Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Fatigue, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Extreme exhaustion with inability to do anything involving focus or energy; Raised temperature temp 99.7; Swelling; Chills; A little bit warm at the injection site; Itchy at the injection site; Red circular mark at injection site; rashy at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (A little bit warm at the injection site), VACCINATION SITE PRURITUS (Itchy at the injection site), VACCINATION SITE ERYTHEMA (Red circular mark at injection site), VACCINATION SITE RASH (rashy at the injection site) and VACCINATION SITE SWELLING (Swelling) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A and 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Autoimmune disorder NOS (Autoimmune Diagnosis) since 2017 and Penicillin allergy. Concomitant products included DULOXETINE HYDROCHLORIDE (CYMBALTA), LOSARTAN, APIXABAN (ELIQUIS), POTASSIUM, BIOTIN and VITAMIN K NOS for an unknown indication.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Jan-2021, the patient experienced VACCINATION SITE WARMTH (A little bit warm at the injection site), VACCINATION SITE PRURITUS (Itchy at the injection site), VACCINATION SITE ERYTHEMA (Red circular mark at injection site) and VACCINATION SITE RASH (rashy at the injection site). On 16-Jan-2021, the patient experienced VACCINATION SITE SWELLING (Swelling) and CHILLS (Chills). On 17-Jan-2021, the patient experienced BODY TEMPERATURE INCREASED (Raised temperature temp 99.7). On an unknown date, the patient experienced FATIGUE (Extreme exhaustion with inability to do anything involving focus or energy). At the time of the report, VACCINATION SITE WARMTH (A little bit warm at the injection site), VACCINATION SITE PRURITUS (Itchy at the injection site), VACCINATION SITE ERYTHEMA (Red circular mark at injection site), VACCINATION SITE RASH (rashy at the injection site) and VACCINATION SITE SWELLING (Swelling) outcome was unknown and CHILLS (Chills), BODY TEMPERATURE INCREASED (Raised temperature temp 99.7) and FATIGUE (Extreme exhaustion with inability to do anything involving focus or energy) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter considered VACCINATION SITE RASH (rashy at the injection site), VACCINATION SITE SWELLING (Swelling), CHILLS (Chills), BODY TEMPERATURE INCREASED (Raised temperature temp 99.7) and FATIGUE (Extreme exhaustion with inability to do anything involving focus or energy) to be probably related. No further causality assessments were provided for VACCINATION SITE WARMTH (A little bit warm at the injection site), VACCINATION SITE PRURITUS (Itchy at the injection site) and VACCINATION SITE ERYTHEMA (Red circular mark at injection site).    Treatment medications included acetaminophen on 17-JAN-2021.   This case was linked to MOD-2021-031462 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2021: Medical History, patient details and second dose details were updated