Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Body temperature, Chills, Insomnia, Mobility decreased
Clinical narrative: mild capsulitis / may be close to getting a frozen shoulder; calcific bursitis; degenerate tearing of rotting cap with not true retraction on the left shoulder; acromioclavicular arthritis/sings of wearing of the muscle; not able to move their arm without excruciating pain,/not able to move their fingers without excruciating pain/is in so much pain/tremendous amount of pain; big shivers; a fever of 101.9°F; ultrasound that showed evidence that the injection had been administered into the tendon instead of the deltoid muscle; not able to lift their left arm up over their head, without help from the other arm/cannot move the left shoulder; wake up in the middle of the night with high level pain, every night; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (not able to lift their left arm up over their head, without help from the other arm/cannot move the left shoulder), INSOMNIA (wake up in the middle of the night with high level pain, every night), PERIARTHRITIS (mild capsulitis / may be close to getting a frozen shoulder), PERIARTHRITIS CALCAREA (calcific bursitis) and MUSCLE ATROPHY (degenerate tearing of rotting cap with not true retraction on the left shoulder) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043L20A and 037K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Tremor. Concomitant products included PRIMIDONE for Tremor, DULOXETINE, ROSUVASTATIN, ALENDRONATE SODIUM (ALENDRONATE), MELOXICAM, CALCIUM, NICOTINIC ACID (B3 NIACIN), CURCUMA LONGA RHIZOME, PIPER NIGRUM FRUIT (TURMERIC +), BIOTIN, BETA-CAROTENE, FOLIC ACID, WITHANIA SOMNIFERA (ASHWAGANDHA [WITHANIA SOMNIFERA]) and PHYLLANTHUS EMBLICA for an unknown indication.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Feb-2021, the patient experienced MOBILITY DECREASED (not able to lift their left arm up over their head, without help from the other arm/cannot move the left shoulder), PAIN IN EXTREMITY (not able to move their arm without excruciating pain,/not able to move their fingers without excruciating pain/is in so much pain/tremendous amount of pain), CHILLS (big shivers), PYREXIA (a fever of 101.9°F) and PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (ultrasound that showed evidence that the injection had been administered into the tendon instead of the deltoid muscle). In February 2021, the patient experienced INSOMNIA (wake up in the middle of the night with high level pain, every night). In June 2021, the patient experienced PERIARTHRITIS (mild capsulitis / may be close to getting a frozen shoulder), PERIARTHRITIS CALCAREA (calcific bursitis), MUSCLE ATROPHY (degenerate tearing of rotting cap with not true retraction on the left shoulder) and ARTHRITIS (acromioclavicular arthritis/sings of wearing of the muscle). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency; ACETAMINOPHEN for Fever, at an unspecified dose and frequency; IBUPROFEN for Shivers, at a dose of UNK, q6h; DICLOFENAC (transdermal) for Pain in arm, at an unspecified dose and frequency; BUPIVACAINE HYDROCHLORIDE, EPINEPHRINE BITARTRATE (MARCAINE E) for Pain in arm, at a dose of 5cc of 0.5% and TRIAMCINOLONE ACETONIDE (KENALOG [TRIAMCINOLONE ACETONIDE]) for Pain in arm, at a dose of 0.5 cc 40mg/ml. On 12-Feb-2021, PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (ultrasound that showed evidence that the injection had been administered into the tendon instead of the deltoid muscle) had resolved. In February 2021, MOBILITY DECREASED (not able to lift their left arm up over their head, without help from the other arm/cannot move the left shoulder) had resolved. At the time of the report, INSOMNIA (wake up in the middle of the night with high level pain, every night), PERIARTHRITIS (mild capsulitis / may be close to getting a frozen shoulder), PERIARTHRITIS CALCAREA (calcific bursitis), MUSCLE ATROPHY (degenerate tearing of rotting cap with not true retraction on the left shoulder), ARTHRITIS (acromioclavicular arthritis/sings of wearing of the muscle), PAIN IN EXTREMITY (not able to move their arm without excruciating pain,/not able to move their fingers without excruciating pain/is in so much pain/tremendous amount of pain), CHILLS (big shivers) and PYREXIA (a fever of 101.9°F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Jun-2021, Ultrasound scan: abnormal (abnormal) Report showed mild capsulitis, calcific bursitis, degenerate tearing of rotting cap with not true retraction on the left shoulder and acromioclavicular arthritis, signs of wearing of the muscle. Report showed evidence that the injection had been administered into the tendon, instead of the deltoid muscle.. On an unknown date, Body temperature: 101.9 degree fahrenheit (High) 101.9 degree Fahrenheit.         The physician recommended physical therapy to the patient. Patient would like to be part of the clinical trials for the Booster vaccine, and mentions that the patient had worked as a clinical research coordinator in the past and were aware of the compliance requirements for those, so the patient was considered to be very compliant.; Sender's Comments: This case concerns a 68-year-old, female subject with no reported relevant medical history, who experienced unexpected events of Mobility decreased, Insomnia, Periarthritis, Periarthritis calcarean, Muscle atrophy, Arthritis, Pain in extremity and expected events Chills, Pyrexia. The events occurred approximately 29 days after the first dose of Moderna COVID-19 Vaccine administration. The rechallenge was not applicable since both doses were administered according to the recommended schedule. The reporter did not provide causality assessment. The benefit-risk relationship of the study drug is not affected by this report.