Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Blood test, Computerised tomogram, Gait disturbance
Clinical narrative: when it stops, tremors and seizures on his leg muscles starts.; what he had could not let him function properly anymore, cannot drive, cannot scuba dive, could no longer live actively; loosing ability to walk, cannot seat upright; uncontrollable muscle cramps on his legs every 2 minutes that went on for hours and hours, huge cramps, Currently, patient is still with episodes of spasms in his left thigh and left groin; so unbearable, rated pain as 8/10, 10 being the highest; lower back and hips with strong pain; tremors; 2 days ago his shoulder joints started aching.; dull aches everywhere in his body; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (when it stops, tremors and seizures on his leg muscles starts.) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SEIZURE (when it stops, tremors and seizures on his leg muscles starts.) (seriousness criterion medically significant), MOVEMENT DISORDER (what he had could not let him function properly anymore, cannot drive, cannot scuba dive, could no longer live actively), GAIT DISTURBANCE (loosing ability to walk, cannot seat upright), MUSCLE SPASMS (uncontrollable muscle cramps on his legs every 2 minutes that went on for hours and hours, huge cramps, Currently, patient is still with episodes of spasms in his left thigh and left groin), PAIN (so unbearable, rated pain as 8/10, 10 being the highest), BACK PAIN (lower back and hips with strong pain), TREMOR (tremors), ARTHRALGIA (2 days ago his shoulder joints started aching.) and MYALGIA (dull aches everywhere in his body). The patient was treated with IBUPROFEN for Adverse event, at a dose of 12-16 Ibuprofen depending on how bad; ACETAMINOPHEN at a dose of 500 mg twice a day; TRAMADOL at a dose of 50 mg four times per day and CELECOXIB at a dose of 200 mg once a day. At the time of the report, SEIZURE (when it stops, tremors and seizures on his leg muscles starts.), MOVEMENT DISORDER (what he had could not let him function properly anymore, cannot drive, cannot scuba dive, could no longer live actively), GAIT DISTURBANCE (loosing ability to walk, cannot seat upright), MUSCLE SPASMS (uncontrollable muscle cramps on his legs every 2 minutes that went on for hours and hours, huge cramps, Currently, patient is still with episodes of spasms in his left thigh and left groin), PAIN (so unbearable, rated pain as 8/10, 10 being the highest), BACK PAIN (lower back and hips with strong pain), TREMOR (tremors), ARTHRALGIA (2 days ago his shoulder joints started aching.) and MYALGIA (dull aches everywhere in his body) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood test: normal (normal) normal. In 2021, Computerised tomogram: normal (normal) normal. In 2021, Magnetic resonance imaging: normal (normal) normal. In 2021, X-ray: normal (normal) x rays of back and hip are normal..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided by the reporter.  According to reporter, the patient went to a physical therapist but reported only worsened his situation and decided not to go on with the therapy anymore.  Steroids were reported as a additional treatment medication.  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.; 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.