scholarly journals Outcomes of operative versus non-operative interventions on rectus abdominis diastasis: a combination of a retrospective analysis and a systematic review

2019 ◽  
Author(s):  
sue yuan ◽  
Yunxia Li ◽  
Qi Li ◽  
Lu Fan ◽  
Jie Zhou
Keyword(s):  
Systematic Review ◽  
Adverse Events ◽  
Rectus Abdominis ◽  
Operative Intervention ◽  
Abdominal Hernia ◽  
Cochrane Library ◽  
Abdominal Muscles ◽  
Recurrence Rates ◽  
Mesh Placement

Abstract Background There is no current consensus on the treatment of Rectus abdominis diastasis (RAD). This study aimed to assess the recurrence rates and adverse events after operative or non-operative intervention.Methods We performed a retrospective study and a systematic review. Patients with a diagnosis of RAD who underwent the mesh placement procedure were eligible. Data were collected from The Research Patient Data Registry. Then, a systematic literature search of Pubmed, Embase, and The Cochrane Library databases was performed. A modified Downs and Black checklist for randomized and non-randomized studies of healthcare interventions (DB) was used to evaluate the methodological quality of the studies.Results Data of 82 patients was collected. The 5-year cumulative incidence of recurrence of abdominal hernia was high (females 37.0% vs males 43.4%, P = 0.557). Of 3908 citations, 27 studies describing 2,372 patients were included into the systematic review. In non-operative group, seven studies (25.93%) with a total of 603 subjects reported no patient relapsed after a follow-up of 12 months; a 40% recurrence rate was reported after a follow-up of 5 years in one study, the adverse events associated with operation mainly included seroma (5.13%), a sensibility disorder of the abdominal skin (2.26%), and minor scarring (1.56%). Muscle strength training, such as training of the pelvic floor muscles, abdominal muscles, rectus abdominis, internal/external oblique, or transverse abdominal muscles, was performed in all included non-surgery studies, neither adverse events nor recurrence was reported.Conclusion Operative intervention may be effective at restoring the functions of the rectus muscles and at improving the stability of abdominal wall in the short-term, while non-operative intervention has a limited effect, especially for those RAD combined with hernia.

scholarly journals Outcomes of Arthroscopic Capsular Release in the Beach-Chair Versus Lateral Decubitus Position: A Systematic Review

2019 ◽  
Vol 7 (12) ◽  
pp. 232596711988817 ◽  
Author(s):  
Darby A. Houck ◽  
John W. Belk ◽  
Armando F. Vidal ◽  
Eric C. McCarty ◽  
Jonathan T. Bravman ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Outcomes ◽  
Cochrane Library ◽  
Recurrence Rates ◽  
Capsular Release ◽  
Arthroscopic Capsular Release ◽  
Patient Reported ◽  
Lateral Decubitus ◽  
Beach Chair

Background: Arthroscopic capsular release (ACR) for the treatment of adhesive capsulitis of the shoulder can be performed in either the beach-chair (BC) or lateral decubitus (LD) position. Purpose: To determine the clinical outcomes and recurrence rates after ACR in the BC versus LD position. Study Design: Systematic review; Level of evidence, 4. Methods: A systematic review using PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines was performed by searching PubMed, Embase, and the Cochrane Library databases for studies reporting clinical outcomes of patients undergoing ACR in either the BC or LD position. All English-language literature from 1990 through 2017 reporting on clinical outcomes after ACR with a minimum 3-month follow-up were reviewed by 2 independent reviewers. Recurrence rates, range of motion (ROM) results, and patient-reported outcome (PRO) scores were collected. Study methodological quality was evaluated using the modified Coleman Methodology Score (MCMS). Results: A total of 30 studies (3 level 1 evidence, 2 level 2 evidence, 4 level 3 evidence, 21 level 4 evidence) including 665 shoulders undergoing ACR in the BC position (38.1% male; mean age, 52.0 ± 3.9 years; mean follow-up, 35.4 ± 18.4 months) and 603 shoulders in the LD position (41.8% male; mean age, 53.0 ± 2.3 years; mean follow-up, 37.2 ± 16.8 months) were included. There were no significant differences in overall mean recurrence rates between groups (BC, 2.5%; LD, 2.4%; P = .81) or in any PRO scores between groups ( P > .05). There were no significant differences in improvement in ROM between groups, including external rotation at the side (BC, 36.4°; LD, 42.8°; P = .91), forward flexion (BC, 64.4°; LD, 79.3°; P = .73), abduction (BC, 77.8°; LD, 81.5°; P = .82), or internal rotation in 90° of abduction (BC, 40.8°; LD, 45.5°; P = .70). Significantly more patients in the BC group (91.6%) underwent concomitant manipulation than in the LD group (63%) ( P < .0001). There were significantly more patients with diabetes in the LD group (22.4%) versus the BC group (9.6%) ( P < .0001). Conclusion: Low rates of recurrent shoulder stiffness and excellent improvements in ROM can be achieved after ACR in either the LD or BC position. Concomitant manipulation under anesthesia is performed more frequently in the BC position compared with the LD position.

