Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Vitamin B6, Vitamin E, White blood cell count
Clinical narrative: Acute worsening of atypical parkinson's syndrome; Acute worsening of atypical parkinson's syndrome; Osteoarthritis to his right shoulder; Injection site pain after dose one; This literature-non-study case was reported in a literature article and describes the occurrence of PARKINSONISM (Acute worsening of atypical parkinson's syndrome) and CONDITION AGGRAVATED (Acute worsening of atypical parkinson's syndrome) in a 71-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.   LITERATURE REFERENCE:      Concurrent medical conditions included Parkinson's syndrome (1-year  history of a tremor hands (right side more than the left),  which occurred while at rest or performing actions. Around the  same time, patient noticed a decline in fine motor skills particularly with handwriting, which became more unsteady and difficult to read. A few months after that, patient began to experience changes  in gait that continued to progress and had become more  prominent in the last 6 months. Patient described these changes as a  mixture of weakness and "unsteadiness" in which his legs would freeze an  would lose  balance, often falling).   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PARKINSONISM (Acute worsening of atypical parkinson's syndrome) (seriousness criteria death and hospitalization), CONDITION AGGRAVATED (Acute worsening of atypical parkinson's syndrome) (seriousness criteria death and hospitalization), OSTEOARTHRITIS (Osteoarthritis to his right shoulder) and INJECTION SITE PAIN (Injection site pain after dose one). The patient was treated with BACLOFEN at a dose of 10 milligram three times a day and CARBIDOPA, LEVODOPA (CARBIDOPA/LEVODOPA) at a dose of 25/100 milligram. The patient died on an unknown date. The reported cause of death was acute worsening of atypical parkinson's syndrome and acute worsening of atypical parkinson's syndrome. It is unknown if an autopsy was performed. At the time of death, OSTEOARTHRITIS (Osteoarthritis to his right shoulder) and INJECTION SITE PAIN (Injection site pain after dose one) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Alpha 1 globulin (0.10-0.40): 0.33 g/dL. On an unknown date, Alpha 2 globulin (0.50-1.10): 0.74 g/dL. On an unknown date, Anion gap (10-18): 13 millimole per litre. On an unknown date, Antibody test (0.0-0.9): less than (<) 0.2 AI, less than (<) 0.2 AI, 2.6 AI, less than (<) 0.2 AI, less than (<) 0.2 AI, less than (<) 0.2 AI and less than (<) 0.2 AI. On an unknown date, Antinuclear antibody: (Positive) Positive. On an unknown date, Antiribosomal P antibody (0.0-0.9): less than (<)  0.2 AI. On an unknown date, Beta globulin (0.70-1.60): 0.87 g/dL. On an unknown date, Blood albumin (2.90-5.10): 3.84 g/dL. On an unknown date, Blood bicarbonate (22-29): 24 millimole per litre. On an unknown date, Blood calcium (8.6-10.2): 10.2 mg/dl. On an unknown date, Blood chloride (96-105): 101 millimole per litre. On an unknown date, Blood copper (70.0-140.0): 116.3 microgram per decilitre. On an unknown date, Blood creatine phosphokinase (Unknown-less than 190): 93 U/L. On an unknown date, Blood creatinine (0.70-1.03): 1.02 mg/dl. On an unknown date, Blood glucose (65-99): 113 mg/dl. On an unknown date, Blood immunoglobulin G (0.0-0.9): less than (<)  0.2 AI and less than (<)  0.2 AI. On an unknown date, Blood potassium (3.4-5.1): 4 millimole per litre. On an unknown date, Blood sodium (136-145): 138 millimole per litre. On an unknown date, Blood thyroid stimulating hormone (0.270-4.200): 2.780 micro international unit per litre. On an unknown date, Blood urea (6-23): 13 mg/dl. On an unknown date, C-reactive protein (0.00-0.50): 2.07 mg/dl. On an unknown date, Double stranded DNA antibody (Unknown-4): less than (<) 1 IU/mL. On an unknown date, Electromyogram: indicated chronic motor neuron involvement, demonstrated evidence of a mild, diffuse, chronic lower motor neuron process affecting the right cervical, thoracic, and lumbosacral regions. This finding, indicating a low-grade neuropathy, suggested that the patient could have had some underlying motor neuron disease contributing to his condition. On an unknown date, Haematocrit (40-51): 48 %. On an unknown date, Haemoglobin (13.7-7.5): 16 g/dL. On an unknown date, Immunoglobulins (0.60-2.00): 0.92 g/dL. On an unknown date, Mean cell volume (79-98): 88 fL. On an unknown date, Platelet count (165-366): 241 10 thousand cells per microlitre. On an unknown date, Protein total (6.1-8.2): 6.7 g/dL. On an unknown date, Red blood cell count (4.4-5.9): 5.5 x 10^6/µL. On an unknown date, Red blood cell sedimentation rate (0.0-32): 15 millimetre per hour. On an unknown date, Rheumatoid factor (Unknown-less than 13): less than (<) 10 IU/mL. On an unknown date, SARS-CoV-2 test: Asymptomatic. On an unknown date, Treponema test: Non reactive. On an unknown date, Vitamin B1 (70-180): 96 nmol/L. On an unknown date, Vitamin B12 (232-1245): 278 pg/ml. On an unknown date, Vitamin B6 (20.0-25.0): 27.4 nmol/L. On an unknown date, Vitamin E (5.5-18): 5.8 milligram per litre. On an unknown date, White blood cell count (3.9-11.2): 9.4 10 thousand per microlitre.     For mRNA-1273 (Spikevax) (Unknown), the reporter considered PARKINSONISM (Acute worsening of atypical parkinson's syndrome), CONDITION AGGRAVATED (Acute worsening of atypical parkinson's syndrome) and INJECTION SITE PAIN (Injection site pain after dose one) to be related. No further causality assessment was provided for OSTEOARTHRITIS (Osteoarthritis to his right shoulder).    No concomitant medications were reported.  The patient was admitted to hospital after falling the night due to extreme weakness that began hours after receiving the second dose of the COVID-19 vaccine. Patient did not have a well-known past medical history as patient had not seen a physician in the past 20 years. While patient had not sought prior medical advice, patient did admit that noticed changes within health in the year preceding this admission. Patient was concerned about fall risk, therefore he had started to use a walker 1 to 2 months prior to admission. On the day of admission, the patient reported having felt at his baseline the previous day. However, a few hours after receiving the second dose of his COVID-19 vaccine, his weakness began with increased "unsteadiness" and difficulty ambulating. That evening, when he tried to get into bed, he fell and was unable to get up. Next morning patient was to the hospital for further workup.  Upon examination, it was noted that he had a resting tremor, severe rigidity, and bradykinesia with the right side significantly more affected than the left. Notably, he was found to have a moderate degree of osteoarthritis to his right shoulder, possibly contributing to more limited range of motion on this extremity. Neurology was consulted and reported that his clinical picture indicated likely asymmetric atypical Parkinson's syndrome. He was started on carbidopa/levodopa, with plans to slowly increase the dose until reaching dose of 2 tablets 3 times a day. However, the EMG abnormalities noted were mild and did not meet criteria for the diagnosis of an official motor neuron disease, such as amyotrophic lateral sclerosis (ALS). Therefore, the interpretation of this finding was that the patient had an atypical Parkinson's syndrome with motor neuron involvement.  Company comment: This  literature-non-study case report concerns a 71-year.old male patient with previous medical history of Parkinson's syndrome, who experienced serious (due to hospitalization and fatal outcome) unexpected events of Parkinsonism and Condition aggravated, non serious unexpected event of Osteoarthritis and non serious expected event of Injection site pain. The patient developed injection site pain 24 hours after he received the first dose of the mRNA-1273 vaccine. The outcome of this event was not specified at the time of this reporting and no additional details regarding clinical course of this event were disclosed. However, hours after receiving the second dose of the vaccine, the patient presented with significant weakness that reportedly worsened after this vaccination. However, it should be noted that the patient had noticed changes within his health in the year preceding this deterioration (tremor in his hands, a decline in fine motor skills, changes in his gait that continued to progress and had become more prominent in the last 6 months). Therefore, upon examination (physical examination, brain and spine MRI, EMG), it was established that the patient had an atypical Parkinson's syndrome with motor neuron involvement. In addition, he was found to have a moderate degree of osteoarthritis to his right shoulder, possibly contributing to more limited range of motion