Reporte zur Charge 041C21A, 047C21

Symptomtext

vaccine made her Cushing's disease worse; She was also very cold; Everything was moving in her room, tv. etc; Had three mini strokes; Nerve problems on the side of her face; Her whole body was itching; She felt crawling in her back, felt very intense, it just grabbed her/Stated that something was crawling in her chest; Shaking like she had Parkinson's disease. Had the shakes all day long; Started regurgitating; Experiencing insomnia; Her mouth was twisted/It hurts to speak (it comes and goes); This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Had three mini strokes), FACIAL NERVE DISORDER (Nerve problems on the side of her face), PRURITUS (Her whole body was itching), FORMICATION (She felt crawling in her back, felt very intense, it just grabbed her/Stated that something was crawling in her chest), TREMOR (Shaking like she had Parkinson's disease. Had the shakes all day long), REGURGITATION (Started regurgitating), INSOMNIA (Experiencing insomnia) and MOVEMENT DISORDER (Her mouth was twisted/It hurts to speak (it comes and goes)) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047C21A and 041C21A, 047C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Cushing's disease (she's had for 32 years, She conveyed that the vaccine made her Cushing's disease worse.). On 15-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In June 2021, the patient experienced CEREBROVASCULAR ACCIDENT (Had three mini strokes) (seriousness criterion medically significant), FACIAL NERVE DISORDER (Nerve problems on the side of her face) (seriousness criterion medically significant), PRURITUS (Her whole body was itching) (seriousness criterion medically significant), FORMICATION (She felt crawling in her back, felt very intense, it just grabbed her/Stated that something was crawling in her chest) (seriousness criterion medically significant), TREMOR (Shaking like she had Parkinson's disease. Had the shakes all day long) (seriousness criterion medically significant), REGURGITATION (Started regurgitating) (seriousness criterion medically significant), INSOMNIA (Experiencing insomnia) (seriousness criterion medically significant), MOVEMENT DISORDER (Her mouth was twisted/It hurts to speak (it comes and goes)) (seriousness criterion medically significant), FEELING COLD (She was also very cold) and OSCILLOPSIA (Everything was moving in her room, tv. etc). On an unknown date, the patient experienced PITUITARY-DEPENDENT CUSHING'S SYNDROME (vaccine made her Cushing's disease worse). At the time of the report, CEREBROVASCULAR ACCIDENT (Had three mini strokes), FACIAL NERVE DISORDER (Nerve problems on the side of her face), PRURITUS (Her whole body was itching), FORMICATION (She felt crawling in her back, felt very intense, it just grabbed her/Stated that something was crawling in her chest), TREMOR (Shaking like she had Parkinson's disease. Had the shakes all day long), REGURGITATION (Started regurgitating), INSOMNIA (Experiencing insomnia), MOVEMENT DISORDER (Her mouth was twisted/It hurts to speak (it comes and goes)), PITUITARY-DEPENDENT CUSHING'S SYNDROME (vaccine made her Cushing's disease worse), FEELING COLD (She was also very cold) and OSCILLOPSIA (Everything was moving in her room, tv. etc) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging: 3 mini strokes (abnormal) 3 mini strokes. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Patient further reported that the MRI presented that she had 3 mini strokes but she didn't to know it. Patient is also seeing a Neurologist and they've been running several tests and said it was the Moderna vaccine, visited emergency department four times. Concomitant medication use was unknown Treatment information was unknown Company Comment: This spontaneous case concerns a 66 year-old female patient with a history of pituitary-dependent Cushing's syndrome who experienced the unexpected serious (medically significant) events of cerebrovascular accident (AESI) and the non serious unexpected events of facial nerve disorder, formication, tremor, movement disorder, regurgitation, feeling cold, oscillopsia, pruritis and condition aggravated of Cushing?s disease. The events occurred with unknown latency related to the second dose of the Moderna COVID 19 vaccine. The rechallenge was not applicable. The medical history Cushing's disease remains a confounder for the events. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report. This case was linked to MOD-2021-367184 (Patient Link).; Sender's Comments: This spontaneous case concerns a 66 year-old female patient with a history of pituitary-dependent Cushing's syndrome who experienced the unexpected serious (medically significant) events of cerebrovascular accident (AESI) and the non serious unexpected events of facial nerve disorder, formication, tremor, movement disorder, regurgitation, feeling cold, oscillopsia, pruritis and the aggravation of known Cushing?s disease. The events occurred with unknown latency related to the second dose of the Moderna COVID 19 vaccine. The rechallenge was not applicable. The medical history Cushing's disease remains a confounder for the events. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.