Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Fatigue, Gait disturbance, Hypertension, Mobility decreased
Clinical narrative: lost function in his legs/ Mobility issues; blood pressure way up/ blood pressure abnormal; weakness in legs; Problems walking; Stabilty issues; off the medication for one month due to not able to afford the medication; out of medication for 1.5 months/ missed up to approximately 8 doses; Fatigue; This spontaneous case was reported by an other (subsequently medically confirmed) and describes the occurrence of MOBILITY DECREASED (lost function in his legs/ Mobility issues) and HYPERTENSION (blood pressure way up/ blood pressure abnormal) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product FAMPRIDINE (AMPYRA) for Multiple sclerosis.    Concurrent medical conditions included Multiple sclerosis. Concomitant products included CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]), TESTOSTERONE CIPIONATE (TESTOSTERONE [TESTOSTERONE CIPIONATE]), FINASTERIDE (PROPECIA), PROGESTERONE, DULOXETINE HYDROCHLORIDE (CYMBALTA), OLMESARTAN MEDOXOMIL (BENICAR) and TERIFLUNOMIDE (AUBAGIO) for an unknown indication.   On 09-Jan-2015, the patient FAMPRIDINE (AMPYRA) (Oral) dosage was changed to 10 mg twice a day. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and FAMPRIDINE (AMPYRA) (Oral) 10 mg twice a day. On an unknown date, FAMPRIDINE (AMPYRA) (Oral) dosage was changed to 10 mg twice a day, FAMPRIDINE (AMPYRA) (Oral) dosage was changed to 10 mg twice a day and FAMPRIDINE (AMPYRA) (Oral) dosage was changed to 10 mg twice a day. On an unknown date, the patient experienced MOBILITY DECREASED (lost function in his legs/ Mobility issues) (seriousness criterion hospitalization), HYPERTENSION (blood pressure way up/ blood pressure abnormal) (seriousness criterion hospitalization), MUSCULAR WEAKNESS (weakness in legs), GAIT DISTURBANCE (Problems walking), BALANCE DISORDER (Stabilty issues), THERAPY INTERRUPTED (off the medication for one month due to not able to afford the medication), THERAPY CESSATION (out of medication for 1.5 months/ missed up to approximately 8 doses) and FATIGUE (Fatigue). At the time of the report, MOBILITY DECREASED (lost function in his legs/ Mobility issues), HYPERTENSION (blood pressure way up/ blood pressure abnormal), MUSCULAR WEAKNESS (weakness in legs), GAIT DISTURBANCE (Problems walking), BALANCE DISORDER (Stabilty issues), THERAPY INTERRUPTED (off the medication for one month due to not able to afford the medication), THERAPY CESSATION (out of medication for 1.5 months/ missed up to approximately 8 doses) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication information were not provided.  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.