Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Stomatitis, Temperature intolerance, Tinnitus, Tremor, Undifferentiated connective tissue disease
Clinical narrative: Still having some heart issues but whatever is going on in her body is moving from one thing to another; pain; Psychiatric issues of being gaslit by doctors and government, what she has gone through has't been recognized; Lost over 40 pounds; her arm physically tried to push the needle out; multilevel degenerative disc disease; Had paralyzed vocal chords for quite a while that still comes and goes; heat intolerance; Had markers for Lyme and Sjogrens', hair loss, mouth sores; Had markers for Lyme and Sjogrens', hair loss, mouth sores; Tinnitus started within last two months; Had markers for Lyme and Sjogrens', hair loss, mouth sores.; Had markers for Lyme and Sjogrens'; Dry mouth, dry eyes, hearing loss on left side.; Diagnosed with Raynaud's, undifferentiated connective tissue disease; Diagnosed with Raynaud's, undifferentiated connective tissue disease; Beginning in 2022, was in neurology for sleep apnea, which she had never had her in her life/horrible snoring; From there went into full body rash that was head to toe.; Associated diagnosis of mast cell disease - listed on 11/24/21; insomnia - wasn't sleeping at all for days; the next day her arm was sore and bruised; the next day her arm was sore and bruised; her primary issue was suffering from brain fog; Then started with full body tremors; This spontaneous case was reported by a patient and describes the occurrence of CARDIAC DISORDER (Still having some heart issues but whatever is going on in her body is moving from one thing to another), MASTOCYTOSIS (Associated diagnosis of mast cell disease - listed on 11/24/21), LYME DISEASE (Had markers for Lyme and Sjogrens', hair loss, mouth sores.), SJOGREN'S SYNDROME (Had markers for Lyme and Sjogrens'), BRAIN FOG (her primary issue was suffering from brain fog) and DEAFNESS UNILATERAL (Dry mouth, dry eyes, hearing loss on left side.) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Lyme disease (Has Lyme disease that was an old Lyme that was probably re-triggered due to vaccine.).    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 13-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced BRAIN FOG (her primary issue was suffering from brain fog) (seriousness criterion medically significant). On 14-Jan-2021, the patient experienced INJECTION SITE BRUISING (the next day her arm was sore and bruised) and INJECTION SITE PAIN (the next day her arm was sore and bruised). In 2021, the patient experienced TREMOR (Then started with full body tremors). In November 2021, the patient experienced INSOMNIA (insomnia - wasn't sleeping at all for days). On 24-Nov-2021, the patient experienced MASTOCYTOSIS (Associated diagnosis of mast cell disease - listed on 11/24/21) (seriousness criterion medically significant). In 2022, the patient experienced LYME DISEASE (Had markers for Lyme and Sjogrens', hair loss, mouth sores.) (seriousness criterion medically significant), SJOGREN'S SYNDROME (Had markers for Lyme and Sjogrens') (seriousness criterion medically significant), DEAFNESS UNILATERAL (Dry mouth, dry eyes, hearing loss on left side.) (seriousness criterion medically significant), RAYNAUD'S PHENOMENON (Diagnosed with Raynaud's, undifferentiated connective tissue disease), UNDIFFERENTIATED CONNECTIVE TISSUE DISEASE (Diagnosed with Raynaud's, undifferentiated connective tissue disease), SLEEP APNOEA SYNDROME (Beginning in 2022, was in neurology for sleep apnea, which she had never had her in her life/horrible snoring), VOCAL CORD PARALYSIS (Had paralyzed vocal chords for quite a while that still comes and goes), TEMPERATURE INTOLERANCE (heat intolerance), ALOPECIA (Had markers for Lyme and Sjogrens', hair loss, mouth sores), STOMATITIS (Had markers for Lyme and Sjogrens', hair loss, mouth sores), TINNITUS (Tinnitus started within last two months) and RASH (From there went into full body rash that was head to toe.). On an unknown date, the patient experienced CARDIAC DISORDER (Still having some heart issues but whatever is going on in her body is moving from one thing to another) (seriousness criteria hospitalization, disability and medically significant), PAIN (pain), MENTAL DISORDER (Psychiatric issues of being gaslit by doctors and government, what she has gone through has't been recognized), WEIGHT DECREASED (Lost over 40 pounds), DEVICE DIFFICULT TO USE (her arm physically tried to push the needle out) and