copenlu/druid huggingface dataset:
Claim: Study shows myocarditis from COVID-19 vaccination carries serious risk of death (Joseph Mackinnon, 2024-01-29)
Evidence (2022-03-02): While mRNA COVID-19 vaccines like tozinameran (Pfizer-BioNTech BNT162b2) and elasomeran (Moderna mRNA-1273) have shown a high level of efficacy and effectiveness in real life, some concerns about vaccination-related pericarditis and/or myocarditis have been raised.1,2 After the initial signals from Israel, the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) alerted on the risk of pericarditis and/or myocarditis with mRNA COVID-19 vaccines.2,3 In August 2021, the US Centers for Disease Control and Prevention (CDC) published data suggesting a higher rate of vaccination-related myocarditis in young men, but no stratification was made on the adolescent age group.4 Recently, two observational studies from Israel estimated the incidence of myocarditis to be around 0.64 and 1.42 per 100 000 persons after the first dose of tozinameran and 3.83 per 100 000 after the second dose.5,6 The risk difference between the first and second doses of tozinameran was evaluated to be 1.76 per 100 000 persons, with a great difference among boys between 16 and 19 years of age.6 To date, no data have been published on young adolescents between 12 and 15 years of age.
Claim: Study shows myocarditis from COVID-19 vaccination carries serious risk of death (Joseph Mackinnon, 2024-01-29)
Evidence (2023-03-27): Several other studies have highlighted the association between COVID-19 vaccination and the risk of myocarditis and other cardiac events. Vaccination with mRNA vaccines is associated with an increased risk of myocarditis or myopericarditis, especially in young people, in investigation using data from the US21,22, Denmark11, and England23, with higher increased risk generally found among young males24. We found little evidence of increased risk of death due to cardiac events after an mRNA vaccine for either sex. Whilst there was some indication of a potential increase in risk for men after a second dose of a mRNA vaccine, the result was sensitive to the choice of the risk period. [...] Whilst COVID-19 vaccination has been linked to an increased risk of myocarditis and other cardiac events in young people, we found no evidence of substantially increased mortality risk, either due to cardiac events or overall, from mRNA vaccines, which suggest that cases of myocarditis or myopericarditis due to mRNA COVID-19 vaccines are unlikely to be fatal. We do, however, find evidence of an increased risk of cardiac death after a first dose of a non mRNA vaccine among females. It should also be noted that non mRNA vaccines are no longer used in the UK vaccination programme28. This provides reassurance that mRNA vaccines pose minimal risk of increased mortality in the first twelve weeks post-vaccination in young individuals. However, it is important to continue to monitor mortality after vaccination as more deaths are being registered, and extend the surveillance to other age groups and deaths from other causes.
Claim: Study shows myocarditis from COVID-19 vaccination carries serious risk of death (Joseph Mackinnon, 2024-01-29)
Evidence (2022-07-05): Netherlands Heart Journal: Monthly Journal of the Netherlands Society of Cardiology and the Netherlands Heart Foundation, 30(4), 190–197. https://doi.org/10.1007/s12471-022-01677-9 - Su, J. R., McNeil, M. M., Welsh, K. J., Marquez, P. L., Ng, C., Yan, M., & Cano, M. V. (2021). Myopericarditis after vaccination, Vaccine Adverse Event Reporting System (VAERS), 1990-2018. Vaccine, 39(5), 839–845. https://doi.org/10.1016/j.vaccine.2020.12.046 - Cordero, A., Cazorla, D., Escribano, D., Quintanilla, M. A., López-Ayala, J. M., Berbel, P. P., & Bertomeu-González, V. (2022). Myocarditis after RNA-based vaccines for coronavirus. International Journal of Cardiology, 353, 131–134. https://doi.org/10.1016/j.ijcard.2022.01.037 - Chou, O., Zhou, J., Lee, T., Kot, T., Lee, S., Wai, A., Wong, W. T., Zhang, Q., Cheng, S. H., Liu, T., Vassiliou, V. S., Cheung, B., & Tse, G. (2022). Comparisons of the risk of myopericarditis between COVID-19 patients and individuals receiving COVID-19 vaccines: a population-based study. Clinical Research in Cardiology: Official Journal of the German Cardiac Society, 1–6. https://doi.org/10.1007/s00392-022-02007-0 - Annie, F. H., Alkhaimy, H., Nanjundappa, A., & Elashery, A. (2022). Association Between Myocarditis and Mortality in COVID-19 Patients in a Large Registry. Mayo Clinic Proceedings.
