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1.
Vaccine ; 40(32): 4394-4402, 2022 Jul 30.
Article in English | MEDLINE | ID: covidwho-1946788

ABSTRACT

BACKGROUND: Rapid deployment of COVID-19 vaccines is challenging for safety surveillance, especially on adverse events of special interest (AESIs) that were not identified during the pre-licensure studies. This study evaluated the risk of hospitalisations for predefined diagnoses among the vaccinated population in Malaysia. METHODS: Hospital admissions for selected diagnoses between 1 February 2021 and 30 September 2021 were linked to the national COVID-19 immunisation register. We conducted self-controlled case-series study by identifying individuals who received COVID-19 vaccine and diagnosis of thrombocytopenia, venous thromboembolism, myocardial infarction, myocarditis/pericarditis, arrhythmia, stroke, Bell's Palsy, and convulsion/seizure. The incidence of events was assessed in risk period of 21 days postvaccination relative to the control period. We used conditional Poisson regression to calculate the incidence rate ratio (IRR) and 95% confidence interval (CI) with adjustment for calendar period. RESULTS: There was no increase in the risk for myocarditis/pericarditis, Bell's Palsy, stroke, and myocardial infarction in the 21 days following either dose of BNT162b2, CoronaVac, and ChAdOx1 vaccines. A small increased risk of venous thromboembolism (IRR 1.24; 95% CI 1.02, 1.49), arrhythmia (IRR 1.16, 95% CI 1.07, 1.26), and convulsion/seizure (IRR 1.26; 95% CI 1.07, 1.48) was observed among BNT162b2 recipients. No association between CoronaVac vaccine was found with all events except arrhythmia (IRR 1.15; 95% CI 1.01, 1.30). ChAdOx1 vaccine was associated with an increased risk of thrombocytopenia (IRR 2.67; 95% CI 1.21, 5.89) and venous thromboembolism (IRR 2.22; 95% CI 1.17, 4.21). CONCLUSION: This study shows acceptable safety profiles of COVID-19 vaccines among recipients of BNT162b2, CoronaVac, and ChAdOx1 vaccines. This information can be used together with effectiveness data for risk-benefit analysis of the vaccination program. Further surveillance with more data is required to assess AESIs following COVID-19 vaccination in short- and long-term.


Subject(s)
COVID-19 Vaccines , COVID-19 , BNT162 Vaccine , Bell Palsy/chemically induced , Bell Palsy/epidemiology , COVID-19/epidemiology , COVID-19/prevention & control , COVID-19 Vaccines/adverse effects , ChAdOx1 nCoV-19 , Humans , Malaysia/epidemiology , Myocardial Infarction/chemically induced , Myocardial Infarction/epidemiology , Myocarditis/chemically induced , Myocarditis/epidemiology , Pericarditis/chemically induced , Pericarditis/epidemiology , Seizures/chemically induced , Stroke/chemically induced , Stroke/epidemiology , Thrombocytopenia/chemically induced , Thrombocytopenia/epidemiology , Vaccines, Inactivated , Venous Thromboembolism/chemically induced , Venous Thromboembolism/epidemiology
2.
BMJ Case Rep ; 15(6)2022 Jun 29.
Article in English | MEDLINE | ID: covidwho-1909698

ABSTRACT

We report a rare case of severe myopericarditis in a healthy man in his 20s after the third dose of an mRNA COVID-19 vaccine. His symptoms and troponinemia resolved with a beta-blocker in addition to standard anti-inflammatory therapy, highlighting the utility of multimodal therapy.


Subject(s)
COVID-19 Vaccines/adverse effects , COVID-19 , Myocarditis , Pericarditis , COVID-19/prevention & control , COVID-19 Vaccines/administration & dosage , Combined Modality Therapy , Humans , Immunization, Secondary , Male , Myocarditis/chemically induced , Pericarditis/chemically induced , Pericarditis/drug therapy , RNA, Messenger/therapeutic use , mRNA Vaccines
3.
Eur J Med Res ; 27(1): 80, 2022 Jun 02.
Article in English | MEDLINE | ID: covidwho-1875029

