Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Lumbar puncture, Magnetic resonance imaging, Metabolic function test, Neuralgic amyotrophy, Rotator cuff syndrome
Clinical narrative: Slight rotator cuff tear; Started with COVID-19 symptoms; Parsonage-Turner syndrome; This spontaneous case was reported by a patient and describes the occurrence of NEURALGIC AMYOTROPHY (Parsonage-Turner syndrome) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Family history included Heart disorder (heart issues). Concurrent medical conditions included Diabetic (Diabetic 8 years diagnosed) and Blood pressure high (Blood pressure high 25 years been diagnosed). Concomitant products included NAPROXEN SODIUM for Inflammation.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In September 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2022, the patient experienced NEURALGIC AMYOTROPHY (Parsonage-Turner syndrome) (seriousness criterion medically significant). On 15-Aug-2022, the patient experienced COVID-19 (Started with COVID-19 symptoms). On an unknown date, the patient experienced ROTATOR CUFF SYNDROME (Slight rotator cuff tear). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 16-Aug-2022 to 20-Aug-2022 for COVID-19, at a dose of 300mg/100mg dose in the morning and evening and PREDNISONE at an unspecified dose and frequency. At the time of the report, NEURALGIC AMYOTROPHY (Parsonage-Turner syndrome) had not resolved and COVID-19 (Started with COVID-19 symptoms) and ROTATOR CUFF SYNDROME (Slight rotator cuff tear) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2022, Blood magnesium: in normal ranges. In 2022, Blood potassium: in normal ranges. In 2022, Electromyogram: Patient was fine after Moderna second booster. In 2022, Full blood count: in normal ranges. In 2022, Lumbar puncture: Lumbar puncture to check for cells and proteins, that was all normal, No signs of cancer. In 2022, Magnetic resonance imaging: in normal ranges. In 2022, Metabolic function test: in normal ranges. In 2022, X-ray: Patient was fine after Moderna second booster, in normal ranges. On 16-Aug-2022, SARS-CoV-2 test: (Positive) Positive. On an unknown date, Electromyogram: showed cervical  nerve 6 had impingement, but it was further out from the neck. The extremity of the C6 nerve works in hand and forearm. Her forearm works, it was the part that feeds her shoulder that seems to be pinched..         The patient received first dose of Moderna vaccine in Jan-2021, then got 2nd dose 8 weeks after that, at the end of Sep-2021 she got her 1st booster dose, and 2nd booster in Mar-2022. All the shots patient received were of the Moderna vaccine. After 5 weeks of 2nd booster shot, she experienced Parsonage Turner syndrome; the reasoning for the paralysis. Doctor and patient both were thinking she got this from the COVID-19 Vaccine.  Patient had to go through physical therapy, in affected range of motion. When patient was put on Paxlovid, she was able to move shoulders again. As she completed treatment with Paxlovid and the medicine wore off, she had trouble moving shoulders again.  Patient stated that, she had a slight rotator cuff tear, but it should not have restricted range of motion. She clarified her paralysis was just in the left shoulder, not both shoulders. She could move her arm back but couldn't take it out much to left. She had a slightly rotator cuff tear, but she could have movement out and up, but clarifies she could not reach up and give someone her hand and that was where the impingement seems to be.  Patient took Paxlovid on 16-Aug-2022 from Tuesday to Saturday. During this time by Thursday, patient was able to start lifting arm. Paxlovid helped and she could move it and was able to move her shoulder. By Saturday, patient could get arm up over the head in a standing position. Five days after completing Paxlovid, started to lose this movement, couldn't even get arm up to 90 degrees. Patient stated with her Parsonage-Turner Syndrome and COVID-19, she was tired. Her doctor was nowputting her on Prednisone to see if that would work. She just wants to get through it to see what was working for her. Patient had no signs of cancer.   After Paxlovid, patient had underwent MRI and X-rays with no result provided on unknown date. Patient stated all steroids seemed to screw up the sugar numbers of the patient, wanted to get a cured without causing death.  Company Comment: This spontaneous case concerns a 69-year-old, female patient with concurrent conditions of diabetes and hypertension, who experienced an unexpected, medically significant event of Neuralgic amyotrophy and an unexpected, non-serious AESI COVID-19 after receiving a 2nd booster dose of mRNA-1273 vaccine. Patient presented with left shoulder paralysis and was diagnosed with Parsonage-Turner syndrome 5 weeks post vaccination. Electromyography test showed impingement of the 6th cervical nerve on an unknown date. An unspecified diagnostic revealed slight rotator cuff tear. Complete blood count, complete metabolic panel, magnesium, potassium, lumbar puncture analysis, magnetic resonance imaging, and X-rays were within the normal range. Physical therapy was started on an unknown date. Approximately 5 months post vaccination, patient had COVID-19 symptoms. A positive COVID-19 test confirmed the diagnosis the next day, prompting immediate Paxlovid treatment. Reportedly, she was able to lift her arm over her head in a standing position on the 3rd day of paxlovid treatment. She could not raise her arm up to a 90-degree position after the 5-day duration of paxlovid. Prednisone was given as a treatment. Outcome of the event Parsonage-Turner syndrome was not resolved. Her underlying diabetes and hypertension could be considered contributory factors to Parsonage-Turner syndrome. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events' seriousness assessed based on medical judgement.  This case was linked to MOD-2022-639231 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-Sep-2022: Follow-up information received includes quality complaint number was added.; Sender's Comments: This spontaneous case concerns a 69-year-old, female patient with concurrent conditions of diabetes and hypertension, who experienced an unexpected, medically significant event of Neuralgic amyotrophy and an unexpected, non-serious AESI COVID-19 after receiving a 2nd booster dose of mRNA-1273 vaccine. Patient presented with left shoulder paralysis and was diagnosed with Parsonage-Turner syndrome 5 weeks post vaccination. Electromyography test showed impingement of the 6th cervical nerve on an unknown date. An unspecified diagnostic revealed slight rotator cuff tear. Complete blood count, complete metabolic panel, magnesium, potassium, lumbar puncture analysis, magnetic resonance imaging, and X-rays were within the normal range. Physical therapy was started on an unknown date. Approximately 5 months post vaccination, patient had COVID-19 symptoms. A positive COVID-19 test confirmed the diagnosis the next day, prompting immediate Paxlovid treatment. Reportedly, she was able to lift her arm over her head in a standing position on the 3rd day of paxlovid treatment. She could not raise her arm up to a 90-degree position after the 5-day duration of paxlovid. Prednisone was given as a treatment. Outcome of the event Parsonage-Turner syndrome was not resolved. Her underlying diabetes and hypertension could be considered contributory factors to Parsonage-Turner syndrome. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events' seriousness assessed based on medical judgement.