Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Restlessness, Tremor
Clinical narrative: urgent care doctor who said the reaction was vaccine related.; unable to rest properly; Fatigue; Dizziness; inflammation; Chills; fever 101; Joint stiffness; legs would collapse/Mobility was becoming an issue; severe shaking; aching/gotten progressively worse/excruciating pain; pain in lower back; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TREMOR (severe shaking), PAIN (aching/gotten progressively worse/excruciating pain), BACK PAIN (pain in lower back), INFLAMMATION (inflammation) and HYPERSENSITIVITY (urgent care doctor who said the reaction was vaccine related.) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008B21-2A and 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Coronary artery disease. Concurrent medical conditions included Diabetes (Type 1) since 30-May-1999, Blood pressure high since 30-Jan-2015 and Drug allergy (Opioids allergy). Concomitant products included LISINOPRIL for Blood pressure, INSULIN GLARGINE (LANTUS), INSULIN LISPRO (HUMALOG) and DULOXETINE HYDROCHLORIDE (CYMBALTA) for Diabetes, TOPIRAMATE (TOPAMAX) for Migraine.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced TREMOR (severe shaking), PAIN (aching/gotten progressively worse/excruciating pain), BACK PAIN (pain in lower back), MOBILITY DECREASED (legs would collapse/Mobility was becoming an issue) and PYREXIA (fever 101). 31-Mar-2021, the patient experienced JOINT STIFFNESS (Joint stiffness). On 08-Apr-2021, the patient experienced INFLAMMATION (inflammation). On 12-Apr-2021, the patient experienced DIZZINESS (Dizziness). On 16-Apr-2021, the patient experienced FATIGUE (Fatigue). On 20-Apr-2021, the patient experienced RESTLESSNESS (unable to rest properly). On 22-Apr-2021, the patient experienced HYPERSENSITIVITY (urgent care doctor who said the reaction was vaccine related.). The patient was treated with TRAMADOL for Symptomatic treatment, at a dose of 1 dosage form; TIZANIDINE for Symptomatic treatment, at a dose of 1 dosage form; NABUMETONE for Symptomatic treatment, at a dose of 1 dosage form; GABAPENTIN for Symptomatic treatment, at a dose of 300 mg; Physical therapy for Tremor; Physical therapy for Pain; Physical therapy for Back pain; Physical therapy for Inflammation; Physical therapy for Hypersensitivity; Physical therapy for Joint stiffness; Physical therapy for Mobility decreased; Physical therapy for Restlessness and Physical therapy for Fatigue. On 01-Apr-2021, PYREXIA (fever 101) had resolved. At the time of the report, TREMOR (severe shaking), PAIN (aching/gotten progressively worse/excruciating pain), BACK PAIN (pain in lower back), INFLAMMATION (inflammation), HYPERSENSITIVITY (urgent care doctor who said the reaction was vaccine related.), JOINT STIFFNESS (Joint stiffness), MOBILITY DECREASED (legs would collapse/Mobility was becoming an issue), DIZZINESS (Dizziness), RESTLESSNESS (unable to rest properly) and FATIGUE (Fatigue) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Mar-2021, Body temperature: 101 (High) 101. On 31-Mar-2021, Magnetic resonance imaging: little inflammation (Inconclusive) Little inflammation.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medication also included:  Muscle relaxer,  Predisone (Lab work)   This case was linked to US-MODERNATX, INC.-MOD-2021-072584 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 13-Apr-2021: Follow up received on 13--APR-2021 contains Reporter information added. Events updated. On 25-May-2021: Follow up received on 25-MAY-2021 contains Patient demographics, Vaccination facility details, dose details, Concomitant medication and treatment medications added. Medical history and events updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-072584:CROSSLINKED WITH DOSE 1