Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate irregular, Oxygen saturation, Suspected COVID-19
Clinical narrative: CAT scan of my lungs on 16Sep2021, and it shows there was covid-19; congestive heart failure; irregular heart rate; fast pulse/ rapid pulse/ heart rate goes up; shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC FAILURE CONGESTIVE (congestive heart failure) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 037K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Asthma (Occasionally, weather related, in the spring and the fall the patient would have asthma). Concurrent medical conditions included Sjogren's (autoimmune condition called Sjogren's) and Pulmonary hypertension. Concomitant products included LOSARTAN and AMLODIPINE for an unknown indication.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced DYSPNOEA (shortness of breath). In March 2021, the patient experienced HEART RATE INCREASED (fast pulse/ rapid pulse/ heart rate goes up). On 19-Jun-2021, the patient experienced HEART RATE IRREGULAR (irregular heart rate). On 21-Jul-2021, the patient experienced CARDIAC FAILURE CONGESTIVE (congestive heart failure) (seriousness criteria disability and medically significant). On 16-Sep-2021, the patient experienced SUSPECTED COVID-19 (CAT scan of my lungs on 16Sep2021, and it shows there was covid-19). At the time of the report, CARDIAC FAILURE CONGESTIVE (congestive heart failure), HEART RATE INCREASED (fast pulse/ rapid pulse/ heart rate goes up) and DYSPNOEA (shortness of breath) had not resolved and HEART RATE IRREGULAR (irregular heart rate) and SUSPECTED COVID-19 (CAT scan of my lungs on 16Sep2021, and it shows there was covid-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Heart rate: abnormal (abnormal) rapid pulse since March 2021. On 19-Jun-2021, Heart rate: irregular heart rate (abnormal) irregular heart rate. On 16-Sep-2021, Computerised tomogram: it shows there was covid-19 (abnormal) it shows there was covid-19. On 16-Sep-2021, Oxygen saturation: 96 to down 85 (Low) 96 to down 85. On an unknown date, Oxygen saturation: decreased (Low) Decreased.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Treatment information was provided.  The patient had the second shot in February, and since then, she had trouble with shortness of breath. She had rapid pulse since March 2021. She did an echo with the heart doctor and nothing showed up. However, on 19Jun2021, she did an EKG, and this showed that I have an irregular heart rate. On 21Jul2021, she ended up with congestive heart failure. She just got the results from the CAT scan of her lungs on 16Sep2021, and it shows there was covid-19. She never tested for covid, she never had a fever. The only thing that could have done this was the vaccine. Now, she can't do anything. If she does something, her oxygen falls down. She had been with oxygen ever since she had the heart failure.  She still needs the oxygen. She had fatigue, and her oxygen goes down, and her heart rate goes up. On 16Sep2021 was the first time she had dinner. Oxygen went from  96 to down 85. In the end, she couldn't get the dinner done.  On unknown date the patient experienced fatigue and decreased activity.  Company Comment: This case concerns a 80-year-old female patient with a previous relevant medical history of Sjogren's disease, Asthma and Pulmonary hypertension, who experienced the unexpected events of Heart rate irregular and Cardiac failure congestive after Spikevax (mRNA- 1273 vaccine / Moderna COVID-19 Vaccine). Additionally, Suspected COVID-19 was also reported. The onset of the event Heart rate irregular occurred approximately 4 months and 29 days after the second dose of Spikevax and Cardiac failure congestive 6 months after the second dose. COVID-19 was suspected because of an abnormal computerised tomogram performed 7 months and 26 days after the second dose, but the diagnosis was not confirmed. The rechallenge was not applicable, as the events were reported exclusively after the second dose. Previous history of pulmonary hypertension remains a confounder. The benefit-risk relationship of Spikevax vaccine is not affected by    Most recent FOLLOW-UP information incorporated above includes: On 17-Sep-2021: Follow up received on 17-SEP-2021 contained significant information, events were added, lab tests were added, historical condition and current conditions were added, onset date of events were added.; Sender's Comments: This case concerns a 80-year-old female patient with a previous relevant medical history of Sjogren's disease, Asthma and Pulmonary hypertension, who experienced the unexpected events of Heart rate irregular and Cardiac failure congestive after Spikevax (mRNA- 1273 vaccine / Moderna COVID-19 Vaccine). Additionally, Suspected COVID-19 was also reported. The onset of the event Heart rate irregular occurred approximately 4 months and 29 days after the second dose of Spikevax and Cardiac failure congestive 6 months after the second dose. COVID-19 was suspected because of an abnormal computerised tomogram performed 7 months and 26 days after the second dose, but the diagnosis was not confirmed. The rechallenge was not applicable, as the events were reported exclusively after the second dose. Previous history of pulmonary hypertension remains a confounder. The benefit-risk relationship of Spikevax vaccine is not affected by this report.