Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Pericarditis, Suspected COVID-19
Clinical narrative: he began having symptoms of acute pericarditis a month and a half after the 2nd dose/diagnosed with pericarditis; lightheaded and dizziness; Covid symptoms for 1 day after the 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of PERICARDITIS (he began having symptoms of acute pericarditis a month and a half after the 2nd dose/diagnosed with pericarditis) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Symptoms began, beginning of December then again on 16 or 17 Dec 2020. COVID-19 test was performed on 30-Dec-2020 which got positive.) in December 2020.    On 25-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced SUSPECTED COVID-19 (Covid symptoms for 1 day after the 2nd dose). On 25-Mar-2021, the patient experienced DIZZINESS (lightheaded and dizziness). On 05-Jun-2021, the patient experienced PERICARDITIS (he began having symptoms of acute pericarditis a month and a half after the 2nd dose/diagnosed with pericarditis) (seriousness criterion medically significant). The patient was treated with COLCHICINE for Pericarditis, at a dose of 1 dosage form. At the time of the report, PERICARDITIS (he began having symptoms of acute pericarditis a month and a half after the 2nd dose/diagnosed with pericarditis) was resolving, DIZZINESS (lightheaded and dizziness) outcome was unknown and SUSPECTED COVID-19 (Covid symptoms for 1 day after the 2nd dose) had resolved.            No concomitant medication information provided.   Patient received booster dose (lot # 065F21A) on 23-Nov-2021 of the Moderna Covid-19 Vaccine. He had Covid symptoms for one day after the second dose. Right away after the second dose he felt lightheaded and dizzy. He began symptoms of acute pericarditis a month and a half after the second dose and was diagnosed with pericarditis on 05-Jun-2021. He had heart attack symptoms such as chest pain on his left side radiating to chest bone, his back, and left shoulder. He went to the ER 4 times with false symptoms of a heart attack. He would wake up with a sharp pain on his left side before doing anything that would last a short time then go away. But then he would be able to climb stairs with no trouble at all, which was confusing. It started as strong, dull pain, then he was ok for about 2 weeks, then it changed to sharp pain and episodes of fatigue that lasted from 30 seconds to 1 minute and a half. He also said the second wave of pain episodes would happen 2 to 3 times a day and last 20 seconds to a minute and a half. Also when laying down he couldn't breathe. He states that the symptoms are continuing but much less frequent and much less intense. Patient would continue to see a cardiologist. On an unknown date EKG, blood work, echograms, and a CT scan done because of suspected blood clot, unknown results.  Company Comment: This spontaneous case concerns a 69-year-old male patient with no details on relevant medical history, who experienced the expected serious (medically significant) event of Pericarditis and the non serious event of Suspected COVID-19 (AESI) after mRNA- 1273 Moderna vaccine. The onset of the event Suspected COVID-19 occurred after the second dose of mRNA- 1273 vaccine, the event reported as COVID symptoms, and had a duration of 1 day. SARS-CoV-2 test was not performed. The onset of Pericarditis occurred 1 month and a half after the second dose and the diagnosis was confirmed approximately 2 months and 6 days after the second dose. Clinical manifestations included Chest pain, Fatigue and Dyspnoea. Electrocardiogram, laboratory, echocardiogram and CT scan were performed, but results are not available. Outpatient treatment with colchicine was given. At the time of the report, the symptoms were resolving. The rechallenge is not applicable, since the events were reported exclusively after the second dose. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.   This case was linked to MOD-2021-396494 (Patient Link).; Sender's Comments: This spontaneous case concerns a 69-year-old male patient with no details on relevant medical history, who experienced the expected serious (medically significant) event of Pericarditis and the non serious event of Suspected COVID-19 (AESI) after mRNA- 1273 Moderna vaccine. The onset of the event Suspected COVID-19 occurred after the second dose of mRNA- 1273 vaccine, the event reported as COVID symptoms, and had a duration of 1 day. SARS-CoV-2 test was not performed. The onset of Pericarditis occurred 1 month and a half after the second dose and the diagnosis was confirmed approximately 2 months and 6 days after the second dose. Clinical manifestations included Chest pain, Fatigue and Dyspnoea. Electrocardiogram, laboratory, echocardiogram and CT scan were performed, but results are not available. Outpatient treatment with colchicine was given. At the time of the report, the symptoms were resolving. The rechallenge is not applicable, since the events were reported exclusively after the second dose. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report