scholarly journals Natural history and treatment options of radiation-induced brain cavernomas: a systematic review

2021 ◽  
Author(s):  
Gildas Patet ◽  
Andrea Bartoli ◽  
Torstein R. Meling
Keyword(s):  
Systematic Review ◽  
Natural History ◽  
Radiation Treatment ◽  
Neurological Deficits ◽  
Cochrane Library ◽  
Average Dose ◽  
Cavernous Malformations ◽  
Radiation Induced ◽  
The Mean

AbstractRadiation-induced cavernous malformations (RICMs) are delayed complications of brain irradiation during childhood. Its natural history is largely unknown and its incidence may be underestimated as RCIMS tend to develop several years following radiation. No clear consensus exists regarding the long-term follow-up or treatment. A systematic review of Embase, Cochrane Library, PubMed, Google Scholar, and Web of Science databases, following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, was performed. Based on our inclusion/exclusion criteria, 12 articles were included, totaling 113 children with RICMs, 86 were treated conservatively, and 27 with microsurgery. We were unable to precisely define the incidence and natural history from this data. The mean age at radiation treatment was 7.3 years, with a slight male predominance (54%) and an average dose of 50.0 Gy. The mean time to detection of RICM was 9.2 years after radiation. RICM often developed at distance from the primary lesion, more specifically frontal (35%) and temporal lobe (34%). On average, 2.6 RICMs were discovered per child. Sixty-seven percent were asymptomatic. Twenty-one percent presented signs of hemorrhage. Clinical outcome was favorable in all children except in 2. Follow-up data were lacking in most of the studies. RICM is most often asymptomatic but probably an underestimated complication of cerebral irradiation in the pediatric population. Based on the radiological development of RICMs, many authors suggest a follow-up of at least 15 years. Studies suggest observation for asymptomatic lesions, while surgery is reserved for symptomatic growth, hemorrhage, or focal neurological deficits.

scholarly journals Treatment strategies for cerebrospinal shunt infections: a systematic review of observational studies

BMJ Open ◽  
2020 ◽  
Vol 10 (12) ◽  
pp. e038978
Author(s):  
Joan L Robinson ◽  
Dolores Freire ◽  
Liza Bialy
Keyword(s):  
Systematic Review ◽  
Small Sample Size ◽  
Treatment Strategies ◽  
Small Sample ◽  
Cochrane Library ◽  
Csf Shunt ◽  
Entry Site ◽  
Recurrence Rates ◽  
Ovid Medline ◽  
Shunt Infections

ObjectiveA systematic review was conducted of studies comparing time to cerebrospinal fluid (CSF) sterilisation or rate of recurrence with different treatment strategies for CSF shunt infections.MethodsA librarian-directed search was conducted of Epub Ahead of Print, In-Process & Other Non-Indexed Citations, Ovid Medline Daily and Ovid Medline, Ovid Embase, Wiley Cochrane Library, CINAHL Plus with Full Text via EBSCOhost, Scopus Advanced Search, and Web of Science Core Collection from 1990 to May 2019. Studies of any design that compared outcomes in groups of any age with different management strategies were included. Studies that compared complete versus incomplete shunt removal were excluded. Quality assessment was performed with the Newcastle-Ottawa Scale.ResultsThe search identified 2208 records, of which 8 met the inclusion criteria. All were cohort studies of moderate quality. Four studies compared the duration of antibiotics; none demonstrates that a longer course prevented recurrences. Two studies analysed addition of rifampin, with one showing a decrease in recurrences while the other had a small sample size. No studies analysed the addition of intraventricular antibiotics, but one showed equally good results with once versus twice daily administration. One study reported no difference in recurrences with placement of antibiotic-impregnated catheters. Recurrence rates did not differ with shunt replacement minimum of 7 days vs less than 7 days after CSF became sterile. There were no recurrences in either group when shunt replacement was performed after sterile CSF cultures were obtained at 24 vs 48 hours after antibiotics were discontinued. A new shunt entry site did not decrease recurrences.DiscussionThe main limitations are the lack of high-quality studies, the small sample sizes and the heterogeneity which precluded meta-analysis. Addition of rifampin for staphylococcal infections may decrease relapse but requires further study.

