Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Dizziness, Erythema, Injection site warmth, Insomnia
Clinical narrative: extreme pain in left arm at time of second injection; felt dizzy; shoulder turned red all the way down to her elbow was swollen and hot; shoulder turned red all the way down to her elbow was swollen and hot; shoulder turned red all the way down to her elbow was swollen and hot; felt lethargic; couldn't sleep because arm washttps://ilssafety1f.quintiles.com/img/tabs/tab_left_move.gif so painful.; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (extreme pain in left arm at time of second injection), DIZZINESS (felt dizzy), ERYTHEMA (shoulder turned red all the way down to her elbow was swollen and hot), PERIPHERAL SWELLING (shoulder turned red all the way down to her elbow was swollen and hot) and INJECTION SITE WARMTH (shoulder turned red all the way down to her elbow was swollen and hot) in a 59-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.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced PAIN IN EXTREMITY (extreme pain in left arm at time of second injection), DIZZINESS (felt dizzy), ERYTHEMA (shoulder turned red all the way down to her elbow was swollen and hot), PERIPHERAL SWELLING (shoulder turned red all the way down to her elbow was swollen and hot), INJECTION SITE WARMTH (shoulder turned red all the way down to her elbow was swollen and hot), LETHARGY (felt lethargic) and INSOMNIA (couldn't sleep because arm so painful). The patient was treated with CORTISONE for Adverse event, at an unspecified dose and frequency and IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (extreme pain in left arm at time of second injection), DIZZINESS (felt dizzy), ERYTHEMA (shoulder turned red all the way down to her elbow was swollen and hot), PERIPHERAL SWELLING (shoulder turned red all the way down to her elbow was swollen and hot), INJECTION SITE WARMTH (shoulder turned red all the way down to her elbow was swollen and hot), LETHARGY (felt lethargic) and INSOMNIA (couldn't sleep because arm was so painful.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Body temperature: 102 (High) Fever. In April 2021, Magnetic resonance imaging: abnormal (abnormal) MRI shows the bursa going through the joint, all of the joints are torn and partial tear to rotator cuff.. In April 2021, Oxygen saturation: 130 bpm (High) High.         The patient stated  that she has talked to Physicians, and they feel something in the bursa is effected by the vaccine, because the cells in the bursa are very different than a deltoid muscle, and they feel she is only about 35 percent vaccinated because it works differently in a bursa The patient is scheduled for cortisone  shot in November and also applies ice for 20 min, heat for 20 min ice 20 min on affected area  No concomitant medications were reported   This case was linked to MOD-2021-328653 (Patient Link).