Sex: F
Vaccine: COVID19
Symptoms: Skin texture abnormal, Vaccination site pain
Clinical narrative: Left shoulder really hurt; Left arm skin crinkled; Intermittent pain primarily in lower left arm and sometimes entire left side of body; Arm was sore at the injection site; Unable to go back to sleep/did not sleep well; pain in left arm/arm was sore from elbow to wrist/inner lower left arm was painful, intermittent pain primarily in lower left arm, arm sore all day; Pain in upper torso; Left side of head felt like balloon, had puffiness on left side, physically felt it, it did not feel puffy; Throat started to swell; Felt terrible/felt miserable; Soreness; Extremely tired; A spontaneous report, was received from a Consumer (patient), an 83 years-old female patient, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273), and experienced left side of head felt like balloon, had puffiness on left side, physically felt it, it did not feel puffy, throat started to swell, unable to go back to sleep, pain in left arm/arm was sore from elbow to wrist/inner lower left arm was painful, pain in upper torso upper, intermittent pain primarily in lower left arm and sometimes entire left side of body, left arm skin crinkled, felt terrible/felt miserable, soreness, extremely tired, arm was sore at the injection site, and left shoulder really hurt.  The patient's medical history was not reported. No relevant concomitant medications were reported.     On 06 Feb 20201, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 029L20A), intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 06 Feb 2021, the patient felt terrible right after the vaccine, and was extremely tired. The patient developed soreness which was overwhelming, and throat started to swell (felt like it lasted for an hour). The patient also reported that her left side of head felt like a balloon, then it felt like she had puffiness on the left side, but when she physically felt it, it did not feel puffy. The patient got on the exercycle for an hour. On 07 Feb 2021, the patient stayed in bed and felt miserable until 11:15 AM and got on the exercycle. On the same day, the patient was unable to go back to sleep. She had pain in left arm and upper torso which was unbearable and continued until the evening of 07 Feb 2021. On 09 Feb 2021, the patient did not sleep well and during night her arm was sore at the injection site and from elbow to wrist. On 10 Feb 2021, the patient developed intermittent pain primarily in lower left arm and sometimes in entire left side of body. On 11 Feb 2021, the patient could not sleep on her left side because of the pain. The patient's left arm skin on top was crinkled and when she held her arm horizontal to floor and was sore all day. On 12 Feb 2021, 5:45 AM, the patient could not go back to sleep as left shoulder really hurt. The patient's inner lower left arm was painful. Off and on after 12 Feb 2021, the patient arm would hurt between wrist and elbow on top. The patient had nothing on the right side. No treatment information was provided.    Action taken with second dose of mRNA-1273 in response to the events was unknown.    The outcome of the events, left side of head felt like balloon, had puffiness on left side, physically felt it, it did not feel puffy, and throat started to swell, were recovered/resolved on 06 Feb 2021, event pain in upper torso was recovered/resolved on 07 Feb 2021, events unable to go back to sleep/did not sleep well, intermittent pain primarily in lower left arm and sometimes entire left side of body, left arm skin crinkled, felt terrible/felt miserable, extremely tired, arm was sore at the injection site, left shoulder really hurt, were recovered/resolved on 12 Feb 2021, events pain in left arm/arm was sore from elbow to wrist/inner lower left arm was painful, and soreness were unknown.; Reporter's Comments: Based on the information provide which includes a strong temporal association, a causal association between the reported event and the administration of the mRNA-1273 vaccine cannot be excluded. shoulder pain, vaccination site pain and tiredness are  consistent with the known safety profile of vaccine