scholarly journals Stereotactic radiosurgery for treating meningiomas eligible for complete resection

2021 ◽  
Vol 16 (1) ◽  
Author(s):  
Maximilian I. Ruge ◽  
Juman Tutunji ◽  
Daniel Rueß ◽  
Eren Celik ◽  
Christian Baues ◽  
...  
Keyword(s):  
Adverse Events ◽  
Stereotactic Radiosurgery ◽  
Medical Condition ◽  
Local Tumor Control ◽  
Complete Resection ◽  
Neurological Deficits ◽  
Tumor Control ◽  
Recurrence Rates ◽  
Treatment Volume

Abstract Background For meningiomas, complete resection is recommended as first-line treatment while stereotactic radiosurgery (SRS) is established for meningiomas of smaller size considered inoperable. If the patient´s medical condition or preference excludes surgery, SRS remains a treatment option. We evaluated the efficacy and safety of SRS in a cohort comprising these cases. Methods In this retrospective single-centre analysis we included patients receiving single fraction SRS either by modified LINAC or robotic guidance by Cyberknife for potentially resectable intracranial meningiomas. Treatment-related adverse events as well as local and regional control rates were determined from follow-up imaging and estimated by the Kaplan–Meier method. Results We analyzed 188 patients with 218 meningiomas. The median radiological, and clinical follow-up periods were 51.4 (6.2–289.6) and 55.8 (6.2–300.9) months. The median tumor volume was 4.2 ml (0.1–22), and the mean marginal radiation dose was 13.0 ± 3.1 Gy, with reference to the 80.0 ± 11.2% isodose level. Local recurrence was observed in one case (0.5%) after 239 months. The estimated 2-, 5-, 10- and 15-year regional recurrence rates were 1.5%, 3.0%, 6.6% and 6.6%, respectively. Early adverse events (≤ 6 months after SRS) occurred in 11.2% (CTCEA grade 1–2) and resolved during follow-up in 7.4% of patients, while late adverse events were documented in 14.4% (grade 1–2; one case grade 3). Adverse effects (early and late) were associated with the presence of symptoms or neurological deficits prior to SRS (p < 0.03) and correlated with the treatment volume (p < 0.02). Conclusion In this analysis SRS appears to be an effective treatment for patients with meningiomas eligible for complete resection and provides reliable long-term local tumor control with low rates of mild morbidity.

scholarly journals Prioritising recommendations following analyses of adverse events in healthcare: a systematic review

2020 ◽  
Vol 9 (4) ◽  
pp. e000843
Author(s):  
Kelly Bos ◽  
Maarten J van der Laan ◽  
Dave A Dongelmans
Keyword(s):  
Systematic Review ◽  
Adverse Events ◽  
Data Extraction ◽  
Data Sources ◽  
Cochrane Library ◽  
High Quality ◽  
Data Synthesis ◽  
Study Selection ◽  
Personal Opinion ◽  
User Friendly