INTERVERTEBRAL DISC DEGENERATION (multilevel degenerative disc disease). The patient was treated with LISINOPRIL at an unspecified dose and frequency and METOPROLOL at an unspecified dose and frequency. At the time of the report, CARDIAC DISORDER (Still having some heart issues but whatever is going on in her body is moving from one thing to another), MASTOCYTOSIS (Associated diagnosis of mast cell disease - listed on 11/24/21), LYME DISEASE (Had markers for Lyme and Sjogrens', hair loss, mouth sores.), SJOGREN'S SYNDROME (Had markers for Lyme and Sjogrens'), BRAIN FOG (her primary issue was suffering from brain fog), DEAFNESS UNILATERAL (Dry mouth, dry eyes, hearing loss on left side.), RAYNAUD'S PHENOMENON (Diagnosed with Raynaud's, undifferentiated connective tissue disease), UNDIFFERENTIATED CONNECTIVE TISSUE DISEASE (Diagnosed with Raynaud's, undifferentiated connective tissue disease), TREMOR (Then started with full body tremors), INSOMNIA (insomnia - wasn't sleeping at all for days), VOCAL CORD PARALYSIS (Had paralyzed vocal chords for quite a while that still comes and goes), TEMPERATURE INTOLERANCE (heat intolerance), ALOPECIA (Had markers for Lyme and Sjogrens', hair loss, mouth sores), STOMATITIS (Had markers for Lyme and Sjogrens', hair loss, mouth sores), TINNITUS (Tinnitus started within last two months), PAIN (pain), MENTAL DISORDER (Psychiatric issues of being gaslit by doctors and government, what she has gone through has't been recognized), INJECTION SITE BRUISING (the next day her arm was sore and bruised), RASH (From there went into full body rash that was head to toe.) and INJECTION SITE PAIN (the next day her arm was sore and bruised) had not resolved, SLEEP APNOEA SYNDROME (Beginning in 2022, was in neurology for sleep apnea, which she had never had her in her life/horrible snoring) had resolved and WEIGHT DECREASED (Lost over 40 pounds), DEVICE DIFFICULT TO USE (her arm physically tried to push the needle out) and INTERVERTEBRAL DISC DEGENERATION (multilevel degenerative disc disease) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Jan-2021, Weight decreased: Lost over 40 pounds. On 20-Jan-2021, Heart rate: 171. In September 2021, SARS-CoV-2 test: Negative. On an unknown date, Magnetic resonance imaging neck: found some multilevel degenerative disk disease.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered RAYNAUD'S PHENOMENON (Diagnosed with Raynaud's, undifferentiated connective tissue disease) and UNDIFFERENTIATED CONNECTIVE TISSUE DISEASE (Diagnosed with Raynaud's, undifferentiated connective tissue disease) to be related. No further causality assessments were provided for CARDIAC DISORDER (Still having some heart issues but whatever is going on in her body is moving from one thing to another), MASTOCYTOSIS (Associated diagnosis of mast cell disease - listed on 11/24/21), LYME DISEASE (Had markers for Lyme and Sjogrens', hair loss, mouth sores.), SJOGREN'S SYNDROME (Had markers for Lyme and Sjogrens'), BRAIN FOG (her primary issue was suffering from brain fog), DEAFNESS UNILATERAL (Dry mouth, dry eyes, hearing loss on left side.), TREMOR (Then started with full body tremors), SLEEP APNOEA SYNDROME (Beginning in 2022, was in neurology for sleep apnea, which she had never had her in her life/horrible snoring), INSOMNIA (insomnia - wasn't sleeping at all for days), VOCAL CORD PARALYSIS (Had paralyzed vocal chords for quite a while that still comes and goes), TEMPERATURE INTOLERANCE (heat intolerance), ALOPECIA (Had markers for Lyme and Sjogrens', hair loss, mouth sores), STOMATITIS (Had markers for Lyme and Sjogrens', hair loss, mouth sores), TINNITUS (Tinnitus started within last two months), PAIN (pain), MENTAL DISORDER (Psychiatric issues of being gaslit by doctors and government, what she has gone through has't been recognized), WEIGHT DECREASED (Lost over 40 pounds), DEVICE DIFFICULT TO USE (her arm physically tried to push the needle out), INTERVERTEBRAL DISC DEGENERATION (multilevel degenerative disc disease), INJECTION SITE BRUISING (the next day her arm was sore and bruised), RASH (From there went into full body rash that was head to toe.) and INJECTION SITE PAIN (the next day her arm was sore and bruised).    The patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  The concomitant medication was not reported by reporter.  