Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Erythema, Fatigue, Headache, Myalgia
Clinical narrative: low grade temperature of 100 F; tired; headache; body aches; redness on arm/redness is little bigger than a half dollar size; Pain in arm; injection site is warm to touch/ arm was really warm; injection site is red; injection site is painful; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (redness on arm/redness is little bigger than a half dollar size), PAIN IN EXTREMITY (Pain in arm), VACCINATION SITE WARMTH (injection site is warm to touch/ arm was really warm), VACCINATION SITE ERYTHEMA (injection site is red) and VACCINATION SITE PAIN (injection site is painful) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Cardiac disorder (Heart disease), Blood pressure high, Autoimmune connective tissue disorder, Asthma and Ulcerative colitis. Concomitant products included VENLAFAXINE HYDROCHLORIDE (EFFEXOR), TRAZODONE, DILTIAZEM HYDROCHLORIDE (CARDIZEM CD), PRAMIPEXOLE, MONTELUKAST SODIUM (SINGULAIR) and BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) for an unknown indication.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Jan-2022, the patient experienced ERYTHEMA (redness on arm/redness is little bigger than a half dollar size), PAIN IN EXTREMITY (Pain in arm), VACCINATION SITE WARMTH (injection site is warm to touch/ arm was really warm), VACCINATION SITE ERYTHEMA (injection site is red) and VACCINATION SITE PAIN (injection site is painful). On 03-Jan-2022, the patient experienced HEADACHE (headache) and MYALGIA (body aches). On 04-Jan-2022, the patient experienced PYREXIA (low grade temperature of 100 F) and FATIGUE (tired). The patient was treated with ACRIVASTINE (BENADRYL [ACRIVASTINE]) in January 2021 for Adverse event, at an unspecified dose and frequency and IBUPROFEN (MOTRIN [IBUPROFEN]) in January 2021 for Adverse event, at an unspecified dose and frequency. At the time of the report, ERYTHEMA (redness on arm/redness is little bigger than a half dollar size), PAIN IN EXTREMITY (Pain in arm), VACCINATION SITE WARMTH (injection site is warm to touch/ arm was really warm), VACCINATION SITE ERYTHEMA (injection site is red), VACCINATION SITE PAIN (injection site is painful) and FATIGUE (tired) had not resolved, HEADACHE (headache) outcome was unknown and MYALGIA (body aches) and PYREXIA (low grade temperature of 100 F) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Jan-2022, Body temperature: 100 f (High) Low grade temperature of 100 F.         Patient does not have a vaccination card so do not have an exact date or lot number of the vaccination.  Patient took Benadryl and Motrin, which helped bring down the fever and body ache,but it still have side effects on her arm.   Most recent FOLLOW-UP information incorporated above includes: On 04-Jan-2022: Updated reporter occupation. Added patient detail, concomitant medication, treatment medication and new events.