Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site pruritus, Vomiting
Clinical narrative: Vaccination site pain; sweating; shaking out of control; transpiring so badly; sweating a lot; fever/ low grade fever of 99.5°F; so much vomiting; not being feeling well; tired; bad headache; arm is still pink/ arm was red from the injection site to the elbow/it was itchy; arm is still pink/ arm was red from the injection site to the elbow/it was itchy; in and out of sleep; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (not being feeling well), TREMOR (shaking out of control), SLEEP DISORDER (in and out of sleep), URINARY INCONTINENCE (transpiring so badly) and HYPERHIDROSIS (sweating a lot) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical history reported.  Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included PREDNISONE and LEFLUNOMIDE for an unknown indication.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In September 2021, the patient experienced SLEEP DISORDER (in and out of sleep), VACCINATION SITE ERYTHEMA (arm is still pink/ arm was red from the injection site to the elbow/it was itchy ) and VACCINATION SITE PRURITUS (arm is still pink/ arm was red from the injection site to the elbow/it was itchy). On 16-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MALAISE (not being feeling well), FATIGUE (tired) and HEADACHE (bad headache). On 17-Sep-2021, the patient experienced TREMOR (shaking out of control), URINARY INCONTINENCE (transpiring so badly), HYPERHIDROSIS (sweating a lot), PYREXIA (fever/ low grade fever of 99.5°F) and VOMITING (so much vomiting). On 20-Sep-2021, the patient experienced HYPERHIDROSIS (sweating). On an unknown date, the patient experienced VACCINATION SITE PAIN (Vaccination site pain). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency and IBUPROFEN at a dose of 100 mg. In September 2021, HYPERHIDROSIS (sweating a lot) and VACCINATION SITE PRURITUS (arm is still pink/ arm was red from the injection site to the elbow/it was itchy) had resolved. On 17-Sep-2021, TREMOR (shaking out of control) had resolved. At the time of the report, MALAISE (not being feeling well), SLEEP DISORDER (in and out of sleep), URINARY INCONTINENCE (transpiring so badly), HYPERHIDROSIS (sweating), VACCINATION SITE ERYTHEMA (arm is still pink/ arm was red from the injection site to the elbow/it was itchy ), VACCINATION SITE PAIN (Vaccination site pain), FATIGUE (tired), PYREXIA (fever/ low grade fever of 99.5°F) and VOMITING (so much vomiting) outcome was unknown and HEADACHE (bad headache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Sep-2021, Body temperature: 98.7 (Inconclusive) temperature was 98,7°F. On an unknown date, Body temperature: 99.5 (Inconclusive) low grade fever of 99.5°F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   For vomiting HCP prescribed anti-nausea pill.   This case was linked to MOD-2021-327059 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-Sep-2021: Non-significant Follow Up Appended