Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Blood pressure measurement, Cardiac tamponade, Inappropriate schedule of product administration, Myocarditis
Clinical narrative: felt like sun burn; myocarditis; Pericarditis/shortness of breath; Arthritis/arthritis shoulder pain; cardiac tamponade; First Moderna shot was 1/1/21 and second on 2/23/21; This spontaneous case was reported by a patient and describes the occurrence of ARTHRITIS (Arthritis/arthritis shoulder pain), CARDIAC TAMPONADE (cardiac tamponade), SUNBURN (felt like sun burn), MYOCARDITIS (myocarditis) and PERICARDITIS (Pericarditis/shortness of breath) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Stent placement (Two stents placed in her heart) in 2018. Concurrent medical conditions included Blood pressure high and Heart disorder (Heart issues).   On 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Feb-2021, the patient experienced ARTHRITIS (Arthritis/arthritis shoulder pain) (seriousness criteria hospitalization and medically significant), CARDIAC TAMPONADE (cardiac tamponade) (seriousness criteria hospitalization and medically significant), SUNBURN (felt like sun burn) (seriousness criteria hospitalization and medically significant), MYOCARDITIS (myocarditis) (seriousness criteria hospitalization and medically significant), PERICARDITIS (Pericarditis/shortness of breath) (seriousness criteria hospitalization and medically significant) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First Moderna shot was 1/1/21 and second on 2/23/21). The patient was hospitalized for 7 days due to CARDIAC TAMPONADE. The patient was treated with Surgery (surgery was due to pericarditis and Myocarditis on 09-Mar-2021) for Myocarditis and Surgery (surgery was due to pericarditis and Myocarditis on 09-Mar-2021) for Pericarditis. At the time of the report, ARTHRITIS (Arthritis/arthritis shoulder pain), CARDIAC TAMPONADE (cardiac tamponade), SUNBURN (felt like sun burn), MYOCARDITIS (myocarditis), PERICARDITIS (Pericarditis/shortness of breath) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First Moderna shot was 1/1/21 and second on 2/23/21) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood pressure measurement: Going down.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   History of heart problems and she was doing fines she has been on medication for high blood pressure since stents placing.   The patient had first two shots then two booster.  It was unknown if patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Patient had an adverse event during the call. She said it was already reported to Moderna back in 2021. First Moderna shot was on 01-Jan-2021, the second it was schedule for 2/18 but it was reschedule due to storm to 23-Feb-2021, after the second shot she was having arthritis shoulder pain, felt like sun burn, shortest of breath and. Friday she called heart doctor and had x-ray schedule but by Sunday she was having a lot of problem, and went to the hospital and she was admitted, and she had to get surgery, surgery was due to pericarditis and Myocarditis on 09-Mar-2021. Pericardia Syntheses for cardiac tamponade, hospitalized for 7 days. They drain pericarditis sack, blood pressure was going down, she got surgery 24 hours after going to the hospital. Advise by 3 diff doctor, pcp, heart and another DR, not to get booster. She disagree and still got boosters. No complication with first or second booster.   The symptoms of pericarditis was reported as shortest of breath. It was reported pericarditis was not connected to vaccine back then.  No treatment medication was reported.  Company comment: This spontaneous case concerns an 81-year-old female patient with relevant underlying conditions of heart disorder and high blood pressure who experienced the serious (medically significant and hospitalization) expected AESIs Myocarditis and Pericarditis and serious (medically significant and hospitalization) unexpected events of Cardiac tamponade, Arthritis and Sunburn which occurred on the same day after receiving second dose of mRNA-1273 vaccine. She was hospitalized and treated with surgery. Inappropriate schedule of product administration (First Moderna shot was 1/1/21 and second on 2/23/21) also noted in the case. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns an 81-year-old female patient with relevant underlying conditions of heart disorder and high blood pressure who experienced the serious (medically significant and hospitalization) expected AESIs Myocarditis and Pericarditis and serious (medically significant and hospitalization) unexpected events of Cardiac tamponade, Arthritis and Sunburn which occurred on the same day after receiving second dose of mRNA-1273 vaccine. She was hospitalized and treated with surgery. Inappropriate schedule of product administration (First Moderna shot was 1/1/21 and second on 2/23/21) also noted in the case. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.