Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Biliary cyst, Blindness, Body temperature, COVID-19
Clinical narrative: retaining fluid; gained substantial amount of weight; facial swelling; can't even walk to get my mail; extraordinary abdominal swelling that makes look like was 9 months pregnant; gall bladder looks cyst-like, then deflates; severe pain; doesn't feel any different when I test positive for COVID/original COVID infection stayed in my body; Vaccination failure; strokes/stroke-like symptoms; multisystem inflammatory syndrome adult (MIS-A)/entire body is inflamed/organ inflammation/limbs get inflamed; vision declines/losing vision; paralysis on one side of my body; seizure-like episodes; heart symptoms; This spontaneous case was reported by a patient and describes the occurrence of CEREBROVASCULAR ACCIDENT (strokes/stroke-like symptoms), MULTISYSTEM INFLAMMATORY SYNDROME IN ADULTS (multisystem inflammatory syndrome adult (MIS-A)/entire body is inflamed/organ inflammation/limbs get inflamed), BLINDNESS (vision declines/losing vision), HEMIPLEGIA (paralysis on one side of my body) and SEIZURE LIKE PHENOMENA (seizure-like episodes) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032821A and 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Corona virus infection (Tested positive on 15 Mar 2021 ). Concurrent medical conditions included Mast cell activation syndrome.   On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In July 2021, the patient experienced HEMIPLEGIA (paralysis on one side of my body) (seriousness criterion medically significant), SEIZURE LIKE PHENOMENA (seizure-like episodes) (seriousness criterion medically significant) and CARDIAC DISORDER (heart symptoms). On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (strokes/stroke-like symptoms) (seriousness criterion medically significant), MULTISYSTEM INFLAMMATORY SYNDROME IN ADULTS (multisystem inflammatory syndrome adult (MIS-A)/entire body is inflamed/organ inflammation/limbs get inflamed) (seriousness criterion medically significant), BLINDNESS (vision declines/losing vision) (seriousness criterion medically significant), FLUID RETENTION (retaining fluid), WEIGHT INCREASED (gained substantial amount of weight), SWELLING FACE (facial swelling), GAIT INABILITY (can't even walk to get my mail), ABDOMINAL DISTENSION (extraordinary abdominal swelling that makes look like was 9 months pregnant), BILIARY CYST (gall bladder looks cyst-like, then deflates), PAIN (severe pain), COVID-19 (doesn't feel any different when I test positive for COVID/original COVID infection stayed in my body) and VACCINATION FAILURE (Vaccination failure). At the time of the report, CEREBROVASCULAR ACCIDENT (strokes/stroke-like symptoms), MULTISYSTEM INFLAMMATORY SYNDROME IN ADULTS (multisystem inflammatory syndrome adult (MIS-A)/entire body is inflamed/organ inflammation/limbs get inflamed), BLINDNESS (vision declines/losing vision), HEMIPLEGIA (paralysis on one side of my body), CARDIAC DISORDER (heart symptoms), FLUID RETENTION (retaining fluid), WEIGHT INCREASED (gained substantial amount of weight), SWELLING FACE (facial swelling), GAIT INABILITY (can't even walk to get my mail), ABDOMINAL DISTENSION (extraordinary abdominal swelling that makes look like was 9 months pregnant), PAIN (severe pain), COVID-19 (doesn't feel any different when I test positive for COVID/original COVID infection stayed in my body) and VACCINATION FAILURE (Vaccination failure) outcome was unknown and SEIZURE LIKE PHENOMENA (seizure-like episodes) and BILIARY CYST (gall bladder looks cyst-like, then deflates) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Mar-2021, SARS-CoV-2 test: (Positive) Positive. In August 2021, Computerized tomogram: there was something that looked like a gall bladder. In May 2022, SARS-CoV-2 test: (Positive) Positive. In June 2022, Computerized tomogram: a gall bladder, it appeared again. It looks cyst-like, then deflates, then comes and goes. On 24-Jul-2022, SARS-CoV-2 test: (Positive) Positive. On an unknown date, Body temperature: fever one minute and then a low body temperature the next minute. might have high temperature. On an unknown date, Histamine level: overproducing histamine. On an unknown date, Weight: 170 pounds and 210 lbs.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  It was reported that symptoms worsened. No other vaccines given within 1 month prior to Moderna COVID-19 vaccine. Patient reported taking steroids in August 2021. When patient stopped taking the steroids, patient symptoms would come back. Patient would do 60 mg down to 5 mg between August 2021 - April 2022. In December 2021, patient was doing immunoglobin infusions to try to help with her symptoms. Patient completely stopped it in May 2022.  