Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Electrocardiogram, Heart rate irregular, Palpitations, SARS-CoV-2 test
Clinical narrative: COVID-19; irregular heart beat; palpitations; This spontaneous case was reported by a patient and describes the occurrence of HEART RATE IRREGULAR (irregular heart beat), PALPITATIONS (palpitations) and COVID-19 (COVID-19) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 053E21A, 030M20A and 025J or L20A) for COVID-19 vaccination.     The patient had no allergies to medications, food and other products.  Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Sep-2021, the patient experienced HEART RATE IRREGULAR (irregular heart beat) and PALPITATIONS (palpitations). In December 2021, the patient experienced COVID-19 (COVID-19). In January 2022, COVID-19 (COVID-19) had resolved. At the time of the report, HEART RATE IRREGULAR (irregular heart beat) and PALPITATIONS (palpitations) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2021, SARS-CoV-2 test: (Positive) Positive. On an unknown date, Electrocardiogram: palpitations.   No medical history was reported but patient had been on Lipitor for approximately 3-4 months now after received the first booster dose and an eye drops.  Patient stated that 10 days after getting the 1st booster dose of the Moderna Covid-19 vaccine, he had some irregular heart beat and palpitations. He consulted with a cardiologist and was told that this may or may not be connected with the vaccine. He was also told that this was not myocarditis. ECG was done and was told that it showed palpitations. No medication was prescribed for it.  No other vaccines given within 1 month prior to Moderna COVID-19 vaccine.  Adverse event caused patient to consult a cardiologist. The patient did not experienced a similar event in the past. The patient did not experienced symptoms like this before receiving the Moderna COVID-19 vaccine.  No history of Myocarditis/pericarditis.  No treatment information was provided by the reporter.  Company Comment: This spontaneous case concerns an 84-year-old, male patient with history of concomitant intake of Lipitor (atorvastatin) for an unknown indication, who experienced the unexpected, non-serious events of heart rate irregular (AESI), palpitations and COVID-19. The events heart rate irregular and palpitations occurred 10 days after receiving the first booster dose (third dose in the COVID-19 vaccination series) of the mRNA-1273 original vaccine. The event COVID-19 occurred approximately 3 to 4 months after receiving the first booster dose of the mRNA-1273 original vaccine. It was reported that the patient experienced some irregular heartbeat and palpitations. On an unspecified date, he sought consultation with a cardiologist and was told that the events may or may not be related with the vaccine. The patient was also told that the events were not symptoms of myocarditis. An Electrocardiogram was done which showed 'palpitations'. No blood tests were done. No medication was prescribed. The events had not resolved at the time of the report. Approximately 3 to 4 months after vaccination, the patient experienced COVID-19. Symptoms (unspecified) were reported as 'pretty mild'. No treatment was received. The event had resolved at the time of the report. The patient's history of an underlying medical condition (not reported), which is probably being treated with the reported concomitant medication, may be a risk factor for the event COVID-19. The patient's advanced age (high risk for infections) remains a confounder for the event COVID-19. The benefit-risk relationship of the mRNA-1273 original vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns an 84-year-old, male patient with history of concomitant intake of Lipitor (atorvastatin) for an unknown indication, who experienced the unexpected, non-serious events of heart rate irregular (AESI), palpitations and COVID-19. The events heart rate irregular and palpitations occurred 10 days after receiving the first booster dose (third dose in the COVID-19 vaccination series) of the mRNA-1273 original vaccine. The event COVID-19 occurred approximately 3 to 4 months after receiving the first booster dose of the mRNA-1273 original vaccine. It was reported that the patient experienced some irregular heartbeat and palpitations. On an unspecified date, he sought consultation with a cardiologist and was told that the events may or may not be related with the vaccine. The patient was also told that the events were not symptoms of myocarditis. An Electrocardiogram was done which showed 'palpitations'. No blood tests were done. No medication was prescribed. The events had not resolved at the time of the report. Approximately 3 to 4 months after vaccination, the patient experienced COVID-19. Symptoms (unspecified) were reported as 'pretty mild'. No treatment was received. The event had resolved at the time of the report. The patient's history of an underlying medical condition (not reported), which is probably being treated with the reported concomitant medication, may be a risk factor for the event COVID-19. The patient's advanced age (high risk for infections) remains a confounder for the event COVID-19. The benefit-risk relationship of the mRNA-1273 original vaccine is not affected by this report.