Systematic review of spontaneous reports of myocarditis and pericarditis in transplant recipients and immunocompromised patients following COVID-19 mRNA vaccination

Lane, Samantha; Yeomans, Alison; Shakir, Saad

doi:10.1136/bmjopen-2021-060425

Cited by 11 publications

(9 citation statements)

References 31 publications

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“…Findings from 12 studies from the original review 15 were carried forward (Q1=5, 25 26 27 28 29 Q2=2, 29 30 Q3 part 2=10 25 26 27 28 31 32 33 34 35 36 ). From the search update, we identified 34 new reports across all questions (Q1=9, 37 38 39 40 41 42 43 44 45 Q2=5, 37 41 45 46 47 Q3 part 1=1, 48 Q4=3, 39 49 50 Q5=21 9 51 52 53 54 55 56 57 58 59 60 61 62 63 64 65 66 67 68 69 70 ). We excluded five studies that only reported on combined myocarditis and pericarditis (as we located studies reporting these separately), 71 72 73 74 75 eight studies that did not report on confirmed cases, 76 77 78 79 80 81 82 83 and three studies 84 85 <...…”

Section: Resultsmentioning

confidence: 99%

Incidence, risk factors, natural history, and hypothesised mechanisms of myocarditis and pericarditis following covid-19 vaccination: living evidence syntheses and review

Pillay

Gaudet

Wingert

et al. 2022

BMJ

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ObjectivesTo synthesise evidence on incidence rates and risk factors for myocarditis and pericarditis after use of mRNA vaccination against covid-19, clinical presentation, short term and longer term outcomes of cases, and proposed mechanisms.DesignLiving evidence syntheses and review.Data sourcesMedline, Embase, and the Cochrane Library were searched from 6 October 2020 to 10 January 2022; reference lists and grey literature (to 13 January 2021). One reviewer completed screening and another verified 50% of exclusions, using a machine learning program to prioritise records. A second reviewer verified all exclusions at full text, extracted data, and (for incidence and risk factors) risk of bias assessments using modified Joanna Briggs Institute tools. Team consensus determined certainty of evidence ratings for incidence and risk factors using GRADE (Grading of Recommendations, Assessment, Development and Evaluation).Eligibility criteria for selecting studiesLarge (>10 000 participants) or population based or multisite observational studies and surveillance data (incidence and risk factors) reporting on confirmed myocarditis or pericarditis after covid-19 mRNA vaccination; case series (n≥5, presentation, short term clinical course and longer term outcomes); opinions, letters, reviews, and primary studies focused on describing or supporting hypothesised mechanisms.Results46 studies were included (14 on incidence, seven on risk factors, 11 on characteristics and short term course, three on longer term outcomes, and 21 on mechanisms). Incidence of myocarditis after mRNA vaccines was highest in male adolescents and male young adults (age 12-17 years, range 50-139 cases per million (low certainty); 18-29 years, 28-147 per million (moderate certainty)). For girls and boys aged 5-11 years and women aged 18-29 years, incidence of myocarditis after vaccination with BNT162b2 (Pfizer/BioNTech) could be fewer than 20 cases per million (low certainty). Incidence after a third dose of an mRNA vaccine had very low certainty evidence. For individuals of 18-29 years, incidence of myocarditis is probably higher after vaccination with mRNA-1273 (Moderna) compared with Pfizer (moderate certainty). Among individuals aged 12-17, 18-29, or 18-39 years, incidence of myocarditis or pericarditis after dose two of an mRNA vaccine for covid-19 might be lower when administered ≥31 days compared with ≤30 days after dose one (low certainty). Data specific to men aged 18-29 years indicated that the dosing interval might need to increase to ≥56 days to substantially drop myocarditis or pericarditis incidence. For clinical course and short term outcomes, only one small case series (n=8) was found for 5-11 year olds. In adolescents and adults, most (>90%) myocarditis cases involved men of a median 20-30 years of age and with symptom onset two to four days after a second dose (71-100%). Most people were admitted to hospital (≥84%) for a short duration (two to four days). For pericarditis, data were limited but more variation than myocarditis has been reported in patient age, sex, onset timing, and rate of admission to hospital. Three case series with longer term (3 months; n=38) follow-up suggested persistent echocardiogram abnormalities, as well as ongoing symptoms or a need for drug treatments or restriction from activities in >50% of patients. Sixteen hypothesised mechanisms were described, with little direct supporting or refuting evidence.ConclusionsThese findings indicate that adolescent and young adult men are at the highest risk of myocarditis after mRNA vaccination. Use of a Pfizer vaccine over a Moderna vaccine and waiting for more than 30 days between doses might be preferred for this population. Incidence of myocarditis in children aged 5-11 years is very rare but certainty was low. Data for clinical risk factors were very limited. A clinical course of mRNA related myocarditis appeared to be benign, although longer term follow-up data were limited. Prospective studies with appropriate testing (eg, biopsy and tissue morphology) will enhance understanding of mechanism.

