Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: exacerbation of COPD; congestive heart failure; diagnosed with AV block; a-fibrillation; seizure, unresponsive for 15 minutes, kind of came in and out of consciousness, couldn't move his arms, couldn't smile; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (seizure, unresponsive for 15 minutes, kind of came in and out of consciousness, couldn't move his arms, couldn't smile), CHRONIC OBSTRUCTIVE PULMONARY DISEASE (exacerbation of COPD), CARDIAC FAILURE CONGESTIVE (congestive heart failure), ATRIOVENTRICULAR BLOCK (diagnosed with AV block) and ATRIAL FIBRILLATION (a-fibrillation) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048D21A, 001A21A and 027L20A) for COVID-19 vaccination.     The patient's past medical history included Cardioversion (heart conversion to get him out of a-fibrillation.) and Pacemaker insertion (cardiac). Concurrent medical conditions included Atrial flutter (Start date- 5 yeas ago, Worsened after 3rd dose.) since 2018, Rheumatoid arthritis (Same as before.) since 1984 and COPD (Start date- 15 years ago, Worsened after 3rd dose.) since 2008.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 100 microgram. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 100 microgram. On 28-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 100 microgram. On 28-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SEIZURE (seizure, unresponsive for 15 minutes, kind of came in and out of consciousness, couldn't move his arms, couldn't smile) (seriousness criterion medically significant). In February 2022, the patient experienced CHRONIC OBSTRUCTIVE PULMONARY DISEASE (exacerbation of COPD) (seriousness criterion hospitalization). On an unknown date, the patient experienced CARDIAC FAILURE CONGESTIVE (congestive heart failure) (seriousness criteria hospitalization and medically significant), ATRIOVENTRICULAR BLOCK (diagnosed with AV block) (seriousness criterion medically significant) and ATRIAL FIBRILLATION (a-fibrillation) (seriousness criterion medically significant). The patient was hospitalized on sometime in February 2022 due to CHRONIC OBSTRUCTIVE PULMONARY DISEASE, and then for 15 days due to CARDIAC FAILURE CONGESTIVE. The patient was treated with TORASEMIDE (TORSEMIDE) for Atrial fibrillation, at an unspecified dose and frequency; AMIODARONE for Atrial fibrillation, at an unspecified dose and frequency and FUROSEMIDE (LASIX [FUROSEMIDE]) (intravenous) for Fluid imbalance, at an unspecified dose and frequency. At the time of the report, SEIZURE (seizure, unresponsive for 15 minutes, kind of came in and out of consciousness, couldn't move his arms, couldn't smile), CHRONIC OBSTRUCTIVE PULMONARY DISEASE (exacerbation of COPD), CARDIAC FAILURE CONGESTIVE (congestive heart failure), ATRIOVENTRICULAR BLOCK (diagnosed with AV block) and ATRIAL FIBRILLATION (a-fibrillation) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Cardiovascular evaluation: abnormal (abnormal) he went into a-fibrillation and remained on a-fibrillation for 30 days..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.  Company comment : This is a spontaneous case concerning a 85-year-old, male patient with relevant concurrent medical condition of atrial flutter and chronic obstructive pulmonary disease (COPD) and with vaccine history of receiving first and second dose of mRNA-1273 vaccine as previous doses, who experienced the unexpected serious AESI event of seizure (medically significant), atrial fibrillation (medically significant), congestive heart failure (medically significant and hospitalization), and AV block (medically significant) and the unexpected serious (hospitalization) event of exacerbation of COPD. The event seizure occurred approximately 3 hours after the third dose of mRNA-1273 vaccine administration while the events atrial fibrillation, congestive heart failure, AV block and exacerbation of COPD exact occurrence unknown but stated that the events occurred after the third dose of mRNA-1273 vaccine administration. The events were described as, 3 hours after the third dose of mRNA-1273 patient became unresponsive for 15 minutes, kind of came in and out of consciousness, couldn't smile, couldn't move his arms and the patient wife thought he was having transient ischemic attack and was transported to the hospital and was subsequently diagnosed with seizure. Patient was kept overnight, and was sent home with heart monitor then patient experienced atrial fibrillation for 30 days and patient had congestive heart failure. Patient was hospitalized for 15 days, and patient received IV Furosemide (Lasix) and patient underwent cardioversion to get him out of atrial fibrillation and received new medication: Amiodarone and Torsemide. Patient remained out of atrial fibrillation however patient was diagnosed with AV block and was given pacemaker. The concurrent medical condition of atrial flutter remain confounder for the events atrial fibrillation, seizure, AV block and congestive heart failure while the concurrent medical condition of COPD remain confounder for the events atrial fibrillation, AV block, congestive heart failure, seizure and COPD exacerbation. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   No concomitant was reported by patient. Treatment medication was reported by patient as oxygen, nebulizer treatment, and antibiotics, Heart Conversion and pace maker. patient reported that 3 hours after 3 dose she thought her husband got TIA, unresponsive for 15 minutes,  kind of came in and out of consciousness, couldn't smile, couldn't move his arms and admitted to hospital, kept him overnight, and sent him home with heart monitor. Patient remained on a-fibrillation for 30 days, Then they did heart conversion to get him out of a-fibrillation. Patient was at hospital for 15 days.They put him on new medication amiodarone and torsemide, patient was remained out of a-fibrillation. In Feb 2022 patient got admitted for exacerbation of COPD. Then about 2 weeks ago he was diagnosed with AV block and put in a pacemaker. Patient reported that he had not experienced similar event in past. Patient reported that he had taken 3 dose due to Rheumatoid Arthritis.; Sender's Comments: This is a spontaneous case concerning a 85-year-old, male patient with relevant concurrent medical condition of atrial flutter and chronic obstructive pulmonary disease (COPD) and with vaccine history of receiving first and second dose of mRNA-1273 vaccine as previous doses, who experienced the unexpected serious AESI event of seizure (medically significant), atrial fibrillation (medically significant), congestive heart failure (medically significant and hospitalization), and AV block (medically significant) and the unexpected serious (hospitalization) event of exacerbation of COPD. The event seizure occurred approximately 3 hours after the third dose of mRNA-1273 vaccine administration while the events atrial fibrillation, congestive heart failure, AV block and exacerbation of COPD exact occurrence unknown but stated that the events occurred after the third dose of mRNA-1273 vaccine administration. The events were described as, 3 hours after the third dose of mRNA-1273 patient became unresponsive for 15 minutes, kind of came in and out of consciousness, couldn't smile, couldn't move his arms and the patient wife thought he was having transient ischemic attack and was transported to the hospital and was subsequently diagnosed with seizure. Patient was kept overnight, and was sent home with heart monitor then patient experienced atrial fibrillation for 30 days and patient had congestive heart failure. Patient was hospitalized for 15 days, and patient received IV Furosemide (Lasix) and patient underwent cardioversion to get him out of atrial fibrillation and received new medication: Amiodarone and Torsemide. Patient remained out of atrial fibrillation however patient was diagnosed with AV block and was given pacemaker. The concurrent medical condition of atrial flutter remain confounder for the events atrial fibrillation, seizure, AV block and congestive heart failure while the concurrent medical condition of COPD remain confounder for the events atrial fibrillation, AV block, congestive heart failure, seizure and COPD exacerbation. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.