Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Inappropriate schedule of product administration, Pericarditis, SARS-CoV-2 test
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PERICARDITIS (1-2 days after the booster patient got sick, got diagnosed with Pericarditis/ Patient was coughing alot but finally was diagnosed with Pericarditis) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030h21a, 037c21a and 030b21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Patient had no history relating to mentioned AE and both Acute and Chronic illnesses at the time of vaccination. No other vaccines given within 1 month prior to Moderna COVID-19 vaccine. Concurrent medical conditions included Allergy to nuts (Tree nuts), Blood pressure high and Cholesterol. On 18-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, the patient experienced PERICARDITIS (1-2 days after the booster patient got sick, got diagnosed with Pericarditis/ Patient was coughing a lot but finally was diagnosed with Pericarditis) (seriousness criteria hospitalization and medically significant). In February 2022, the patient experienced COVID-19 (Had COVID). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). The patient was treated with LEVETIRACETAM (KEPPRA [LEVETIRACETAM]) at an unspecified dose and frequency and Surgery (Drain fluid out of pericardium) for Pericarditis. At the time of the report, PERICARDITIS (1-2 days after the booster patient got sick, got diagnosed with Pericarditis/ Patient was coughing a lot but finally was diagnosed with Pericarditis) was resolving and COVID-19 (Had COVID) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2022, SARS-CoV-2 test: (Positive) Positive. In June 2022, SARS-CoV-2 test: (Positive) Positive. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered PERICARDITIS (1-2 days after the booster patient got sick, got diagnosed with Pericarditis/ Patient was coughing a lot but finally was diagnosed with Pericarditis) to be related. No further causality assessments were provided for COVID-19 (Had COVID) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). Concomitant product was reported as blood pressure and cholesterol medication (unspecified). Patient was initially diagnosed with bronchitis. Patient was coughing alot but finally was diagnosed with pericarditis and had surgery to drain fluid out of pericardium. Patient had a neurology appointment on the day of reporting. The neurologist told patient that was a possible side effect of the Moderna vaccine. Patient was still in pain from the surgery and coughing as a residual effects from the surgery. The symptoms had improved. Patient was tested for cardiac lab values (ECG, cardiac test, cardiac enzymes) and had them on paper. Patient was tested COVID positive, first time on Feb-2022 and the second time about a month ago. No hospitalization was required due to COVID. Company Comment: This is a Spontaneous case reported by a consumer, concerning a 75-year-old male patient, with no relevant medical history, who experienced the expected and serious (due to hospitalization and medically significant) AESI of Pericarditis, and the non-serious unexpected AESI of COVID-19, which occurred after the third dose of mRNA-1273 vaccine. Patient started with cough 1-2 days after vaccination with mRNA-1273 vaccine, with final diagnosis of Pericarditis. He had surgery in which fluid was drained out of his pericardium. 2 months after the same dose of mRNA-1273 vaccine, patient experienced COVID-19. Inappropriate schedule of vaccine administered was also noted. No information disclosed about diagnostic tests performed. At the time of the report, Pericarditis was resolving. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. This case was linked to MOD-2022-615888 (Patient Link). Sender's Comments: This is a Spontaneous case reported by a consumer, concerning a 75-year-old male patient, with no relevant medical history, who experienced the expected and serious (due to hospitalization and medically significant) AESI of Pericarditis, and the non-serious unexpected AESI of COVID-19, which occurred after the third dose of mRNA-1273 vaccine. Patient started with cough 1-2 days after vaccination with mRNA-1273 vaccine, with final diagnosis of Pericarditis. He had surgery in which fluid was drained out of his pericardium. 2 months after the same dose of mRNA-1273 vaccine, patient experienced COVID-19. Inappropriate schedule of vaccine administered was also noted. No information disclosed about diagnostic tests performed. At the time of the report, Pericarditis was resolving. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.