Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Inappropriate schedule of product administration
Clinical narrative: Not able to walk/had a hard time walking unless she held on to something; first dose was given on 29-JUL-2021 and second dose was given on 05-SEP-2021 (more than 35 days); This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (Not able to walk/had a hard time walking unless she held on to something) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 088021A and 006D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 29-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose was given on 29-JUL-2021 and second dose was given on 05-SEP-2021 (more than 35 days)). On 15-Sep-2021, the patient experienced GAIT DISTURBANCE (Not able to walk/had a hard time walking unless she held on to something) (seriousness criterion disability). On 05-Sep-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose was given on 29-JUL-2021 and second dose was given on 05-SEP-2021 (more than 35 days)) had resolved. At the time of the report, GAIT DISTURBANCE (Not able to walk/had a hard time walking unless she held on to something) outcome was unknown.            Concomitant medication use information was not provided by reporter. Treatment medication use information was not provided by reporter. About 10 days after the second dose of vaccination, patient found herself not able to walk. When she got up, she had a hard time walking unless she held on to something.  Company comment: This report concerns a 50 year old female patient with no relevant medical history who experienced an unexpected serious event of gait disturbance (reported as not able to walk or have hard time walking). The event was reported with a seriousness criteria of disability. The event occurred approximately 10 days after vaccination with second dose of mRNA-1273. Based on the current available information, inappropriate schedule of vaccine administration (as the latency between the 2 vaccine doses is more than 35 days) was considered as an additional event. The rechallenge was assessed as not applicable as the event happened after the second dose of the vaccine. The outcome of the event was reported as unknown at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report. The onset date for the event of gait disturbance was found to be discrepant in the SD, however it was captured as per the  reported information in the SD narrative.; Sender's Comments: This report concerns a 50 year old female patient with no relevant medical history who experienced an unexpected serious event of gait disturbance (reported as not able to walk or have hard time walking). The event was reported with a seriousness criteria of disability. The event occurred approximately 10 days after vaccination with second dose of mRNA-1273. Based on the current available information, inappropriate schedule of vaccine administration (as the latency between the 2 vaccine doses is more than 35 days) was considered as an additional event. The rechallenge was assessed as not applicable as the event happened after the second dose of the vaccine. The outcome of the event was reported as unknown at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report. The onset date for the event of gait disturbance was found to be discrepant in the , however it was captured as per the  reported information in the narrative.