Age: 63.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fatigue, Femoroacetabular impingement, Full blood count, Loss of personal independence in daily activities, Rash
Clinical narrative: Enormous fatigue; It takes me forever to get things done; Bone pain; Joint pain; Significant bruising, I bruise easily; My spine from my neck to my sacrum is deformed/The normal curvature of my spine has reversed; Double hip impingement; Cognitive issues; Memory loss; Sleep problems; I've had a substantial amount of weight loss with no dieting or exercise; The fatigue was overwhelming/I was exhausted; I started getting rashes; This spontaneous case was reported by an other health care professional and describes the occurrence of FATIGUE (The fatigue was overwhelming/I was exhausted), RASH (I started getting rashes), FATIGUE (Enormous fatigue), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (It takes me forever to get things done), BONE PAIN (Bone pain), ARTHRALGIA (Joint pain), CONTUSION (Significant bruising, I bruise easily), SPINAL DEFORMITY (My spine from my neck to my sacrum is deformed/The normal curvature of my spine has reversed), FEMOROACETABULAR IMPINGEMENT (Double hip impingement), COGNITIVE DISORDER (Cognitive issues), AMNESIA (Memory loss), SLEEP DISORDER (Sleep problems) and WEIGHT DECREASED (I've had a substantial amount of weight loss with no dieting or exercise) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017E21A and 066D21A) for COVID-19 vaccination.     It was unknown if patient had other vaccines given within 1 month prior to Moderna COVID-19 vaccine.  The patient's past medical history included Hip discomfort, Back discomfort, Herniated disc, Spinal fusion ((L5,S1) Recent change in status shows worsening) in 2019, Skin biopsy (done by dermatologist) and Whole body scan (suspect multiple myeloma). Family history included Family history of cancer. Concurrent medical conditions included IgA deficiency (IGA deficient for yrs, Recent change in status shows worsening), Protein allergy (allergic to IGA, IGA allergy all life), Sulfonamide allergy, Degenerative disc disease (since early 20s. Recent change in status shows worsening) and Multiple myeloma.   On 08-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Sep-2021, the patient experienced FATIGUE (The fatigue was overwhelming/I was exhausted) (seriousness criterion medically significant). In September 2021, the patient experienced RASH (I started getting rashes) (seriousness criterion medically significant). On 01-Aug-2022, the patient experienced FATIGUE (Enormous fatigue) (seriousness criterion medically significant), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (It takes me forever to get things done) (seriousness criterion medically significant), BONE PAIN (Bone pain) (seriousness criterion medically significant), ARTHRALGIA (Joint pain) (seriousness criterion medically significant), CONTUSION (Significant bruising, I bruise easily) (seriousness criterion medically significant), SPINAL DEFORMITY (My spine from my neck to my sacrum is deformed/The normal curvature of my spine has reversed) (seriousness criterion medically significant), FEMOROACETABULAR IMPINGEMENT (Double hip impingement) (seriousness criterion medically significant), COGNITIVE DISORDER (Cognitive issues) (seriousness criterion medically significant), AMNESIA (Memory loss) (seriousness criterion medically significant), SLEEP DISORDER (Sleep problems) (seriousness criterion medically significant) and WEIGHT DECREASED (I've had a substantial amount of weight loss with no dieting or exercise) (seriousness criterion medically significant). At the time of the report, FATIGUE (The fatigue was overwhelming/I was exhausted), RASH (I started getting rashes), FATIGUE (Enormous fatigue), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (It takes me forever to get things done), BONE PAIN (Bone pain), ARTHRALGIA (Joint pain), CONTUSION (Significant bruising, I bruise easily), SPINAL DEFORMITY (My spine from my neck to my sacrum is deformed/The normal curvature of my spine has reversed), FEMOROACETABULAR IMPINGEMENT (Double hip impingement), COGNITIVE DISORDER (Cognitive issues), AMNESIA (Memory loss), SLEEP DISORDER (Sleep problems) and WEIGHT DECREASED (I've had a substantial amount of weight loss with no dieting or exercise) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Aug-2022, Weight: substantial amount of weight loss with no dieting or exercise. On an unknown date, Full blood count: Nomal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   In September or October 2021 patient started getting rashes. Patient geneticist said it's believed to be from IGA allergy. The symptoms of fatigue, rashes, weight loss, spinal deformity, activities of daily living impaired, bone pain, joint pain, bruising, double hip impingement, Memory loss, cognitive issues were worsened. No concomitant medication reported. No treatment medication reported.  