ABSTRACT

BACKGROUND: Vaccination against SARS-CoV-2 has been the main tool to contain the pandemic. The rush development of the 3 vaccines and their expedited approval have led to inoculation of millions of patients around the world, leading to a containment of the disease. Despite continuous viral mutations and the identification of weaker variants, the severity of the infections has been mild, with many patients being either asymptomatic or recovering at home. Currently the focus has shifted from the host of organ damage related to the infection to potential side effects of the vaccine. Myocarditis has been reported as one of the potential side effects from the mRNA vaccine, affecting young healthy individuals. Up to September 30, 2021, 1.243 cases of myocarditis after vaccination with BNT162b2 Comirnaty© were registered in young adults by the Paul-Ehrlich-Institute in Germany alone. The exact pathophysiology and the risk factors for myocarditis following vaccination remain unclear. We present a case series of eight patients with cardiac symptom shortly after SARS-CoV-2 mRNA vaccination (BNT162b6, Biontech, Comirnaty© or mRNA-1237 Moderna, Spikevax©). PATIENTS AND METHODS: Eight patients between 13 and 56 years of age, vaccinated with either BNT162b2 or mRNA-1273 mRNA vaccine between January and August 2021 developed cardiac side effects shortly after either their first or second dose of the vaccine. Clinical data were retrieved from the clinical information system and analyzed. To support diagnosis of myocarditis or pericarditis, cardiac magnetic resonance imaging (MRI) was performed shortly after the onset of symptoms, with further investigations in severe cases. Symptoms were defined as dyspnea, chest pain and cardiac arrhythmia as determined by electrocardiography. RESULTS: Eight patients (5 males and 3 females) developed cardiac symptoms compatible with myocarditis, according to the CDC criteria, shortly after SARS-CoV-2 mRNA vaccination. Three patients (2 males, 1 female) required hospitalization due to severe chest pain and elevated troponin levels. All patients recovered fully within 7 days from the symptom onset. CONCLUSIONS: Our data suggest that cardiac adverse events such as myocarditis or pericarditis shortly after SARS-CoV-2 mRNA vaccination are rare but possible and occur particularly in male patients.


Subject(s)
BNT162 Vaccine , COVID-19 , Myocarditis , Vaccination , mRNA Vaccines , Adolescent , Adult , BNT162 Vaccine/adverse effects , COVID-19/prevention & control , Chest Pain , Female , Humans , Male , Middle Aged , Myocarditis/chemically induced , Pericarditis/chemically induced , SARS-CoV-2/genetics , Vaccination/adverse effects , Vaccines, Synthetic/adverse effects , Young Adult , mRNA Vaccines/adverse effects
4.
Vaccine ; 40(32): 4663-4671, 2022 Jul 30.
Article in English | MEDLINE | ID: covidwho-1867871

ABSTRACT

BACKGROUND: Canadian and international data suggest the risk of myocarditis and/or pericarditis is elevated during the week after mRNA COVID-19 vaccination, particularly in younger age groups, in males, and after second doses. OBJECTIVES: This article examines whether there is a product-specific difference in the risk for myocarditis and/or pericarditis between the two mRNA vaccines administered in Canada: BNT162b2 (Pfizer-BioNTech Comirnaty) and mRNA-1273 (Moderna Spikevax). MATERIALS AND METHODS: Reporting rates of myocarditis and/or pericarditis were calculated from reports received by the Canadian Adverse Events Following Immunization Surveillance System from December 2020-March 2022. Excess cases and attributable incidence among individuals aged 18-39 were estimated for each vaccine in comparison with background rates from 2015 to 2019. Head-to-head comparisons used Poisson regression, conditioned on week of vaccine administration, to estimate rate ratios for the week after mRNA-1273 vaccination versus the week after BNT162b2, by age and sex as well as overall. Analyses were restricted to May 30-March 13, 2021, when heightened media awareness was unlikely to have affected reporting rates for the two products differentially. RESULTS: In 18-29 year-old males who received a second dose of mRNA COVID-19 vaccine, attributable risk of myocarditis and/or pericarditis was found to be 5.69 (95% CI: 4.07 - 7.95; p < 0.001) times higher among mRNA-1273 recipients (n = 106) as compared to BNT162b2 recipients (n = 33). In the same group, Poisson regression modelling estimated that the risk of myocarditis and/or pericarditis was 4.72 (p-value = <0.001) times higher after mRNA-1723 compared to BNT162b2 vaccination. CONCLUSIONS: The risk of myocarditis and/or pericarditis is higher after mRNA-1723 vaccination than BNT162b2 vaccination in those aged 18-39 years, especially in males aged 18-29 years, where the risk is several times higher.