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Section: Resultsmentioning

confidence: 99%

Incidence, risk factors, natural history, and hypothesised mechanisms of myocarditis and pericarditis following covid-19 vaccination: living evidence syntheses and review

Pillay

Gaudet

Wingert

et al. 2022

BMJ

View full text Add to dashboard Cite

show abstract

“…In the general population, the myocarditis reporting rates were 40.6 and 2.4 cases per million doses in males aged 12 − 29 and ≥ 30 years, respectively, and 4.2 and 1.0 cases per million doses in females aged 12 − 29 and ≥ 30 years, respectively [38]. In a population of patients affected by secondary immunodeficiency, the incidence was similar to the general population [39].…”

Section: Discussionmentioning

confidence: 83%

Safety of mRNA COVID-19 Vaccines in Patients with Inborn Errors of Immunity: an Italian Multicentric Study

et al. 2022

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Purpose Little is known about vaccine safety in inborn errors of immunity (IEI) patients during the current vaccination campaign for COVID-19. To better investigate the reactogenicity and adverse event profile after two, three, and four doses of mRNA vaccines, we conducted an observational, multicentric study on 342 PID patients from four Italian Referral Centres. Methods We conducted a survey on self-reported adverse reactions in IEI patients who received mRNA vaccine by administering a questionnaire after each dose. Results Over the whole study period, none of the patients needed hospitalization or had hypersensitivity reactions, including anaphylaxis and delayed injection site reaction. After two vaccination doses, 35.4% of patients showed only local reactogenicity-related symptoms (RrS), 44.4% reported both systemic and local RrS, and 5% reported only systemic RrS. In more than 60% of cases, local or systemic RrS were mild. After the first and second booster doses, patients showed fewer adverse events (AEs) than after the first vaccination course. Patients aged 50 years and older reported adverse events and RrS less frequently. Among AEs requiring treatment, one common variable immune deficiency patient affected by T cell large granular lymphocytic leukemia developed neutropenia and one patient had Bell’s paralysis perhaps during herpes zoster reactivation. Conclusion Although our follow-up period is relatively short, the safety data we reported are reassuring. This data would help to contrast the vaccine hesitancy often manifested by patients with IEI and to better inform their healthcare providers.

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“…COVID-19 vaccine myocarditis is believed to result from overly exuberant immune system activation and typically appears around 3 days after vaccination [ 33 ]. It can occur in persons with underlying cancer, but was not likely in this patient, whose vaccine was given 10 months prior to hospitalization [ 34 ].…”

Section: Discussionmentioning

confidence: 99%

A Rare Single Case of COVID-19-Induced Acute Myocarditis and Encephalopathy Presenting Simultaneously

et al. 2023

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The ongoing coronavirus disease 2019 (COVID-19) pandemic may result in cardiovascular complications such as myocarditis, while encephalitis is a potentially life-threatening COVID-19-associated central nervous system complication. This case illustrates the possibility of developing severe multisystem symptoms from a COVID-19 infection, despite having received the COVID-19 vaccine within the year. Delay in treatment for myocarditis and encephalopathy can lead to permanent and possibly fatal damage. Our patient, a middle-aged female with a complicated medical history, initially came in without characteristic manifestations of myocarditis such as shortness of breath, chest pain, or arrhythmia, but with an altered mental status. Through further laboratory tests, the patient was diagnosed with myocarditis and encephalopathy, which were resolved within weeks through medical management and physical/occupational therapy. This case presentation describes the first reported case of concomitant COVID-19 myocarditis and encephalitis after receiving a booster dose within the year.

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Systematic review of spontaneous reports of myocarditis and pericarditis in transplant recipients and immunocompromised patients following COVID-19 mRNA vaccination

Cited by 11 publications

References 31 publications

Incidence, risk factors, natural history, and hypothesised mechanisms of myocarditis and pericarditis following covid-19 vaccination: living evidence syntheses and review

Incidence, risk factors, natural history, and hypothesised mechanisms of myocarditis and pericarditis following covid-19 vaccination: living evidence syntheses and review

Safety of mRNA COVID-19 Vaccines in Patients with Inborn Errors of Immunity: an Italian Multicentric Study

A Rare Single Case of COVID-19-Induced Acute Myocarditis and Encephalopathy Presenting Simultaneously

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