Company Comment :This spontaneous case concerns a 63 year old female patient with relevant medical history of Hip discomfort, Back discomfort, Degenerative disc disease (since early 20s. Recent change in status shows worsening), Herniated disc, Spinal fusion ((L5,S1) Recent change in status shows worsening) in 2019, Skin biopsy (done by dermatologist)  Multiple myeloma and Ig A deficiency ,  who experienced Serious ( medically significant ) unexpected events of fatigue ( the fatigue was overwhelming) /  I was exhausted ) which occurred one day post vaccination with the 2nd dose o mRNA-1273 vaccine . On an unknown date in Sept 2021 post vaccination with the mRNA-1273 vaccines , the patient experienced Serious ( medically significant ) , unexpected event of rash . Seven days prior to vaccination with the 1st dose of mRNA-1273 vaccine this patient experienced Serious ( medically significant ) , unexpected events of fatigue ( enormous fatigue ) , loss of personal independence in daily activities ( It takes  me forever to get things done ) , bone pain , weight loss  arthralgia , contusion ( significant bruising , I bruise easily) , spinal deformity ( My spine from my neck to my sacrum is deformed/The normal curvature of my spine has reversed), FEMOROACETABULAR IMPINGEMENT (Double hip impingement), COGNITIVE DISORDER (Cognitive issues), AMNESIA (Memory loss) and SLEEP DISORDER (Sleep problems) . The patient  reported weight loss and she denies that she was dieting .  The details surrounding the events like treatment information , medical consultation or  if any laboratories /diagnostic procedures done were not reported. Outcome of the events was reported as not resolved. The above medical history of multiple myeloma and  hip discomfort , back discomfort , degenerative disc disease ( worsening ) herniated disc , spinal fusion are considered confounders for the events fatigue ,  loss of personal independence in daily activities  , bone pain , arthralgia , spinal deformity , femoroacetabular impingement , sleep disorder while the history of Ig A deficiency and previous history of skin biopsy are considered as confounders for the event RASH. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.   This case was linked to MOD-2022-616438.; Sender's Comments: This spontaneous case concerns a 63 year old female patient with relevant medical history of Hip discomfort, Back discomfort, Degenerative disc disease (since early 20s. Recent change in status shows worsening), Herniated disc, Spinal fusion ((L5,S1) Recent change in status shows worsening) in 2019, Skin biopsy (done by dermatologist)  Multiple myeloma and Ig A deficiency ,  who experienced Serious ( medically significant ) unexpected events of fatigue ( the fatigue was overwhelming) /  I was exhausted ) which occurred one day post vaccination with the 2nd dose o mRNA-1273 vaccine . On an unknown date in Sept 2021 post vaccination with the mRNA-1273 vaccines , the patient experienced Serious ( medically significant ) , unexpected event of rash . Seven days prior to vaccination with the 1st dose of mRNA-1273 vaccine this patient experienced Serious ( medically significant ) , unexpected events of fatigue ( enormous fatigue ) , loss of personal independence in daily activities ( It takes  me forever to get things done ) , bone pain , weight loss  arthralgia , contusion ( significant bruising , I bruise easily) , spinal deformity ( My spine from my neck to my sacrum is deformed/The normal curvature of my spine has reversed), FEMOROACETABULAR IMPINGEMENT (Double hip impingement), COGNITIVE DISORDER (Cognitive issues), AMNESIA (Memory loss) and SLEEP DISORDER (Sleep problems) . The patient  reported weight loss and she denies that she was dieting .  The details surrounding the events like treatment information , medical consultation or  if any laboratories /diagnostic procedures done were not reported. Outcome of the events was reported as not resolved. The above medical history of multiple myeloma and  hip discomfort , back discomfort , degenerative disc disease ( worsening ) herniated disc , spinal fusion are considered confounders for the events fatigue ,  loss of personal independence in daily activities  , bone pain , arthralgia , spinal deformity , femoroacetabular impingement , sleep disorder while the history of Ig A deficiency and previous history of skin biopsy are considered as confounders for the event RASH. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.