Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Immunisation reaction, Loss of consciousness, Loss of personal independence in daily activities, Memory impairment
Clinical narrative: This went on for 9 months, and she develop seizure,10 seizures a day, with two different seizures medication.; the dystonia posturing; falling and  passing out; This continue on  and she  started having brain fog, could not remember  things,; falling and  passing out; lost activity of daily living ,could not  make food,  or load the dishwasher; In the very begging could not get out bed for 4 and 1/2 days,  and she doesn't remember anything of  the first day and half.; This continue on  and she  started having brain fog, could not remember  things; has speech problems; urine retention; pain in the back; cognitive impermanent; This continue on  and she  started having brain fog, could not remember  things; she though she was going to die; lost her job, and lost of money trying to get well/is very upset; difficulty reading , and doing math; a symptom of having something  biting the leg or arm  and there is nothing there, difficulty reading , and doing math; severe dizziness could not roll over in bed; he woke up at 11 at night with a 102.6 degree fahrenheit  fever; nausea and vomiting; severe headache; nausea and vomiting/nauseas; This spontaneous case was reported by a nurse and describes the occurrence of SEIZURE (This went on for 9 months, and she develop seizure,10 seizures a day, with two different seizures medication.), DYSTONIA (the dystonia posturing) and LOSS OF CONSCIOUSNESS (falling and  passing out) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Allergies: Atrovent), Chronic pain, Spasms (Recent change in status such as improvement or worsening yes, (worst)), Limb hyperextension (Recent change in status such as improvement or worsening yes, (worst)) and Dystonia (Recent change in status such as improvement or worsening yes, (worst)). Concomitant products included NALOXONE for Pain, LORAZEPAM (ATIVAN), LEVOTHYROXINE, ASCORBIC ACID, BETACAROTENE, ROSA CANINA (VITAMIN C [ASCORBIC ACID;BETACAROTENE;ROSA CANINA]), ZINC, COLECALCIFEROL (VITAMIN D3) and QUERCETIN for an unknown indication.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021 at 10:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Jan-2021 at 11:00 PM, the patient experienced DIZZINESS (severe dizziness could not roll over in bed), PYREXIA (he woke up at 11 at night with a 102.6 degree fahrenheit  fever), VOMITING (nausea and vomiting), HEADACHE (severe headache) and NAUSEA (nausea and vomiting/nauseas). On an unknown date, the patient experienced SEIZURE (This went on for 9 months, and she develop seizure,10 seizures a day, with two different seizures medication.) (seriousness criterion medically significant), DYSTONIA (the dystonia posturing) (seriousness criterion medically significant), LOSS OF CONSCIOUSNESS (falling and  passing out) (seriousness criterion medically significant), MEMORY IMPAIRMENT (This continue on  and she  started having brain fog, could not remember  things,), FALL (falling and  passing out), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (lost activity of daily living ,could not  make food,  or load the dishwasher), DISTURBANCE IN ATTENTION (In the very begging could not get out bed for 4 and 1/2 days,  and she doesn't remember anything of  the first day and half.), the first episode of FEELING ABNORMAL (This continue on  and she  started having brain fog, could not remember  things), SPEECH DISORDER (has speech problems), DYSURIA (urine retention), BACK PAIN (pain in the back), COGNITIVE DISORDER (cognitive impermanent), the second episode of FEELING ABNORMAL (This continue on  and she  started having brain fog, could not remember  things), FEELING ABNORMAL (she though she was going to die), DEPRESSED MOOD (lost her job, and lost of money trying to get well/is very upset), DISTURBANCE IN ATTENTION (difficulty reading , and doing math) and IMMUNISATION REACTION (a symptom of having something  biting the leg or arm  and there is nothing there, difficulty reading , and doing math). At the time of the report, SEIZURE (This went on for 9 months, and she develop seizure,10 seizures a day, with two different seizures medication.), DYSTONIA (the dystonia posturing), LOSS OF CONSCIOUSNESS (falling and  passing out), MEMORY IMPAIRMENT (This continue on  and she  started having brain fog, could not remember  things,), FALL (falling and  passing out), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (lost activity of daily living ,could not  make food,  or load the dishwasher), DISTURBANCE IN ATTENTION (In the very begging could not get out bed for 4 and 1/2 days,  and she doesn't remember anything of  the first day and half.), SPEECH DISORDER (has speech problems), DYSURIA (urine retention), BACK PAIN (pain in the back), COGNITIVE DISORDER (cognitive impermanent), the last episode of FEELING ABNORMAL (This continue on  and she  started having brain fog, could not remember  things), FEELING ABNORMAL (she though she was going to die), DEPRESSED MOOD (lost her job, and lost of money trying to get well/is very upset), DISTURBANCE IN ATTENTION (difficulty reading , and doing math), IMMUNISATION REACTION (a symptom of having something  biting the leg or arm  and there is nothing there, difficulty reading , and doing math), DIZZINESS (severe dizziness could not roll over in bed), PYREXIA (he woke up at 11 at night with a 102.6 degree fahrenheit  fever), VOMITING (nausea and vomiting), HEADACHE (severe headache) and NAUSEA (nausea and vomiting/nauseas) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Jan-2021, Body temperature: 102.6 102.6 degree fahrenheit.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that patient seek for unspecified medical care. No treatment medication was provided. Company comment: This spontaneous case concerns a 60-year-old, female patient with no relevant medical history, who experienced the unexpected, serious (Medically significant) AESI of Seizure and unexpected, serious (Medically significant) event of Dystonia and Loss of consciousness. The exact date of onset of the events was not specified in respect to the administration of first and second dose of mRNA-1273, hence latency could not be assessed. It has been reported that after the second dose of mRNA-1273, patient experienced fever, dizziness, headache, nausea and vomiting, patient was also bedridden. Condition progressed to brain fog, memory loss and loss of consciousness, the condition persisted for 9 months, the patient developed seizure, claiming 10 episodes per day. Patient developed speech problems, urinary retention, lower back pain, shortness of breath and dystonia. The events were resolving at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events' seriousness retained as per medical judgment.; Sender's Comments: This spontaneous case concerns a 60-year-old, female patient with no relevant medical history, who experienced the unexpected, serious (Medically significant) AESI of Seizure and unexpected, serious (Medically significant) event of Dystonia and Loss of consciousness. The exact date of onset of the events was not specified in respect to the administration of first and second dose of mRNA-1273, hence latency could not be assessed. It has been reported that after the second dose of mRNA-1273, patient experienced fever, dizziness, headache, nausea and vomiting, patient was also bedridden. Condition progressed to brain fog, memory loss and loss of consciousness, the condition persisted for 9 months, the patient developed seizure, claiming 10 episodes per day. Patient developed speech problems, urinary retention, lower back pain, shortness of breath and dystonia. The events were resolving at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events' seriousness retained as per medical judgment.