Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure fluctuation, Cardiac failure, Fluid retention, Weight, Weight increased
Clinical narrative: Heart failure; Gained 100 pounds in a short period of time/ retaining fluid; Gained 100 pounds in a short period of time/ retaining fluid; Blood pressure change; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC FAILURE (Heart failure) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    No Medical History information was reported.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced BLOOD PRESSURE FLUCTUATION (Blood pressure change). On an unknown date, the patient experienced CARDIAC FAILURE (Heart failure) (seriousness criterion medically significant), WEIGHT INCREASED (Gained 100 pounds in a short period of time/ retaining fluid) and FLUID RETENTION (Gained 100 pounds in a short period of time/ retaining fluid). At the time of the report, CARDIAC FAILURE (Heart failure), BLOOD PRESSURE FLUCTUATION (Blood pressure change), WEIGHT INCREASED (Gained 100 pounds in a short period of time/ retaining fluid) and FLUID RETENTION (Gained 100 pounds in a short period of time/ retaining fluid) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Weight: Gained 100 pounds.         No concomitant medication was reported.  In August 2021, the patient stopped taking Skyrizi as between the COVID vaccinations and taking Skyrizi, patient blood pressure changed. Patient also gained 100 pounds in a short period of time and was retaining fluid. Patient also had heart failure.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment information was reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company comment.  This spontaneous case concerns a 63  year  old, male patient, with current condition of plaque psoriasis, who received two doses of mRNA-1273 vaccine and experienced the serious (medically significant) unexpected AESI of cardiac failure, among other non  serious events. Onset date of the event was not reported; hence latency and temporal association cannot be properly assessed. On an unspecified date, the patient presented fluid retention, blood pressure fluctuation and weight increased, which could be related with cardiac failure. The outcome was not recovered. No further relevant clinical information was available for medical reviewing. Co-suspect product included Risankizumab. Patient´s medical history of psoriasis could be confounding for cardiovascular disease, which is a risk factor for cardiac failure. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 63  year  old, male patient, with current condition of plaque psoriasis, who received two doses of mRNA-1273 vaccine and experienced the serious (medically significant) unexpected AESI of cardiac failure, among other non  serious events. Onset date of the event was not reported; hence latency and temporal association cannot be properly assessed. On an unspecified date, the patient presented fluid retention, blood pressure fluctuation and weight increased, which could be related with cardiac failure. The outcome was not recovered. No further relevant clinical information was available for medical reviewing. Co-suspect product included Risankizumab. Patient´s medical history of psoriasis could be confounding for cardiovascular disease, which is a risk factor for cardiac failure. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.