Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria, Vaccination site pruritus, Vaccination site rash, Vaccination site swelling
Clinical narrative: Sick feeling; Hives local, spread till elbow like giant hive; Chill; Rash is size of a quarter and spreading through out the upper arm; Covid arm- which is itching and tingling; Rash is red and hot to touch; Rash is size of a quarter (and spreading through out the upper arm); Fever of 101.0 Fahrenheit; Fatigue; Joint pain; Muscle pain; Headache; Swelling at injection site; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash is size of a quarter and spreading through out the upper arm), VACCINATION SITE PRURITUS (Covid arm- which is itching and tingling), MALAISE (Sick feeling), URTICARIA (Hives local, spread till elbow like giant hive) and RASH ERYTHEMATOUS (Rash is red and hot to touch) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 01B21A and 022C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Pollen allergy. Concomitant products included ATORVASTATIN for Blood cholesterol abnormal, ESTRADIOL for Menopause.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced VACCINATION SITE SWELLING (Swelling at injection site), PYREXIA (Fever of 101.0 Fahrenheit), FATIGUE (Fatigue), ARTHRALGIA (Joint pain), MYALGIA (Muscle pain) and HEADACHE (Headache). On 01-Apr-2021, the patient experienced RASH (Rash is size of a quarter and spreading through out the upper arm), VACCINATION SITE PRURITUS (Covid arm- which is itching and tingling), RASH ERYTHEMATOUS (Rash is red and hot to touch) and VACCINATION SITE RASH (Rash is size of a quarter (and spreading through out the upper arm)). On an unknown date, the patient experienced MALAISE (Sick feeling), URTICARIA (Hives local, spread till elbow like giant hive) and CHILLS (Chill). The patient was treated with PARACETAMOL (TYLENOL) at a dose of unknown; IBUPROFEN at an unspecified dose and frequency; CAMPHOR, DIPHENHYDRAMINE HYDROCHLORIDE, ZINC OXIDE (BENADRYL SKIN ALLERGY RELIEF) (oral) on 02-Apr-2021 for Antihistamine therapy, at a dose of 25 mg once a day and CHLORPHENAMINE MALEATE, IBUPROFEN, PHENYLEPHRINE HYDROCHLORIDE (ADVIL ALLERGY AND CONGESTION RELIEF) (oral) on 31-Mar-2021 at a dose of 400 mg every six hours. On 03-Apr-2021, PYREXIA (Fever of 101.0 Fahrenheit), FATIGUE (Fatigue), ARTHRALGIA (Joint pain), MYALGIA (Muscle pain) and HEADACHE (Headache) had resolved. On 08-Apr-2021, RASH (Rash is size of a quarter and spreading through out the upper arm), VACCINATION SITE PRURITUS (Covid arm- which is itching and tingling), URTICARIA (Hives local, spread till elbow like giant hive), VACCINATION SITE SWELLING (Swelling at injection site), VACCINATION SITE RASH (Rash is size of a quarter (and spreading through out the upper arm)) and CHILLS (Chill) had resolved, RASH ERYTHEMATOUS (Rash is red and hot to touch) had not resolved. At the time of the report, MALAISE (Sick feeling) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Mar-2021, Body temperature: high (High) 101 Fahrenheit. On 01-Apr-2021, Body temperature: high (High) 100.5 Fahrenheit. On 02-Apr-2021, Body temperature: high (High) 100.5 Fahrenheit. On 03-Apr-2021, Body temperature: high (High) 100 Fahrenheit. On 04-Apr-2021, Body temperature: high (High) 98.6 Fahrenheit.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Addition of patient  demographic , addition of concomitant medication and treatment medication, event outcome updated resolved.