Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Oedema, Pain in extremity, Periarthritis, Swelling, Vaccination site pain
Clinical narrative: no range of motion immobilize; frozen shoulder/inflammation in my shoulder area; hard for her to get out of bed; The patient states that she cannot function on left side, cannot wash her hair, reports no range of motion on left side; edema on her shoulder; huge muscle knots/Large lumps (muscle knots) appeared on my shoulder-neck; pain went into her shoulder and neck; inflammatory reaction; lump in shoulder; body aches; headaches; Shoulder pain became severe; arm hurt; little range of motion on her arm/Severe pain in left arm radiating up through shoulder/neck; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of IMMOBILE (no range of motion immobilize) and PERIARTHRITIS (frozen shoulder/inflammation in my shoulder area) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hay fever and Allergy to animal dander (Animal hair). Concomitant products included MONTELUKAST SODIUM (SINGULAIR) from 05-Oct-2010 to an unknown date for Allergy.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Jan-2021, the patient experienced PAIN IN EXTREMITY (little range of motion on her arm/Severe pain in left arm radiating up through shoulder/neck). On an unknown date, the patient experienced IMMOBILE (no range of motion immobilize) (seriousness criterion medically significant), PERIARTHRITIS (frozen shoulder/inflammation in my shoulder area) (seriousness criterion medically significant), GAIT INABILITY (hard for her to get out of bed), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (The patient states that she cannot function on left side, cannot wash her hair, reports no range of motion on left side), OEDEMA (edema on her shoulder), MUSCLE SWELLING (huge muscle knots/Large lumps (muscle knots) appeared on my shoulder-neck), NECK PAIN (pain went into her shoulder and neck), INFLAMMATION (inflammatory reaction), SWELLING (lump in shoulder), MYALGIA (body aches), HEADACHE (headaches), ARTHRALGIA (Shoulder pain became severe) and VACCINATION SITE PAIN (arm hurt). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; CORTISONE in February 2021 for Frozen shoulder, at an unspecified dose and frequency and Physical therapy (15 sessions) for Periarthritis. At the time of the report, IMMOBILE (no range of motion immobilize), PERIARTHRITIS (frozen shoulder/inflammation in my shoulder area), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (The patient states that she cannot function on left side, cannot wash her hair, reports no range of motion on left side), INFLAMMATION (inflammatory reaction), SWELLING (lump in shoulder), PAIN IN EXTREMITY (little range of motion on her arm/Severe pain in left arm radiating up through shoulder/neck) and ARTHRALGIA (Shoulder pain became severe) had not resolved, GAIT INABILITY (hard for her to get out of bed), OEDEMA (edema on her shoulder), MUSCLE SWELLING (huge muscle knots/Large lumps (muscle knots) appeared on my shoulder-neck), NECK PAIN (pain went into her shoulder and neck) and VACCINATION SITE PAIN (arm hurt) outcome was unknown and MYALGIA (body aches) and HEADACHE (headaches) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Magnetic resonance imaging: frozen shoulder (abnormal) Doctor determined  frozen shoulder right after the vaccine. In February 2021, X-ray: frozen shoulder (abnormal) Doctor determined  frozen shoulder right after the vaccine.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment included over the counter pain relievers, applied heat and did stretching exercises. There was no relief, then tried a session with an acupuncturist and a therapeutic masseuse- neither helped this condition.  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.  Patient visited orthopedist specializing in the shoulder on 08-Feb-2021, had X-rays and MRI scans taken over the next few days. Doctor determined frozen shoulder developed right after the vaccine. In April, the pain had not subsided, and patient's condition had not improved. Patient took a second cortisone shot which was not helpful. Soon after, the physical therapist and the patient came to the conclusion that therapy was not working. The pain was constant, her range of motion was very limited. There was no improvement despite following doctor's treatment plan. The shoulder lumps/muscle knots are large. On 08-Jun-2021, patient was examined by a renown sports injury orthopedist. He determined that patient might need surgery. He explained that the inflammation in her shoulder area was an inflammatory reaction to the Moderna vaccine. In an effort to avoid surgery, patient was referred to a doctor of Physiatry who will be administering another cortisone shot and will be overseeing next step, possibly another round of physical therapy. Surgery for these situations was complicated and there was no guarantee of recovery. Also, patient was in perfect health before this vaccine and it is evident that she was suffering a reaction to the Moderna vaccine.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-186544 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: Non significant follow up On 09-Jun-2021: Follow up received on 09-Jun-2021 and contain significant information. Added medical history, treatment medication and lab data. Added new events "shoulder pain became severe"(PT-arthralgia) , "inflammatory reaction to the vaccine"(PT-inflammation),"Severe pain in left arm radiating up through shoulder/neck"(added to PT-pain in extremity). The outcome of the events headache and body ache  changed from unknown to recovered. Added batch number for dose two vaccine. Updated concomitant drug details, height, weight and race of the patient and reporter from other HCP to consumer.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.