Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Pruritus, Pyrexia, Vaccination site warmth
Clinical narrative: Fiery Arm after 3rd shot; Large portion of their arm was red/redness was about 4inches longer and 3inches wide, Arm was red; Left arm started to itch; Arm is sore; Had a fever of 101.1; Painful back; Felt really fatigued; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm is sore), ERYTHEMA (Large portion of their arm was red/redness was about 4inches longer and 3inches wide, Arm was red), PRURITUS (Left arm started to itch), VACCINATION SITE WARMTH (Fiery Arm after 3rd shot) and BACK PAIN (Painful back) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 062E21A, 010M20A and 029K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Ovarian cancer (ovarian cancer survivor) since an unknown date. Concurrent medical conditions included Brain cancer metastatic and Low blood pressure. Concomitant products included METFORMIN, PITAVASTATIN CALCIUM (LIVALO), EZETIMIBE (ZETIA), DENOSUMAB (PROLIA), ASPIRIN [ACETYLSALICYLIC ACID], CALCIUM LACTATE, DL- LACTIC ACID (VAGISAN COMBI), GABAPENTIN (NEURONTIN) and TRAMADOL for an unknown indication.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Sep-2021, the patient experienced CHILLS (Chills). On 02-Sep-2021, the patient experienced BACK PAIN (Painful back) and FATIGUE (Felt really fatigued). On 02-Sep-2021 at 10:00 AM, the patient experienced PYREXIA (Had a fever of 101.1). On 03-Sep-2021, the patient experienced PAIN IN EXTREMITY (Arm is sore). On 03-Sep-2021 at 2:00 PM, the patient experienced PRURITUS (Left arm started to itch). On 03-Sep-2021 at 3:00 PM, the patient experienced ERYTHEMA (Large portion of their arm was red/redness was about 4inches longer and 3inches wide, Arm was red). On an unknown date, the patient experienced VACCINATION SITE WARMTH (Fiery Arm after 3rd shot). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Arm is sore), ERYTHEMA (Large portion of their arm was red/redness was about 4inches longer and 3inches wide, Arm was red), PRURITUS (Left arm started to itch), VACCINATION SITE WARMTH (Fiery Arm after 3rd shot), BACK PAIN (Painful back), FATIGUE (Felt really fatigued) and CHILLS (Chills) outcome was unknown and PYREXIA (Had a fever of 101.1) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Sep-2021, Blood pressure measurement: increased (High) increased. On 02-Sep-2021, Body temperature: 101.1 (High) fever of 101.1.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient reported that using computer makes her nausea. She had pain in the lower left hand in the back which went up to the thoracic area, took pain killer which did not help. Patient stated that she had low blood pressure. When she was in pain her blood pressure was high.   This case was linked to MOD-2021-307464, MOD-2021-307114.   Most recent FOLLOW-UP information incorporated above includes: On 07-Sep-2021: Follow-up received contains significant information- Event Back pain, concomitant drugs Neurontin & Tramadol updated. On 10-Sep-2021: Significant follow up- Event added