Claim: Study shows myocarditis from COVID-19 vaccination carries serious risk of death (Joseph Mackinnon, 2024-01-29)
Evidence (2024-09-30): While the rationale for coronavirus disease 2019 (COVID-19) vaccination is to reduce complications and overall mortality, some cardiovascular complications from the vaccine itself have been demonstrated. Myocarditis and pericarditis are recognized as rare acute adverse events after mRNA vaccines in young males, while evidence regarding other cardiovascular events remains limited and inconsistent. This study assessed the risks of several cardiovascular and cerebrovascular events in a Swedish nationwide register-based cohort. [...] Risk of myopericarditis (mRNA vaccines only), extrasystoles, and transient ischaemic attack was transiently increased after COVID-19 vaccination, but full vaccination substantially reduced the risk of several more severe COVID-19-associated cardiovascular outcomes, underscoring the protective benefits of complete vaccination. [...] In this unique, complete nationwide cohort, we found decreased risks of several serious cardiovascular outcomes after COVID-19 vaccination, likely related to the protection of vaccination against severe COVID-19. Increased risks were observed for two relatively mild cardiovascular conditions, i.e. extrasystoles and TIA. We confirmed previously reported increased risks of myocarditis and pericarditis shortly after COVID-19 mRNA vaccination.3 Overall, our results clearly underscore the protective benefits of complete vaccination, especially for elderlies.
Claim: Study shows myocarditis from COVID-19 vaccination carries serious risk of death (Joseph Mackinnon, 2024-01-29)
Evidence (2023-06-25): The present nationwide study involving more than 44 million vaccinated individuals in Korea demonstrated several clinically important findings on acute myocarditis after COVID-19 vaccination. First, VRM was a very rare complication of COVID-19 vaccination (1.08 cases per 100 000 vaccinated persons) and mainly developed in association with mRNA vaccines, especially in young males. Second, the demographic characteristics of COVID-19 VRM differed from those of the previous studies. Third, notably, we demonstrated severe COVID-19 VRM including FM or death was not uncommon (19.8% of total VRM). Sudden cardiac death attributable to COVID-19 VRM demonstrated in this study warrants the careful monitoring or warning of SCD as a potentially fatal complication of COVID-19 vaccination, especially in individuals who are ages under 45 years with mRNA vaccination. Fourth, the incidence of severe cases of COVID-19 VRM significantly decreased in the third vaccination than in the first or second COVID-19 vaccination (Structured Graphical Abstract). [...] Sudden cardiac death was the most serious and worrisome adverse reaction of COVID-19 vaccination in our study. In eight SCD cases, VRM was not suspected as a clinical diagnosis or a cause of death before performing an autopsy. All SCD cases attributable to COVID-19 VRM were aged under 45 years and received mRNA vaccines. Vaccine-related myocarditis was the only possible cause of death in all SCD cases. Therefore, SCD attributable to COVID-19 VRM demonstrated in this study warrants the careful monitoring or warning of SCD as a potentially fatal complication of COVID-19 vaccination, especially in individuals who are ages under 45 years and receiving mRNA vaccination.
Claim: Study shows myocarditis from COVID-19 vaccination carries serious risk of death (Joseph Mackinnon, 2024-01-29)
Evidence (2023-06-01): Our findings are in line with multiple meta-analyses66–69 that have evaluated the complex relationship between mRNA vaccinations and the rare risk of cardiac injury, indicating that vaccination with mRNA COVID-19 vaccines is associated with a short-term greater risk of myocarditis, however, the absolute risk appears to be low. This association has been demonstrated through different types of epidemiological studies, including national spontaneous reporting system studies,70–73 comparisons of observed-to-expected rate studies,74 75 case–control studies,54 76 self-controlled cases series35 77–79 and cohort studies.48 77 80–82 To better understand whether these findings reflect an actual increase in incidence or simply improved reporting and carditis diagnosis, a recent meta-analysis aimed to evaluate and compare the incidence of myopericarditis following COVID-19 vaccinations to that of all other non-COVID-19 vaccines.83 This meta-analysis included data from 22 studies (including 260 million individuals and more than 400 million vaccine doses), and reported an overall incidence of 33.3 cases per million vaccine doses, which did not differ significantly between people who received COVID-19 vaccines and those who received non-COVID-19 vaccines. Nonetheless, the rate of myopericarditis in young males after mRNA COVID-19 vaccines was still higher than expected.