Subject(s)
COVID-19 Vaccines , COVID-19 , Myocarditis , Pericarditis , 2019-nCoV Vaccine mRNA-1273 , Adolescent , Adult , BNT162 Vaccine , COVID-19/epidemiology , COVID-19/prevention & control , COVID-19 Vaccines/adverse effects , Canada/epidemiology , Humans , Male , Myocarditis/chemically induced , Myocarditis/epidemiology , Pericarditis/chemically induced , Pericarditis/epidemiology , Vaccination/adverse effects , Young Adult , mRNA Vaccines
5.
BMJ Open ; 12(5): e059223, 2022 05 25.
Article in English | MEDLINE | ID: covidwho-1865178

ABSTRACT

OBJECTIVES: To combine spontaneously reported data from multiple countries to estimate reporting rate, and better understand risk factors for myocarditis and pericarditis following COVID-19 messenger RNA (mRNA) vaccines. DESIGN: Systematic review of spontaneously reported data from UK, USA and European Union/European Economic Area (EU/EEA) and of the scientific literature. DATA SOURCES: UK Yellow Card scheme, Vaccine Adverse Event Reporting System (VAERS), EudraVigilance were searched from date of vaccine launch to 14 March 2022-16 March 2022. PubMed/MEDLINE and Embase were searched to 15 March 2022. ELIGIBILITY CRITERIA: We included publicly available spontaneous reporting data for 'Myocarditis' and 'Pericarditis' from UK, USA and EU/EEA following COVID-19 mRNA vaccines. Pharmacoepidemiological observational studies investigating myocarditis/pericarditis following mRNA COVID-19 vaccines were included (no restrictions on language or date). Critical Appraisal Skills Programme tools assessed study quality. DATA EXTRACTION AND SYNTHESIS: Two researchers extracted data. Events of myocarditis and pericarditis were presented for each data source, stratified by vaccine, age, sex and dose (where available). Reporting rates were calculated for myocarditis and pericarditis for each population. For published pharmacoepidemiological studies, design, participant characteristics, and study results were tabulated. RESULTS: Overall, 18 204 myocarditis and pericarditis events were submitted to the UK, USA and EU/EEA regulators during the study period. Males represented 62.24% (n=11 331) of myocarditis and pericarditis reports. In the UK and USA, most reports concerned vaccinees aged <40 years (59.7% and 47.3% of reported events, respectively); trends in age were less clear for EU/EEA. Reports were more frequent following a second dose (47.1% of reports, where data available). Reporting rates were consistent between the data sources. Thirty-two pharmacoepidemiological studies were included; results were consistent with our spontaneous report analyses. CONCLUSIONS: Younger vaccinees more frequently report myocarditis and pericarditis following mRNA COVID-19 vaccines than older vaccinees. Results from published literature supported the results of our analyses.


Subject(s)
COVID-19 Vaccines , COVID-19 , Myocarditis , Pericarditis , mRNA Vaccines , Adult , COVID-19/epidemiology , COVID-19/prevention & control , COVID-19 Vaccines/adverse effects , Europe/epidemiology , Female , Humans , Male , Myocarditis/chemically induced , Pericarditis/chemically induced , SARS-CoV-2 , United Kingdom/epidemiology , United States/epidemiology , Vaccination/adverse effects , mRNA Vaccines/adverse effects
6.
Vaccine ; 40(24): 3305-3312, 2022 05 26.
Article in English | MEDLINE | ID: covidwho-1805293

