COVID-19 Vaccine Safety Studies among Vulnerable Populations: A Systematic Review and Meta-analysis of 120 Observational Studies and Randomized Clinical Trials DOI

Sima Mohammadi,

Malede Mequanent Sisay, Putri Widi Saraswati

и другие.

medRxiv (Cold Spring Harbor Laboratory), Год журнала: 2024, Номер unknown

Опубликована: Дек. 29, 2024

Abstract BACKGROUND The COVID-19 vaccines were rapidly developed and tested, but concerns about vaccine-related adverse events remain, especially in vulnerable groups like pregnant women, children, those with certain health conditions. This review aims to summarize rates of such individuals often not included randomized clinical trials (RCT). METHOD From December 2019 February 2022, we searched Embase Medline for observational studies RCTs on post-COVID-19 vaccination groups. We examined serious non-serious specific medical conditions, infants, individuals, socioeconomically disadvantaged individuals. Cumulative risks all calculated. Incidence rate (IR) 95% confidence intervals reported that met the follow-up period criteria based referenced literature. For data exposed unexposed groups, calculated odds ratio. Pooled incidence per 1000 person-days using a random-effects model. Sub-group analyses conducted vaccine types doses, heterogeneity assessed I 2 . FINDINGS Of 4,254 papers, 235 eligibility criteria, including 120 171,073 participants (113 observational, eight RCTs. 17 severe 7 non-severe event categories. Lymphadenopathy (IR: 1.95[1.20;3.19]), autoimmune disease multiple sclerosis flare-up (1.13 [0.47;2.68]), cardiac symptoms (0.26[0.00;10.58]) most events. Allergic reactions more common among (7.03[4.10;12.06]) cancer (4.87[2.21;10.76]) vaccinees who received second dose had higher proportions flare-ups (39.27 [18.08;85.31] vs 22.13 [10.22; 47.93]); (6.11[2.05-18.22] 3.78[2.53-5.65]); (5.34[1.69;16.90] 5.05[1.40,18.19]) studies. INTERPRETATION highlights safety populations, enhancing strategies. Further real-world research is needed validate extend our findings, addressing gaps

Язык: Английский

Self‐Reported Adverse Events Following COVID‐19 Vaccination Among Medical Sciences Students After a Symptomatology Training Program: A Cross‐Sectional Study DOI Creative Commons
Taraneh Tavanaei Tamanaei, Mohammad Bagher Oghazian,

Mehran Mojtabaee

и другие.

Health Science Reports, Год журнала: 2025, Номер 8(3)

Опубликована: Март 1, 2025

Accurate and transparent investigation of adverse events (AEs) following COVID-19 vaccination enhances social trust confidence in programs. This study aimed to assess the prevalence vaccination-related AEs among medical sciences students. In this cross-sectional study, a self-administered survey via Google Forms was conducted evaluate associated with AZD1222 (Oxford-AstraZeneca) BBIBP-CorV (Sinopharm) vaccines Data were collected participation training program focused on symptomatology AEs, which designed reduce confirmation bias. A total 263 students from North Khorasan University Medical Sciences, Bojnurd, Iran, participated data collection occurring August 8 September 1, 2021. The median age population 23 years (IQR: 22-24), 207 participants being female (78.7%). Following first dose, significantly more common Oxford-AstraZeneca group compared Sinopharm [OR 12.93 (5.57-30.03), p < 0.001]. However, second there no significant difference between 1.45 (0.86-2.46), = 0.17]. Injection site pain, fever, body/muscle headache, feeling unwell, fatigue most both vaccines, variations doses. type vaccine sex only factors influencing AEs. Notably, odds experiencing higher women men. findings indicated that for vaccine. Further research is necessary explore impact utilizing standardized definitions terminology ensuring accurate consistent reporting.

Язык: Английский

Процитировано

0

Health-related quality of life in adolescents with myocarditis and pericarditis after BNT162b2 COVID-19 vaccination: Korean national surveillance DOI
Yoonsun Yoon, Myung-Jae Hwang, Seung Hwan Shin

и другие.

European Journal of Cardiovascular Nursing, Год журнала: 2025, Номер unknown

Опубликована: Март 5, 2025

Abstract Aims Concerns have been raised regarding the potential causal relationship between myocarditis and mRNA COVID-19 vaccines. In response, Korea Disease Control Prevention Agency actively monitored pericarditis in adolescents who received vaccines South Korea. Understanding long-term health outcomes of these cases is essential for developing evidence-based national policies. We aimed to identify health-related quality life (HRQoL) through follow-up observations this population. Methods results This cross-sectional descriptive study was conducted utilizing a self-reported online structured survey. Adolescents diagnosed with or after receiving vaccination were recruited from those compensation decisions Agency. Health-related life, depression, anxiety, subjective status, self-efficacy measured, correlations differences among variables analysed. The 45 participants obtained an average HRQoL score 81.6 out 100 points. mean depression 13, 44.4% reporting increase depressive symptoms, following their diagnosis pericarditis. Anxiety, 2.96, reported increased by 51.1% diagnosis. 59. Conclusion These suggest that individuals experiencing may encounter physical psychological challenges, underscoring need comprehensive support evaluation.

