Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: dementia; diabetic; She has some leak, I believe it's leakage of blood into the brain or something like that; allergies; she slept a lot. He expressed that she also slept a lot before dementia diagnosis also; she loses her balance; she had problems with memory; she did have kind of a nasty reaction to it; aches, body aches; dizzy/dizzy from walking; extremely tired; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DEMENTIA (dementia), DIABETES MELLITUS (diabetic) and CEREBRAL MICROHAEMORRHAGE (She has some leak, I believe it's leakage of blood into the brain or something like that) in an 83-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) (batch nos. ASKU and ASKU) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Congestive heart failure (it was quite a few years ago.). Concomitant products included DABIGATRAN ETEXILATE MESILATE (PRADAXA) for Prophylaxis.   On an unknown date, the patient received first dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, received second dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DEMENTIA (dementia) (seriousness criterion medically significant), DIABETES MELLITUS (diabetic) (seriousness criterion medically significant), CEREBRAL MICROHAEMORRHAGE (She has some leak, I believe it's leakage of blood into the brain or something like that) (seriousness criterion medically significant), MULTIPLE ALLERGIES (allergies), HYPERSOMNIA (she slept a lot. He expressed that she also slept a lot before dementia diagnosis also), BALANCE DISORDER (she loses her balance), MEMORY IMPAIRMENT (she had problems with memory), IMMUNISATION REACTION (she did have kind of a nasty reaction to it), PAIN (aches, body aches), DIZZINESS (dizzy/dizzy from walking) and FATIGUE (extremely tired). At the time of the report, DEMENTIA (dementia), DIABETES MELLITUS (diabetic) and MULTIPLE ALLERGIES (allergies) had not resolved, CEREBRAL MICROHAEMORRHAGE (She has some leak, I believe it's leakage of blood into the brain or something like that), HYPERSOMNIA (she slept a lot. He expressed that she also slept a lot before dementia diagnosis also), BALANCE DISORDER (she loses her balance), MEMORY IMPAIRMENT (she had problems with memory) and DIZZINESS (dizzy/dizzy from walking) outcome was unknown and IMMUNISATION REACTION (she did have kind of a nasty reaction to it), PAIN (aches, body aches) and FATIGUE (extremely tired) had resolved.     It was reported that patient had the two prior shots but never had the booster, this was quite a while ago when it first came out and she did have kind of a nasty reaction to it, but she came out, she came out all right. For at least a week or 2, she was extremely tired, had, body aches, and she slept a lot. She also slept a lot before dementia diagnosis also. Right now the dementia had gotten steadily worse over the last year. She had been through multiple tests which results were not reported and to multiple professionals to see how bad it was, She had some leak, it was leakage of blood into the brain or something like that. She was diagnosed a year ago although She had it for a bunch because she was getting dizzy from walking, sometimes she loses her balance. She had problems with memory and balance. She would forget to keep her appointments. She took a lot of medication, a lot of different medications. Used to have a pill box for her and she wanted to do it. She would  forget to take certain ones. Because of the Dementia, she was not always alert. Sometimes she was okay, that's how dementia goes. Sometimes she was fine. Other times she was got trouble remembering what happened. She was diagnosed with Diabetes stating just recently a few years. She also had allergies.  Company Comment: This spontaneous case concerns a 83-year-old female patient, with medical history of congestive heart failure and treatment with dabigatran reported, who experienced the unexpected, serious (medically significant) events of dementia, diabetes mellitus and Cerebral microhaemorrhage in context of SPIKEVAX COVID-19 VACCINE NOS dose administration, which unknown dose of COVID-19 vaccination schedule. Latency cannot be calculated due to events and vaccination dates unknown. The patient has experienced also balance disorder, hypersomnia, memory impairment, dizziness which could be in association with each other and reported serious events. Treatment with dabigatran can be considered as a risk factor for the event of cerebral microhaemorrhage while congestive heart failure remain a confounder for the experienced conditions of hypersomnia, balance disorder, memory impairment and dizziness. No further details on clinical course with chronological order of symptoms experienced, concomitant medications, etiologic and diagnostic work up, treatment were provided for medical review. Cerebral microhaemorrhage outcome was unknown when dementia and diabetes mellitus were not recovered at the time of the report. The benefit-risk relationship of SPIKEVAX COVID-19 VACCINE NOS vaccine is not affected by this report.