize target population to reduce morbidity and mortality post-vaccination.

The Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) outbreak has caused massive damage to the global healthcare system and economy. To compete with the SARS-COV-2 pandemic, several vaccines have been proposed to immunize the population. The present study aimed to investigate the adverse effects following the three doses of COVID-19 vaccination, Pfizer (BioNTech), (Oxford-AstraZeneca (ChAdOx1 CoV-19), and Moderna among the adult population in the Eastern province of Saudi Arabia. In this study, the total number of participants were 426, among them 277 (65%) were females and 149 (35%) were males. An online survey using Google forms in the English language and translated into the Arabic language was used to record the information. The questionnaire was distributed to participants who received either Pfizer-BioNTech, Oxford-AstraZeneca or Moderna vaccines. The general characteristics of participants were obtained, alongside an evaluation of the vaccination's adverse effects. The results revealed that Pfizer-BioNTech COVID-19 vaccines caused significantly less adverse effects than Oxford–AstraZeneca (ChAdOx1) and Moderna (p < 0.001), and females experienced more adverse effects after vaccination compared to males. Injection site pain was the most common adverse event among the participants (60.6%), followed by fatigue, headache, and pain (43.9%), muscle and joint pain (32.4%), increased body temperature and shivering (24.2%). In addition, the group of individuals under the age of sixty was more likely to experience side effects than the participants with other age groups. All three vaccines, Pfizer-BioNTech, Oxford–AstraZeneca (ChAdOx1 CoV-19) and Moderna, cause post-vaccinal adverse effects; however, Moderna and Oxford–AstraZeneca (ChAdOx1) causes adverse effects more frequently than the Pfizer-BioNTech. [ABSTRACT FROM AUTHOR]

Background: The unprecedented speed of COVID-19 vaccine development and approval has raised public concern about its safety. However, studies on public discourses and opinions on social media focusing on adverse events (AEs) related to COVID-19 vaccine are rare. Objective: This study aimed to analyze Korean tweets about COVID-19 vaccines (Pfizer, Moderna, AstraZeneca, Janssen, and Novavax) after the vaccine rollout, explore the topics and sentiments of tweets regarding COVID-19 vaccines, and examine their changes over time. We also analyzed topics and sentiments focused on AEs related to vaccination using only tweets with terms about AEs. Methods: We devised a sophisticated methodology consisting of 5 steps: keyword search on Twitter, data collection, data preprocessing, data analysis, and result visualization. We used the Twitter Representational State Transfer application programming interface for data collection. A total of 1,659,158 tweets were collected from February 1, 2021, to March 31, 2022. Finally, 165,984 data points were analyzed after excluding retweets, news, official announcements, advertisements, duplicates, and tweets with <2 words. We applied a variety of preprocessing techniques that are suitable for the Korean language. We ran a suite of analyses using various Python packages, such as latent Dirichlet allocation, hierarchical latent Dirichlet allocation, and sentiment analysis. Results: The topics related to COVID-19 vaccines have a very large spectrum, including vaccine-related AEs, emotional reactions to vaccination, vaccine development and supply, and government vaccination policies. Among them, the top major topic was AEs related to COVID-19 vaccination. The AEs ranged from the adverse reactions listed in the safety profile (eg, myalgia, fever, fatigue, injection site pain, myocarditis or pericarditis, and thrombosis) to unlisted reactions (eg, irregular menstruation, changes in appetite and sleep, leukemia, and deaths). Our results showed a notable difference in the topics for each vaccine brand. The topics pertaining to the Pfizer vaccine mainly mentioned AEs. Negative public opinion has prevailed since the early stages of vaccination. In the sentiment analysis based on vaccine brand, the topics related to the Pfizer vaccine expressed the strongest negative sentiment. Conclusions: Considering the discrepancy between academic evidence and public opinions related to COVID-19 vaccination, the government should provide accurate information and education. Furthermore, our study suggests the need for management to correct the misinformation related to vaccine-related AEs, especially those affecting negative sentiments. This study provides valuable insights into the public discourses and opinions regarding COVID-19 vaccination. [ABSTRACT FROM AUTHOR]

This study aims to characterize the adverse events (AEs) following the administration of the mRNA-1273 COVID-19 vaccine from the Vaccine Adverse Event Reporting System (VAERS) data. In this case/non-case analysis, reports between 1 January 2021, and 27 October 2022, were extracted from VAERS. AEs were defined as preferred terms (PTs) by Medical Dictionary for Regulatory Activities (MedDRA) terminology. Disproportionality analyses were conducted to calculate the reporting odds and proportional reporting ratios. The Bayesian approach was used to calculate information component (IC) values and Empirical Bayesian Geometric Mean scores for all the AEs detected. 186 MedDRA PTs compromising 702,495 AEs associated with the mRNA-1273 vaccine were identified. Three statistically significant signals were identified for general and systemic AEs, administration site conditions, and product issues. Cardiac disorders were rarely reported, the most common being; 489 reports for 'myocarditis' (19.44%), 475 for 'acute myocardial infarction' (18.88%), 457 for 'myocardial infarction' (18.16%), 290 for 'bradycardia' (11.53%) and 281 for 'pericarditis' (11.17%). The most frequently identified AEs following mRNA-1273 vaccination agree with those listed within the Summary of Product Characteristics. In addition, disproportionality analysis did not find any statistically significant signals for myocarditis or pericarditis. [ABSTRACT FROM AUTHOR]