She received the first Moderna vaccine and didn't felt well and slept for 24 hours. She was tested positive when she woke up, so the connection of the vaccine and testing positive was very troubling. Patient stayed home for 14 days and later went back to work. patient didn't think it was wise to take the second dose because the CDC recommended a 90-day waiting period. Patient had to visit numerous hospitals and was also in a post-COVID program. Patient was hospitalized 8 times. patient truly believed that it had something to do with the vaccine because patient was healthy the day before taking the vaccine. Vaccine brought something out and did something to patient body. Patient stated that she need to get better and it had been two years and was untreated for a million issues, so was looking to go somewhere else for help. Patient wanted to get into another organization. Patient never had a flu vaccine, shingles, had not taken any vaccines since was a child.   Company Comment: This spontaneous concerns a 57-year-old female patient with relevant medical history of mast cell disorder and COVID-19 (in the month prior), who experienced the unexpected, serious   (medically significant) adverse events of special interest Cerebrovascular accident (strokes/stroke-like symptoms), Multisystem inflammatory syndrome in adults, and events of Blindness (vision declines/losing vision), Hemiplegia, and  Seizure like phenomena (seizure-like episodes) in the context of having received the second dose of mRNA-1273 vaccine. The events Cerebrovascular accident, Multisystem inflammatory syndrome in adults, and Blindness occurred on unknown dates, and the events Hemiplegia, and  Seizure like phenomena occurred sometime 3 months after vaccination. Onset latency could not be determined as exact dates of the onset of events were not provided. As reported, patient experienced inflammation of the entire body, and presented with seizure-like episodes, stroke-like symptoms, paralysis on one side of my body, and vision loss for which she sought medical care. She was started on steroids at tapered doses which she had taken on and off for about 8 months. She also underwent immunoglobulin infusions for a duration of 6 months. Patient also had 3 positive COVID-19 tests, the last 2 of which were documented after the second dose vaccination.  Patient previously received mRNA-1273 vaccine as the first dose 28 days prior to current vaccine. The relevant medical history of mast cell disorder and COVID-19 could be considered as risk factors to the event Multisystem inflammatory syndrome in adults. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.  This case was linked to MOD-2022-653374 (Patient Link).; Sender's Comments: This spontaneous concerns a 57-year-old female patient with relevant medical history of mast cell disorder and COVID-19 (in the month prior), who experienced the unexpected, serious   (medically significant) adverse events of special interest Cerebrovascular accident (strokes/stroke-like symptoms), Multisystem inflammatory syndrome in adults, and events of Blindness (vision declines/losing vision), Hemiplegia, and  Seizure like phenomena (seizure-like episodes) in the context of having received the second dose of mRNA-1273 vaccine. The events Cerebrovascular accident, Multisystem inflammatory syndrome in adults, and Blindness occurred on unknown dates, and the events Hemiplegia, and  Seizure like phenomena occurred sometime 3 months after vaccination. Onset latency could not be determined as exact dates of the onset of events were not provided. As reported, patient experienced inflammation of the entire body, and presented with seizure-like episodes, stroke-like symptoms, paralysis on one side of my body, and vision loss for which she sought medical care. She was started on steroids at tapered doses which she had taken on and off for about 8 months. She also underwent immunoglobulin infusions for a duration of 6 months. Patient also had 3 positive COVID-19 tests, the last 2 of which were documented after the second dose vaccination.  Patient previously received mRNA-1273 vaccine as the first dose 28 days prior to current vaccine. The relevant medical history of mast cell disorder and COVID-19 could be considered as risk factors to the event Multisystem inflammatory syndrome in adults. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.