Sex: U
Vaccine: COVID19
Symptoms: Cardiac disorder, Inflammation, Magnetic resonance imaging heart, Myocarditis
Clinical narrative: MYOCARDITIS; INFLAMMATORY HEART DISEASE; INFLAMMATORY HEART DISEASE; This spontaneous report was received from literature. This report concerned two patients of unspecified age and sex. The objective of this study was to assess the prevalence of inflammatory heart disease (IHD) in a group of patients who had a CMR after receiving a COVID-19 vaccine. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient's received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) 1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. From 01-JAN-2021 to 08-JUN-2021, 303 patients underwent a Cardiac Magnetic resonance imaging (CMR) at a Medical Center. The date of vaccination, type of vaccine and COVID testing results and date for each of these patients were ascertained. All patients who were vaccinated prior to the CMR exam constituted the study population. Inflammatory Heart Disease (IHD) by CMR was defined as abnormality of 2 or more pulse sequences of the Criteria, Delayed enhancement after gadolinium, and prolongation of myocardial or pericardial T1 or T2 relaxation times. Of 303 patients with a CMR during the study period, 77 were vaccinated prior to CMR. The mean time between vaccination and CMR was 41 days. 42 patients had a Pfizer vaccine, 30 had Moderna and 5 received Johnson and Johnson vaccine. 10 Pfizer recipients had IHD findings on CMR (24%), as did 7 of Moderna (23%) and 2 of Johnson and Johnson vaccine (40%). 13 patients had a positive COVID test prior to vaccination and IHD was present on CMR in 9 patients (69%) in this subgroup, while only 8 of 63 (13%) without a positive COVID-19 test before vaccination showed evidence of IHD. On an unspecified date, the 2 patients showed myocarditis, inflammatory heart disease(Inflammation, Cardiac disorder) on CMR study. Laboratory data (dates unspecified) included: Cardiac Magnetic resonance imaging test (NR: not provided) showed inflammatory heart disease. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the inflammatory heart disease(Inflammation), myocarditis and inflammatory heart disease(Cardiac disorder) was not reported. Although retrospective, these data provide valuable information about the occurrence of IHD after COVID-19 vaccination using CMR imaging. A similar percentage of patients vaccinated with any of the 3 vaccines appear to subsequently show evidence of IHD on CMR, more so if previously COVID positive. However, evidence of IHD on post-vaccine CMR does not definitively establish causality. CMR exams before and after COVID-19 vaccination using Criteria will be required to prove a cause-effect relationship. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220148810 -: Covid-19 Vaccine Ad26.Cov2.S - Myocarditis, inflammatory heart disease(Inflammation), inflammatory heart disease(Cardiac disorder) . This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).