Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Blood cholesterol, Fall, Gait disturbance
Clinical narrative: some problems with his balance; fall; he now has trouble walking; This spontaneous case was reported by a patient and describes the occurrence of GAIT DISTURBANCE (he now has trouble walking) and BALANCE DISORDER (some problems with his balance) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A, 012M20A and 004F21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high and High cholesterol. Concomitant products included ROSUVASTATIN for Hypertension and High cholesterol.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In June 2021, the patient experienced BALANCE DISORDER (some problems with his balance) (seriousness criterion medically significant). In 2021, the patient experienced GAIT DISTURBANCE (he now has trouble walking) (seriousness criterion medically significant) and FALL (fall). At the time of the report, GAIT DISTURBANCE (he now has trouble walking) and BALANCE DISORDER (some problems with his balance) had not resolved and FALL (fall) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood cholesterol: (Positive) No noticeable changes to blood cholesterol, tested positive for the antibody prior to receiving..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   In June of 2021 patient slowly became aware of some problems with his balance. Reporter stated all his vaccines have been Moderna and he had not received any more Covid vaccines since. Reporter stated the issues with his balance had steadily progressed since then to the point where he was now unable to play golf as he did before and he had trouble walking and had started to use a handicapped parking pass. Caller stated he had been seen by a vestibular balance specialist and has now started seeing an "Atlas Orthogonal Chiropractor." Caller stated his HCP prescribed walking as a treatment and caller sustained a fall onto his hip during walk around a track. The fall was reported to have happened within the last 1-2 months with no hospitalization reported. It was reported that one additional batch number RA00597 also found on card, unable to identify what this number is.  Patient has been taking several different medications, one of which (rosuvastatin) he reported he had a "side-effects from." Caller stated he was then switched to an injection which he stopped taking "at the end of last year" to check if it would help with his balance, and there has been no improvement in his symptoms.  Company Comment: This is a spontaneous case concerning a 75-year-old, male patient with no relevant medical history, who experienced the unexpected serious (medically significant) events of Gait disturbance and Balance disorder. The patient received three doses of dose of mRNA-1273 vaccine. Four months following his second dose, he began to notice balance problems which have worsened over time, preventing him from playing golf and causing difficulty in walking. Consequently, he need to use a handicapped parking pass. He has consulted a vestibular balance specialist and recently fell onto his hip while walking around a track, although he was not hospitalized. No further information on clinical course, investigations and treatment received was available in the report. Advance age is a risk factor for the events. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 75-year-old, male patient with no relevant medical history, who experienced the unexpected serious (medically significant) events of Gait disturbance and Balance disorder. The patient received three doses of dose of mRNA-1273 vaccine. Four months following his second dose, he began to notice balance problems which have worsened over time, preventing him from playing golf and causing difficulty in walking. Consequently, he need to use a handicapped parking pass. He has consulted a vestibular balance specialist and recently fell onto his hip while walking around a track, although he was not hospitalized. No further information on clinical course, investigations and treatment received was available in the report. Advance age is a risk factor for the events. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.