Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Pruritus, Pyrexia, Tenderness, Vaccination site pain
Clinical narrative: Vaccination site pain; fever of 101 to 102 at times; site was warm to touch; arm felt like it was going to fall off; Fatigue; headache; Hot to touch; Itching; Tender; Arm-red rash; Injection Site swelling; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching), TENDERNESS (Tender), VACCINATION SITE WARMTH (site was warm to touch), INJECTION SITE JOINT WARMTH (Hot to touch) and VACCINATION SITE PAIN (arm felt like it was going to fall off) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for an unreported indication: SHINGRIX. Concurrent medical conditions included Drug allergy (Allergy to Naproxen.). Concomitant products included CYANOCOBALAMIN (B12 [CYANOCOBALAMIN]), RALOXIFENE HYDROCHLORIDE, BIOTIN and FISH OIL for an unknown indication.   On 03-Feb-2021 at 3:02 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021 at 3:29 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced PRURITUS (Itching), TENDERNESS (Tender), INJECTION SITE JOINT WARMTH (Hot to touch), INJECTION SITE RASH (Arm-red rash) and INJECTION SITE SWELLING (Injection Site swelling). On 30-Mar-2021, the patient experienced VACCINATION SITE WARMTH (site was warm to touch), VACCINATION SITE PAIN (arm felt like it was going to fall off), FATIGUE (Fatigue), HEADACHE (headache) and PYREXIA (fever of 101 to 102 at times). On an unknown date, the patient experienced VACCINATION SITE PAIN (Vaccination site pain). The patient was treated with CALCIUM CITRATE, COLECALCIFEROL (CALCIUM CITRATE + D3) (oral) ongoing since an unknown date at a dose of 1 dosage form. On 21-Mar-2021, INJECTION SITE JOINT WARMTH (Hot to touch), INJECTION SITE RASH (Arm-red rash) and INJECTION SITE SWELLING (Injection Site swelling) had resolved. On 31-Mar-2021, VACCINATION SITE WARMTH (site was warm to touch), VACCINATION SITE PAIN (arm felt like it was going to fall off), FATIGUE (Fatigue), HEADACHE (headache) and PYREXIA (fever of 101 to 102 at times) had resolved. At the time of the report, PRURITUS (Itching) and TENDERNESS (Tender) had resolved and VACCINATION SITE PAIN (Vaccination site pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Mar-2021, Body temperature: high (High) fever of 101 and 102.    Treatment medicines were not included.   This case was linked to MOD-2021-251554, MOD-2021-043307 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Follow-up received on 08-JUL-2021 and contains significant information updated patient demographics, medical history, added concomitant medications, added new events headache, vaccination site pain ,vaccination site warmth, updated event outcome of all the events. On 30-Jul-2021: Non-significant follow up appended