Sex: F
Vaccine: COVID19
Symptoms: Amyotrophic lateral sclerosis, Aphasia, Dysphonia, Gait disturbance, General physical health deterioration
Clinical narrative: cannot talk; Amyotrophic lateral sclerosis; Has deteriorated significantly; tingling in her feet and hands; numbness in her feet and hands; Difficuty walking; She couldn't open jars; voice was weak; This spontaneous case was reported by a consumer and describes the occurrence of AMYOTROPHIC LATERAL SCLEROSIS (Amyotrophic lateral sclerosis) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced DYSPHONIA (voice was weak). On 20-Mar-2021, the patient experienced MUSCULAR WEAKNESS (She couldn't open jars). In April 2021, the patient experienced PARAESTHESIA (tingling in her feet and hands), HYPOAESTHESIA (numbness in her feet and hands) and GAIT DISTURBANCE (Difficuty walking). In July 2021, the patient experienced GENERAL PHYSICAL HEALTH DETERIORATION (Has deteriorated significantly). In August 2021, the patient experienced AMYOTROPHIC LATERAL SCLEROSIS (Amyotrophic lateral sclerosis) (seriousness criterion medically significant). On an unknown date, the patient experienced APHASIA (cannot talk). The patient was treated with EDARAVONE (RADICAVA) for ALS, at an unspecified dose and frequency. At the time of the report, AMYOTROPHIC LATERAL SCLEROSIS (Amyotrophic lateral sclerosis), MUSCULAR WEAKNESS (She couldn't open jars), PARAESTHESIA (tingling in her feet and hands), HYPOAESTHESIA (numbness in her feet and hands), GAIT DISTURBANCE (Difficuty walking), GENERAL PHYSICAL HEALTH DETERIORATION (Has deteriorated significantly), APHASIA (cannot talk) and DYSPHONIA (voice was weak) outcome was unknown.            Concomitant medications was not reported. Treatment history was not reported.  The reporter's causality assessment for the events AMYOTROPHIC LATERAL SCLEROSIS, DYSPHONIA, MUSCULAR WEAKNESS, APHASIA, HYPOAESTHESIA, GAIT DISTURBANCE, GENERAL PHYSICAL HEALTH DETERIORATION and PARAESTHESIA in relation to Edaravone  therapy was not related.  Company Comment: This is a case of Amyotrophic Lateral Sclerosis 6 moths after receiving the second dose of the product in a woman of unknown age. 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. Further information has been requested.   This case was linked to MOD-2021-293348 (Patient Link).   Reporter did not allow further contact; Sender's Comments: This is a case of Amyotrophic Lateral Sclerosis 6 moths after receiving the second dose of the product in a woman of unknown age. 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. Further information has been requested.