Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Pericarditis, Product dose omission issue
Clinical narrative: pericarditis; Has not had second dose of vaccine.; Pain in arm; chest pain; shortness of breath,difficult breathing; thought it was gas; burp; This spontaneous case was reported by a patient and describes the occurrence of PERICARDITIS (pericarditis) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included AMLODIPINE BESILATE (AMLODIPINE BESYLATE) for Blood pressure, SIMVASTATIN for Cholesterol, OMEPRAZOLE for an unknown indication.    On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-May-2021, the patient experienced CHEST PAIN (chest pain), DYSPNOEA (shortness of breath,difficult breathing), FLATULENCE (thought it was gas), ERUCTATION (burp) and PAIN IN EXTREMITY (Pain in arm). On 02-May-2021, the patient experienced PERICARDITIS (pericarditis) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Has not had second dose of vaccine.). The patient was hospitalized from 02-May-2021 to 04-May-2021 due to PERICARDITIS. The patient was treated with COLCHICINE (COLCHICINE A) on 04-May-2021 at an unspecified dose and frequency and ACETYLSALICYLIC ACID (ASPIRIN 81) on 04-May-2021 at an unspecified dose and frequency. At the time of the report, PERICARDITIS (pericarditis), CHEST PAIN (chest pain), DYSPNOEA (shortness of breath,difficult breathing), FLATULENCE (thought it was gas), ERUCTATION (burp), PRODUCT DOSE OMISSION ISSUE (Has not had second dose of vaccine.) and PAIN IN EXTREMITY (Pain in arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-May-2021, Catheterisation cardiac: pericarditis (abnormal) Pericarditis.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient received the first dose of the vaccine on 03-Apr-2021 , Batch number 001C2(Z)1A( patient can't distinguish)and on the next day she experienced chest pain( started around 7 pm), shortness of breath, difficulty breathing. Patient did not go to ER right away thought it was gas, When she drink water she would burp. It got worse that night.. Patient had pain in the arm that was occurring before chest pain and can't remember what she took which was either Tylenol or ibuprofen.  On the following day on 02-May-2021patient went to ER, they tried to control the pain and was admitted to hospital and had blood work done but no result was reported. On the next day, 03-May-2021 patient had stress test done but no result was reported and was transferred to another hospital for emergency Cath lab procedure, finding that she had pericarditis. Patient discharge on 04-May-2021 and was prescribed Colchicine and low dose baby aspirin. Patient has not had the second dose of vaccine.  Company Comment : Very limited information regarding the events has been provided at this time.  Further information is expected.; Sender's Comments: Very limited information regarding the events has been provided at this time.  Further information is expected.