Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Skin irritation
Clinical narrative: My hands were so sore; Two sores on buttocks; Pain in legs and shoulders; had pain in legs and shoulders; Unable to bend or lift; I had stiffness all over my body/stiff neck; polymyalgia/muscular problems all through my body; it was painful; I couldn't even get off the toilet; I was unable to walk after the 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (I had stiffness all over my body/stiff neck), MOTOR DYSFUNCTION (Unable to bend or lift), PAIN (it was painful), MOBILITY DECREASED (I couldn't even get off the toilet) and GAIT INABILITY (I was unable to walk after the 1st dose) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038K20A and 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Osteoporosis.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced PAIN (it was painful), MOBILITY DECREASED (I couldn't even get off the toilet), GAIT INABILITY (I was unable to walk after the 1st dose) and MYALGIA (polymyalgia/muscular problems all through my body). On 03-Feb-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (I had stiffness all over my body/stiff neck). On 07-Feb-2021, the patient experienced MOTOR DYSFUNCTION (Unable to bend or lift), PAIN IN EXTREMITY (had pain in legs and shoulders) and ARTHRALGIA (Pain in legs and shoulders). On 08-Mar-2021, the patient experienced SKIN IRRITATION (Two sores on buttocks). On 18-Mar-2021, the patient experienced PAIN IN EXTREMITY (My hands were so sore). The patient was treated with ATORVASTATIN CALCIUM (STATIN [ATORVASTATIN CALCIUM]) on 07-Feb-2021 at an unspecified dose and frequency; PREDNISONE on 08-Feb-2021 for Muscular pain, Stiffness, Pain of extremities, Shoulder pain and Mobility decreased, at a dose of 20 mg; PREDNISONE (oral) on 19-Mar-2021 for Muscular pain, Stiffness, Pain of extremities, Shoulder pain and Mobility decreased, at a dose of 10 mg; PREDNISONE on 26-Mar-2021 for Muscular pain, Stiffness, Pain of extremities, Shoulder pain and Mobility decreased, at a dose of 5 mg; PREDNISONE on 10-May-2021 for Muscular pain, Stiffness, Pain of extremities, Shoulder pain and Mobility decreased, at a dose of 8 mg; PREDNISONE 18-Mar-2021 for Hand pain, at an unspecified dose and frequency; PREDNISONE 23-Feb-2021 for Hand pain, at an unspecified dose and frequency and MUPIROCIN from 08-Mar-2021 to 18-Mar-2021 for Skin irritation, at a dose of UNK UNK, bid. At the time of the report, MUSCULOSKELETAL STIFFNESS (I had stiffness all over my body/stiff neck), MOTOR DYSFUNCTION (Unable to bend or lift), PAIN (it was painful), MOBILITY DECREASED (I couldn't even get off the toilet), GAIT INABILITY (I was unable to walk after the 1st dose), PAIN IN EXTREMITY (had pain in legs and shoulders), PAIN IN EXTREMITY (My hands were so sore), ARTHRALGIA (Pain in legs and shoulders) and MYALGIA (polymyalgia/muscular problems all through my body) outcome was unknown and SKIN IRRITATION (Two sores on buttocks) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Feb-2021, Blood test: within normal limits (normal) Patient reported that all of her blood work was fine.  No details were provided.. On 10-Feb-2021, Red blood cell sedimentation rate: within normal limits (normal) Patient reported that her sed rate was fine.  No details were provided.. On 02-Mar-2021, Red blood cell sedimentation rate: 80 (High) No reference range was reported..     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant products reported   This case was linked to INC.-MOD-2021-161587 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: Follow up received: added treatments, added events and subsumed some, AI has the details On 21-May-2021: Added Patient History, Product in Event tab, On 01-Jul-2021: Non-Significant follow up appended to adverse event report; possible NNI; Sender's Comments:  INC.-MOD-2021-161587:Same reporter