Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Angioedema, Condition aggravated, Erythema, Influenza like illness, Nausea
Clinical narrative: Larger itchy red spot below hte infection site; Larger itchy red spot below hte infection site; Red spot on arm looked like a giant hive; Condition aggravated; Like having a RA flare; Flu-like reaction; Nausea; Fever of 101 for 24 hours; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Like having a RA flare) and ANGIOEDEMA (Red spot on arm looked like a giant hive) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Rheumatoid arthritis and Osteoarthritis. Concomitant products included VALSARTAN and AMLODIPINE for Blood pressure management, MELOXICAM for Pain, METHOTREXATE for Rheumatoid arthritis, RITUXIMAB (RITUXAN), METOPROLOL and FOLIC ACID for an unknown indication.   On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Mar-2021, the patient experienced RHEUMATOID ARTHRITIS (Like having a RA flare) (seriousness criterion medically significant), INFLUENZA LIKE ILLNESS (Flu-like reaction) and PYREXIA (Fever of 101 for 24 hours). 21-Mar-2021, the patient experienced CONDITION AGGRAVATED (Condition aggravated) and NAUSEA (Nausea). On 25-Mar-2021, the patient experienced ANGIOEDEMA (Red spot on arm looked like a giant hive) (seriousness criterion medically significant), ERYTHEMA (Larger itchy red spot below hte infection site) and PRURITUS (Larger itchy red spot below hte infection site). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. On 22-Mar-2021, PYREXIA (Fever of 101 for 24 hours) had resolved. On 26-Mar-2021, INFLUENZA LIKE ILLNESS (Flu-like reaction) had resolved. On 27-Mar-2021, RHEUMATOID ARTHRITIS (Like having a RA flare), CONDITION AGGRAVATED (Condition aggravated) and NAUSEA (Nausea) had resolved. On 11-Apr-2021, ANGIOEDEMA (Red spot on arm looked like a giant hive), ERYTHEMA (Larger itchy red spot below hte infection site) and PRURITUS (Larger itchy red spot below hte infection site) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test: negative (Negative) Negative SARS COVID-2 IG antibody..         Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-169506 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow-up information received on 25-May-2021 contains no new information.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.