on this extremity. Despite therapy with carbidopa/levodopa and Baclofen and rehabilitation measures, minimal improvement occurred. The patient was hospitalized 5 months after the initial discharge, due to continued worsening of his symptoms with a profound weakness and inability to ambulate, as well as failure to thrive. Two months after this hospitalization, he passed away. Underlying medical signs of an atypical Parkinson's syndrome before obtaining the vaccine and lack of prior medical care remain major confounding factors in this case, having in mind that atypical Parkinson's syndromes are known for rapid progression. The authors stated that it was plausible that a vaccine could serve as a trigger for disease flare up due to an undoubted correlation between the vaccine administration and the patient's change in symptoms. The causality is assessed as related for the events of Parkinsonism, Condition aggravated and Injection site pain. The causality for the event of Osteoarthritis is assessed as not related having in mind that osteoarthritis is a chronic degenerative joint disease that affects mostly middle-aged and this event is most likely related to pre-existing disease which was an incidental finding during physical examination. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 03-Nov-2022: Live follow up received by safety on 03-Nov-2022 has email with full text article received and contains significant information. Reporter information, literature information, laboratory data, product information,treatment medications and event information was updated.; Sender's Comments: This  literature-non-study case report concerns a 71-year.old male patient with previous medical history of Parkinson's syndrome, who experienced serious (due to hospitalization and fatal outcome) unexpected events of Parkinsonism and Condition aggravated, non serious unexpected event of Osteoarthritis and non serious expected event of Injection site pain. The patient developed injection site pain 24 hours after he received the first dose of the mRNA-1273 vaccine. The outcome of this event was not specified at the time of this reporting and no additional details regarding clinical course of this event were disclosed. However, hours after receiving the second dose of the vaccine, the patient presented with significant weakness that reportedly worsened after this vaccination. However, it should be noted that the patient had noticed changes within his health in the year preceding this deterioration (tremor in his hands, a decline in fine motor skills, changes in his gait that continued to progress and had become more prominent in the last 6 months). Therefore, upon examination (physical examination, brain and spine MRI, EMG), it was established that the patient had an atypical Parkinson's syndrome with motor neuron involvement. In addition, he was found to have a moderate degree of osteoarthritis to his right shoulder, possibly contributing to more limited range of motion on this extremity. Despite therapy with carbidopa/levodopa and Baclofen and rehabilitation measures, minimal improvement occurred. The patient was hospitalized 5 months after the initial discharge, due to continued worsening of his symptoms with a profound weakness and inability to ambulate, as well as failure to thrive. Two months after this hospitalization, he passed away. Underlying medical signs of an atypical Parkinson's syndrome before obtaining the vaccine and lack of prior medical care remain major confounding factors in this case, having in mind that atypical Parkinson's syndromes are known for rapid progression. The authors stated that it was plausible that a vaccine could serve as a trigger for disease flare up due to an undoubted correlation between the vaccine administration and the patient's change in symptoms. The causality is assessed as related for the events of Parkinsonism, Condition aggravated and Injection site pain. The causality for the event of Osteoarthritis is assessed as not related having in mind that osteoarthritis is a chronic degenerative joint disease that affects mostly middle-aged and this event is most likely related to pre-existing disease which was an incidental finding during physical examination. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Reported Cause(s) of Death: Acute worsening of atypical parkinson's syndrome; Acute worsening of atypical parkinson's syndrome