Global burden of vaccine‐associated hepatobiliary and gastrointestinal adverse drug reactions, 1967–2023: A comprehensive analysis of the international pharmacovigilance database

Journal of Medical Virology, Journal Year: 2024, Volume and Issue: 96(7)

Published: July 1, 2024

Abstract Although previous studies have focused on hepatobiliary and gastrointestinal adverse drug reactions (ADRs) associated with COVID‐19 vaccines, literature such ADRs other vaccines is limited, particularly a global scale. Therefore, we aimed to investigate the burden of vaccine‐associated identify implicated in these occurrences. This study utilized data from World Health Organization (WHO) international pharmacovigilance database extract reports 1967 2023 (total = 131 255 418). Through reporting counts, reported odds ratios (ROR) 95% confidence interval (CI), information components (IC) IC 0.25 , examined association between 16 incidence across 156 countries. Of 6 842 303 ADRs, 10 786 liver injury, 927 870 symptoms, 2978 pancreas bile duct 96 intra‐abdominal hemorrhage were identified. Most surged after 2020, majority attributed messenger RNA (mRNA) vaccines. Hepatitis A exhibited highest injury (ROR [95% CI]: 10.30 [9.65–10.99]; [IC ]: 3.33 [3.22]), followed by hepatitis B, typhoid, rotavirus. Specifically, ischemic had significant both Ad5‐vectored mRNA Gastrointestinal symptoms all except for tuberculosis rotavirus (11.62 [11.45–11.80]; 3.05 [3.03]) typhoid (11.02 [10.66–11.39]; 3.00 [2.96]). Pancreas (1.99 [1.89–2.09]; 0.90 [0.83]), MMR (measles, mumps, rubella), papillomavirus For hemorrhage, inactivated whole‐virus (3.93 [1.86–8.27]; 1.71 [0.41]) association, (1.81 [1.42–2.29]; 0.77 [0.39]). short time onset, within 1 day, low mortality rate. scale database, occurred emphasizing importance healthcare workers' vigilant monitoring timely management.

Language: Английский

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Global and regional burden of vaccine‐associated facial paralysis, 1967–2023: Findings from the WHO international pharmacovigilance database

Journal of Medical Virology, Journal Year: 2024, Volume and Issue: 96(6)

Published: May 24, 2024

Abstract The scarce and conflicting data on vaccine‐associated facial paralysis limit our understanding of vaccine safety a global scale. Therefore, this study aims to evaluate the burden identify extent its association with individual vaccines, thereby contributing development more effective vaccination program. We used from 1967 2023 (total reports, n = 131 255 418 418) World Health Organization International Pharmacovigilance Database. Global reporting counts, reported odds ratios (ROR), information components (ICs) were computed elucidate between 16 vaccines occurrence across 156 countries. identified 26 197 reports (men, 10 507 [40.11%]) 49 537 all‐cause paralysis. Vaccine‐associated has been consistently reported; however, pronounced increase in incidence emerged after onset coronavirus disease 2019 (COVID‐19) pandemic, which is attributable COVID‐19 mRNA vaccine. Most associated paralysis, differing levels association, except for tuberculosis vaccines. had highest (ROR, 28.31 [95% confidence interval, 27.60–29.03]; IC, 3.37 [IC 0.25 , 3.35]), followed by encephalitis, influenza, hepatitis A, papillomavirus, B, typhoid, varicella‐zoster, meningococcal, Ad‐5 vectored COVID‐19, measles, mumps rubella, diphtheria, tetanus toxoids, pertussis, polio, Hemophilus influenza type b, pneumococcal, rotavirus diarrhea, inactivated whole‐virus Concerning age‐ sex‐specific risks, was strongly older age groups males. serious adverse outcome death rate extremely low (0.07% 0.00%, respectively). An vaccine‐induced primarily owing observed most Given higher male close monitoring these demographics when administering that are significantly reactions crucial.

