Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Computerised tomogram, Fall, Gait inability, Impaired quality of life
Clinical narrative: muscle pain; weakness; fallen twice; can't lift his arms/can't move arm and legs; can't walk; burns because he was unable to lift a 1lb spatula due to muscle weakness; uses a cane to walk/sits on the couch; hasn't work for 1 month(Used to work 6 days a week); his quality of life is no good/this is bad/Has gotten worse in a month; This spontaneous case was reported by a patient family member or friend and describes the occurrence of MYALGIA (muscle pain), ASTHENIA (weakness), FALL (fallen twice), MOBILITY DECREASED (can't lift his arms/can't move arm and legs), GAIT INABILITY (can't walk) and MUSCULAR WEAKNESS (burns because he was unable to lift a 1lb spatula due to muscle weakness) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. W5M21A, 022CZ1A, 031B21A and 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetic and Hypertension.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2022, the patient experienced MYALGIA (muscle pain) (seriousness criterion hospitalization), ASTHENIA (weakness) (seriousness criterion hospitalization), FALL (fallen twice) (seriousness criterion hospitalization), MOBILITY DECREASED (can't lift his arms/can't move arm and legs) (seriousness criterion hospitalization), GAIT INABILITY (can't walk) (seriousness criterion hospitalization), MUSCULAR WEAKNESS (burns because he was unable to lift a 1lb spatula due to muscle weakness) (seriousness criterion hospitalization), WALKING AID USER (uses a cane to walk/sits on the couch), IMPAIRED WORK ABILITY (hasn't work for 1 month(Used to work 6 days a week)) and IMPAIRED QUALITY OF LIFE (his quality of life is no good/this is bad/Has gotten worse in a month). The patient was hospitalized from 17-Jul-2022 to 22-Jul-2022 due to ASTHENIA, FALL, GAIT INABILITY, MOBILITY DECREASED, MUSCULAR WEAKNESS and MYALGIA. At the time of the report, MYALGIA (muscle pain), ASTHENIA (weakness), FALL (fallen twice), MOBILITY DECREASED (can't lift his arms/can't move arm and legs), GAIT INABILITY (can't walk), MUSCULAR WEAKNESS (burns because he was unable to lift a 1lb spatula due to muscle weakness), WALKING AID USER (uses a cane to walk/sits on the couch), IMPAIRED WORK ABILITY (hasn't work for 1 month(Used to work 6 days a week)) and IMPAIRED QUALITY OF LIFE (his quality of life is no good/this is bad/Has gotten worse in a month) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In July 2022, Computerised tomogram: (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered MYALGIA (muscle pain), ASTHENIA (weakness), FALL (fallen twice), MOBILITY DECREASED (can't lift his arms/can't move arm and legs), GAIT INABILITY (can't walk), MUSCULAR WEAKNESS (burns because he was unable to lift a 1lb spatula due to muscle weakness), WALKING AID USER (uses a cane to walk/sits on the couch), IMPAIRED WORK ABILITY (hasn't work for 1 month(Used to work 6 days a week)) and IMPAIRED QUALITY OF LIFE (his quality of life is no good/this is bad/Has gotten worse in a month) to be related.    Concomitant medication list was not provided. On 17-Jul-2022, the patient was admitted to hospital and all tests were negative, including a CT. He was discharged on 22-Jul-2022 with no diagnosis. He also saw a neuro muscular/ALS specialists and all tests were negative. The primary care believes that that could be related to the booster. Treatment information was not provided.  Company comment: This spontaneous case concerns a 63 year old male patient with relevant current medical history of Diabetes and Hypertension , who experienced Serious ( Hospitalization ) , unexpected events of myalgia , asthenia , fall ( fallen twice )  , mobility decreased (can't lift his arms/can't move arm and legs), GAIT INABILITY (can't walk) and muscular weakness  (burns because he was unable to lift a 1lb spatula due to muscle weakness) and non-serious , unexpected events of WALKING AID USER (uses a cane to walk/sits on the couch) , IMPAIRED WORK ABILITY (hasn't work for 1 month(Used to work 6 days a week), IMPAIRED QUALITY OF LIFE (his quality of life is no good/this is bad/Has gotten worse in a month). These events occurred on an unknown date in May 2022 post vaccination with the 4th dose of mRNA-1273 vaccine . The dose 1, 2 3 Covid 19 vaccine of this patient were also mRNA-1273 vaccine.  This patient went to the doctor because of his muscle pain and weakness. The patient can't lift his arms, fallen twice, can't walk. He uses a cane to walk, sits on the couch, can't move his  arm and legs and wasn't able to  work for 1 month(Used to work 6 days a week).  He is a cook and came home with burns because he was unable to lift a 1lb spatula due to muscle weakness. Caregiver stated this is bad, his quality of life is no good.  HIs condition has  gotten worse in a month, The patient went the hospital but was not admitted, however on the next visit  he was admitted .  All the tests  performed were negative, including a CT ( type of CT not reported) . He was discharged  after 5 days of admission  with no diagnosis. He also saw a Neuro Muscular/ALS  specialists and all tests were negative. Primary care believes that this could be related to the Booster . Treatment details were not provided. Outcome of all of the events was not resolved. The current medical condition of diabetes and hypertension  can be considered as a confounder for the event muscular weakness and asthenia ( diabetes and hypertension can cause neuropathies as complications that can manifest as muscular weakness and asthenia ) . The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.; Sender's Comments: This spontaneous case concerns a 63 year old male patient with relevant current medical history of Diabetes and Hypertension , who experienced Serious ( Hospitalization ) , unexpected events of myalgia , asthenia , fall ( fallen twice )  , mobility decreased (can't lift his arms/can't move arm and legs), GAIT INABILITY (can't walk) and muscular weakness  (burns because he was unable to lift a 1lb spatula due to muscle weakness) and non-serious , unexpected events of WALKING AID USER (uses a cane to walk/sits on the couch) , IMPAIRED WORK ABILITY (hasn't work for 1 month(Used to work 6 days a week), IMPAIRED QUALITY OF LIFE (his quality of life is no good/this is bad/Has gotten worse in a month). These events occurred on an unknown date in May 2022 post vaccination with the 4th dose of mRNA-1273 vaccine . The dose 1, 2 3 Covid 19 vaccine of this patient were also mRNA-1273 vaccine.  This patient went to the doctor because of his muscle pain and weakness. The patient can't lift his arms, fallen twice, can't walk. He uses a cane to walk, sits on the couch, can't move his  arm and legs and wasn't able to  work for 1 month(Used to work 6 days a week).  He is a cook and came home with burns because he was unable to lift a 1lb spatula due to muscle weakness. Caregiver stated this is bad, his quality of life is no good.  HIs condition has  gotten worse in a month, The patient went the hospital but was not admitted, however on the next visit  he was admitted .  All the tests  performed were negative, including a CT ( type of CT not reported) . He was discharged  after 5 days of admission  with no diagnosis. He also saw a Neuro Muscular/ALS  specialists and all tests were negative. Primary care believes that this could be related to the Booster . Treatment details were not provided. Outcome of all of the events was not resolved. The current medical condition of diabetes and hypertension  can be considered as a confounder for the event muscular weakness and asthenia ( diabetes and hypertension can cause neuropathies as complications that can manifest as muscular weakness and asthenia ) . The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.