Claim: Study shows myocarditis from COVID-19 vaccination carries serious risk of death (Joseph Mackinnon, 2024-01-29)
Evidence (2023-05-05): When new COVID-19 vaccines were first administered two years ago, public health officials found an increase in cases of myocarditis, an inflammation of the heart muscle, particularly among young males who had been vaccinated with mRNA vaccines. It was unclear, however, what exactly was causing this reaction. [...] Myocarditis is a generally mild inflammation of heart tissue which can cause scarring but is usually resolved within days. The increased incidence of myocarditis during vaccination was seen primarily in males in their teens or early 20s, who had been vaccinated with mRNA vaccines, which are designed to elicit immune responses specifically to the SARS-CoV-2 virus. [...] Lucas noted that, according to CDC findings, the risk of severe forms of myocarditis is greater in individuals who contract the COVID-19 virus than in those who receive vaccines. She emphasized that vaccination offers the best protection from COVID-19-related disease.
Claim: Study shows myocarditis from COVID-19 vaccination carries serious risk of death (Joseph Mackinnon, 2024-01-29)
Evidence (2022-06-25): Cases of myocarditis and pericarditis have been reported following the receipt of Covid-19 mRNA vaccines. As vaccination campaigns are still to be extended, we aimed to provide a comprehensive assessment of the association, by vaccine and across sex and age groups. Using nationwide hospital discharge and vaccine data, we analysed all 1612 cases of myocarditis and 1613 cases of pericarditis that occurred in France in the period from May 12, 2021 to October 31, 2021. We perform matched case-control studies and find increased risks of myocarditis and pericarditis during the first week following vaccination, and particularly after the second dose, with adjusted odds ratios of myocarditis of 8.1 (95% confidence interval [CI], 6.7 to 9.9) for the BNT162b2 and 30 (95% CI, 21 to 43) for the mRNA-1273 vaccine. The largest associations are observed for myocarditis following mRNA-1273 vaccination in persons aged 18 to 24 years. Estimates of excess cases attributable to vaccination also reveal a substantial burden of both myocarditis and pericarditis across other age groups and in both males and females. [...] Witberg, G. et al. Myocarditis after Covid-19 vaccination in a Large Health Care Organization. N. Engl. J. Med. 2132–2139 https://doi.org/10.1056/NEJMoa2110737 (2021). [...] Patone, M. et al. Risks of myocarditis, pericarditis, and cardiac arrhythmias associated with COVID-19 vaccination or SARS-CoV-2 infection. Nat. Med. 1–13 https://doi.org/10.1038/s41591-021-01630-0 (2021).
Claim: Study shows myocarditis from COVID-19 vaccination carries serious risk of death (Joseph Mackinnon, 2024-01-29)
Evidence (2023-03-26): Several studies have reported associations between coronavirus (COVID-19) vaccination and risk of cardiac diseases, especially in young people; we assessed the impact of COVID-19 vaccination and positive SARS-CoV-2 tests on the risk of cardiac and all-cause mortality in young people (aged 12 to 29 years) in England using a self-controlled case series design. [...] Statistician's comment "Today’s analysis looks at the risk of death after COVID-19 vaccination in young people. Existing studies show that COVID-19 vaccination is linked to an increased risk of cardiac diseases. [...] "Whilst vaccination carries some risks, these need to be assessed in light of its benefits. Our analysis shows that the risk of death is greatly increased following a positive test for COVID-19 even in young people and many studies show that vaccines are highly effective at preventing hospitalisation or death following COVID-19 infection.
Claim: Study shows myocarditis from COVID-19 vaccination carries serious risk of death (Joseph Mackinnon, 2024-01-29)
Evidence (2022-01-25): Vaccination against COVID-19 provides clear public health benefits, but vaccination also carries potential risks. The risks and outcomes of myocarditis after COVID-19 vaccination are unclear. [...] Based on passive surveillance reporting in the US, the risk of myocarditis after receiving mRNA-based COVID-19 vaccines was increased across multiple age and sex strata and was highest after the second vaccination dose in adolescent males and young men. This risk should be considered in the context of the benefits of COVID-19 vaccination. [...] In this review of reports to VAERS between December 2020 and August 2021, myocarditis was identified as a rare but serious adverse event that can occur after mRNA-based COVID-19 vaccination, particularly in adolescent males and young men. However, this increased risk must be weighed against the benefits of COVID-19 vaccination.18
Claim: Study shows myocarditis from COVID-19 vaccination carries serious risk of death (Joseph Mackinnon, 2024-01-29)
Evidence (2024-09-26): In addition, public health experts are monitoring vaccine safety and side effect data for cases of rare heart-related complications, myocarditis or pericarditis, after receiving the Pfizer or Moderna vaccines. (Myocarditis is inflammation of the heart muscle, while pericarditis is inflammation of the heart’s outer lining.) Research shows the benefits of COVID-19 vaccination outweigh the low risk of myocarditis after receiving the vaccine. Cases of myocarditis and/or pericarditis have been more common in adolescent boys and young men. A 2021 study shows that most people under age 21 who developed myocarditis thought to be linked to COVID-19 vaccination had mild symptoms that improved quickly. [...] Yes. The CDC recommends an updated (2023-24) COVID-19 vaccine for women who are pregnant or are anticipating a pregnancy. Pregnant or recently pregnant women face an elevated risk of death or severe illness from COVID-19, including illness requiring hospitalization, intensive care, or a ventilator or other special equipment to breathe, according to the CDC. Also, risk of pregnancy complications with COVID-19 is higher.