Language: Английский

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Exploring the relationship between experience of vaccine adverse events and vaccine hesitancy: A scoping review

Human Vaccines & Immunotherapeutics, Journal Year: 2025, Volume and Issue: 21(1)

Published: March 9, 2025

Fear of side effects is the main motive for vaccine refusal. However, before COVID-19 pandemic, little attention had been paid to actual experience adverse events and its relationship with hesitancy. This scoping review aimed analyze impact VH on EAE vice versa. We reviewed 55 articles. Most studies focused vaccination employed cross-sectional surveys self-reported indicators. These identified significant correlations between VH. Social cognitive models shed some light influence VH, while converse usually explained by nocebo effect that predominately accounts converse. emerging research field hampered inconsistencies in theoretical explanations, assessments relationship, measurements these two phenomena. A more comprehensive consideration individual experience, both objective subjective, would help develop effective communication strategies improve pharmacological surveillance.

Language: Английский

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Allergy-like nocebo events reported with COVID-19 vaccines: a case control study

Expert Opinion on Drug Safety, Journal Year: 2025, Volume and Issue: unknown

Published: April 23, 2025

Allergy-like symptoms after COVID-19 vaccination are frequently reported, though true allergic reactions rare. Clinical trials suggest many reported may reflect nocebo effects. This study aimed to characterize responses and identify associated factors. A case-control was conducted using pharmacovigilance records a cross-sectional questionnaire. Cases were defined as patients reporting allergy-like without anaphylaxis; controls reactogenicity or localized reactions. Data on demographics, medical history, vaccinations, psychological factors analyzed multivariate logistic regression risk with Among 1038 participants, 320 cases 718 controls. cutaneous (71.8%) respiratory (38.8%) symptoms, 43.4% occurring the first dose. Nocebo positively history of allergy (OR 1.78, 95%CI: 1.32-2.4) COMIRNATY vaccine 1.60, 1.20-2.14), negatively correlated perceived effectiveness 0.93, 0.88-0.98). The effect appears differ by type is more common in individuals lower effectiveness. While further research needed validate these findings, this underscores importance clear, evidence-based communication reduce responses.

Language: Английский

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Prior therapeutic experiences and treatment expectations are differentially associated with pain-related disability in individuals with chronic pain

Scientific Reports, Journal Year: 2025, Volume and Issue: 15(1)

Published: April 26, 2025

Language: Английский

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Patients’ Expectations and Perspectives on Follow-up Care after Bariatric Surgery in Germany

Obesity Surgery, Journal Year: 2025, Volume and Issue: unknown

Published: April 30, 2025

Abstract Background Bariatric surgery is the most effective treatment for patients with obesity. After surgery, lifelong follow-up care recommended to improve weight-loss outcomes. However, attendance low, and reasons have yet be determined. Therefore, present study aimed identify patients’ expectations perspectives on after bariatric current unmet needs ways increase attendance. Methods Patients who underwent at a university medical center attended least one appointment completed an online questionnaire. The questionnaire consisted of open-ended questions regarding care. Content analysis was applied qualitatively analyze results. Results In total, 164 responded question (participation rate 50.1%). On average, had three appointments time study. Expectations concerning content included regular examinations, blood tests, psychological nutritional counseling support. Notably, criticized its lack support, many suggesting that these services incorporated. Interestingly, rarely connected better Regular laboratory results were among positive aspects Conclusions mostly related few seemed recognize importance improved educating about critical role might also lead more successful long-term

Language: Английский

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Pharmacovigilance in Vaccines: Importance, Main Aspects, Perspectives, and Challenges—A Narrative Review

Pharmaceuticals, Journal Year: 2024, Volume and Issue: 17(6), P. 807 - 807

Published: June 19, 2024

Pharmacovigilance plays a central role in safeguarding public health by continuously monitoring the safety of vaccines, being critical climate vaccine hesitancy, where trust is paramount. strategies employed to gather information on adverse events following immunization (AEFIs) include pre-registration data, media reports, clinical trials, and societal reporting. Early detection AEFIs during trials crucial for thorough analysis preventing serious reactions once vaccines are deployed. This review highlights importance reporting, encompassing contributions from community members, healthcare workers, pharmaceutical companies. Technological advancements such as quick response (QR) codes can facilitate prompt AEFI While demonstrably safe, possibility necessitates continuous post-marketing surveillance. However, underreporting remains challenge, underscoring engagement pharmacovigilance. narrative comprehensively examines synthesizes key aspects virus pharmacovigilance, with special considerations specific population groups. We explore applicable legislation, spectrum associated major unique challenges perspectives surrounding pharmacovigilance this domain.

