Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Electromyogram, Fatigue, Immunisation reaction, Magnetic resonance imaging, Nerve conduction studies
Clinical narrative: received his first dose of COVID-19 vaccine without any clinically significant side effects other than transient malaise and fatigue; received his first dose of COVID-19 vaccine without any clinically significant side effects other than transient malaise and fatigue; Parsonage-Turner syndrome; This literature-non-study case was reported in a literature article and describes the occurrence of NEURALGIC AMYOTROPHY (Parsonage-Turner syndrome) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.   LITERATURE REFERENCE:     Concurrent medical conditions included Hypertension and Hyperlipidemia.   In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NEURALGIC AMYOTROPHY (Parsonage-Turner syndrome) (seriousness criterion medically significant), IMMUNISATION REACTION (received his first dose of COVID-19 vaccine without any clinically significant side effects other than transient malaise and fatigue) and FATIGUE (received his first dose of COVID-19 vaccine without any clinically significant side effects other than transient malaise and fatigue). The patient was treated with IBUPROFEN for Inflammation, at a dose of 800 milligram four times per day; PREDNISONE for Brachial plexitis, at a dose of 80 milligram once a day and PREDNISONE for Brachial plexitis, at a dose of 20 milligram once a day. At the time of the report, NEURALGIC AMYOTROPHY (Parsonage-Turner syndrome) had resolved and IMMUNISATION REACTION (received his first dose of COVID-19 vaccine without any clinically significant side effects other than transient malaise and fatigue) and FATIGUE (received his first dose of COVID-19 vaccine without any clinically significant side effects other than transient malaise and fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Electromyogram: Evidence of the left lower trunk denervation. The EMG studies includes, Left first dorsal interosseous Increased insertional activity - Normal recruitment, normal motor unit action potentials. Left extensor indicis proprius Mildly reduced recruitment - Normal motor unit action potentials. Left flexor digitorum profundus 4 - Severely reduced recruitment. Normal motor unit action potentials, Left C8 paraspinal muscles, Left infraspinatus, Left deltoid ,Left pronator teres, Left extensor digitorum communis all were Normal.. In 2021, Magnetic resonance imaging: increased short-TI inversion recovery (STIR) signal and increased T2-weighted signal, with mild T1 postcontrast enhancement of the medial left scalene muscles along the inferior brachial plexus consistent with inflammatory changes and intramuscular edema.. In 2021, Nerve conduction studies: The Nerve conduction studies data includes, Left median digit II - Normal Sensory nerve action potential (SNAP), Right median digit II - Reduced SNAP amplitude compared to contralateral side. Left and right ulnar digit V - Normal SNAP, Left radial snuffbox - Normal SNAP, Right radial snuffbox-Reduced SNAP amplitude compared to contralateral side.. In 2021, Neurological examination: decreased strength in the left finger extensors (4+/5), particularly in the left fourth and fifth digits, and thenar eminence (4+/5).. In 2021, Reflex test: normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NEURALGIC AMYOTROPHY (Parsonage-Turner syndrome), IMMUNISATION REACTION (received his first dose of COVID-19 vaccine without any clinically significant side effects other than transient malaise and fatigue) and FATIGUE (received his first dose of COVID-19 vaccine without any clinically significant side effects other than transient malaise and fatigue) to be related.    No concomitant medications were reported.  The patient experienced mild shoulder soreness and transient rigors in the first 12-24 h. However, 2 weeks postvaccination, developed intense, unremitting left shoulder girdle pain with associated muscle tenderness that was not relieved with conservative measures such as stretching, heat, or anti-inflammatories. Within the next few days, the patient also noted sensory loss with paresthesia and hypoesthesia in the left fourth and fifth digits, as well as on the ulnar aspect of the forearm. Sensation was impaired to light touch distally in the left fourth and fifth digits and to a lesser extent in the third digit.  The Nerve conduction studies data also includes, Left and right lateral antebrachial cutaneous - Normal SNAP. Left and right medial antebrachial cutaneous Normal SNAP. Left median abductor pollicis brevis - Normal CMAP (Compound muscle action potential). Right median abductor pollicis brevis - Reduced CMAP amplitude compared to contralateral side. Left ulnar abductor digiti minimi - Reduced CMAP amplitude compared to right side. Normal distal latency and conduction velocity. Right ulnar abductor digiti minimi - Normal CMAP.  Two other cases with Moderna product (MOD-2021-293314 and MOD-2021-281733) were identified and already reported from prior literature cases.  Company comment: This is a literature non-study case concerning a 64-year-old previously healthy right handed neurosurgeon patient, with no relevant medical history, who experienced Parsonage Turner Syndrome (PTS)/acute brachial neuritis/neuralgic amyotrophy and vaccination associated rigors 12-24 hours after a second dose of mRNA-127 and worsened for two weeks in left deltoid. Other relevant history was first COVID vaccination in left deltoid with mRNA-1273 with reported vaccination related malaise and fatigue. Initial symptoms at time of vaccination included mild shoulder pain and transient rigors and worsened over 2 weeks post vaccination to include intense, unremitting left shoulder girdle pain with muscle tenderness unrelieved by stretching, heat, and anti-inflammatories. Deterioration continued with paresthesia and hypoesthesia in the left fingers 4 & 5 and ulnar aspect of forearm and decreased strength in left finger extensors of 4+/5 and thenar eminence at 4+/5. Sensation was also impaired in left fingers 3,4, and 5. Electromyogram (EMG) showed evidence of the left lower trunk denervation, supported by magnetic resonance imaging (MRI) findings of edema and inflammation of muscles along the inferior brachial plexus. Treatment started with a prednisone taper with gradual improvement and near complete resolving by 4 months. PTS can be caused by genetics, infection, vaccination, surgery, trauma or autoimmune etiologies with the most common being post viral infection. The benefit-risk relationship of mRNA-1273 is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2022: Upon internal review on 25-Aug-2022, Significant corrections were performed. Event seriousness upgraded. Lab data, dose description were updated as per latest convention; Sender's Comments: This is a literature non-study case concerning a 64-year-old previously healthy right handed neurosurgeon patient, with no relevant medical history, who experienced Parsonage Turner Syndrome (PTS)/acute brachial neuritis/neuralgic amyotrophy and vaccination associated rigors 12-24 hours after a second dose of mRNA-127 and worsened for two weeks in left deltoid. Other relevant history was first COVID vaccination in left deltoid with mRNA-1273 with reported vaccination related malaise and fatigue. Initial symptoms at time of vaccination included mild shoulder pain and transient rigors and worsened over 2 weeks post vaccination to include intense, unremitting left shoulder girdle pain with muscle tenderness unrelieved by stretching, heat, and anti-inflammatories. Deterioration continued with paresthesia and hypoesthesia in the left fingers 4 & 5 and ulnar aspect of forearm and decreased strength in left finger extensors of 4+/5 and thenar eminence at 4+/5. Sensation was also impaired in left fingers 3,4, and 5. Electromyogram (EMG) showed evidence of the left lower trunk denervation, supported by magnetic resonance imaging (MRI) findings of edema and inflammation of muscles along the inferior brachial plexus. Treatment started with a prednisone taper with gradual improvement and near complete resolving by 4 months. PTS can be caused by genetics, infection, vaccination, surgery, trauma or autoimmune etiologies with the most common being post viral infection. The benefit-risk relationship of mRNA-1273 is not affected by this report.