Current safety data from Phase 3 clinical trials have concluded that apart from transient local and systemic reactions, no safety concerns were identified for the Moderna COVID-19 vaccine (mRNA-1273). However, Phase 3 studies are insufficient to detect rare adverse events (AEs). A literature search of the two major electronic databases, Embase and PubMed, was performed to enable the identification and characterization of all relevant articles from December 2020 to November 2022. This narrative review summarizes the key safety outcomes associated with the mRNA-1273 vaccine to inform healthcare decisions and increase public awareness of mRNA-1273 vaccine safety. The primary adverse events (AEs) reported within a diverse population, receiving the mRNA-1273 vaccine, were; localized injection site pain, fatigue, headache, myalgia, and chills. In addition, the mRNA-1273 vaccine was also associated with; less than a 1-day change in the menstrual cycle, a 10-fold higher risk of myocarditis and pericarditis within young males aged 18–29 years and increased levels of anti-polyethylene glycol (PEG) antibodies. The transient nature of commonly observed AEs and the rare occurrence of severe events within mRNA-1273 recipients show no significant safety concerns which should prevent vaccination. However, large-scale epidemiological studies with longer follow-up periods are required to surveillance rare safety outcomes. [ABSTRACT FROM AUTHOR]

Objective: The World Health Organization declared the COVID‐19 pandemic on 11 March 2020. In 2021, several vaccines were provisionally approved to reduce the risk of transmission and hospitalisation of COVID‐19 infection. A surge in COVID‐19 vaccination was seen between August and October 2021 in Victoria, Australia. We hypothesised this led to an increase in ED presentations. Methods: Patients in the present study were adults who presented to the ED within 21 days of receiving a dose of a COVID‐19 vaccine between 11 August 2021 and 14 November 2021. All cases underwent chart reviews to extract epidemiological features, clinical presentations, ED assessments, investigations and disposition. Results: Notably, 968 patients were included in the study, comprising 6.1% of all ED presentations during the study period. The median age was 31 years. 82.9% of patients were younger than 45 years. 20.1% of patients arrived by ambulance. Chest pain was the most common presenting complaint (43.6%), followed by headache (10.3%) and palpitations (8.2%). The most common investigations were a full blood examination (73.5%), an ECG (63.8%) and serum troponin (49.1%). 64.8% of patients were directly discharged home and 22.1% were sent home after a short stay admission. Only 2.2% of patients were admitted to the hospital. Conclusion: A majority of patients who presented to the ED after their COVID vaccinations were young and discharged home after the initial assessment. These presentations have significantly increased the workload in prehospital settings and EDs, contributing to increased investigation usage, ED treatment space occupancy, and increased costs to the health system. There was a significant surge in ED presentations after mass vaccination against COVID‐19 gained momentum in Victoria during the sixth lockdown between August and October 2021. 6.1% of presentations to our ED during the study period were related to COVID‐19 vaccinations. Almost 83% of presentations comprised people aged <45 years and 20% of these presentations were transported to the ED by ambulance. [ABSTRACT FROM AUTHOR]

Recent studies regarding COVID-19 show a growing tendency to talk about the COVID-19 Pandemic on online channels. With the recent release of the Pfizer vaccine of COVID-19, people keep posting many rumors regarding the safety concerns of the Vaccine, especially among older people. Due to the rapid spread of the COVID-19 virus and the worldwide Pandemic developed, the rush to develop the COVID-19 Vaccine has become an alarming priority in health care services worldwide. In this research work, we have systematically evaluated people's views towards the COVID-19 Vaccine, and shreds of evidence are supported empirically. The study mainly focuses on the empirical evidence and intensive discussions on what is currently known about the mechanism of action, efficacy, and toxicity of the most promising vaccines (Moderna), (Pfizer/BioNtech), (Astrazenac/Oxford), and (Sputnik V) against COVID-19. Our study's primary objective is to provide an analysis of the questionnaire regarding people's opinions, preferences, and acceptance of the COVID-19 vaccines. We have created an online questionnaire using a google form to collect data from various countries supposed to employ COVID-19 vaccines. The questionnaires were distributed to people in many Arab and foreign countries such as Egypt, Saudi Arabia, India, England, China, and Japan. A total of 516 responses were returned and analyzed using statistical, and Seasonal Autoregressive Integrated Moving Average (SARIMA) approaches. The SARIMA model is used to predict the total number of vaccines in the next few days. To attain the most accurate forecast and prediction, the SARIMA model parameters are investigated with a grid search method. Finally, the combination of the parameters (1 , 0 , 1) × (1 , 0 , 0 , 1) is considered to be the best SARIMA model because it has the lowest AIC values of −4100.11 and the best Correlation coefficients of 0.984. [ABSTRACT FROM AUTHOR]