Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: Short black out; Accelerating aging; Slower in movement; slower in  thinking; Less muscle strength; Less endurance; More unsteady in uneven grounds; Increased lightheadedness; Reduced appetite; Increased breathlessness; Heart palpitations; Lack of motivation; Increased memory issues,find challenging retaining and organizing information; Feel disoriented when preforming tasks; Attention deficit; Anxiety; Fell asleep while having coffee when taking a break from working hard  although not sure if this is not a short black out.; takes them 3 -4 times as long to complete a task; Short term memory went down the tube; Blood pressure was sky high; severe lack of energy; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Short black out), PREMATURE AGEING (Accelerating aging), BRADYKINESIA (Slower in movement), BRADYPHRENIA (slower in  thinking) and MUSCULAR WEAKNESS (Less muscle strength) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037K20A or 037K2019 and 042G20A or 042620A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  The patient's past medical history included Heart attack (Patient stated that 25 years ago had a heart attack, Later they found out they have a heart murmur.), Heart valve regurgitation (leaky heart valve) and Macular degeneration. Concomitant products included ACICLOVIR SODIUM (ACYCLOVIR ABBOTT VIAL) for an unknown indication.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, 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 experienced LOSS OF CONSCIOUSNESS (Short black out), PREMATURE AGEING (Accelerating aging), BRADYKINESIA (Slower in movement), BRADYPHRENIA (slower in  thinking), MUSCULAR WEAKNESS (Less muscle strength), EXERCISE TOLERANCE DECREASED (Less endurance), GAIT DISTURBANCE (More unsteady in uneven grounds), DIZZINESS (Increased lightheadedness), DECREASED APPETITE (Reduced appetite), DYSPNOEA (Increased breathlessness), PALPITATIONS (Heart palpitations), APATHY (Lack of motivation), MEMORY IMPAIRMENT (Increased memory issues,find challenging retaining and organizing information), DISORIENTATION (Feel disoriented when preforming tasks), ATTENTION DEFICIT HYPERACTIVITY DISORDER (Attention deficit), ANXIETY (Anxiety), SOMNOLENCE (Fell asleep while having coffee when taking a break from working hard  although not sure if this is not a short black out.), DISTURBANCE IN ATTENTION (takes them 3 -4 times as long to complete a task), AMNESIA (Short term memory went down the tube), HYPERTENSION (Blood pressure was sky high) and ASTHENIA (severe lack of energy). At the time of the report, LOSS OF CONSCIOUSNESS (Short black out), BRADYKINESIA (Slower in movement), BRADYPHRENIA (slower in  thinking), MUSCULAR WEAKNESS (Less muscle strength), EXERCISE TOLERANCE DECREASED (Less endurance), GAIT DISTURBANCE (More unsteady in uneven grounds), DIZZINESS (Increased lightheadedness), DECREASED APPETITE (Reduced appetite), DYSPNOEA (Increased breathlessness), PALPITATIONS (Heart palpitations), APATHY (Lack of motivation), MEMORY IMPAIRMENT (Increased memory issues,find challenging retaining and organizing information), DISORIENTATION (Feel disoriented when preforming tasks), ATTENTION DEFICIT HYPERACTIVITY DISORDER (Attention deficit), ANXIETY (Anxiety), SOMNOLENCE (Fell asleep while having coffee when taking a break from working hard  although not sure if this is not a short black out.), DISTURBANCE IN ATTENTION (takes them 3 -4 times as long to complete a task), AMNESIA (Short term memory went down the tube), HYPERTENSION (Blood pressure was sky high) and ASTHENIA (severe lack of energy) outcome was unknown and PREMATURE AGEING (Accelerating aging) had not resolved.            Concomitant medication included high blood pressure medication. No treatment information was mentioned. Patient  also stated that she had consulted with a functional HCP in regards of this and they had some tests done and advice the patient to get a pace-maker.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  However, patient's underlying condition of leaky heart valve could be a confounder. Further information has been requested.   Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: FU document contains Initial additional information-Events added (Heart issues, severe lack of energy); Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  However, patient's underlying condition of leaky heart valve could be a confounder. Further information has been requested.