Received Nov 14, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | — | IM |
went into defib; reoccurring pericarditis, not acute; inflammation went further down into my heart/Patient has chronic reoccurring inflammation; within that 30 minutes, immediately started having um chest pain; heart palpitations; left bundle branch block and a lot of heart issues; chronic reoccurring inflammation; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC FIBRILLATION (went into defib), PERICARDITIS (reoccurring pericarditis, not acute) and CARDITIS (inflammation went further down into my heart/Patient has chronic reoccurring inflammation) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced CARDIAC FIBRILLATION (went into defib) (seriousness criterion medically significant), PERICARDITIS (reoccurring pericarditis, not acute) (seriousness criterion medically significant), CARDITIS (inflammation went further down into my heart/Patient has chronic reoccurring inflammation) (seriousness criterion medically significant), BUNDLE BRANCH BLOCK LEFT (left bundle branch block and a lot of heart issues) and INFLAMMATION (chronic reoccurring inflammation). an unknown date, the patient experienced CHEST PAIN (within that 30 minutes, immediately started having um chest pain) and PALPITATIONS (heart palpitations). The patient was treated with Rilonacept (Arcalyst) at an unspecified dose and frequency. At the time of the report, CARDIAC FIBRILLATION (went into defib), CHEST PAIN (within that 30 minutes, immediately started having um chest pain) and PALPITATIONS (heart palpitations) outcome was unknown and PERICARDITIS (reoccurring pericarditis, not acute), CARDITIS (inflammation went further down into my heart/Patient has chronic reoccurring inflammation), BUNDLE BRANCH BLOCK LEFT (left bundle branch block and a lot of heart issues) and INFLAMMATION (chronic reoccurring inflammation) had not resolved. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown. No concomitant medication was reported. It was reported that patient had one dose of Spikevax a few years ago, might be in 2021 or 2022 within 30 minutes. Patient got vaccine, by the time she went home, within that 30 minutes patient immediately started had chest pain and heart palpitations and it was continued, but it was mild, and so patient just tried to bear with it, but over the summer it finally went even worse and like almost patient went into defib so supposed the inflammation went further down into heart. Patient had a reoccurring pericarditis, not acute. it went deeper into heart because it was messing with electrical and patient was having left bundle branch block and a lot of heart issues. It had debilitated and now she did not. Patient could not even get out of bed most of the time, barely just to get up and used the bedside commode. Patient was healthy, it was thought that she had a heart blockage at one time, heart was completely looked better than that. Patient had no plaque in heart. It was all from that vaccine. And over the summer, patient had been to 5 hospitals. Patient been in and out of the hospital. Patient had chronic reoccurring inflammation. She had been put on arcalyst since the end of July but so far it was not working. It was unknown if the patient experienced any additional symptoms/events.; Reporter's Comments: The benefit-risk relationship of the product is not affected by this report.