Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Autoimmune disorder, Electrocardiogram, Myocardial necrosis marker, Pericarditis
Clinical narrative: she had a severe autoimmune reaction; severe case of pericarditis; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Feb-2022 and was forwarded to Moderna on 05-Feb-2022.    This spontaneous case was reported by a consumer and describes the occurrence of AUTOIMMUNE DISORDER (she had a severe autoimmune reaction) and PERICARDITIS (severe case of pericarditis) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 06H21A, 00A21A and 013L20A) for COVID-19 vaccination.     The patient's past medical history included Hypothyroidism.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Dec-2021, the patient experienced PERICARDITIS (severe case of pericarditis) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced AUTOIMMUNE DISORDER (she had a severe autoimmune reaction) (seriousness criteria hospitalization and medically significant). The patient was hospitalized for 10 days due to AUTOIMMUNE DISORDER and PERICARDITIS. The patient was treated with IBUPROFEN at a dose of 1 UNK; PREDNISONE at a dose of 1 dosage form and Surgery (took lot of fluid from the pericardial sac) for Pericarditis. At the time of the report, AUTOIMMUNE DISORDER (she had a severe autoimmune reaction) and PERICARDITIS (severe case of pericarditis) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Electrocardiogram: not provided not provided. On an unknown date, Myocardial necrosis marker: not provided not provided.         Lot of Concomitant medications were used by patient. Treatment drugs ibuprofen was used as anti inflammatory drug, prednisone was used as Steroids.  The patient was stated that they took lot of fluid from the pericardial sac where a procedure was done. Patient stated that lot of lab tests were performed with unknown results.  COMPANY COMMENT : This spontaneous case concerns a 68-year-old, female patient with relevant medical history of hypothyroid, who experienced the serious unexpected event of autoimmune disorder (reported as she had a severe autoimmune reaction) and expected serious AESI event of pericarditis on a 1 month 4 days after the third dose of mRNA-1273. The patient was hospitalized for 10 days. The patient was treated with IBUPROFEN, PREDNISONE and procedure (took lot of fluid from the pericardial sac) for Pericarditis. At the time of the report events had not resolved. Inappropriate schedule of vaccine administered noted between 1st and  2nd dose of  mRNA-1273. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-473304 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 04-Feb-2022: Patient date of birth was updated.; Sender's Comments: This spontaneous case concerns a 68-year-old, female patient with relevant medical history of hypothyroid, who experienced the serious unexpected event of autoimmune disorder (reported as she had a severe autoimmune reaction) and expected serious AESI event of pericarditis on a 1 month 4 days after the third dose of mRNA-1273. The patient was hospitalized for 10 days. The patient was treated with IBUPROFEN, PREDNISONE and procedure (took lot of fluid from the pericardial sac) for Pericarditis. At the time of the report events had not resolved. Inappropriate schedule of vaccine administered noted between 1st and  2nd dose of  mRNA-1273. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.