Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac function test, Echocardiogram, Electrocardiogram, Electrocardiogram ambulatory, Myocardial necrosis marker
Clinical narrative: pericarditis; This spontaneous case was reported by an other health care professional and describes the occurrence of PERICARDITIS (pericarditis) in a 44-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 026c21b) for COVID-19 vaccination.     Concurrent medical conditions included COVID-19 since 08-Feb-2022.    On 22-Feb-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 23-Feb-2022, the patient experienced PERICARDITIS (pericarditis) (seriousness criterion medically significant). The patient was treated with COLCHICINE at an unspecified dose and frequency; IBUPROFEN at an unspecified dose and frequency; PANTOPRAZOLE at an unspecified dose and frequency and METOPROLOL at an unspecified dose and frequency. At the time of the report, PERICARDITIS (pericarditis) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Feb-2022, SARS-CoV-2 test: positive Positive. On 07-Mar-2022, Electrocardiogram: abnormal Abnormal. On an unknown date, Cardiac function test: normal normal. On an unknown date, Echocardiogram: not provided not provided. On an unknown date, Electrocardiogram: normal normal. On an unknown date, Electrocardiogram ambulatory: not provided not provided. On an unknown date, Myocardial necrosis marker: normal normal. On an unknown date, Troponin: normal normal.     The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.   For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were reported  Patient had symptoms on 23 Feb 2022 included chest pain, in the left breast near the chest, felt really cold and tired, the next day  on 24 Feb 2022 went to the doctor and told them that she felt pain on the left chest and over the rib, they told her that could be shingles and gave her  a prescription.On the 7 Mar 2022, still had chest pain, like a burning sensation  from the left side across the chest and on left shoulder and went to the emergency room and she had an abnormal EKG,  and everything else was normal, but could not lay flat and lay over and was diagnosed with pericarditis and was send to  cardiologist and prescribe her colchicine, ibuprofen  and pantoprazole. Went to the cardiologist, they did a Holter and ECO and she was having palpitations and still had them and they took the colchicine and put her on metoprolol. She still had the pain and can not get of the medication because everything comes back. Patient had no allergies. The symptoms were chest pain, dyspnea, palpitations, musculoskeletal chest pain, acute chest syndrome, chest discomfort, lethargy, myocardial edema and angina pectoris which improved. Patient had no myocardial edema, cardiomyopathy, pericardial effusion, infective pericardial effusion and pericardial effusion malignant. Update received on 03 Feb 2022 regarding symptoms.  Company Comment - This spontaneous case concerns a 44-year-old female patient, with medical history of COVID 19 (reported onset 15 days prior to event), who experienced the expected AESI of pericarditis, which was considered as medically significant. The event occurred approximately 1 day after the first dose of mRNA-1273. As reported, one day after vaccination patient had chest pain, in the left breast near the chest and felt really cold and tired. Twelve days after vaccination as the symptom of chest pain continued patient went to emergency room and had an abnormal EKG, could not lay flat and lay over and was diagnosed with pericarditis and sent to cardiologist. Patient's symptoms included chest pain, dyspnea, palpitations, musculoskeletal chest pain, acute chest syndrome, chest discomfort, lethargy, myocardial edema and angina pectoris. Troponin was reported to be normal. Patient was prescribed with colchicine, ibuprofen  and pantoprazole but the event was still ongoing with palpitations and patient was also placed on metoprolol. Patient's medical history of COVID 19 two weeks prior to onset of symptoms remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 44-year-old female patient, with medical history of COVID 19 (reported onset 15 days prior to event), who experienced the expected AESI of pericarditis, which was considered as medically significant. The event occurred approximately 1 day after the first dose of mRNA-1273. As reported, one day after vaccination patient had chest pain, in the left breast near the chest and felt really cold and tired. Twelve days after vaccination as the symptom of chest pain continued patient went to emergency room and had an abnormal EKG, could not lay flat and lay over and was diagnosed with pericarditis and sent to cardiologist. Patient's symptoms included chest pain, dyspnea, palpitations, musculoskeletal chest pain, acute chest syndrome, chest discomfort, lethargy, myocardial edema and angina pectoris. Troponin was reported to be normal. Patient was prescribed with colchicine, ibuprofen  and pantoprazole but the event was still ongoing with palpitations and patient was also placed on metoprolol. Patient's medical history of COVID 19 two weeks prior to onset of symptoms remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.