Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder, Chills, Dysstasia, Gait disturbance, Infection
Clinical narrative: Something wrong with her heart after 2nd vaccine/ she does not recall what type of heart problem; could not stand up after 2nd vaccine; Could not walk after 2nd vaccine; Infection after 2nd vaccine; Fever after 2nd vaccine/she started having a High Fever; Very cold right hand & right side of body after 2nd vaccine; Chills on and off right side of the body after 2nd vaccine; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC DISORDER (Something wrong with her heart after 2nd vaccine/ she does not recall what type of heart problem), DYSSTASIA (could not stand up after 2nd vaccine), GAIT DISTURBANCE (Could not walk after 2nd vaccine), INFECTION (Infection after 2nd vaccine) and PYREXIA (Fever after 2nd vaccine/she started having a High Fever) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048B21A and 017B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Stroke (Right hand was somewhat numb after stroke) in December 2020 and Numbness in hand. Concurrent medical conditions included Blood pressure high and Diabetes.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Apr-2021, the patient experienced CARDIAC DISORDER (Something wrong with her heart after 2nd vaccine/ she does not recall what type of heart problem) (seriousness criterion hospitalization), DYSSTASIA (could not stand up after 2nd vaccine) (seriousness criterion hospitalization), GAIT DISTURBANCE (Could not walk after 2nd vaccine) (seriousness criterion hospitalization), INFECTION (Infection after 2nd vaccine) (seriousness criterion hospitalization), PYREXIA (Fever after 2nd vaccine/she started having a High Fever) (seriousness criterion hospitalization), VACCINATION SITE COLDNESS (Very cold right hand & right side of body after 2nd vaccine) and CHILLS (Chills on and off right side of the body after 2nd vaccine). On 01-May-2021, CARDIAC DISORDER (Something wrong with her heart after 2nd vaccine/ she does not recall what type of heart problem), DYSSTASIA (could not stand up after 2nd vaccine), GAIT DISTURBANCE (Could not walk after 2nd vaccine), INFECTION (Infection after 2nd vaccine) and PYREXIA (Fever after 2nd vaccine/she started having a High Fever) had resolved. At the time of the report, VACCINATION SITE COLDNESS (Very cold right hand & right side of body after 2nd vaccine) and CHILLS (Chills on and off right side of the body after 2nd vaccine) had not resolved.            Other medications not provided by the reporter. Treatment medications was not provided by the reporter.  Patient had experienced High Fever not measured. Company Comment This case concerns a 75-year-old, female patient with relevant medical history of stroke, who experienced the unexpected events of cardiac disorder, dysstasia, gait disturbance, infection and pyrexia. The events occurred the same day after the second dose of mRNA-1273. The rechallenge was not applicable since the events happened after the second dose. The benefit-risk relationship of mRNA-1273 is not affected by this report.   The MI agent mentioned Pericarditis and Myocarditis, but Patient states that those do not sound familiar. The Patient had experienced on her right hand and right side of body gets very cold, like chills on and off and she still gets this reaction from time to time.; Sender's Comments: This case concerns a 75-year-old, female patient with relevant medical history of stroke, who experienced the unexpected events of cardiac disorder, dysstasia, gait disturbance, infection and pyrexia. The events occurred the same day after the second dose of mRNA-1273. The rechallenge was not applicable since the events happened after the second dose. The benefit-risk relationship of mRNA-1273 is not affected by this report.