Age: 69.0
Sex: M
Vaccine: COVID19-2, COVID19-2
Symptoms: Cardiac flutter, Extrasystoles, Heart rate
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of CARDIAC FLUTTER (Heart fluttering/Fast beating heart) and EXTRASYSTOLES (2 episodes when he felt his heart skipped a beat) in a 69-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 immunisation. The patient's past medical history included Bypass surgery. Concurrent medical conditions included Drug allergy and Pericarditis (pericarditis on 2013 after receiving a bypass heart surgery. He was already hospitalized and after the surgery he suffered pericarditis). Concomitant products included LEVOTHYROXINE, METOPROLOL and ACETYLSALICYLIC ACID (ASPIRINE) for an unknown indication. On 09-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 09-Sep-2022, the patient experienced CARDIAC FLUTTER (Heart fluttering/Fast beating heart) (seriousness criterion medically significant) and EXTRASYSTOLES (2 episodes when he felt his heart skipped a beat) (seriousness criterion medically significant). On 09-Sep-2022, CARDIAC FLUTTER (Heart fluttering/Fast beating heart) had resolved. At the time of the report, EXTRASYSTOLES (2 episodes when he felt his heart skipped a beat) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Sep-2022, Heart rate: Fast beating. For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments. The patient was not tested positive for Covid19 in past. The patient took 1st dose on 04-Jan-2021 with lot number 025J20-2A, 2nd dose on 29-Jan-2021 with lot number 030L20A, 1st booster dose on 27-Oct-2021 with lot number 939906, 2nd booster dose on 06-Apr-2022 with lot number 007J21-2A. The patient went to sleep and the symptoms subsisted and after that patient had just 2 episodes, when felt heart skipped a beat. No treatment information was provided. The symptom of cardiac flutter included tachycardia. Company Comment: This is a spontaneous case, reported by a patient, concerning a 69-year-old male patient with medical condition of Pericarditis with Bypass heart surgery and concomitant medication of Levothyroxine, who experienced the unexpected serious (medically significant) adverse events of special interest Cardiac flutter reported as heart flutter/tachycardia, and Extrasystoles reported as skipped heart beat, which occurred on the same day after receiving a dose of mRNA-1273.222 as the fifth dose of COVID-19 vaccine. The patient was initially administered with the two initial doses of unknown vaccine approximately 21 months prior, the interval between the two doses is 25 days, the third dose of unknown vaccine was given approximately 9 months later, and the fourth dose of unknown vaccine was administered 6 months after the third dose. It has been reported that the patient went to sleep, and the symptoms subsisted, there have been only two episodes of extrasystole since then. No further details about the clinical course, other diagnostic procedures and treatments were provided. The event Cardiac flutter has resolved while the outcome of the event Extrasystoles was unknown. The medical condition of Pericarditis with Bypass heart surgery and concomitant medication of Levothyroxine remain as confounders for the events. The benefit-risk relationship of mRNA-1273.222 is not affected by this report. Events' seriousness retained as per medical judgment. Most recent FOLLOW-UP information incorporated above includes: On 12-Sep-2022: Live Follow-up received, suspect information updated. Sender's Comments: This is a spontaneous case, reported by a patient, concerning a 69-year-old male patient with medical condition of Pericarditis with Bypass heart surgery and concomitant medication of Levothyroxine, who experienced the unexpected serious (medically significant) adverse events of special interest Cardiac flutter reported as heart flutter/tachycardia, and Extrasystoles reported as skipped heart beat, which occurred on the same day after receiving a dose of mRNA-1273.222 as the fifth dose of COVID-19 vaccine. The patient was initially administered with the two initial doses of unknown vaccine approximately 21 months prior, the interval between the two doses is 25 days, the third dose of unknown vaccine was given approximately 9 months later, and the fourth dose of unknown vaccine was administered 6 months after the third dose. It has been reported that the patient went to sleep, and the symptoms subsisted, there have been only two episodes of extrasystole since then. No further details about the clinical course, other diagnostic procedures and treatments were provided. The event Cardiac flutter has resolved while the outcome of the event Extrasystoles was unknown. The medical condition of Pericarditis with Bypass heart surgery and concomitant medication of Levothyroxine remain as confounders for the events. The benefit-risk relationship of mRNA-1273.222 is not affected by this report. Events' seriousness retained as per medical judgment.