Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Disability, Feeling abnormal, Gait disturbance, Immunisation reaction, Loss of personal independence in daily activities
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (He was in critical condition which lasted for a month), DISABILITY (Disabled ever since), GAIT DISTURBANCE (Cannot let him walk alone to the bathroom) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Did not recover to be able to live a normal life, needs assistance with anything he does, needs assistance in being fed, needs constant care) in an 83-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. Concurrent medical conditions included Hypertension (Hypertension which is being treated and is under control). In March 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (He was in critical condition which lasted for a month) (seriousness criterion hospitalization), DISABILITY (Disabled ever since) (seriousness criteria disability and medically significant), GAIT DISTURBANCE (Cannot let him walk alone to the bathroom) (seriousness criterion disability), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Did not recover to be able to live a normal life, needs assistance with anything he does, needs assistance in being fed, needs constant care) (seriousness criterion disability), MEMORY IMPAIRMENT (Memory is only good for 5 minutes) and FEELING ABNORMAL (He has been hard on his daughter). The patient was treated with OXYGEN at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (He was in critical condition which lasted for a month) had resolved, DISABILITY (Disabled ever since), GAIT DISTURBANCE (Cannot let him walk alone to the bathroom), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Did not recover to be able to live a normal life, needs assistance with anything he does, needs assistance in being fed, needs constant care) and MEMORY IMPAIRMENT (Memory is only good for 5 minutes) had not resolved and FEELING ABNORMAL (He has been hard on his daughter) outcome was unknown. No concomitant medications were provided. Patient received the first dose of the Moderna COVID-19 vaccine sometime in late Dec2020 or early Jan2021. He received the second dose of the Moderna COVID-19 vaccine in Mar2021 (around 2 weeks before he was going to be discharged from the rehabilitation). Patient did not have any history of 'direct' allergies. Medical history includes Hypertension which is being treated and is under control. Company comment: This spontaneous case concerns an 83-year-old, male patient with no relevant medical history reported, who experienced the unexpected, serious (hospitalization) event of vaccination complication ('critical condition which lasted for a month'); the unexpected, serious (disability and medically significant) event of disability; the unexpected, serious (disability) events of gait disturbance and loss of personal independence in daily activities; and other associated unexpected, non-serious events after administration of the second dose of the Moderna mRNA-1273 vaccine. The reporter stated that 2 days after vaccination, the patient was in 'critical condition which lasted for a month'. He was then hospitalized. No further clinical information (including details about hospitalization) was available for medical review. The reporter stated that the patient has been disabled ever since. He required oxygen for 24 hours and the patient's memory is 'only good for 5 minutes'. The patient needed assistance with anything that he does. Family members cannot let him walk alone to the bathroom and the patient needed assistance in being fed. He also needed constant care from his daughter and son-in-law, and he had been hard on his daughter. The reporter stated that the patient did not recover to be able to live a normal life. The patient is being seen by four specialists, however, details regarding the consultations, laboratory tests and treatment were not provided. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report. Further information has been requested. This case was linked to MOD-2022-506255 (Patient Link). Sender's Comments: This spontaneous case concerns an 83-year-old, male patient with no relevant medical history reported, who experienced the unexpected, serious (hospitalization) event of vaccination complication ('critical condition which lasted for a month'); the unexpected, serious (disability and medically significant) event of disability; the unexpected, serious (disability) events of gait disturbance and loss of personal independence in daily activities; and other associated unexpected, non-serious events after administration of the second dose of the Moderna mRNA-1273 vaccine. The reporter stated that 2 days after vaccination, the patient was in 'critical condition which lasted for a month'. He was then hospitalized. No further clinical information (including details about hospitalization) was available for medical review. The reporter stated that the patient has been disabled ever since. He required oxygen for 24 hours and the patient's memory is 'only good for 5 minutes'. The patient needed assistance with anything that he does. Family members cannot let him walk alone to the bathroom and the patient needed assistance in being fed. He also needed constant care from his daughter and son-in-law, and he had been hard on his daughter. The reporter stated that the patient did not recover to be able to live a normal life. The patient is being seen by four specialists, however, details regarding the consultations, laboratory tests and treatment were not provided. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report. Further information has been requested.