The patient having some heart issues but whatever was going on in her body was moving from one thing to another. All of this was triggered by the vaccine. She was in the hospital for the heart rate. She got out, got her heart under control. Around Mother's Day (2021) was sending heart monitor back. Then started with full body tremors. She had MRI of cervical spine with contrast and found some multilevel degenerative disk disease and went into physical therapy. She lost over 40 pounds, prior to that she worked out daily, was 125lbs, a mother of 2, worked full time, got up at 5 am, and worked out daily. Her lowest weight was 86lbs; currently hovering at 104 and continuing to try to gain the weight. Then in Nov 2021, she went to Clinic for insomnia. She wasn't sleeping at all for days. Her brain fog was huge at that time. Not sure if was from sleep deprivation or because of medication. Now sleep was under control, but brain fog was constant. She had cognitive testing and couldn't draw a clock. Enhanced tremor and observed with hands outstretched from fingers to toes. She had tons of blood work. Went to gastroenterology - nausea, diarrhea, abdominal cramping. So thirsty she couldn't get enough to drink. Went to ER to ask for IV because so weak. Did swallowing tests with her. Associated diagnosis of mast cell disease - listed on 11/24/21. She did swallow tests. Beginning in 2022, she was in neurology for sleep apnea, which she had never had her in her life. This was thankfully gone away, but had horrible snoring, was stopping breathing in the middle of the night, super scary. From there went into full body rash that was head to toe. She had gone to dermatology, and they put her on steroids. She had paralyzed vocal cords for quite a while that still comes and goes; voice was still raspy. At one point, she couldn't form sentences. She would open her mouth and one word would come out but couldn't form sentences. When tremors were at the worst couldn't navigate stairs, would fall, and hit head on piano bench. Husband would find her on bathroom floor. She diagnosed with Raynaud's, undifferentiated connective tissue disease. She had markers for Lyme and Sjogren's, hair loss, mouth sores. Has Lyme disease that was an old Lyme that was probably re-triggered due to vaccine. But kind of seems like everything when it happens, she seems to get it under control then it attacks another part of her body. She thought that's the gist of it. After being healthy, now suffers from immune disorders, cardiovascular issues, circulatory issues, neurological issues, orthopedic issues, pain, go along with it. Psychiatric issues of being gaslit by doctors and government, what she had gone through had not been recognized.   This case was linked to US-MODERNATX, INC.-MOD-2024-761576 (Linked Report).  Company Comment: This is a spontaneous case concerning a 52-year-old, female patient with medical history of Lyme disease, who experienced the unexpected serious (medically significant) events of brain fog, mast cell disease, Lyme, Sjogrens' and Deafness unilateral and the unexpected serious (Hospitalization) event of cardiac disorder.  The events occurred after the administration of the first dose of mRNA-1273 vaccine. She is experiencing brain fog and confusion, which they attribute to the vaccine. The day after vaccination, she had arm soreness and bruising. They were unable to return to work for several days. A week later, she visited a clinic with a high heart rate (HR) of 171 and were prescribed Lisinopril and Metoprolol, which she had since stopped taking. She continues to experience heart issues and other symptoms that seem to migrate within their body. After a hospital stay for their heart rate, they were discharged with their heart condition managed. Sometime after that, while returning a heart monitor, she began experiencing full body tremors. An MRI revealed multilevel degenerative disk disease. About 11 months after vaccination, the patient visited the Clinic due to severe insomnia and significant brain fog, uncertain if it was caused by sleep deprivation or medication. The patient underwent cognitive testing and was unable to draw a clock, and an enhanced tremor was noted from fingers to toes. After extensive blood work, the patient saw a gastroenterologist for nausea, diarrhea, and abdominal cramping, and experienced extreme thirst. An ER visit was necessary due to weakness, and swallowing tests were conducted. The patient was diagnosed with mast cell disease during the same month. During the next year, the patient was treated for sleep apnea, which has since resolved, though it included severe snoring and apnea episodes. The patient developed a full-body rash, requiring dermatological treatment