Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Inappropriate schedule of product administration, Loss of personal independence in daily activities, Neurological decompensation, SARS-CoV-2 test
Clinical narrative: diagnosed with the VIRUS.; Dose 1 taken on 21Nov2021 and Dose 2 taken on 31May2022; A mini-stroke; Lost her vision in one of her eyes due to having a mini-stroke; Dementia/She lost all the orientation/Began to suffer from other psychological and mental issues/deterioration in welness health/Amnesia/Memory loss; Became severely depressed; deterioration in welness health, judgement, motor memory, reasoning, decision making, cognitive, and neurological functioning; deterioration in welness health, judgement, motor, memory, reasoning, decision making, cognitive, and neurological functioning; lost control of her ability to care for herself and other family members/loss of ability; Gravely ill; This spontaneous case was reported by a patient family member or friend and describes the occurrence of TRANSIENT ISCHAEMIC ATTACK (A mini-stroke), BLINDNESS (Lost her vision in one of her eyes due to having a mini-stroke) and DEMENTIA (Dementia/She lost all the orientation/Began to suffer from other psychological and mental issues/deterioration in welness health/Amnesia/Memory loss) in a 71-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 059A22A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 21-Nov-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 31-May-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 31-May-2022,  after starting mRNA-1273 (Spikevax), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 taken on 21Nov2021 and Dose 2 taken on 31May2022). In 2022, the patient experienced TRANSIENT ISCHAEMIC ATTACK (A mini-stroke) (seriousness criterion medically significant), BLINDNESS (Lost her vision in one of her eyes due to having a mini-stroke) (seriousness criterion medically significant), DEMENTIA (Dementia/She lost all the orientation/Began to suffer from other psychological and mental issues/deterioration in welness health/Amnesia/Memory loss) (seriousness criterion medically significant), DEPRESSION (Became severely depressed), GENERAL PHYSICAL HEALTH DETERIORATION (deterioration in welness health, judgement, motor memory, reasoning, decision making, cognitive, and neurological functioning), NEUROLOGICAL DECOMPENSATION (deterioration in welness health, judgement, motor, memory, reasoning, decision making, cognitive, and neurological functioning), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (lost control of her ability to care for herself and other family members/loss of ability) and ILLNESS (Gravely ill). On 06-Aug-2022, the patient experienced COVID-19 (diagnosed with the VIRUS.). At the time of the report, TRANSIENT ISCHAEMIC ATTACK (A mini-stroke), BLINDNESS (Lost her vision in one of her eyes due to having a mini-stroke), DEMENTIA (Dementia/She lost all the orientation/Began to suffer from other psychological and mental issues/deterioration in welness health/Amnesia/Memory loss), DEPRESSION (Became severely depressed), GENERAL PHYSICAL HEALTH DETERIORATION (deterioration in welness health, judgement, motor memory, reasoning, decision making, cognitive, and neurological functioning), NEUROLOGICAL DECOMPENSATION (deterioration in welness health, judgement, motor, memory, reasoning, decision making, cognitive, and neurological functioning), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (lost control of her ability to care for herself and other family members/loss of ability) and ILLNESS (Gravely ill) had not resolved and COVID-19 (diagnosed with the VIRUS.) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 taken on 21Nov2021 and Dose 2 taken on 31May2022) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Aug-2022, SARS-CoV-2 test: Positive.     For mRNA-1273 (Spikevax) (Unknown), the reporter considered TRANSIENT ISCHAEMIC ATTACK (A mini-stroke), BLINDNESS (Lost her vision in one of her eyes due to having a mini-stroke), DEMENTIA (Dementia/She lost all the orientation/Began to suffer from other psychological and mental issues/deterioration in welness health/Amnesia/Memory loss), DEPRESSION (Became severely depressed), GENERAL PHYSICAL HEALTH DETERIORATION (deterioration in welness health, judgement, motor memory, reasoning, decision making, cognitive, and neurological functioning), NEUROLOGICAL DECOMPENSATION (deterioration in welness health, judgement, motor, memory, reasoning, decision making, cognitive, and neurological functioning), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (lost control of her ability to care for herself and other family members/loss of ability), ILLNESS (Gravely ill) and COVID-19 (diagnosed with the VIRUS.) to be related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 taken on 21Nov2021 and Dose 2 taken on 31May2022).    Concomitant medications were not reported.  It was reported that patient was administered with second lethal dosage of the Moderna VIRUS COVID-19 Vaccine (mRNA, LNP-S, PF, 100mcg/0.5mL) on 31-May-2022. Shortly thereafter, she lost all orientation, became severely depressed and began to suffer from other psychological and mental issues, began an extreme decline/deterioration in wellness health, judgement, motor, memory, reasoning, decision-making, cognitive, and neurological functioning, unannounced she left home for three months without just cause amnesia, lost her vision in one of her eyes due to a mini-stroke and lost control of her ability to care for herself and other family members such as life skills, daily living skills, social skills, up-keeping of her home duties, preparation of meals, parental duties in caring for special needs family members, severe memory loss and disorientation, making up stories/lying, failure to/loss of all understanding of the importance to self-medicate, loss of ability and they seek to obtain medical help. Few of her medical symptoms related to her health problems and issues as a direct result of being vaccinated twice with the MODERNA  VIRUS COVID-19 Vaccine as supported by many medical doctors/researchers, the current medical literature, case studies experiments, investigations, virology and epidemiology research findings. Her severe dementia/memory/cognitive/neurological/brain malfunctions, deterioration and related health complications cannot continue to be ignored. Around 01-Aug-2022, patient's entire family of three including patient were diagnosed with the VIRUS. Patient was gravely ill and may die as her symptoms are getting worse and worse as each day goes by.  Reported stated that the patient must receive qualified medical treatment immediately.  Company Comment: Company comment: This spontaneous case concerns a 71-year-old female patient, with no medical history reported, who experienced the unexpected, serious (medically significant) AESI of Transient ischaemic attack, unexpected, serious (medically significant) events Blindness and Dementia that occurred in context with second dose of mRNA-1273 vaccine. Shortly after the second dose patient lost all orientation, became severely depressed and began to suffer from other psychological and mental issues, had extreme decline/deterioration in wellness health, judgement, motor, memory, reasoning, decision-making, cognitive, and neurological functioning, she left home unannounced for three months without any cause-amnesia, lost her vision in one of her eyes due to a mini-stroke and lost control of her ability to care for herself and other family members. Patient was tested positive for covid after the vaccination. Patient had received two doses of mRNA-1273 vaccine at an interval of 191 days (Inappropriate schedule of vaccination).  The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: Company comment: This spontaneous case concerns a 71-year-old female patient, with no medical history reported, who experienced the unexpected, serious (medically significant) AESI of Transient ischaemic attack, unexpected, serious (medically significant) events Blindness and Dementia that occurred in context with second dose of mRNA-1273 vaccine. Shortly after the second dose patient lost all orientation, became severely depressed and began to suffer from other psychological and mental issues, had extreme decline/deterioration in wellness health, judgement, motor, memory, reasoning, decision-making, cognitive, and neurological functioning, she left home unannounced for three months without any cause-amnesia, lost her vision in one of her eyes due to a mini-stroke and lost control of her ability to care for herself and other family members. Patient was tested positive for covid after the vaccination. Patient had received two doses of mRNA-1273 vaccine at an interval of 191 days (Inappropriate schedule of vaccination).  The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.