PurposeThe purpose of this systematic review was to identify an appropriate method—a user-friendly and validated method—that prioritises recommendations following analyses of adverse events (AEs) based on objective features.Data sourcesThe electronic databases PubMed/MEDLINE, Embase (Ovid), Cochrane Library, PsycINFO (Ovid) and ERIC (Ovid) were searched.Study selectionStudies were considered eligible when reporting on methods to prioritise recommendations.Data extractionTwo teams of reviewers performed the data extraction which was defined prior to this phase.Results of data synthesisEleven methods were identified that are designed to prioritise recommendations. After completing the data extraction, none of the methods met all the predefined criteria. Nine methods were considered user-friendly. One study validated the developed method. Five methods prioritised recommendations based on objective features, not affected by personal opinion or knowledge and expected to be reproducible by different users.ConclusionThere are several methods available to prioritise recommendations following analyses of AEs. All these methods can be used to discuss and select recommendations for implementation. None of the methods is a user-friendly and validated method that prioritises recommendations based on objective features. Although there are possibilities to further improve their features, the ‘Typology of safety functions’ by de Dianous and Fiévez, and the ‘Hierarchy of hazard controls’ by McCaughan have the most potential to select high-quality recommendations as they have only a few clearly defined categories in a well-arranged ordinal sequence.

scholarly journals Potential of biomarkers during pharmacological therapy setting for postmenopausal osteoporosis: a systematic review

2021 ◽  
Vol 16 (1) ◽  
Author(s):  
Filippo Migliorini ◽  
Nicola Maffulli ◽  
Filippo Spiezia ◽  
Giuseppe Maria Peretti ◽  
Markus Tingart ◽  
...  
Keyword(s):  
Systematic Review ◽  
Adverse Events ◽  
Postmenopausal Osteoporosis ◽  
Randomized Clinical Trials ◽  
Type I Collagen ◽  
Therapy Monitoring ◽  
Pharmacological Therapy ◽  
Type I ◽  
Gastrointestinal Adverse Events

Abstract Background Biochemical markers of bone turnover (BTMs), such as the bone alkaline phosphatase (bALP), procollagen type I N propeptide (PINP), serum cross-linked C-telopeptides of type I collagen (bCTx), and urinary cross-linked N-telopeptides of type I collagen (NTx), are used to manage therapy monitoring in osteoporotic patients. This systematic review analyzed the potential of these BMTs in predicting the clinical outcomes in terms of BMD, t-score, rate of fractures, and adverse events during the therapy setting in postmenopausal osteoporosis. Methods All randomized clinical trials (RCTs) reporting data on biomarkers for postmenopausal osteoporosis were accessed. Only articles reporting quantitative data on the level of biomarkers at baseline and on the outcomes of interest at the last follow-up were eligible. Results A total of 36,706 patients were retrieved. Greater values of bALP were associated with a greater rate of vertebral (P = 0.001) and non-vertebral fractures (P = 0.0001). Greater values of NTx at baseline were associated with a greater rate of adverse events at the last follow-up (P = 0.02). Greater values of CTx at baseline were associated with a greater rate of adverse events leading to discontinuation (P = 0.04), gastrointestinal adverse events (P = 0.0001), musculoskeletal adverse events (P = 0.04), and mortality (P = 0.04). Greater values of PINP at baseline were associated with greater rates of gastrointestinal adverse events (P = 0.02) at the last follow-up. Conclusion The present analysis supports the adoption of BMTs during pharmacological therapy setting of patients suffering from osteoporosis. Level of evidence I, systematic review of RCTs

scholarly journals Daily sodium consumption and CVD mortality in the general population: systematic review and meta-analysis of prospective studies

2014 ◽  
Vol 18 (4) ◽  
pp. 695-704 ◽  
Author(s):  
Rosana Poggio ◽  
Laura Gutierrez ◽  
María G Matta ◽  
Natalia Elorriaga ◽  
Vilma Irazola ◽  
...  
Keyword(s):  
Systematic Review ◽  
Relative Risk ◽  
General Population ◽  
Prospective Studies ◽  
Meta Analysis ◽  
Cochrane Library ◽  
Random Effects Models ◽  
Meta Regression ◽  
Cvd Mortality

AbstractObjectiveThe purpose of the present study was to determine whether elevated dietary Na intake could be associated with CVD mortality.DesignWe performed a systematic review and meta-analysis of prospective studies representing the general population. The adjusted relative risks and their 95 % confidence intervals were pooled by the inverse variance method using random-effects models. Heterogeneity, publication bias, subgroup and meta-regression analyses were performed.SettingsMEDLINE (since 1973), Embase (since 1975), the Cochrane Library (since 1976), ISI Web of Science, Google Scholar (until September 2013) and secondary referencing were searched for inclusion in the study.SubjectEleven prospective studies with 229 785 participants and average follow-up period of 13·37 years (range 5·5–19 years).ResultsHigher Na intake was significantly associated with higher CVD mortality (relative risk=1·12; 95 % CI 1·06, 1·19). In the sensitivity analysis, the exclusion of studies with important relative weights did not significantly affect the results (relative risk=1·08; 95 % CI 1·01, 1·15). The meta-regression analysis showed that for every increase of 10 mmol/d in Na intake, CVD mortality increased significantly by 1 % (P=0·016). Age, hypertensive status and length of follow-up were also associated with increased CVD mortality.ConclusionsHigher Na intake was associated with higher CVD mortality in the general population; this result suggests a reduction in Na intake to prevent CVD mortality from any cause.

