Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Bedridden, Dementia, Gait inability, Movement disorder
Clinical narrative: dementia; bed ridden all of sudden after Moderna vaccine; He is not able to work; not able to eat by hand; became weak; Body aches/ sore arm which was worst on next day; This spontaneous case was reported by a consumer and describes the occurrence of DEMENTIA (dementia) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026C21A and 021C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Stroke in 2017. Concurrent medical conditions included Dementia (dementia and stroke together in 2017) since 2017 and Diabetes. Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID], ATORVASTATIN, METFORMIN, AMANTADINE, LISINOPRIL and GLIPIZIDE for an unknown indication.   On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-May-2021, the patient experienced DEMENTIA (dementia) (seriousness criterion medically significant), BEDRIDDEN (bed ridden all of sudden after Moderna vaccine), GAIT INABILITY (He is not able to work), MOVEMENT DISORDER (not able to eat by hand), ASTHENIA (became weak) and MYALGIA (Body aches/ sore arm which was worst on next day). The patient was treated with IBUPROFEN SODIUM (IBUPROFEN [IBUPROFEN SODIUM]) on 29-May-2021 at an unspecified dose and frequency and PARACETAMOL (TYLENOL) on 28-May-2021 at an unspecified dose and frequency. At the time of the report, DEMENTIA (dementia), BEDRIDDEN (bed ridden all of sudden after Moderna vaccine), GAIT INABILITY (He is not able to work), MOVEMENT DISORDER (not able to eat by hand), ASTHENIA (became weak) and MYALGIA (Body aches/ sore arm which was worst on next day) outcome was unknown.            Treatment medication not reported.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.  Wife called in on behalf of husband and report that, patient received Moderna vaccine 2nd dose on 28 May 2021 in right arm and same day afternoon he has sore arm and worst on next day. After that he had body ache and dementia. He had dementia and stroke together in 2017. He is bed ridden all of sudden after Moderna vaccine. He is not able to walk, not able to eat by hand and he became weak and he is able to do all by himself earlier before vaccine. On 28 May 2021 he took Tylenol and on 29 May 2021 he took Ibuprofen and on 30 May 2021 he took his regular medicine which are Aspirin, Metformin, Atorvastatin, Amantadine, Lisinopril and Glipizide.  Company Comment : 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.; Sender's Comments: 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.