Sex: U
Vaccine: COVID19
Symptoms: C-reactive protein, Echocardiogram, Ejection fraction, Electrocardiogram, Magnetic resonance imaging heart
Clinical narrative: Vaccine associated myocarditis; This literature-non-study case was reported in a literature article and describes the occurrence of MYOCARDITIS (Vaccine associated myocarditis) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.   LITERATURE REFERENCE:     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date,  after starting mRNA-1273 (Spikevax), the patient experienced MYOCARDITIS (Vaccine associated myocarditis) (seriousness criteria hospitalization and medically significant). At the time of the report, MYOCARDITIS (Vaccine associated myocarditis) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, C-reactive protein (Unknown-8 milligram per litre): 29.5 milligram per litre. On an unknown date, Echocardiogram: Showed no pericardial effusion. On an unknown date, Ejection fraction: 58 %. On an unknown date, Electrocardiogram: Showed sinus rhythm with premature ventricular complexes or fusion complexes. On an unknown date, Magnetic resonance imaging heart: After 8 days from symptom onset showed myocardial edema and late gadolinium enhancement. On an unknown date, N-terminal prohormone brain natriuretic peptide (Unknown-450 pg/ml): 347 pg/ml. On an unknown date, SARS-CoV-2 antibody test: Free spike 32.72 pg/mL, Total spike 41.92 pg/mL. On an unknown date, Troponin T (Unknown-14 ng/L): 1008 ng/L.     For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered MYOCARDITIS (Vaccine associated myocarditis) to be related.    This case belonged to patient ID from the table.  This study was conducted from January 2021 through February 2022, and blood was collected prospectively from 61 adolescents and young adults between 12 and 21 years of age, who either developed myocarditis or had no vaccine related complications after vaccination with either the Pfizer BNT162b2 or Moderna mRNA-1273 COVID-19 mRNA vaccine.  Concomitant and treatment medications were not reported.  Time between vaccine and symptom onset was reported as 2 days. Patient had symptoms of chest pain and palpitations.  Criteria was positive for myocarditis. According to CDC definition myocarditis was confirmed.  Authors concluded that, Immuno-profiling of vaccinated adolescents and young adults revealed that the mRNA vaccine-induced immune responses did not differ between individuals who developed myocarditis and individuals who did not. However, free spike antigen was detected in the blood of adolescents and young adults who developed post-mRNA vaccine myocarditis, advancing insight into its potential underlying cause.  Company Comment: This literature non study case concerns a patient (between 12 and 21 years of age) and of unknown gender, with no cardiovascular pathology identified, who experienced the expected, serious (hospitalization, medically significant) AESI of Myocarditis (reported as Vaccine associated myocarditis) , unknown days after receiving the second dose of mRNA-1273 vaccine. The patient received the first dose of the same vaccine on an unknown date. Time between vaccine (dose number not specified) and symptom onset was reported as 2 days. Patient presented with chest pain and palpitations to the hospital. On investigation, had elevated troponin. Echocardiogram showed no pericardial effusion. Electrocardiogram showed sinus rhythm with premature ventricular complexes or fusion complexes. Magnetic resonance imaging heart- after 8 days from symptom onset showed myocardial edema and late gadolinium enhancement. SARS-CoV-2 antibody test showed free spike protein of 32.72 pg/mL and total spike protein of 41.92 pg/mL. Criteria was positive for myocarditis. According to CDC definition, myocarditis was confirmed. No information on risk factors, treatment of the event and its outcome was available in the report. Authors concluded that, Immuno-profiling of vaccinated adolescents and young adults revealed that the mRNA vaccine-induced immune responses did not differ between individuals who developed myocarditis and individuals who did not. However, free spike antigen was detected in the blood of adolescents and young adults who developed post-mRNA vaccine myocarditis, advancing insight into its potential underlying cause. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-719580 (E2B Linked Report). Sender's Comments: This literature non study case concerns a patient (between 12 and 21 years of age) and of unknown gender, with no cardiovascular pathology identified, who experienced the expected, serious (hospitalization, medically significant) AESI of Myocarditis (reported as Vaccine associated myocarditis), unknown days after receiving the second dose of mRNA-1273 vaccine. The patient received the first dose of the same vaccine on an unknown date. Time between vaccine (dose number not specified) and symptom onset was reported as 2 days. Patient presented with chest pain and palpitations to the hospital. On investigation, had elevated troponin. Echocardiogram showed no pericardial effusion. Electrocardiogram showed sinus rhythm with premature ventricular complexes or fusion complexes. Magnetic resonance imaging heart- after 8 days from symptom onset showed myocardial edema and late gadolinium enhancement. SARS-CoV-2 antibody test showed free spike protein of 32.72 pg/mL and total spike protein of 41.92 pg/mL. Criteria was positive for myocarditis. According to CDC definition, myocarditis was confirmed. No information on risk factors, treatment of the event and its outcome was available in the report. Authors concluded that, Immuno-profiling of vaccinated adolescents and young adults revealed that the mRNA vaccine-induced immune responses did not differ between individuals who developed myocarditis and individuals who did not. However, free spike antigen was detected in the blood of adolescents and young adults who developed post-mRNA vaccine myocarditis, advancing insight into its potential underlying cause. The benefit-risk relationship of mRNA-1273 is not affected by this report. US-MODERNATX, INC.-MOD-2023-719580:Patient ID