with steroids. Additionally, the patient has experienced intermittent vocal cord paralysis, resulting in a raspy voice and difficulty forming sentences. The patient had to visit dermatology and was prescribed steroids due to a condition affecting her vocal cords, which caused paralysis and a raspy voice that intermittently persists. She experienced difficulty forming sentences and severe tremors, which led to mobility issues and falls. She has been diagnosed with Raynaud's and undifferentiated connective tissue disease, with indications of Lyme disease and Sjogren's syndrome, accompanied by hair loss and mouth sores. The Lyme disease, which it is reported as possible dormant, may have been reactivated following a vaccination. She also experiences dry mouth, dry eyes, hearing loss in the left ear, and recent tinnitus. Onset dates have not been provided for most of the events, hence latency with vaccination is unclear. Intervertebral disc degeneration is assessed as not related as it is an incidental finding and due to inconsistent with the safety profile of the vaccine. Patients medical history of Lyme disease is a confounder for the same event and its symptoms. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 27-Feb-2024: Product investigation report received. Reference number added.; Sender's Comments: This is a spontaneous case concerning a 52-year-old, female patient with medical history of Lyme disease, who experienced the unexpected serious (medically significant) events of brain fog, mast cell disease, Lyme, Sjogrens' and Deafness unilateral and the unexpected serious (Hospitalization) event of cardiac disorder.  The events occurred after the administration of the first dose of mRNA-1273 vaccine. She is experiencing brain fog and confusion, which they attribute to the vaccine. The day after vaccination, she had arm soreness and bruising. They were unable to return to work for several days. A week later, she visited a clinic with a high heart rate (HR) of 171 and were prescribed Lisinopril and Metoprolol, which she had since stopped taking. She continues to experience heart issues and other symptoms that seem to migrate within their body. After a hospital stay for their heart rate, they were discharged with their heart condition managed. Sometime after that, while returning a heart monitor, she began experiencing full body tremors. An MRI revealed multilevel degenerative disk disease. About 11 months after vaccination, the patient visited the Clinic due to severe insomnia and significant brain fog, uncertain if it was caused by sleep deprivation or medication. The patient underwent cognitive testing and was unable to draw a clock, and an enhanced tremor was noted from fingers to toes. After extensive blood work, the patient saw a gastroenterologist for nausea, diarrhea, and abdominal cramping, and experienced extreme thirst. An ER visit was necessary due to weakness, and swallowing tests were conducted. The patient was diagnosed with mast cell disease during the same month. During the next year, the patient was treated for sleep apnea, which has since resolved, though it included severe snoring and apnea episodes. The patient developed a full-body rash, requiring dermatological treatment with steroids. Additionally, the patient has experienced intermittent vocal cord paralysis, resulting in a raspy voice and difficulty forming sentences. The patient had to visit dermatology and was prescribed steroids due to a condition affecting her vocal cords, which caused paralysis and a raspy voice that intermittently persists. She experienced difficulty forming sentences and severe tremors, which led to mobility issues and falls. She has been diagnosed with Raynaud's and undifferentiated connective tissue disease, with indications of Lyme disease and Sjogren's syndrome, accompanied by hair loss and mouth sores. The Lyme disease, which it is reported as possible dormant, may have been reactivated following a vaccination. She also experiences dry mouth, dry eyes, hearing loss in the left ear, and recent tinnitus. Onset dates have not been provided for most of the events, hence latency with vaccination is unclear. Intervertebral disc degeneration is assessed as not related as it is an incidental finding and due to inconsistent with the safety profile of the vaccine. Patients medical history of Lyme disease is a confounder for the same event and its symptoms. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. US-MODERNATX, INC.-MOD-2024-761576:Same reporter (Invalid case)