Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Antinuclear antibody, Arthralgia, Blood creatine phosphokinase, Body temperature, C-reactive protein
Clinical narrative: Discomfort in the left leg/discomfort and pain in the left leg; discomfort when she squats/could bend her knee and squat semi-normally.; Leg pain; Pain in muscles on both sides of neck; Unable to squat or even get up; Pain in legs woke her up at night, pain proceeded to her bilateral lower extremities; Pain when bending knees,Upon straightening knees would have pain as well,Pain was mostly in knee; Muscle around knees, upper part and side of both legs became /sore like her arms; Couldn't put pressure on elbows/pain was from the elblow up; Could not push self out of bed; Couldn't move arms to the side; Felt like she received vaccine in right arm; Other arm became very sore/ Pain was from the elbow up; chills; Sore arm/pain in her left arm at the injection site; severe pain when she tries to straighten or bend the knee; pain in neck muscles on both sides; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of GAIT INABILITY (Could not push self out of bed), MOBILITY DECREASED (Unable to squat or even get up), HYPOKINESIA (Couldn't move arms to the side), DISCOMFORT (discomfort when she squats/could bend her knee and squat semi-normally.) and NECK PAIN (Pain in muscles on both sides of neck) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 028120A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Carotid artery dissection in 2000. Concurrent medical conditions included High cholesterol, Blood pressure high (High blood pressure) and Supraventricular tachycardia. Concomitant products included CARVEDILOL, DILTIAZEM, SPIRONOLACTONE and FISH OIL for an unknown indication.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Feb-2021, the patient experienced NECK PAIN (pain in neck muscles on both sides) and ARTHRALGIA (severe pain when she tries to straighten or bend the knee). 27-Feb-2021, the patient experienced INJECTION SITE PAIN (Sore arm/pain in her left arm at the injection site). On 28-Feb-2021, the patient experienced CHILLS (chills). On 02-Mar-2021, the patient experienced GAIT INABILITY (Could not push self out of bed), HYPOKINESIA (Couldn't move arms to the side), FEELING ABNORMAL (Felt like she received vaccine in right arm), PAIN IN EXTREMITY (Other arm became very sore/ Pain was from the elbow up) and ARTHRALGIA (Couldn't put pressure on elbows/pain was from the elblow up). On 06-Mar-2021, the patient experienced MOBILITY DECREASED (Unable to squat or even get up), NECK PAIN (Pain in muscles on both sides of neck), PAIN IN EXTREMITY (Pain in legs woke her up at night, pain proceeded to her bilateral lower extremities), ARTHRALGIA (Pain when bending knees,Upon straightening knees would have pain as well,Pain was mostly in knee) and MYALGIA (Muscle around knees, upper part and side of both legs became /sore like her arms). On 15-Apr-2021, the patient experienced DISCOMFORT (discomfort when she squats/could bend her knee and squat semi-normally.) and PAIN IN EXTREMITY (Leg pain). On an unknown date, the patient experienced LIMB DISCOMFORT (Discomfort in the left leg/discomfort and pain in the left leg). The patient was treated with PREDNISONE at a dose of 10 milligram; PARACETAMOL (TYLENOL) at an unspecified dose and frequency; ESOMEPRAZOLE MAGNESIUM, NAPROXEN (VIMOVO) at an unspecified dose and frequency; CELECOXIB (CELEBREX) at an unspecified dose and frequency and SULFAMETHOXAZOLE, TRIMETHOPRIM (MORTIN) at an unspecified dose and frequency. On 16-Apr-2021, PAIN IN EXTREMITY (Leg pain) had resolved. At the time of the report, GAIT INABILITY (Could not push self out of bed), MOBILITY DECREASED (Unable to squat or even get up), HYPOKINESIA (Couldn't move arms to the side), DISCOMFORT (discomfort when she squats/could bend her knee and squat semi-normally.), NECK PAIN (Pain in muscles on both sides of neck), FEELING ABNORMAL (Felt like she received vaccine in right arm), PAIN IN EXTREMITY (Other arm became very sore/ Pain was from the elbow up), PAIN IN EXTREMITY (Pain in legs woke her up at night, pain proceeded to her bilateral lower extremities), LIMB DISCOMFORT (Discomfort in the left leg/discomfort and pain in the left leg), NECK PAIN (pain in neck muscles on both sides), ARTHRALGIA (Couldn't put pressure on elbows/pain was from the elblow up), ARTHRALGIA (severe pain when she tries to straighten or bend the knee), ARTHRALGIA (Pain when bending knees,Upon straightening knees would have pain as well,Pain was mostly in knee), INJECTION SITE PAIN (Sore arm/pain in her left arm at the injection site), MYALGIA (Muscle around knees, upper part and side of both legs became /sore like her arms) and CHILLS (chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Jan-2021, C-reactive protein: 0.6 (normal) Normal. In March 2021, Antinuclear antibody: normal (normal) Normal. In March 2021, Blood creatine phosphokinase: normal (normal) low side of normal and normal (normal) normal. In March 2021, Body temperature: 100.4 (High) High. In March 2021, C-reactive protein: normal (normal) low side of normal. In March 2021, C-reactive protein increased: 2.2 2.2. In March 2021, Red blood cell sedimentation rate decreased: normal (normal) low side of normal. On 22-Mar-2021, C-reactive protein: 1.2 (normal) normal. On 07-Apr-2021, C-reactive protein: 2.2 (normal) normal. On 30-Apr-2021, C-reactive protein increased: 65.2 (abnormal) 65.2. On 02-May-2021, Magnetic resonance imaging: mild edema (Low) Mild edema of the left distal thigh, left calf musculature.. On 19-May-2021, C-reactive protein: 2.2 (normal) Normal. On 24-Jun-2021, C-reactive protein: 0.6 (normal) Normal. On an unknown date, Renal function test: abnormal (abnormal) Abnormal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On 11-APR-2021,patient was given steroid course. On 05-May-2021,patient  had Myositis Panel test done and the results were negative. On JUN-2021 patient was given a dose of 7.5 mg of prednisone but the pain still persists so dose was titrated to 10mg for 10 days and then also pain persists so dose was titrated to 10mg for 10 days and slowly her side effects began to improve so dose was titrated as follows 10-Jun-2021 down to 7.5mg , 14-Jun-2021 down to 6.25mg ,18-Jun-2021 down to 5.625 mg, 22Jun2021 down to 5mg dose, 27-Jun-2021 down to 4.725mg, 06-Jul-2021 down to 3.75mg.   This case was linked to US-MODERNATX, INC.-MOD-2021-078319 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: Events was updated, Concomitent drug list was updated, Dose dates was updated On 03-May-2021: Follow-up received and contains significant information updated lab data, treatment medications and events. On 21-Jul-2021: Follow-up received and contains significant information updated lab data and treatment medications added events.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-078319:cross linked to Dose 1