Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cardiac disorder, Cardiac stress test, Drug ineffective, Dyspnoea exertional
Clinical narrative: Heart problems since 5-6 months ago/ Was diagnosed a heart condition; problems breathing,problems walking; COVID-19; Lack of drug effect; This spontaneous case was reported by a patient and describes the occurrence of CARDIAC DISORDER (Heart problems since 5-6 months ago/ Was diagnosed a heart condition) and DYSPNOEA EXERTIONAL (problems breathing,problems walking) in a 69-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.     Concurrent medical conditions included Environmental allergy.   On 18-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2022, the patient experienced DYSPNOEA EXERTIONAL (problems breathing,problems walking) (seriousness criteria hospitalization and medically significant). In March 2022, the patient experienced COVID-19 (COVID-19) and DRUG INEFFECTIVE (Lack of drug effect). On an unknown date, the patient experienced CARDIAC DISORDER (Heart problems since 5-6 months ago/ Was diagnosed a heart condition) (seriousness criterion hospitalization). The patient was hospitalized on sometime in May 2022 due to CARDIAC DISORDER and DYSPNOEA EXERTIONAL. At the time of the report, CARDIAC DISORDER (Heart problems since 5-6 months ago/ Was diagnosed a heart condition) and DYSPNOEA EXERTIONAL (problems breathing,problems walking) had not resolved and COVID-19 (COVID-19) and DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2022, SARS-CoV-2 test: positive (Positive) Positive. On an unknown date, Cardiac stress test: heart was fine (normal) Heart was fine, Prior to receiving the vaccine..         Patient was taking some unknown concomitant medication.  Patient started to experience, heart problems since "5-6 months ago", problems walking and breathing "since Jan 2022 if not before and was diagnosed a heart condition on May 2022. Patient was having open heart surgery in June. Patient stated he "have to have 2 vessels replaced, 2 bypasses and a lung biopsy and lung repair" Patient stated he was fine until recently. There was no medical history related to mentioned AE and both Acute and Chronic illnesses at the time of Vaccination. No other vaccine was given within 1 month prior to Moderna COVID-19 vaccine.  Patient did not experience a similar event in the past. For the treatment, patient was taking all kinds of medication. Company comment: This spontaneous case concerns a 69-year-old male patient with relevant medical history of Environmental allergy, who experienced the unexpected serious (medially significant) events of Cardiac disorder, Dyspnoea exertional and unexpected non-serious AESI event of Covid-19, 9-11 months after receiving the second dose of mRNA-1273 vaccine. Additionally, Drug ineffective was also reported.  Approximately 9 months after the vaccination, the patient had dyspnoea and had difficulty in walking. The patient was diagnosed with heart condition (unspecified) since last 5-6 months, was started on treatment (unspecified) and was scheduled for Cardiac bypass surgery, Lung biopsy and Lung repair. This could be suggestive of underlying cardiac and pulmonary pathologies. 11 months after vaccination, he was tested positive for SARS-CoV-2 test. Details of Medical history, personal history, clinical course, investigation reports and treatment were not provided. Elderly age of the patient could be a risk factor. The patient's medical history of Environmental allergy and cardiac condition (unspecified) remain confounders for the events Cardiac disorder and Dyspnoea exertional. The current pandemic situation of Covid-19 could be a confounder for the event Covid-19. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 69-year-old male patient with relevant medical history of Environmental allergy, who experienced the unexpected serious (medially significant) events of Cardiac disorder, Dyspnoea exertional and unexpected non-serious AESI event of Covid-19, 9-11 months after receiving the second dose of mRNA-1273 vaccine. Additionally, Drug ineffective was also reported.  Approximately 9 months after the vaccination, the patient had dyspnoea and had difficulty in walking. The patient was diagnosed with heart condition (unspecified) since last 5-6 months, was started on treatment (unspecified) and was scheduled for Cardiac bypass surgery, Lung biopsy and Lung repair. This could be suggestive of underlying cardiac and pulmonary pathologies. 11 months after vaccination, he was tested positive for SARS-CoV-2 test. Details of Medical history, personal history, clinical course, investigation reports and treatment were not provided. Elderly age of the patient could be a risk factor. The patient's medical history of Environmental allergy and cardiac condition (unspecified) remain confounders for the events Cardiac disorder and Dyspnoea exertional. The current pandemic situation of Covid-19 could be a confounder for the event Covid-19. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.