ABSTRACT

BACKGROUND: Background incidence rates are critical in pharmacovigilance to facilitate identification of vaccine safety signals. We estimated background incidence rates of 11 adverse events of special interest related to COVID-19 vaccines in Ontario, Canada. METHODS: We conducted a population-based retrospective observational study using linked health administrative databases for hospitalizations and emergency department visits among Ontario residents. We estimated incidence rates of Bell's palsy, idiopathic thrombocytopenia, febrile convulsions, acute disseminated encephalomyelitis, myocarditis, pericarditis, Kawasaki disease, Guillain-Barré syndrome, transverse myelitis, acute myocardial infarction, and anaphylaxis during five pre-pandemic years (2015-2019) and 2020. RESULTS: The average annual population was 14 million across all age groups with 51% female. The pre-pandemic mean annual rates per 100,000 population during 2015-2019 were 191 for acute myocardial infarction, 43.9 for idiopathic thrombocytopenia, 28.8 for anaphylaxis, 27.8 for Bell's palsy, 25.0 for febrile convulsions, 22.8 for acute disseminated encephalomyelitis, 11.3 for myocarditis/pericarditis, 8.7 for pericarditis, 2.9 for myocarditis, 2.0 for Kawasaki disease, 1.9 for Guillain-Barré syndrome, and 1.7 for transverse myelitis. Females had higher rates of acute disseminated encephalomyelitis, transverse myelitis and anaphylaxis while males had higher rates of myocarditis, pericarditis, and Guillain-Barré syndrome. Bell's palsy, acute disseminated encephalomyelitis, and Guillain-Barré syndrome increased with age. The mean rates of myocarditis and/or pericarditis increased with age up to 79 years; males had higher rates than females: from 12 to 59 years for myocarditis and ≥12 years for pericarditis. Febrile convulsions and Kawasaki disease were predominantly childhood diseases and generally decreased with age. CONCLUSIONS: Our estimated background rates will permit estimating numbers of expected events for these conditions and facilitate detection of potential safety signals following COVID-19 vaccination.


Subject(s)
COVID-19 Vaccines , COVID-19 , Anaphylaxis/chemically induced , Anaphylaxis/epidemiology , Bell Palsy/chemically induced , Bell Palsy/epidemiology , COVID-19/epidemiology , COVID-19/prevention & control , COVID-19 Vaccines/adverse effects , Encephalomyelitis, Acute Disseminated/chemically induced , Encephalomyelitis, Acute Disseminated/epidemiology , Female , Guillain-Barre Syndrome/chemically induced , Guillain-Barre Syndrome/epidemiology , Humans , Incidence , Male , Mucocutaneous Lymph Node Syndrome/chemically induced , Mucocutaneous Lymph Node Syndrome/epidemiology , Myelitis, Transverse/chemically induced , Myelitis, Transverse/epidemiology , Myocardial Infarction/chemically induced , Myocardial Infarction/epidemiology , Myocarditis/chemically induced , Myocarditis/epidemiology , Ontario/epidemiology , Pericarditis/chemically induced , Pericarditis/epidemiology , Purpura, Thrombocytopenic, Idiopathic/chemically induced , Retrospective Studies , Seizures, Febrile/chemically induced , Seizures, Febrile/epidemiology
7.
Pharmacoepidemiol Drug Saf ; 31(8): 921-925, 2022 Aug.
Article in English | MEDLINE | ID: covidwho-1782663

ABSTRACT

PURPOSE: How completely do hospital discharge diagnoses identify cases of myopericarditis after an mRNA vaccine? METHODS: We assembled a cohort 12-39 year-old patients, insured by Kaiser Permanente Northwest, who received at least one dose of an mRNA vaccine (Pfizer-BioNTech or Moderna) between December 2020 and October 2021. We followed them for up to 30 days after their second dose of an mRNA vaccine to identify encounters for myocarditis, pericarditis or myopericarditis. We compared two identification methods: A method that searched all encounter diagnoses using a brief text description (e.g., ICD-10-CM code I40.9 is defined as 'acute myocarditis, unspecified'). We searched the text description of all inpatient or outpatient encounter diagnoses (in any position) for "myocarditis" or "pericarditis." The other method was developed by the Centers for Disease Control and Prevention's Vaccine Safety Datalink (VSD), which searched for emergency department visits or hospitalizations with a select set of discharge ICD-10-CM diagnosis codes. For both methods, two physicians independently reviewed the identified patient records and classified them as confirmed, probable or not cases using the CDC's case definition. RESULTS: The encounter methodology identified 14 distinct patients who met the confirmed or probable CDC case definition for acute myocarditis or pericarditis with an onset within 21 days of receipt of COVID-19 vaccination. When we extended the search for relevant diagnoses to 30 days since vaccination, we identified two additional patients (for a total of 16 patients) who met the case definition for acute myocarditis or pericarditis, but those patients had been misdiagnosed at the time of their original presentation. Three of these patients had an ICD-10-CM code of I51.4 "Myocarditis, Unspecified;" that code was omitted by the VSD algorithm (in the late fall of 2021). The VSD methodology identified 11 patients who met the CDC case definition for acute myocarditis or pericarditis. Seven (64%) of the 11 patients had initial care for myopericarditis outside of a KPNW facility and their diagnosis could not be ascertained by the VSD methodology until claims were submitted (median delay of 33 days; range of 12-195 days). Among those who received a second dose of vaccine (n = 146 785), we estimated a risk as 95.4 cases of myopericarditis per million second doses administered (95% CI, 52.1-160.0). CONCLUSION: We identified additional valid cases of myopericarditis following an mRNA vaccination that would be missed by the VSD's search algorithm, which depends on select hospital discharge diagnosis codes. The true incidence of myopericarditis is markedly higher than the incidence reported to US advisory committees in the fall of 2021. The VSD should validate its search algorithm to improve its sensitivity for myopericarditis.