Claim: Study shows myocarditis from COVID-19 vaccination carries serious risk of death (Joseph Mackinnon, 2024-01-29)
Evidence (2021-12-14): Although myocarditis and pericarditis were not observed as adverse events in coronavirus disease 2019 (COVID-19) vaccine trials, there have been numerous reports of suspected cases following vaccination in the general population. We undertook a self-controlled case series study of people aged 16 or older vaccinated for COVID-19 in England between 1 December 2020 and 24 August 2021 to investigate hospital admission or death from myocarditis, pericarditis and cardiac arrhythmias in the 1–28 days following adenovirus (ChAdOx1, n = 20,615,911) or messenger RNA-based (BNT162b2, n = 16,993,389; mRNA-1273, n = 1,006,191) vaccines or a severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) positive test (n = 3,028,867). We found increased risks of myocarditis associated with the first dose of ChAdOx1 and BNT162b2 vaccines and the first and second doses of the mRNA-1273 vaccine over the 1–28 days postvaccination period, and after a SARS-CoV-2 positive test. [...] In summary, this population-based study quantifies for the first time the risk of several rare cardiac adverse events associated with three COVID-19 vaccines as well as SARS-CoV-2 infection. Vaccination for SARS-CoV-2 in adults was associated with a small increase in the risk of myocarditis within a week of receiving the first dose of both adenovirus and mRNA vaccines, and after the second dose of both mRNA vaccines. By contrast, SARS-CoV-2 infection was associated with a substantial increase in the risk of hospitalization or death from myocarditis, pericarditis and cardiac arrhythmia.
Claim: Study shows myocarditis from COVID-19 vaccination carries serious risk of death (Joseph Mackinnon, 2024-01-29)
Evidence (2021-04-07): The Committee carried out an in-depth review of 62 cases of cerebral venous sinus thrombosis and 24 cases of splanchnic vein thrombosis reported in the EU drug safety database (EudraVigilance) as of 22 March 2021, 18 of which were fatal.1 The cases came mainly from spontaneous reporting systems of the EEA and the UK, where around 25 million people had received the vaccine. COVID-19 is associated with a risk of hospitalisation and death. The reported combination of blood clots and low blood platelets is very rare, and the overall benefits of the vaccine in preventing COVID-19 outweigh the risks of side effects. [...] Vaxzevria is one of four vaccines authorised in the EU for protecting against COVID-19. Studies show that it is effective at preventing the disease. It also reduces the risk of hospitalisation and deaths from COVID-19.
Claim: Study shows myocarditis from COVID-19 vaccination carries serious risk of death (Joseph Mackinnon, 2024-01-29)
Evidence (2021-12-23): Anyone receiving any COVID-19 vaccine should be informed of the risks associated with COVID-19 vaccines (myocarditis/pericarditis and anaphylaxis) and be advised to seek medical attention if they develop signs or symptoms suggestive of these conditions. [...] Evidence from bivalent and original mRNA COVID-19 vaccines across different age groups show that the risk of myocarditis is lower following boosters compared to dose 2 of the primary series, and that no product-specific difference in the risk of myocarditis has been identified following a booster dose at this time, including in adolescents 12 to 17 years of age. However, the use of Moderna Spikevax COVID-19 vaccines had been limited in those 5 to 17 years of age. While long-term follow-up is ongoing, available data indicate that the majority of individuals who reported myocarditis/pericarditis after mRNA COVID-19 vaccination, though requiring hospitalization, have responded well to conservative therapy and tend to recover quickly. [...] Selected references - Abraham N, Spruin S, Rossi T, Fireman B, Zafack J, Blaser C, et al. Myocarditis and/or Pericarditis Risk After mRNA COVID-19 Vaccination: A Canadian Head to Head Comparison of BNT162b2 and mRNA-1273 Vaccines. JVAC-D-21-03106, Available at SSRN: https://ssrn.com/abstract=3988612 - AstraZeneca Canada Inc. Product monograph - Evusheld™. April 14, 2022.
