Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hypersomnia, Mental impairment
Clinical narrative: so exhausted that she can't think; now does 16 hours a day of sleeping; fatigued; This spontaneous case was reported by a consumer and describes the occurrence of MENTAL IMPAIRMENT (so exhausted that she can't think) in a 74-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Dry heaves (Patient experienced retching event after the first dose of vaccination on a unknown date whose outcome is either unresolved or unknown), Weight decreased (Patient experienced decrease in weight event after the first dose of vaccination on a unknown date whose outcome is either unresolved or unknown) and Nausea (Patient experienced nausea event after the first dose of vaccination on a unknown date whose outcome is either unresolved or unknown). Previously administered products included for an unreported indication: ONDANSETRON (Patient took ondansetron as treatment medication for dry heaves). Concurrent medical conditions included Diabetic (diabetic for 4 or 5 years.).   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced MENTAL IMPAIRMENT (so exhausted that she can't think) (seriousness criterion medically significant), HYPERSOMNIA (now does 16 hours a day of sleeping) and FATIGUE (fatigued). At the time of the report, MENTAL IMPAIRMENT (so exhausted that she can't think), HYPERSOMNIA (now does 16 hours a day of sleeping) and FATIGUE (fatigued) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported.  No treatment medications was reported.  Company Comment:This is a spontaneous case concerning a 74-year-old female patient with reported medical history of diabetes mellitus who experienced the unexpected, serious (medically significant) event of Mental impairment and unexpected, non-serious adverse event of special interest of Hypersomnia which occurred on unknown date after receiving the second dose of mRNA-1273 vaccine. Patient experienced exhaustion leading to thinking difficulty. She was also noted have excessive sleeping time. Information about diagnostic evaluation and treatment details were not reported in the case. Patient's advanced age and medical history are risk factors for Mental impairment and Hypersomnia. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-542581, MOD-2022-542686 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a 74-year-old female patient with reported medical history of diabetes mellitus who experienced the unexpected, serious (medically significant) event of Mental impairment and unexpected, non-serious adverse event of special interest of Hypersomnia which occurred on unknown date after receiving the second dose of mRNA-1273 vaccine. Patient experienced exhaustion leading to thinking difficulty. She was also noted have excessive sleeping time. Information about diagnostic evaluation and treatment details were not reported in the case. Patient's advanced age and medical history are risk factors for Mental impairment and Hypersomnia. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.