Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Blood pressure measurement, Depression, Suicidal ideation
Clinical narrative: afib; suicidal thoughts; depression; This spontaneous case was reported by a patient and describes the occurrence of ATRIAL FIBRILLATION (afib) and SUICIDAL IDEATION (suicidal thoughts) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 072P21A, 026L20A and 032L20A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product METOPROLOL SUCCINATE (METOPROLOL [METOPROLOL SUCCINATE]) for an unknown indication.    Concurrent medical conditions included Blood pressure high. Concomitant products included ATENOLOL for an unknown indication.   On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient started METOPROLOL SUCCINATE (METOPROLOL [METOPROLOL SUCCINATE]) (unknown route) at an unspecified dose. On an unknown date, the patient experienced ATRIAL FIBRILLATION (afib) (seriousness criterion medically significant), SUICIDAL IDEATION (suicidal thoughts) (seriousness criterion medically significant) and DEPRESSION (depression). The patient was treated with APIXABAN (ELIQUIS) at a dose of UNK, bid and FLECAINIDE at a dose of UNK, bid. At the time of the report, ATRIAL FIBRILLATION (afib) had resolved with sequelae and SUICIDAL IDEATION (suicidal thoughts) and DEPRESSION (depression) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: High like 160/100.         The patient had no previous health conditions other than being treated for high blood pressure. The patient called to inform about a severe side effect he experienced after receiving the Moderna booster in Oct 2021. Immediately after the booster, he started feeling fatigued, experiencing shortness of breath, severe palpitations, and dizziness. In Jan 2022, while at home in the evening, he had a frightening episode of severe palpitations, which he initially thought was a heart attack. Emergency services were called, but they did not admit him to the hospital. A day or two later, he visited his primary healthcare provider at Medical Center, who advised him to go to the emergency room due to his irregular heartbeat. At the ER, he was monitored for five hours and diagnosed with atrial fibrillation by a cardiologist. However, he was not admitted to the hospital. His blood pressure medication was changed from Atenolol to Metoprolol, but he had to discontinue it due to depression and suicidal thoughts. The medication was then switched back to Atenolol twice daily. Since the ER visit, his HCP at Cardiology prescribed Eliquis and Flecainide, both taken twice a day, which have restored his heart rhythm. Currently, he was stable, but experiences extreme tiredness in the evenings after work. His HCP reassured him that everything was currently under control, and his next appointment was scheduled for next year, as he had been going every six months.  Company Comment: This is a spontaneous case concerning a 74-year-old male patient with a history of Blood pressure high, who experienced the serious (due to medically significant) unexpected, events of ATRIAL FIBRILLATION (AESI) and SUICIDAL IDEATION, which occurred on an unknown date after a dose of mRNA-1273 vaccine, received as the third dose of COVID-19 vaccination schedule. Doses 1 and 2 were also with mRNA-1273 vaccine. It was reported that immediately after the booster, he started feeling fatigued, experiencing shortness of breath, severe palpitations, and dizziness. Approximately 3 months later, while at home in the evening, he had a frightening episode of severe palpitations, which he initially thought was a heart attack. Emergency services were called, but they did not admit him to the hospital. A day or two later, he visited his primary healthcare provider at Medical Center, who advised him to go to the emergency room due to his irregular heartbeat. At the ER, he was monitored for five hours and diagnosed with atrial fibrillation by a cardiologist. However, he was not admitted to the hospital. His blood pressure medication was changed from Atenolol to Metoprolol, but he had to discontinue it due to depression and suicidal thoughts. The medication was then switched back to Atenolol twice daily. Since the ER visit, his HCP at Cardiology prescribed Eliquis and Flecainide, both taken twice a day, which have restored his heart rhythm. Currently, he was stable, but experiences extreme tiredness in the evenings after work. His HCP reassured him that everything was currently under control, and his next appointment was scheduled for next year, as he had been going every six months. The outcome of the events was reported as resolved with sequelae.  The mentioned medical history of Blood pressure high remains as a confounder for event ATRIAL FIBRILLATION, and concomitant use of Metoprolol remains as a confounder for event SUICIDAL IDEATION.  METOPROLOL was considered as a co-suspect drug. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: Company Comment: This is a spontaneous case concerning a 74-year-old male patient with a history of Blood pressure high, who experienced the serious (due to medically significant) unexpected, events of ATRIAL FIBRILLATION (AESI) and SUICIDAL IDEATION, which occurred on an unknown date after a dose of mRNA-1273 vaccine, received as the third dose of COVID-19 vaccination schedule. Doses 1 and 2 were also with mRNA-1273 vaccine. It was reported that immediately after the booster, he started feeling fatigued, experiencing shortness of breath, severe palpitations, and dizziness. Approximately 3 months later, while at home in the evening, he had a frightening episode of severe palpitations, which he initially thought was a heart attack. Emergency services were called, but they did not admit him to the hospital. A day or two later, he visited his primary healthcare provider at Medical Center, who advised him to go to the emergency room due to his irregular heartbeat. At the ER, he was monitored for five hours and diagnosed with atrial fibrillation by a cardiologist. However, he was not admitted to the hospital. His blood pressure medication was changed from Atenolol to Metoprolol, but he had to discontinue it due to depression and suicidal thoughts. The medication was then switched back to Atenolol twice daily. Since the ER visit, his HCP at Cardiology prescribed Eliquis and Flecainide, both taken twice a day, which have restored his heart rhythm. Currently, he was stable, but experiences extreme tiredness in the evenings after work. His HCP reassured him that everything was currently under control, and his next appointment was scheduled for next year, as he had been going every six months. The outcome of the events was reported as resolved with sequelae.  The mentioned medical history of Blood pressure high remains as a confounder for event ATRIAL FIBRILLATION, and concomitant use of Metoprolol remains as a confounder for event SUICIDAL IDEATION.  METOPROLOL was considered as a co-suspect drug. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.