Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Dementia
Clinical narrative: both were diagnosed with dementia after getting the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of DEMENTIA (both were diagnosed with dementia after getting the vaccine) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 076C21A, 038A21A and 023M20A) for COVID-19 prophylaxis.     Concurrent medical conditions included Memory impairment (Patient had started to have memory problems approximately 2 years ago.).   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DEMENTIA (both were diagnosed with dementia after getting the vaccine) (seriousness criterion medically significant). At the time of the report, DEMENTIA (both were diagnosed with dementia after getting the vaccine) outcome was unknown.            Concomitant product use was not provided by the reporter.  Reported that patient had started to have memory problems approximately 2 years ago. However, after receiving the Moderna COVID-19 vaccine, Patient was diagnosed with dementia and the exact date of diagnosis was not provided. Patient moved in with reporter recently due to deteriorating dementia. Reported that so far there was no hospitalization required due to the dementia.  Patient visit the health care provider as outpatients. Vaccination provider details for patient was unknown. Treatment information was not provided.  Company comment: This is a spontaneous case concerning a 78-year-old, male patient with relevant concurrent medical condition of memory problems which started approximately 2 years ago. Patient experienced the unexpected serious (medically significant) event of dementia. The patient received first and second dose of mRNA-1273 vaccine with dosage interval of 28 days. Patient received third dose of mRNA-1273 vaccine approximately 221 days after the second dose. It was reported that the patient was diagnose with dementia after mRNA-1273 vaccine administration. However, it was not specified after which dose sequence the event occurred. It was reported that the patient has deteriorating dementia which do not require hospitalization. At the time of the report patient sees his health care provider as outpatient. No other information surrounding the event was reported. The patient's age and concurrent medical condition of memory problems which started approximately 2 years ago remain confounders for the event dementia. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-617719 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a 78-year-old, male patient with relevant concurrent medical condition of memory problems which started approximately 2 years ago. Patient experienced the unexpected serious (medically significant) event of dementia. The patient received first and second dose of mRNA-1273 vaccine with dosage interval of 28 days. Patient received third dose of mRNA-1273 vaccine approximately 221 days after the second dose. It was reported that the patient was diagnose with dementia after mRNA-1273 vaccine administration. However, it was not specified after which dose sequence the event occurred. It was reported that the patient has deteriorating dementia which do not require hospitalization. At the time of the report patient sees his health care provider as outpatient. No other information surrounding the event was reported. The patient's age and concurrent medical condition of memory problems which started approximately 2 years ago remain confounders for the event dementia. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.