Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Chills, Chronic left ventricular failure, Crying, Electrocardiogram
Clinical narrative: experienced fever, chills, throwing up, extreme throwing up,couldn't keep anything down, thought I had food poisoning/diagnosed with Chronic systolic heart failure/Heart Failure after 33 days after receiving first dose/Heart too weak; she couldn't drive herself; Chills; Fever; Throwing up; crying; This spontaneous case was reported by a patient and describes the occurrence of CHRONIC LEFT VENTRICULAR FAILURE (experienced fever, chills, throwing up, extreme throwing up,couldn't keep anything down, thought I had food poisoning/diagnosed with Chronic systolic heart failure/Heart Failure after 33 days after receiving first dose/Heart too weak) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    The patient's past medical history included Food poisoning. Concurrent medical conditions included Drug allergy (allergy to Diclofenac).   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced CRYING (crying), CHILLS (Chills), PYREXIA (Fever) and VOMITING (Throwing up). On 09-Mar-2021, the patient experienced IMPAIRED DRIVING ABILITY (she couldn't drive herself). On 11-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CHRONIC LEFT VENTRICULAR FAILURE (experienced fever, chills, throwing up, extreme throwing up, couldn't keep anything down, thought I had food poisoning/diagnosed with Chronic systolic heart failure/Heart Failure after 33 days after receiving first dose/Heart too weak) (seriousness criterion hospitalization). The patient was hospitalized from 09-Mar-2021 to 13-Mar-2021 due to CHRONIC LEFT VENTRICULAR FAILURE. The patient was treated with ATORVASTATIN for Chronic systolic heart failure, at a dose of 40 milligram, Daily; LOSARTAN for Chronic systolic heart failure, at a dose of 25 milligram, daily; FUROSEMIDE for Chronic systolic heart failure, at a dose of 40 milligram, daily; ACETYLSALICYLIC ACID (ASPIRIN 81) for Chronic systolic heart failure, at a dose of 81 milligram once a day and CARVEDILOL for Chronic systolic heart failure, at a dose of 3.25 milligram twice a day. At the time of the report, CHRONIC LEFT VENTRICULAR FAILURE (experienced fever, chills, throwing up, extreme throwing up, couldn't keep anything down, thought I had food poisoning/diagnosed with Chronic systolic heart failure/Heart Failure after 33 days after receiving first dose/Heart too weak) had not resolved and CRYING (crying), IMPAIRED DRIVING ABILITY (she couldn't drive herself), CHILLS (Chills), PYREXIA (Fever) and VOMITING (Throwing up) outcome was unknown.   DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Body temperature: 104 104. In March 2021, Electrocardiogram: chronic systolic heart failure. diagnosed with Chronic systolic heart failure. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.    The patient was healthy and active, and worked two jobs. She has never had a covid positive test nor symptoms. The patient reported experiencing heart failure after 33 days after receiving her first dose of the Moderna vaccine, on 06-Feb-2021. On 05-Mar-2021, (4 days prior to the admission to hospital) she experienced fever, chills, throwing up, extreme throwing up, could not keep anything down, thought she had food poisoning, which she was familiar with. Had it before. She was crying. She could not drive herself. She was admitted on 09-Mar to13-Mar-2021. She stated that her heart was too weak, so they could not do a stress test. She had a camera in her arm and other tests but could not recall. Patient had high fever of 104 while hospitalized and they were worried. She had an EKG and was diagnosed with Chronic systolic heart failure. When prompted for treatment meds, patient provided a list of five medications that she was taking stating, therefore list was in treatment as well as concurrent medications. Heart Failure was ongoing and stated if she stops taking her medications, she would die. Patient reported that on 16-Mar-2021, she received her second vaccine dose (031AZ1A). Patient had no side effects. She did receive heterologous booster dose of the Pfizer vaccine, lot number FF2590.  Company Comment: This is a Spontaneous case concerning a 57-year-old female patient, with no relevant medical history, who experienced the unexpected and serious (due to hospitalization) event of Chronic left ventricular failure, which occurred 1 months and 5 days after the first dose of mRNA-1273 vaccine. Patient reported that she was healthy and active, but approximately 1 month after vaccination with mRNA-1273 vaccine she experienced fever, chills and throwing up. She took a taxi to the hospital because she couldn´t drive herself, and was admitted for 5 days due to chronic systolic heart failure, which was diagnosed by and electrocardiogram and other diagnostic tests that weren´t reported. Patient is receiving treatment with Aspirin 81 mg once a day, Carvedilol 3.25mg twice per day, Furosemide 40mg daily, Losartan 25 mg daily and Atorvastatin 40 mg daily. At the time of the report, the event had not resolved. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a Spontaneous case concerning a 57-year-old female patient, with no relevant medical history, who experienced the unexpected and serious (due to hospitalization) event of Chronic left ventricular failure, which occurred 1 months and 5 days after the first dose of mRNA-1273 vaccine. Patient reported that she was healthy and active, but approximately 1 month after vaccination with mRNA-1273 vaccine she experienced fever, chills and throwing up. She took a taxi to the hospital because she couldn´t drive herself, and was admitted for 5 days due to chronic systolic heart failure, which was diagnosed by and electrocardiogram and other diagnostic tests that weren´t reported. Patient is receiving treatment with Aspirin 81 mg once a day, Carvedilol 3.25mg twice per day, Furosemide 40mg daily, Losartan 25 mg daily and Atorvastatin 40 mg daily. At the time of the report, the event had not resolved. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.