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Although previous studies have focused on hepatobiliary and gastrointestinal adverse drug reactions (ADRs) associated with COVID‐19 vaccines, literature on such ADRs with other vaccines is limited, particularly on a global scale. Therefore, we aimed to investigate the global burden of vaccine‐associated hepatobiliary and gastrointestinal ADRs and identify the vaccines implicated in these occurrences. This study utilized data from the World Health Organization (WHO) international pharmacovigilance database to extract reports of vaccine‐associated hepatobiliary and gastrointestinal ADRs from 1967 to 2023 (total reports = 131 255 418). Through global reporting counts, reported odds ratios (ROR) with 95% confidence interval (CI), and information components (IC) with IC0.25, the study examined the association between 16 vaccines and the incidence of hepatobiliary and gastrointestinal ADRs across 156 countries. Of the 6 842 303 reports in the vaccine‐associated ADRs, 10 786 reports of liver injury, 927 870 reports of gastrointestinal symptoms, 2978 reports of pancreas and bile duct injury, and 96 reports of intra‐abdominal hemorrhage between 1967 and 2023 were identified. Most hepatobiliary and gastrointestinal ADRs surged after 2020, with the majority of reports attributed to COVID‐19 messenger RNA (mRNA) vaccines. Hepatitis A vaccines exhibited the highest association with liver injury (ROR [95% CI]: 10.30 [9.65–10.99]; IC [IC0.25]: 3.33 [3.22]), followed by hepatitis B, typhoid, and rotavirus. Specifically, ischemic hepatitis had a significant association with both Ad5‐vectored and mRNA COVID‐19 vaccines. Gastrointestinal symptoms were associated with all vaccines except for tuberculosis vaccines, particularly with rotavirus (11.62 [11.45–11.80]; 3.05 [3.03]) and typhoid (11.02 [10.66–11.39]; 3.00 [2.96]). Pancreas and bile duct injury were associated with COVID‐19 mRNA (1.99 [1.89–2.09]; 0.90 [0.83]), MMR (measles, mumps, and rubella), and papillomavirus vaccines. For intra‐abdominal hemorrhage, inactivated whole‐virus COVID‐19 vaccines (3.93 [1.86–8.27]; 1.71 [0.41]) had the highest association, followed by COVID‐19 mRNA (1.81 [1.42–2.29]; 0.77 [0.39]). Most of these ADRs had a short time to onset, within 1 day, and low mortality rate. Through a global scale database, the majority of ADRs occurred within 1 day, emphasizing the importance of healthcare workers' vigilant monitoring and timely management. [ABSTRACT FROM AUTHOR]

Due to the limitation of previous studies examining adverse reports of myocarditis and pericarditis associated with vaccines other than the COVID‐19 vaccine, there are challenges in establishing a comprehensive understanding of vaccine safety on a global scale. Hence, the objective of this study was to examine the worldwide burden of vaccine‐associated pericarditis and myocarditis and the vaccines associated with these indications. This study utilized the World Health Organization international pharmacovigilance database, from which records of vaccine‐associated pericarditis and myocarditis between 1969 and 2023 were extracted (over 130 million reports). We calculated global reporting counts, reported odds ratios (RORs), and information components (ICs) to discern the association between 19 vaccines and the occurrence of pericarditis and myocarditis across 156 countries and territories. We identified 49 096 reports (male, n = 30 013) of vaccine‐associated pericarditis and myocarditis among 73 590 reports of all‐cause pericarditis and myocarditis. There has been a significant increase in reports of vaccine‐related cardiac adverse events over time, with a noteworthy surge observed after 2020, attributed to cases of pericarditis associated with COVID‐19 mRNA vaccines. Smallpox vaccines were associated with most pericarditis and myocarditis reports (ROR: 73.68 [95% CI, 67.79–80.10]; IC [IC0.25]: 6.05 [5.91]), followed by COVID‐19 mRNA vaccine (37.77 [37.00–38.56]; 3.07 [3.05]), anthrax vaccine (25.54 [22.37–29.16]; 4.58 [4.35]), typhoid vaccine (6.17 [5.16–7.38]; 2.59 [2.29]), encephalitis vaccine (2.00 [1.48–2.71]; 0.99 [0.47]), influenza vaccine (1.87 [1.71–2.04]; 0.90 [0.75]), and Ad5‐vectored COVID‐19 vaccine (1.40 [1.34–1.46]; 0.46 [0.39]). Concerning age and sex‐specific risks, reports of vaccine‐associated pericarditis and myocarditis were more prevalent among males and in older age groups. The age group between 12 and 17 years exhibited significant sex disproportion. Most of these adverse events had a short time to onset (median time: 1 day) and fatality rate was 0.44%. Our analysis of global data revealed an increase in pericarditis and myocarditis reports associated with vaccines, particularly live vaccines like smallpox and anthrax, notably in young males. While these adverse events are generally rare and mild, caution is warranted, especially for healthcare workers, due to potential myocardial injury‐related in‐hospital mortality. Further study with validated reporting is crucial to enhance accuracy in evaluating the correlation between vaccines and cardiac conditions for preventive measures. [ABSTRACT FROM AUTHOR]

