Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Left arm (Injection Site) Sore, Swollen, Lightly Itchy; Left arm (Injection Site) Sore, Swollen, Lightly Itchy; Left arm (Injection Site) Sore, Swollen, Lightly Itchy; Hypersensitivity reaction; minor gout outbreak; pain and swelling in the joint where their big toe is; Pain and swelling in the joint where their big toe is; Pain and swelling in the joint where their big toe is; This spontaneous case was reported by a consumer and describes the occurrence of GOUT (minor gout outbreak), VACCINATION SITE PAIN (Left arm (Injection Site) Sore, Swollen, Lightly Itchy), VACCINATION SITE SWELLING (Left arm (Injection Site) Sore, Swollen, Lightly Itchy), VACCINATION SITE PRURITUS (Left arm (Injection Site) Sore, Swollen, Lightly Itchy) and ARTHRALGIA (pain and swelling in the joint where their big toe is) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for an unreported indication: SHINGRIX (shingles vaccine they had a gout outbreak) on 12-Sep-2020 and FLU (Flu vaccine). Concurrent medical conditions included Kidney infection since 26-Feb-2009, Hypertension since 20-Sep-2002 and Diabetes since 01-Sep-2008. Concomitant products included LOSARTAN for Blood pressure, INSULIN for Diabetic, ATENOLOL and CLONIDINE for Hypertension, ATORVASTATIN, ACETYLSALICYLIC ACID (BABY ASPIRIN) and COD-LIVER OIL (FISH OIL [COD-LIVER OIL]) for an unknown indication.    On 03-Feb-2021 at 9:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced GOUT (minor gout outbreak), ARTHRALGIA (pain and swelling in the joint where their big toe is), SWELLING (Pain and swelling in the joint where their big toe is) and PAIN (Pain and swelling in the joint where their big toe is). On 10-Feb-2021, the patient experienced HYPERSENSITIVITY (Hypersensitivity reaction). On 11-Feb-2021, the patient experienced VACCINATION SITE PAIN (Left arm (Injection Site) Sore, Swollen, Lightly Itchy), VACCINATION SITE SWELLING (Left arm (Injection Site) Sore, Swollen, Lightly Itchy) and VACCINATION SITE PRURITUS (Left arm (Injection Site) Sore, Swollen, Lightly Itchy). The patient was treated with COLCHICINE ongoing since an unknown date at a dose of 0.6 mg and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 13-Feb-2021, GOUT (minor gout outbreak), VACCINATION SITE PAIN (Left arm (Injection Site) Sore, Swollen, Lightly Itchy), VACCINATION SITE SWELLING (Left arm (Injection Site) Sore, Swollen, Lightly Itchy), VACCINATION SITE PRURITUS (Left arm (Injection Site) Sore, Swollen, Lightly Itchy), ARTHRALGIA (pain and swelling in the joint where their big toe is), PAIN (Pain and swelling in the joint where their big toe is) and HYPERSENSITIVITY (Hypersensitivity reaction) had resolved. On 13-Apr-2021, SWELLING (Pain and swelling in the joint where their big toe is) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-265859 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 11-Feb-2021: Follow up information received contains - Added new events Swollen Injection Site on Left Arm ,Light Itching Injection Site Left Arm. On 24-Jul-2021: Follow up  contain new information received contains -Patients demographics, medical history, Added concomitant medicines, Added new event hypersensitivity.