Claim: Study shows myocarditis from COVID-19 vaccination carries serious risk of death (Joseph Mackinnon, 2024-01-29)
Evidence (2022-08-22): England’s National Immunization database records were then cross-referenced and matched to the national offices with data on COVID-19 infection, hospital admission and death certificates for the same time period, December 1, 2020 through December 15, 2021. Individuals were classified based on age and sex to reveal which groups had the highest risk of myocarditis after a COVID-19 vaccine or after COVID-19 infection and hospitalization. The authors used the self-controlled case series (SCCS) method, which was developed to estimate the relative incidence of an acute event in a pre-defined post-vaccination risk period (1-28 days), compared to other times (pre-vaccination or long after vaccination). Being a within-person comparison, the analyses were controlled to adjust for any fixed characteristics, including sex, race or ethnicity, or chronic health conditions. [...] - An increased risk of vaccine-associated myocarditis was found in men ages 40 and younger after a first dose of either of the mRNA COVID-19 vaccines (4 and 14 estimated extra cases for every one million men vaccinated with respectively Pfizer or Moderna vaccine), or a second dose of any of the three COVID-19 vaccines available in England during the study period: 14, 11 and 97 estimated additional cases of myocarditis for every one million men vaccinated, respectively for the ChAdOx1, the Pfizer-BioNTech or the Moderna vaccine.
Claim: Study shows myocarditis from COVID-19 vaccination carries serious risk of death (Joseph Mackinnon, 2024-01-29)
Evidence (2022-10-07): The risk of developing myocarditis — or inflammation of the heart muscle — is seven times higher with a COVID-19 infection than with the COVID-19 vaccine, according to a recent study by Penn State College of Medicine, scientists. Patients with myocarditis can experience chest pains, shortness of breath or an irregular heartbeat. In severe cases, the inflammation can lead to heart failure and death. [...] The Penn State team conducted the largest study to date on the risk of developing myocarditis as a result of having the coronavirus vs. experiencing inflammation following COVID-19 vaccination. The researchers compared patients with COVID-19 — vaccinated and unvaccinated — to those without the virus. They found the risk of myocarditis was 15 times higher in COVID-19 patients, regardless of vaccination status, compared to individuals who did not contract the virus. [...] "COVID-19 infection and the related vaccines both pose a risk for myocarditis. However, the relative risk of heart inflammation induced by COVID-19 infection is substantially greater than the risk posed by the vaccines," said Dr. Paddy Ssentongo , a resident physician in the Department of Medicine at Penn State Health Milton S. Hershey Medical Center and the lead author of the study. "We hope our findings will help mitigate vaccine hesitancy and increase vaccine uptake."
Claim: Study shows myocarditis from COVID-19 vaccination carries serious risk of death (Joseph Mackinnon, 2024-01-29)
Evidence (2023-03-13): Thankfully, severe myocarditis after mRNA vaccination for COVID-19 is extremely rare. A 2021 study from Nordic scholars, which looked at comparative risks of myocarditis and heart arrhythmia in patients who experienced myocarditis after COVID-19 infection versus immunization found that the risks vary significantly by age group. [...] A survey of all currently available research reveals that the risk of myocarditis after COVID-19 vaccination is highest in young men between the ages of 18 and 39 and older teen boys in the age range of 12 to 17, with the highest risk after the second dose of vaccine. The cause appears to be related to how the immune system processes the mRNA and sometimes generates an excessive immune response. Myocarditis risk related to COVID-19 immunization is markedly lower in children younger than 12 years of age and much lower in adult males older than 50. The risk of severe disease from COVID-19, particularly in those older than 50 years, has been far higher throughout the pandemic than the risk of myocarditis from COVID-19 vaccination. The risk of vaccination myocarditis is uniformly lower in girls than in boys.
Claim: Study shows myocarditis from COVID-19 vaccination carries serious risk of death (Joseph Mackinnon, 2024-01-29)
Evidence (2024-08-05): Vaccines against COVID-19 are the best defense against the virus, as they protect against serious disease, hospitalization, and death.