Language: Английский

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The long-term tolerability of BNT162b2 in children and adolescents (The CoVacU18 Study)

Deutsches Ärzteblatt international, Journal Year: 2025, Volume and Issue: unknown

Published: May 7, 2025

The available safety data on the use of messenger RNA-based COVID-19 vaccine BNT162b2 in persons under age 18 are limited to observation periods up six months. In a retrospective, cross-sectional study, we evaluated self-reported tolerability (SRVT) eleven symptom categories among who were years old when they received at least one dose Germany or after 1 October 2021. Data collected online from parents legal guardians vaccinated persons. Individual participation codes enabled authenticated and pseudonymous survey. subgroup, SRVT was compared with that vaccines against other illnesses than SARS-CoV-2 (e.g., influenza). Tolerability obtained 3228 median 5.7 years; 49.6% male. period 524 days. more commonly reported undesired effects vaccine, mainly older subjects, local reactions-pain (49.7%), redness (23%)-with less common systemic symptoms including fatigue (20.1%), fever (11.4%), general feeling illness (8.0%), headache (6.5%). Compared illnesses, associated (gastrointestinal, musculoskeletal, dermatological, neurological, psychological). 41 (1.3%) subjects their persisted for ≥90 days vaccination BNT162b2: these psychological (15 subjects), neurological (9 dermatological (8 subjects). There 45 serious adverse events; female sex (OR = 4.70, 95% confidence interval [2.17; 10.20]) long-term medication 4.06 [1.53; 10.79]). Vaccination reportedly well tolerated by 98% children adolescents it, although SARS-CoV-2. participants our study may have had positive attitude toward vaccination. On hand, selection bias might exist experienced side effects.

Language: Английский

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The influence of psychological traits and prior experience on treatment expectations

Comprehensive Psychiatry, Journal Year: 2023, Volume and Issue: 127, P. 152431 - 152431

Published: Oct. 14, 2023

Placebo and nocebo responses are modulated by the treatment expectations of participants patients. However, interindividual differences predicting placebo unclear. In this large-scale pooled analysis, we aim to investigate influence psychological traits prior experiences on expectations.This paper analyses data from six different studies (total n = 748). all studies, participants' sociodemographic information, relating stress, somatization, depression anxiety, Big Five behavioral inhibition approach tendencies were assessed using same established questionnaires. Correlation coefficients structural equation models calculated relationship between trait variables expectations.We found small positive correlations side effect improvement (r 0.187), perceived stress 0.154), somatization 0.115), agitation 0.108), anhedonia 0.118), dysthymia 0.118). model previous emerged as strongest predictors (β 0.32, p .005), worsening -0.24, .005) 0.47, .005). Traits related affect - 0.09; .007) negative 0.04; .014) associated with study is first large analysis traits, expectations. Exploratory indicate that symptom expectations, while only Additionally, a proneness experience may be predictor for expectation thus mediate occurrence responses.

Language: Английский

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Migraine worsening after COVID‐19 and COVID‐19 vaccination: Are we facing a nocebo effect?

European Journal of Neurology, Journal Year: 2023, Volume and Issue: 30(12), P. 3877 - 3885

Published: Oct. 4, 2023

In clinical practice patients may report migraine worsening as a consequence of COVID-19 (either infection or vaccines), however, data in this area are lacking. We aimed to investigate the link between and vaccination with its associated factors.An online survey was sent followed up Spanish Headache Clinic, collecting demographic data, information regarding SARS-CoV-2 vaccination. asked if they had noticed their after these events assessed concerns about infection, worsening. also extracted from participants' own electronic diaries (e-diaries), including 1-month before reported and/or compared participants who self-reported since those did not.Of 550 participants, 44.9% (247/550) having at least once 83.3% (458/550) been vaccinated. Sixty-one 52 Among risk factors for perceived two settings (infection vaccination) concern itself (infection: odds ratio [OR] 2.498 [95% CI: 1.02-6.273], p = 0.046; vaccination: OR 17.3 confidence interval 5.3-68], < 0.001). e-diary available 136 patients, 38.2% (52/136) 39.7% (54/136) observed no significant difference headache frequency 1 month vaccination, even when comparing without worsening.Our preliminary point negligible role on possible presence nocebo effect settings, remarkable proportion clear perception

Language: Английский

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