scholarly journals Least possible fixation techniques of 4-part valgus impacted fractures of the proximal humerus: a systematic review

2016 ◽  
Vol 8 (1) ◽  
Author(s):  
Andreas Panagopoulos ◽  
Irini Tatani ◽  
Dimitrios Ntourantonis ◽  
Ioannis Seferlis ◽  
Antonis Kouzelis ◽  
...  
Keyword(s):  
Systematic Review ◽  
Avascular Necrosis ◽  
Proximal Humerus ◽  
Constant Score ◽  
Surgical Techniques ◽  
Case Series ◽  
Cochrane Library ◽  
Operation Rate ◽  
Fixation Techniques

The valgus-impacted (VI) 4-part fractures are a subset of fractures of the proximal humerus with a unique anatomic configuration characterized by a relatively lower incidence of avascular necrosis after operative intervention. We systematically reviewed clinical studies assessing the benefits and harms of least possible fixation techniques (LPFT) for this unique fracture type. Such information would be potentially helpful in developing an evidence-based approach in the management of these complex injuries. We performed analytic searches of PubMed, Embase, Web of Science, Google Scholar and the Cochrane Library, restricting it to the years 1991-2014. Included studies had to describe outcomes and complications after primary osteosynthesis with any type of LPFT apart from plate-screws and intramedullary nailing. Eligibility criteria were also included English language, more than 5 cases, minimum follow up of one year and report of clinical outcome using at least one relevant score (Constant, Neer or ASES). Based on 292 database hits we identified 12 eligible studies including 190 four-part valgus impacted fractures in 188 patients. All eligible studies were case series composed of min 8 to max 45 patients per study. The gender distribution was 60% (112) female and 40% (76) male. The average age of the patients at the time of injury was 54.5 years. In 8/12 studies an open reduction was used for fracture fixation using different surgical techniques including KW, cerclage wires, cannulated screws and osteosutures. Closed reduction and percutaneous fixation was used in 4 studies. Mean follow-up time ranged from 24 to 69 months. A good functional outcome (constant score &gt;80) was reported in 9/12 studies. The most common complication was avascular necrosis of the humeral head with an overall incidence of 11% (range, 0-26.3%). Total avascular necrosis (AVN) was found in 15/188 patients (7.9%) and was more common in percutaneous techniques and partial AVN in 6/188 (3.1%) being more common in open techniques. The overall re-operation rate was very low (3.7%). Insufficient study designs cannot provide definite treatment recommendations and quantitative data synthesis of outcome. In general, LPFT for 4-part VI fractures leads to satisfactory outcomes with low incidence of complications. A considerable risk of biases can be attributed to fracture classification, proper radiological control, mean age of patients, mixed types of fixation methods, nonage adjusted clinical scoring and small follow up periods. These factors are discussed in detail. Level of evidence: systematic review of literature (level IV) as most of the studies were level IV.

Recurrence Rate of Sporadic Pheochromocytomas After Curative Adrenalectomy: A Systematic Review and Meta-analysis

2020 ◽  
Author(s):  
Isabelle Holscher ◽  
Tijs J van den Berg ◽  
Koen M A Dreijerink ◽  
Anton F Engelsman ◽  
Els J M Nieveen van Dijkum
Keyword(s):  
Systematic Review ◽  
Recurrence Rate ◽  
Meta Analysis ◽  
Cochrane Library ◽  
Weighted Mean ◽  
Curative Surgery ◽  
Endocrine Society ◽  
Time To Recurrence ◽  
The Cochrane Library

