Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Ear pain, Hypersensitivity, Oedema, Pain
Clinical narrative: The reaction is described as a diffuse red rash; Which eventually developed edema; Which eventually developed swelling; Developed into pain after 24 hours, especially around the ears; The reaction is described as a diffuse red rash accompanied by itching; Developed into pain aft er 24 hours; A "delayed reaction" bilaterally around the ears, eyes, forehead and parts of the scalp; Low-grade fever of 99-100; Injection site red rash; Injection site red rash; Above and below the injection site, swelling; Followed by arm pain; Above and below the injection site, edema; This spontaneous case was reported by a pharmacist and describes the occurrence of RASH ERYTHEMATOUS (The reaction is described as a diffuse red rash), OEDEMA (Which eventually developed edema), SWELLING (Which eventually developed swelling), EAR PAIN (Developed into pain after 24 hours, especially around the ears) and PRURITUS (The reaction is described as a diffuse red rash accompanied by itching) in an 89-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.     No Medical History information was reported.   In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Dec-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Dec-2021, the patient experienced VACCINATION SITE OEDEMA (Above and below the injecti on site, edema), PYREXIA (Low-grade fever of 99-100), VACCINATION SITE RASH (Injection site red rash), VACCINATION SITE ERYTHEMA (Injecti on site red rash), VACCINATION SITE SWELLING (Above and below the injecti on site, swelling) and VACCINATION SITE PAIN (Followed by arm pain). On 23-Dec-2021, the patient experienced RASH ERYTHEMATOUS (The reaction is described as a diffuse red rash), OEDEMA (Which eventually developed edema), SWELLING (Which eventually developed swelling), EAR PAIN (Developed into pain aft er 24 hours, especially around the ears), PRURITUS (The reaction is described as a diffuse red rash accompanied by itching), PAIN (Developed into pain aft er 24 hours) and HYPERSENSITIVITY (A "delayed reaction" bilaterally around the ears, eyes, forehead and parts of the scalp). The patient was treated with LIDOCAINE (topical) for Adverse event, at a dose of 4 percent; HYDROCORTISONE (topical) for Adverse event, at a dose of 1 percent and METHYLPREDNISOLONE from 30-Dec-2021 to 05-Jan-2022 for Adverse event, at a dose of dose pack. On 18-Dec-2021, PYREXIA (Low-grade fever of 99-100) had resolved. On 21-Dec-2021, VACCINATION SITE OEDEMA (Above and below the injecti on site, edema), VACCINATION SITE RASH (Injection site red rash), VACCINATION SITE ERYTHEMA (Injecti on site red rash), VACCINATION SITE SWELLING (Above and below the injecti on site, swelling) and VACCINATION SITE PAIN (Followed by arm pain) had resolved. At the time of the report, RASH ERYTHEMATOUS (The reaction is described as a diffuse red rash), OEDEMA (Which eventually developed edema), SWELLING (Which eventually developed swelling), EAR PAIN (Developed into pain aft er 24 hours, especially around the ears), PRURITUS (The reaction is described as a diffuse red rash accompanied by itching), PAIN (Developed into pain aft er 24 hours) and HYPERSENSITIVITY (A "delayed reaction" bilaterally around the ears, eyes, forehead and parts of the scalp) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Dec-2021, Body temperature: 99-100 (High) 99-100.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  On 23-Dec-2021, patient developed a "delayed reaction" bilaterally around the ears, eyes, forehead and parts of the scalp. The reaction was described as a diffuse red rash accompanied by itching that developed into pain after 24 hours, especially around the ears which eventually developed swelling and edema. Patient used lidocaine 4 percent cream and hydrocortisone 1percent ointment topically for approximately 1 week with little resolution. On 30-Dec-2021, physician ordered methylprednisolone dose pack for 6 days which was used in conjunction with topical hydrocortisone and slowly fully resolved over approximately 1 week.   This case was linked to MOD-2022-442889 (Patient Link).