The scarce and conflicting data on vaccine‐associated facial paralysis limit our understanding of vaccine safety on a global scale. Therefore, this study aims to evaluate the global burden of vaccine‐associated facial paralysis and to identify the extent of its association with individual vaccines, thereby contributing to the development of a more effective vaccination program. We used data on vaccine‐associated facial paralysis from 1967 to 2023 (total reports, n = 131 255 418 418) from the World Health Organization International Pharmacovigilance Database. Global reporting counts, reported odds ratios (ROR), and information components (ICs) were computed to elucidate the association between the 16 vaccines and the occurrence of vaccine‐associated facial paralysis across 156 countries. We identified 26 197 reports (men, n = 10 507 [40.11%]) of vaccine‐associated facial paralysis from 49 537 reports of all‐cause facial paralysis. Vaccine‐associated facial paralysis has been consistently reported; however, a pronounced increase in reported incidence has emerged after the onset of the coronavirus disease 2019 (COVID‐19) pandemic, which is attributable to the COVID‐19 mRNA vaccine. Most vaccines were associated with facial paralysis, with differing levels of association, except for tuberculosis vaccines. COVID‐19 mRNA vaccines had the highest association with facial paralysis reports (ROR, 28.31 [95% confidence interval, 27.60–29.03]; IC, 3.37 [IC0.25, 3.35]), followed by encephalitis, influenza, hepatitis A, papillomavirus, hepatitis B, typhoid, varicella‐zoster, meningococcal, Ad‐5 vectored COVID‐19, measles, mumps and rubella, diphtheria, tetanus toxoids, pertussis, polio, and Hemophilus influenza type b, pneumococcal, rotavirus diarrhea, and inactivated whole‐virus COVID‐19 vaccines. Concerning age‐ and sex‐specific risks, vaccine‐associated facial paralysis was more strongly associated with older age groups and males. The serious adverse outcome and death rate of vaccine‐associated facial paralysis were extremely low (0.07% and 0.00%, respectively). An increase in vaccine‐induced facial paralysis, primarily owing to COVID‐19 mRNA vaccines, was observed with most vaccines, except tuberculosis vaccines. Given the higher association observed in the older and male groups with vaccine‐associated facial paralysis, close monitoring of these demographics when administering vaccines that are significantly associated with adverse reactions is crucial. [ABSTRACT FROM AUTHOR]

Vaccine‐associated multiple sclerosis (MS) is rare, with insufficient evidence from case reports. Given the scarcity of large‐scale data investigating the association between vaccine administration and adverse events, we investigated the global burden of vaccine‐associated MS and potential related vaccines from 1967 to 2022. Reports on vaccine‐associated MS between 1967 and 2022 were obtained from the World Health Organization International Pharmacovigilance Database (total number of reports = 120 715 116). We evaluated global reports, reporting odds ratio (ROR), and information components (IC) to investigate associations between 19 vaccines and vaccine‐associated MS across 156 countries and territories. We identified 8288 reports of vaccine‐associated MS among 132 980 cases of all‐cause MS. The cumulative number of reports on vaccine‐associated MS gradually increased over time, with a substantial increase after 2020, owing to COVID‐19 mRNA vaccine‐associated MS. Vaccine‐associated MS develops more frequently in males and adolescents. Nine vaccines were significantly associated with higher MS reporting, and the highest disproportional associations were observed for hepatitis B vaccines (ROR 19.82; IC025 4.18), followed by encephalitis (ROR 7.42; IC025 2.59), hepatitis A (ROR 4.46; IC025 1.95), and papillomavirus vaccines (ROR 4.45; IC025 2.01). Additionally, MS showed a significantly disproportionate signal for COVID‐19 mRNA vaccines (ROR 1.55; IC025 0.52). Fatal clinical outcomes were reported in only 0.3% (21/8288) of all cases of vaccine‐associated MS. Although various vaccines are potentially associated with increased risk of MS, we should be cautious about the increased risk of MS following vaccination, particularly hepatitis B and COVID‐19 mRNA vaccines, and should consider the risk factors associated with vaccine‐associated MS. [ABSTRACT FROM AUTHOR]