Subject(s)
COVID-19 Vaccines , COVID-19 , Delivery of Health Care, Integrated , Myocarditis , Pericarditis , Adolescent , Adult , COVID-19/prevention & control , COVID-19 Vaccines/adverse effects , Child , Humans , Myocarditis/chemically induced , Myocarditis/diagnosis , Pericarditis/chemically induced , Pericarditis/diagnosis , Vaccination/adverse effects , Young Adult , mRNA Vaccines
8.
Front Immunol ; 12: 784145, 2021.
Article in English | MEDLINE | ID: covidwho-1674332

ABSTRACT

As the coronavirus disease 2019 (COVID-19) pandemic is ongoing and new variants of severe acute respiratory syndrome coronavirus type 2 (SARS-CoV-2) are emerging, there is an urgent need for vaccines to protect individuals at high risk for complications and to potentially control disease outbreaks by herd immunity. Surveillance of rare safety issues related to these vaccines is progressing, since more granular data emerge about adverse events of SARS-CoV-2 vaccines during post-marketing surveillance. Varicella zoster virus (VZV), Epstein-Barr virus (EBV) and cytomegalovirus (CMV) reactivation has already been reported in COVID-19 patients. In addition, adverse events after SARS-CoV-2 mRNA vaccination have also been in the context of varicella zoster virus (VZV) reactivation and directly associated with the mRNA vaccine. We present the first case of CMV reactivation and pericarditis in temporal association with SARS-CoV-2 vaccination, particularly adenovirus-based DNA vector vaccine ChAdOx1 nCoV-19 against SARS-CoV-2. After initiation of antiviral therapy with oral valganciclovir, CMV viremia disappeared and clinical symptoms rapidly improved. Since huge vaccination programs are ongoing worldwide, post-marketing surveillance systems must be in place to assess vaccine safety that is important for the detection of any events. In the context of the hundreds of millions of individuals to be vaccinated against SARS-CoV-2, a potential causal association with CMV reactivation may result in a considerable number of cases with potentially severe complications.


Subject(s)
/adverse effects , Cytomegalovirus/drug effects , Pericarditis/chemically induced , SARS-CoV-2/immunology , Virus Activation/drug effects , Aged , Antiviral Agents/therapeutic use , COVID-19/prevention & control , Cytomegalovirus/physiology , Cytomegalovirus Infections/chemically induced , Cytomegalovirus Infections/drug therapy , Cytomegalovirus Infections/virology , Female , Humans , Pericarditis/drug therapy , Pericarditis/virology , Treatment Outcome , Valganciclovir/therapeutic use , Viremia/chemically induced , Viremia/drug therapy , Viremia/virology
9.
Int J Clin Pract ; 2022: 2438913, 2022.
Article in English | MEDLINE | ID: covidwho-1662339

ABSTRACT

From the early stages of the pandemic, the development and mass production of a safe and effective vaccine seemed like the greatest tool, to win the fight against the virus. In the present study, we comprehensively conducted a systematic review of all current cases worldwide to better understand whether there is a link between COVID-19 vaccination and one of the most devastating complications, cardiac Inflammation. Our search retrieved over 250 results, of which 130 met the inclusion criteria, and their respective data were extracted. The results suggest that postvaccination myocarditis and pericarditis are more likely to be seen in male, younger, and mRNA-vaccinated individuals. Most affected patients experienced symptoms following the second shot, and complaint of chest pain was the most prevalent presentation. Currently, no direct link can be drawn between the vaccines and the risk of cardiac inflammation.


