Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Vaccination site erythema, Vaccination site irritation, Vaccination site rash
Clinical narrative: Shortness of breath; Does not feel like herself; No energy; Feels like she is sick and coming out of something/She just doesn't feel well/Strange fatigue that she has never experienced before; Having trouble walking the stairs and she it is concerning to her; Irritated red raised rash below the shoulder at the site of injection; Irritated red raised rash below the shoulder at the site of injection; Extreme fatigue that she cannot shake; Tired; Irritated red raised rash below the shoulder at the site of injection; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath), FEELING ABNORMAL (Does not feel like herself), ASTHENIA (No energy), MALAISE (Feels like she is sick and coming out of something/She just doesn't feel well/Strange fatigue that she has never experienced before) and GAIT DISTURBANCE (Having trouble walking the stairs and she it is concerning to her) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 005C21A, 048A21A and 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Open heart surgery (She was a survival of three open heart surgery and has artificial heart valve.). Concomitant products included FLUDROCORTISONE, VITAMIN D [VITAMIN D NOS], WARFARIN SODIUM (JANTOVEN), PARACETAMOL (TYLENOL [PARACETAMOL]) and LIOTHYRONINE for an unknown indication.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (Shortness of breath), FEELING ABNORMAL (Does not feel like herself), ASTHENIA (No energy), MALAISE (Feels like she is sick and coming out of something/She just doesn't feel well/Strange fatigue that she has never experienced before), GAIT DISTURBANCE (Having trouble walking the stairs and she it is concerning to her), VACCINATION SITE IRRITATION (Irritated red raised rash below the shoulder at the site of injection), VACCINATION SITE ERYTHEMA (Irritated red raised rash below the shoulder at the site of injection), FATIGUE (Extreme fatigue that she cannot shake), FATIGUE (Tired) and VACCINATION SITE RASH (Irritated red raised rash below the shoulder at the site of injection). At the time of the report, DYSPNOEA (Shortness of breath), FEELING ABNORMAL (Does not feel like herself), ASTHENIA (No energy), MALAISE (Feels like she is sick and coming out of something/She just doesn't feel well/Strange fatigue that she has never experienced before), GAIT DISTURBANCE (Having trouble walking the stairs and she it is concerning to her), VACCINATION SITE IRRITATION (Irritated red raised rash below the shoulder at the site of injection), VACCINATION SITE ERYTHEMA (Irritated red raised rash below the shoulder at the site of injection), FATIGUE (Extreme fatigue that she cannot shake), FATIGUE (Tired) and VACCINATION SITE RASH (Irritated red raised rash below the shoulder at the site of injection) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medications are provided. Patient does not smoke, drink and she was not overweight. Patient visited cardiologist, they listened to her heart and did blood work, they said she was fine. Patient normally runs up and down her steps, but she was not able to do it, she gets up the steps and her heart was pounding because she was short of breath. She felt very fatigue, it was a strange fatigue that she had never experienced before.   This case was linked to MOD-2021-395918, MOD-2021-395769 (Patient Link).