Язык: Английский

Процитировано

0

Genome-wide association study of myocarditis and pericarditis following COVID-19 vaccination DOI Creative Commons
Marco Cavalli, Niclas Eriksson, Tomasz Baron

и другие.

npj Vaccines, Год журнала: 2025, Номер 10(1)

Опубликована: Май 8, 2025

Язык: Английский

Процитировано

0

COVID-19 vaccine safety studies among special populations: A systematic review and meta-analysis of 120 observational studies and randomized clinical trials DOI Creative Commons

Sima Mohammadi,

Malede Mequanent Sisay, Putri Widi Saraswati

и другие.

Vaccine, Год журнала: 2025, Номер 61, С. 127342 - 127342

Опубликована: Июнь 4, 2025

Язык: Английский

Процитировано

0

The WHO Algorithm for Causality Assessment of Adverse Effects Following Immunization with Genetic-Based Anti-COVID-19 Vaccines: Pitfalls and Suggestions for Improvement DOI Open Access
Paolo Bellavite, Alberto Donzelli, Ciro Isidoro

и другие.

Journal of Clinical Medicine, Год журнала: 2024, Номер 13(23), С. 7291 - 7291

Опубликована: Ноя. 30, 2024

Clarifying and differentiating the causes of diseases is an essential step in any clinical activity, but it takes on particular relevance complexity case that arise following vaccinations. The WHO has proposed a protocol uses list specific questions about vaccine-related adverse events algorithm for making judgement. Here, we analyze discuss important limitations this when applied to new genetic-based anti-COVID-19 vaccines, particularly once dealing with rare unexpected pathological events. main controversial aspects concern: (a) prevailing consideration other possible causes; (b) biological plausibility choice appropriate time window consider effects possibly caused by vaccines; (c) reference scientific literature, which may be very limited often early stages introducing vaccines because short period observation; (d) final classification into only three classes, leaves ample space "indeterminate" category. Failure address these issues lead distorted pharmacovigilance reports significant consequences benefit/harm assessment. In anticipation future pandemics managed needs revised protocols monitoring evaluation take account novel mechanism action real-world epidemiological data.

Язык: Английский

Процитировано

0

COVID-19 Vaccine Safety Studies among Vulnerable Populations: A Systematic Review and Meta-analysis of 120 Observational Studies and Randomized Clinical Trials DOI

Sima Mohammadi,

Malede Mequanent Sisay, Putri Widi Saraswati

и другие.

medRxiv (Cold Spring Harbor Laboratory), Год журнала: 2024, Номер unknown

Опубликована: Дек. 29, 2024

Abstract BACKGROUND The COVID-19 vaccines were rapidly developed and tested, but concerns about vaccine-related adverse events remain, especially in vulnerable groups like pregnant women, children, those with certain health conditions. This review aims to summarize rates of such individuals often not included randomized clinical trials (RCT). METHOD From December 2019 February 2022, we searched Embase Medline for observational studies RCTs on post-COVID-19 vaccination groups. We examined serious non-serious specific medical conditions, infants, individuals, socioeconomically disadvantaged individuals. Cumulative risks all calculated. Incidence rate (IR) 95% confidence intervals reported that met the follow-up period criteria based referenced literature. For data exposed unexposed groups, calculated odds ratio. Pooled incidence per 1000 person-days using a random-effects model. Sub-group analyses conducted vaccine types doses, heterogeneity assessed I 2 . FINDINGS Of 4,254 papers, 235 eligibility criteria, including 120 171,073 participants (113 observational, eight RCTs. 17 severe 7 non-severe event categories. Lymphadenopathy (IR: 1.95[1.20;3.19]), autoimmune disease multiple sclerosis flare-up (1.13 [0.47;2.68]), cardiac symptoms (0.26[0.00;10.58]) most events. Allergic reactions more common among (7.03[4.10;12.06]) cancer (4.87[2.21;10.76]) vaccinees who received second dose had higher proportions flare-ups (39.27 [18.08;85.31] vs 22.13 [10.22; 47.93]); (6.11[2.05-18.22] 3.78[2.53-5.65]); (5.34[1.69;16.90] 5.05[1.40,18.19]) studies. INTERPRETATION highlights safety populations, enhancing strategies. Further real-world research is needed validate extend our findings, addressing gaps

Язык: Английский

Процитировано

0