Subject(s)
COVID-19 Vaccines , COVID-19 , Myocarditis , Pericarditis , COVID-19/prevention & control , COVID-19 Vaccines/adverse effects , Humans , Male , Myocarditis/chemically induced , Pericarditis/chemically induced , mRNA Vaccines/adverse effects
10.
Rev Med Virol ; 32(4): e2318, 2022 07.
Article in English | MEDLINE | ID: covidwho-1588885

ABSTRACT

There have been several local and systemic adverse events associated with mRNA COVID-19 vaccines. Pericarditis, myocarditis and myocardial infarction are examples of cardiac complications related to these vaccines. In this article, we conducted a systematic review of case reports and case series to identify the clinical profile, investigations, and management of reported cardiac complications post-mRNA COVID-19 vaccines. We systematically searched PubMed, Scopus, Web of Science, and Google Scholar, as well as the medRxiv preprint server, with terms including: 'SARS-CoV-2', 'COVID-19', 'messenger RNA vaccine*', 'mRNA-1273 vaccine', 'BNT162 vaccine', 'myocarditis', 'pericarditis', 'stroke' and 'Myocardial Ischemia' up to 25 September 2021. Studies were excluded if they were not case reports or case series, or reported cases from non-mRNA vaccines. Case reports and case series were included that investigated the potential cardiac complications associated with mRNA COVID-19 vaccines. The JBI checklist was used to assess quality and data synthesis was conducted using a qualitative methodology called narrative synthesis. Sixty-nine studies, including 43 case reports and 26 case series, were included. Myocarditis/myopericarditis and pericarditis were the most common adverse events among the 243 reported cardiac complications, post mRNA COVID-19 vaccination. Males with a median age of 21 years had the highest frequency of myocarditis. Almost three quarters (74.4%) of cases with myocarditis had received the BNT162b2 vaccine and 87.7% had received the second dose of the vaccine. Chest pain (96.1%) and fever (38.2%) were the most common presentations. CK-MB, troponin, and NT-proBNP were elevated in 100%, 99.5% and 78.3% of subjects, respectively. ST-segment abnormality was the most common electrocardiogram feature. Cardiac magnetic resonance imaging, which is the gold-standard approach for diagnosing myocarditis, was abnormal in all patients diagnosed with myocarditis. Non-steroidal anti-inflammatory drugs were the most prescribed medication for the management of myocarditis. Apart from inflammatory conditions, some rare cases of Takotsubo cardiomyopathy, myocardial infarction, myocardial infarction with non-obstructive coronary arteries, and isolated tachycardia were also reported following immunisation with mRNA COVID-19 vaccines. We acknowledge that only reviewing case reports and case series studies is one potential limitation of our study. We found that myocarditis was the most commonly reported adverse cardiac event associated with mRNA COVID-19 vaccines, which presented as chest pain with a rise in cardiac biomarkers. Further large-scale observational studies are recommended.


Subject(s)
COVID-19 Vaccines , COVID-19 , Myocardial Infarction , Myocarditis , Pericarditis , Adult , BNT162 Vaccine , COVID-19/prevention & control , COVID-19 Vaccines/adverse effects , Chest Pain/chemically induced , Humans , Male , Myocardial Infarction/chemically induced , Myocarditis/chemically induced , Pericarditis/chemically induced , Vaccination/adverse effects , Young Adult , mRNA Vaccines
11.
Pediatr Infect Dis J ; 41(1): e25-e28, 2022 01 01.
Article in English | MEDLINE | ID: covidwho-1566087

ABSTRACT

In this prospective nationwide multicenter study from Denmark, myopericarditis after Pfizer-BioNTech mRNA COVID-19 vaccination was identified in 13 males and 2 females between May 15 and September 15, 2021, among 133,477 vaccinated males and 127,857 vaccinated females 12-17 years of age, equaling 97 males and 16 females per million. In conclusion, the incidence of myopericarditis after COVID-19 vaccination among males appears higher than reports from the United States.


Subject(s)
/adverse effects , Myocarditis/chemically induced , Myocarditis/epidemiology , Pericarditis/chemically induced , Pericarditis/epidemiology , Adolescent , Child , Denmark/epidemiology , Female , Humans , Incidence , Male , Prospective Studies
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