Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac dysfunction, Dyspnoea, Dysstasia, Gait disturbance, Walking aid user
Clinical narrative: In the hospital with 25% use of heart; can barely breath; can barely stand up; holding to furniture to walk; she walks with a cane; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC DYSFUNCTION (In the hospital with 25% use of heart) and DYSPNOEA (can barely breath) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CARDIAC DYSFUNCTION (In the hospital with 25% use of heart) (seriousness criteria hospitalization and medically significant), DYSPNOEA (can barely breath) (seriousness criterion hospitalization), DYSSTASIA (can barely stand up), GAIT DISTURBANCE (holding to furniture to walk) and WALKING AID USER (she walks with a cane). At the time of the report, CARDIAC DYSFUNCTION (In the hospital with 25% use of heart), DYSPNOEA (can barely breath), DYSSTASIA (can barely stand up), GAIT DISTURBANCE (holding to furniture to walk) and WALKING AID USER (she walks with a cane) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment drugs were reported.  Company comment:  This spontaneous case concerns a 32-year-old female patient with no reported medical history who experienced serious unexpected events of cardiac dysfunction and dyspnoea, that occurred after the dose of the mRNA-1273 however, the exact time to onset and dose number were not provided. The patient was hospitalized due to the events. Additionally, it was reported that the patient had difficult in standing, used a cane for walking and had to hold onto furniture while walking. It was also reported that the patient was fine before.  The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2022-495672, US-MODERNATX, INC.-MOD-2022-495940, US-MODERNATX, INC.-MOD-2022-495761, US-MODERNATX, INC.-MOD-2022-495772, US-MODERNATX, INC.-MOD-2022-496405, US-MODERNATX, INC.-MOD-2022-497818 (E2B Linked Report).; Sender's Comments: This spontaneous case concerns a 32-year-old female patient with no reported medical history who experienced serious unexpected events of cardiac dysfunction and dyspnoea, that occurred after the dose of the mRNA-1273 however, the exact time to onset and dose number were not provided. The patient was hospitalized due to the events. Additionally, it was reported that the patient had difficult in standing, used a cane for walking and had to hold onto furniture while walking. It was also reported that the patient was fine before.  The benefit-risk relationship of mRNA-1273 is not affected by this report. US-MODERNATX, INC.-MOD-2022-495672:(Crosslink) US-MODERNATX, INC.-MOD-2022-495940:(Crosslink) US-MODERNATX, INC.-MOD-2022-495761:(Crosslink) US-MODERNATX, INC.-MOD-2022-495772:(Crosslink) US-MODERNATX, INC.-MOD-2022-496405:(Crosslink) US-MODERNATX, INC.-MOD-2022-497818:(Crosslink)