Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Abnormal dreams, Abnormal sleep-related event, Asthenia, Back pain, Balance disorder
Clinical narrative: Spinal cord issue; Weakness; Parkinson's disease flare up; Hallucination; Syncope; Balance disorder; Movement disorder; Abnormal sleep related event; Musculoskeletal disorder; dyskinesia; Back pain; Limb discomfort; Musculoskeletal stiffness; Neck pain; Fall; Confusional state; Abnormal dreams; Orthostatic hypotension; Livedo reticularis; Somnolence; Dizziness postural; Gait disturbance; A spontaneous report was received from a pharmaceutical provider concerning a 75-year- old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events spinal cord disorder, parkinson's disease flare-up, asthenia, balance disorder, movement disorder, abnormal sleep related event, musculoskeletal disorder, dyskinesia, back pain, limb discomfort, musculoskeletal stiffness, neck pain, hallucination, fall, confusional state, abnormal dreams, orthostatic hypotension, livedo reticularis, somnolence, syncope, dizziness postural and gait disturbance.  The patient's medical history included Parkinson's disease, dyskinesia, arthritis, heart disease, spondylitis, body height decreased  and  two cardiac stent placement. In 2020, after starting Gocovri, the patient experienced hallucinations, falls, balance issues , confusion, jerky movements and weird and intense dreams.    The concomitant medications on use included amantadine/gocovri used for dyskinesia associated with Parkinson's disease, levodopa, carbidopa, entacapone, tamsulosin, magnesium, cholecalciferol, vitamin C (ascorbic acid), paracetamol, cetirizine hydrochloride, fluticasone propionate, acetylsalicylic acid, pravastatin, clopidogrel, ropinirole hydrochloride, rasagiline mesylate, macrogol 3350, methyl cellulose, cyanocobalamin and multivitamin, all used for unknown indication.  On 20-JAN-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA (Batch/Lot number: unknown) through unknown route of administration for prophylaxis of COVID-19 infection.  On 25-JAN-2021, patient had gottn worse, had difficulty walking, his legs felt very heavy and he was high stepping when he walked, he could hardly walk, weakness in legs, muscle stiffness and weakness, necak and back pain. Visited doctor. These events were considered to be not resolved.  On 17-FEB-2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA (Batch/Lot number: unknown) through unknown route of administration for prophylaxis of COVID-19 infection.  On 22-FEB-2021, patient experienced balance disorder, movement disorder, abnormal sleep related event, musculoskeletal disorder, dyskinesia, back pain, limb discomfort, musculoskeletal stiffness, neck pain, hallucination, fall, confusional state, abnormal dreams, orthostatic hypotension, livedo reticularis, somnolence, syncope, dizziness postural and gait disturbance.  On 25-FEB-2021, patient experienced spinal cord disorder, weakness/asthenia and Parkinson's disease flare up/Parkinson's disease. The patient was hospitalized on 25-FEB-2021 and was discharged on 01-MAR-2021.  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.  The events spinal cord disorder, weakness and Parkinson's disease flare up were recovered on 01-MAR-2021.  The outcome of the events  balance disorder, movement disorder, abnormal sleep related event, musculoskeletal disorder, dyskinesia, back pain, limb discomfort, musculoskeletal stiffness, neck pain, hallucination, fall, confusional state, abnormal dreams, orthostatic hypotension, livedo reticularis, somnolence, syncope, dizziness postural and gait disturbance were unknown.; Reporter's Comments: Very limited information regarding these events has been provided at this time. Patient's advanced age along with concomitant medications and underlying conditions may have been contributory for the occurrence of the events. No further follow-up information is expected.; Sender's Comments: Very limited information regarding these events has been provided at this time. Patient's advanced age along with concomitant medications and underlying conditions may have been contributory for the occurrence of the events. No further follow-up information is expected.