Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: constant swelling in her left leg all night long that wakes her up; constant pain in her left leg all night long that wakes her up; decreased energy level; sleeping more/sleeping 8 hours a night/napping; can only sit for a few minutes; taking longer to get up/change position; pain level unbearable/pain is very escalated all over/some days she can barely get out of bed; pain level increased to 9/10 in back and hip area; pain level increased to 9/10 in back and hip area; achiness; massive headache; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (constant swelling in her left leg all night long that wakes her up), PAIN (pain level unbearable/pain is very escalated all over/some days she can barely get out of bed), BACK PAIN (pain level increased to 9/10 in back and hip area), ARTHRALGIA (pain level increased to 9/10 in back and hip area) and PAIN IN EXTREMITY (constant pain in her left leg all night long that wakes her up) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Laminectomy spinal (history of laminectomies). Concurrent medical conditions included Osteoarthritis, GERD, Blood pressure high, Spinal stenosis, High cholesterol and Diverticulitis. Concomitant products included CHONDROITIN SULFATE, GLUCOSAMINE SULFATE, METHYLSULFONYLMETHANE (GLUCOSAMINE CHONDROITIN & MSM) and TURMERIC [CURCUMA LONGA RHIZOME] for Arthritis, METOPROLOL for Blood pressure high, FOLIC ACID for Bowel movement irregularity, FENOFIBRATE and PRAVASTATIN for Cholesterol, OMEPRAZOLE for GERD, FAMOTIDINE for GERD and Diverticulitis, GABAPENTIN for Spinal stenosis.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced VACCINATION SITE PAIN (Sore arm) and HEADACHE (massive headache). On 17-Apr-2021, the patient experienced PAIN (pain level unbearable/pain is very escalated all over/some days she can barely get out of bed) (seriousness criterion medically significant), BACK PAIN (pain level increased to 9/10 in back and hip area) (seriousness criterion medically significant), ARTHRALGIA (pain level increased to 9/10 in back and hip area) (seriousness criterion medically significant), ASTHENIA (decreased energy level), SOMNOLENCE (sleeping more/sleeping 8 hours a night/napping), HYPOKINESIA (can only sit for a few minutes), HYPOKINESIA (taking longer to get up/change position) and MYALGIA (achiness). On 24-Apr-2021, the patient experienced PERIPHERAL SWELLING (constant swelling in her left leg all night long that wakes her up) (seriousness criterion medically significant) and PAIN IN EXTREMITY (constant pain in her left leg all night long that wakes her up) (seriousness criterion medically significant). On 15-Apr-2021, VACCINATION SITE PAIN (Sore arm) and HEADACHE (massive headache) had resolved. At the time of the report, PERIPHERAL SWELLING (constant swelling in her left leg all night long that wakes her up), PAIN (pain level unbearable/pain is very escalated all over/some days she can barely get out of bed), BACK PAIN (pain level increased to 9/10 in back and hip area), ARTHRALGIA (pain level increased to 9/10 in back and hip area), PAIN IN EXTREMITY (constant pain in her left leg all night long that wakes her up), ASTHENIA (decreased energy level), SOMNOLENCE (sleeping more/sleeping 8 hours a night/napping), HYPOKINESIA (can only sit for a few minutes), HYPOKINESIA (taking longer to get up/change position) and MYALGIA (achiness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information included extra strength acetaminophen every 6-8 hours for the pain.  This case concerns a 75-year-old female with serious unexpected events of peripheral swelling, pain in extremity, back pain, pain, arthralgia, and nonserious unexpected asthenia, somnolence, hypokinesia, and expected myalgia, vaccination site pain, headache. Event onset the same day as first dose mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns a 75-year-old female with serious unexpected events of peripheral swelling, pain in extremity, back pain, pain, arthralgia, and nonserious unexpected asthenia, somnolence, hypokinesia, and expected myalgia, vaccination site pain, headache. Event onset the same day as first dose mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.