Background: Vaccine‐associated anaphylaxis is a rare but life‐threatening reaction that occurs within minutes to hours of exposure to allergens. As studies utilizing large‐scale data to investigate this topic are limited, further research is needed to assess its burden, long‐term trends, and associated risk factors so as to gain a comprehensive understanding of vaccine‐associated anaphylaxis globally. Therefore, this study aimed to investigate the global burden of vaccine‐associated anaphylaxis and related vaccines. Method: This study utilized the World Health Organization International Pharmacovigilance Database, in which reports of vaccine‐associated anaphylaxis between 1967 and 2023 were obtained (total reports = 131,255,418). We estimated the global reporting counts, reported odds ratio (ROR), and information component (IC) to identify the relationship between 19 vaccines and associated anaphylaxis in 156 countries and territories. Results: We identified 31,676 reports of vaccine‐associated anaphylaxis among 363,290 reports of all‐cause anaphylaxis. The cumulative number of reports on vaccine‐associated anaphylaxis has gradually increased over time, with a dramatic increase after 2020, owing to reports of COVID‐19 mRNA vaccine‐associated anaphylaxis. The typhoid vaccines were associated with the most anaphylactic reports (ROR: 4.35; IC0.25: 1.86), followed by encephalitis (3.27; 1.45), hepatitis B (2.69; 1.30), cholera (2.65; 0.54), hepatitis A (2.44; 1.12), influenza (2.36; 1.16), inactivated whole‐virus COVID‐19 (2.21; 1.02), and COVID‐19 mRNA vaccines (1.89; 0.79). In terms of age‐ and sex‐specific risks, vaccine‐associated anaphylaxis reports develop more frequently in females and at young ages. The Ad5‐vectored COVID‐19 vaccine anaphylaxis reports were associated with the highest fatality rate (15.0%). Conclusions: Although multiple vaccines are associated with various spectra and risks of anaphylaxis, clinicians should recognize the possibility of anaphylaxis occurring with all vaccines, particularly the COVID‐19 mRNA and inactivated whole‐virus COVID‐19 vaccines, and consider the risk factors associated with vaccine anaphylaxis reports. Further studies are warranted to identify better ways of preventing vaccine‐associated anaphylaxis. [ABSTRACT FROM AUTHOR]

Objective Methods Results Conclusion The scarcity of studies on vaccine‐induced thrombosis and thrombocytopenia syndrome (TTS) limits the comprehensive understanding of vaccine safety on a global scale. Therefore, the objective of this study is to assess the global burden of vaccine‐induced TTS, identify the vaccines most associated with it, and suggest clinical implications regarding vaccination.This study employed the World Health Organization international pharmacovigilance database, extracting records of vaccine‐induced immune thrombotic thrombocytopenia from 1969 to 2023 (total reports, n > 130 million). Global reporting counts, reported odds ratios (ROR), and information components (IC) were calculated to identify the association between 19 vaccines and the occurrence of vaccine‐induced TTS across 156 countries.We identified 24 233 cases (male, n = 11 559 [47.7%]) of vaccine‐induced TTS among 404 388 reports of all‐cause TTS. There has been a significant increase in reports of vaccine‐induced TTS events over time, with a noteworthy surge observed after 2020, attributed to cases of TTS associated with COVID‐19 vaccines. Measles, mumps, and rubella (MMR) vaccines were associated with most TTS reports (ROR [95% confidence interval], 2.87 [2.75–3.00]; IC [IC0.25], 1.51 [1.43]), followed by hepatitis B (HBV, 2.23 [2.07–2.39]; 1.15 [1.03]), rotavirus diarrhea (1.95 [1.78–2.13]; 0.81 [0.53]), encephalitis (1.80 [1.50–2.16]; 0.84 [0.53]), hepatitis A (1.67 [1.50–1.86]; 0.73 [0.55]), adenovirus Type 5 vector‐based (Ad5‐vectored) COVID‐19 (1.64 [1.59–1.68]; 0.69 [0.64]), pneumococcal (1.57 [1.49–1.66]; 0.65 [0.56]), and typhoid vaccines (1.41 [1.12–1.78]; 0.49 [0.11]). Concerning age and sex‐specific risks, reports of vaccine‐induced TTS were more associated with females and younger age groups. The age group between 12 and 17 years exhibited significant sex disproportion. Most of these adverse events had a short time to onset (days; mean [SD], 4.99 [40.30]) and the fatality rate was 2.20%, the highest rate observed in the age group over 65 years (3.79%) and lowest in the age group between 0 and 11 years (0.31%).A rise in vaccine‐induced TTS reports, notably MMR, HBV, and rotavirus diarrhea vaccines, was particularly related to young females. Ad5‐vectored COVID‐19 vaccines showed comparable or lower association with TTS compared to other vaccines. Despite the rarity of these adverse events, vigilance is essential as rare complications can be fatal, especially in older groups. Further studies with validated reporting are imperative to improve the accuracy of assessing the vaccine‐induced TTS for preventive interventions and early diagnosis. [ABSTRACT FROM AUTHOR]