Abstract Background Evidence on follow-up duration for patients with sporadic pheochromocytomas is absent, and current guidelines of the European Society of Endocrinology, American Association of Clinical Endocrinologists and Endocrine Surgeons, and the Endocrine Society are ambiguous about the appropriate duration of follow-up. The aim of this systematic review and meta-analysis is to evaluate the recurrence rate of sporadic pheochromocytomas after curative adrenalectomy. Materials and Methods A literature search in PubMed, Embase, and the Cochrane Library was performed. A study was eligible if it included a clear report on the number of sporadic patients, recurrence rate, and follow-up duration. Studies with an inclusion period before 1990, &lt;2 years of follow-up, &lt;10 patients, and unclear data on the sporadic nature of pheochromocytomas were excluded. A meta-analysis on recurrence was performed provided that the heterogeneity was low (I2 &lt; 25%) or intermediate (I2 26–75%). Hozo’s method was used to calculate weighted mean follow-up duration and weighted time to recurrence with combined standard deviations (SDs). Results A total of 13 studies, including 430 patients, were included in the synthesis. The meta-analysis results describe a pooled recurrence rate after curative surgery of 3% (95% confidence interval: 2–6%, I2 = 0%), with a weighted mean time to recurrence of 49.4 months (SD = 30.7) and a weighted mean follow-up period of 77.3 months (SD = 32.2). Conclusions This meta-analysis shows a very low recurrence rate of 3%. Prospective studies, including economical and health effects of limited follow-up strategies for patients with truly sporadic pheochromocytomas should be considered.

scholarly journals Nervous and Muscular Adverse Events after COVID-19 Vaccination: A Systematic Review and Meta-Analysis of Clinical Trials

Vaccines ◽  
2021 ◽  
Vol 9 (8) ◽  
pp. 939
Author(s):  
Jiaxin Chen ◽  
Yuangui Cai ◽  
Yicong Chen ◽  
Anthony P. Williams ◽  
Yifang Gao ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Adverse Events ◽  
Fixed Effects ◽  
Meta Analysis ◽  
Phase 1 ◽  
Cochrane Library ◽  
Categorical Variables ◽  
Control Group ◽  
Open Label

Background: Nervous and muscular adverse events (NMAEs) have garnered considerable attention after the vaccination against coronavirus disease (COVID-19). However, the incidences of NMAEs remain unclear. We aimed to calculate the pooled event rate of NMAEs after COVID-19 vaccination. Methods: A systematic review and meta-analysis of clinical trials on the incidences of NMAEs after COVID-19 vaccination was conducted. The PubMed, Medline, Embase, Cochrane Library, and Chinese National Knowledge Infrastructure databases were searched from inception to 2 June 2021. Two independent reviewers selected the study and extracted the data. Categorical variables were analyzed using Pearson’s chi-square test. The pooled odds ratio (OR) with the corresponding 95% confidence intervals (CIs) were estimated and generated with random or fixed effects models. The protocol of the present study was registered on PROSPERO (CRD42021240450). Results: In 15 phase 1/2 trials, NMAEs occurred in 29.2% vs. 21.6% (p < 0.001) vaccinated participants and controls. Headache and myalgia accounted for 98.2% and 97.7%, and their incidences were 16.4% vs. 13.9% (OR = 1.97, 95% CI = 1.28–3.06, p = 0.002) and 16.0% vs. 7.9% (OR = 3.31, 95% CI = 2.05–5.35, p < 0.001) in the vaccine and control groups, respectively. Headache and myalgia were more frequent in the newly licensed vaccines (OR = 1.97, 95% CI = 1.28–3.06, p = 0.02 and OR = 3.31, 95% CI = 2.05–5.35, p < 0.001) and younger adults (OR = 1.40, 95% CI = 1.12–1.75, p = 0.003 and OR = 1.54, 95% CI = 1.20–1.96, p < 0.001). In four open-label trials, the incidences of headache, myalgia, and unsolicited NMAEs were 38.7%, 27.4%, and 1.5%. Following vaccination in phase 3 trials, headache and myalgia were still common with a rate of 29.5% and 19.2%, although the unsolicited NMAEs with incidence rates of ≤ 0.7% were not different from the control group in each study. Conclusions: Following the vaccination, NMAEs are common of which headache and myalgia comprised a considerable measure, although life-threatening unsolicited events are rare. NMAEs should be continuously monitored during the ongoing global COVID-19 vaccination program.

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