Sex: F
Vaccine: COVID19
Symptoms: Chromaturia, Fatigue, Headache, Inflammation, Insomnia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (barely slept for 4-5 days - worst two days were 18th and 19th), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Could barely take care of animal), PAIN IN EXTREMITY (pain in inner left arm muscles), MUSCULAR WEAKNESS (left arm was really weak) and SKIN MASS (felt like a "bb" under the skin/it was still going down, (now) small bump under the skin) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included BUPROPION HYDROCHLORIDE (BUPROPION HCL XL), OMEPRAZOLE, TOPIRAMATE, ALBUTEROL [SALBUTAMOL] and MONTELUKAST SODIUM (MONTELUKAST [MONTELUKAST SODIUM]) for an unknown indication. On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced INSOMNIA (barely slept for 4-5 days - worst two days were 18th and 19th), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Could barely take care of animal), PAIN IN EXTREMITY (pain in inner left arm muscles), MUSCULAR WEAKNESS (left arm was really weak), LYMPHADENOPATHY (swollen lymph nodes), VACCINATION SITE SWELLING (slightly swollen on upper left after where Imhad the shot), FATIGUE (fatigue), MYALGIA (achy muscles) and HEADACHE (Bad headache,really bad). On 18-Mar-2021, the patient experienced CHROMATURIA (Light green urine, the next morning after the shot). On an unknown date, the patient experienced SKIN MASS (felt like a "bb" under the skin/it was still going down, (now) small bump under the skin), PRURITUS (slightly itchy wasn't bad, it was just there), INFLAMMATION (Red rash that went from upper arm probably about six inches (down)/when she wore a sleeveless top (in the sun) it got inflamed.) and RASH ERYTHEMATOUS (Red rash that went from upper arm probably about six inches down/rash). On 18-Mar-2021, CHROMATURIA (Light green urine, the next morning after the shot) had resolved. On 14-Apr-2021, PRURITUS (slightly itchy wasn't bad, it was just there) and RASH ERYTHEMATOUS (Red rash that went from upper arm probably about six inches down/rash) had resolved. At the time of the report, INSOMNIA (barely slept for 4-5 days - worst two days were 18th and 19th), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Could barely take care of animal), PAIN IN EXTREMITY (pain in inner left arm muscles), MUSCULAR WEAKNESS (left arm was really weak), SKIN MASS (felt like a "bb" under the skin/it was still going down, (now) small bump under the skin), INFLAMMATION (Red rash that went from upper arm probably about six inches (down)/when she wore a sleeveless top (in the sun) it got inflamed.), VACCINATION SITE SWELLING (slightly swollen on upper left after where Imhad the shot), FATIGUE (fatigue), MYALGIA (achy muscles) and HEADACHE (Bad headache,really bad) had resolved and LYMPHADENOPATHY (swollen lymph nodes) had not resolved.  mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. No treatment medications were reported. Patient had the first dose on 17 Mar 2021 and reported elbow area inside of the arm. She barely could take care of animal.She felt like a "bb" under the skin in that area. On 23-April-2021 it was still going down. She sun affected the rash and provided the following timeline 10:00 am caller noticed, 10:30 neighbor saw the spot 11:00am it was itchy. 09 April 2021 noticed the rash was calmer, 14 April 2021 it appeared to be gone. Caller stated that when she wore sleeveless top in the sun it got inflamed. This case was linked to MOD-2021-410371 (Patient Link). Reporter did not allow further contact.