Sex: U
Vaccine: COVID19
Symptoms: Myocarditis, Pericarditis
Clinical narrative: Myocarditis; Pericarditis; Based on the current case data, this case has been classified as invalid. This literature-study case was reported in a literature article and describes the occurrence of MYOCARDITIS (Myocarditis) and PERICARDITIS (Pericarditis) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.       No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYOCARDITIS (Myocarditis) (seriousness criteria hospitalization and medically significant) and PERICARDITIS (Pericarditis) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (Myocarditis) and PERICARDITIS (Pericarditis) outcome was unknown. Possible      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered MYOCARDITIS (Myocarditis) and PERICARDITIS (Pericarditis) to be possibly related.    No relevant concomitant medications were reported.   Two patients received a second vaccination after onset of myocarditis; neither had worsening of symptoms.  All patients were discharged after a median of 2 days (IQR, 2-3 days). There were no readmissions or deaths. At last available follow-up (median, 23.5 days [IQR, 4.8-41.3 days] after symptom onset), 13 patients (65%; 95% CI, 43%- 82%) had symptom resolution and 7 (35%; 95% CI, 18%-57%) were improving.  Pericarditis developed after the first immunization in 15 cases (40.5%; 95% CI, 26%-57%) and after the second immunization in 22 cases (59.5%; 95% CI, 44%-74%) (mRNA-1273 vaccine, 12 cases (32%).  No treatment information was provided.  Very limited information provided since in the report information of the case is only given as percentage without individual patient data. Medical query raised to author  Company Comment: This case concerns a patient of unknown age and gender with no medical history disclosed, who experienced the expected serious adverse events of special interest of myocarditis and pericarditis. The events occurred on unknown date after the first dose of Spikevax (Moderna COVID-19 vaccine). The rechallenge was unknown since the events occurred after the first dose and there is no information about the second. The event was considered related to the vaccine per the reporter's assessment. The benefit-risk relationship of Spikevax (Moderna COVID-19 vaccine) is not affected by this report. Very limited information is available in this case, so relevant data is requested.   Most recent FOLLOW-UP information incorporated above includes: On 13-Oct-2021: Follow up received by safety on 13-Oct-2021 included an Email and does not contain any new information.; Sender's Comments: This case concerns a patient of unknown age and gender with no medical history disclosed, who experienced the expected serious adverse events of special interest of myocarditis and pericarditis. The events occurred on unknown date after the first dose of Spikevax (Moderna COVID-19 vaccine). The rechallenge was unknown since the events occurred after the first dose and there is no information about the second. The event was considered related to the vaccine per the reporter's assessment. The benefit-risk relationship of Spikevax (Moderna COVID-19 vaccine) is not affected by this report. Very limited information is available in this case, so relevant data is requested.