Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: Red, hot, inflamed, rash on her arm; Inflamed rash on her arm; Insanely itchy rash; insanley itch rash; Red, hot, inflamed, rash on her arm; Injection site pain; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE WARMTH (Red, hot, inflamed, rash on her arm), VACCINATION SITE INFLAMMATION (Inflamed rash on her arm), VACCINATION SITE RASH (Insanely itchy rash), VACCINATION SITE PAIN (Injection site pain) and VACCINATION SITE PRURITUS (insanley itch rash) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037K204 and 043L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypothyroidism since 20-Dec-1999. Concomitant products included LEVOTHYROXINE SODIUM (LEVOTHYROXIN) from 20-Dec-1999 to an unknown date for Thyroid activity decreased.   On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Dec-2020, the patient experienced VACCINATION SITE PAIN (Injection site pain). On 04-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Red, hot, inflamed, rash on her arm), VACCINATION SITE INFLAMMATION (Inflamed rash on her arm), VACCINATION SITE RASH (Insanely itchy rash), VACCINATION SITE PRURITUS (insanley itch rash) and VACCINATION SITE ERYTHEMA (Red, hot, inflamed, rash on her arm). On 30-Dec-2020, VACCINATION SITE PAIN (Injection site pain) had resolved. On 08-Jan-2021, VACCINATION SITE WARMTH (Red, hot, inflamed, rash on her arm), VACCINATION SITE INFLAMMATION (Inflamed rash on her arm) and VACCINATION SITE RASH (Insanely itchy rash) had resolved. At the time of the report, VACCINATION SITE PRURITUS (insanley itch rash) and VACCINATION SITE ERYTHEMA (Red, hot, inflamed, rash on her arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment for the events included over the counter steroid cream and Allegra.  Follow-up received on 26-Mar-2021 included patient demographics, dose and event details.   Most recent FOLLOW-UP information incorporated above includes: On 26-Mar-2021: Height is being addedOn 21 JAN 2021 patient took second vaccineBatch no of first dose addedCurrent condition of hypothyroidism and concomitant medication Levothyroxine 25mcg being addedPatient ethnicity addedEvent outcome added.Treatment information added; Reporter's Comments: This case is cross-linked with case MOD21-01915. This case concerns a 64-year-old female who experienced NS events of unexpected peripheral swelling, rash erythematous, rash pruritic, and expected injection site pain.  Event onset occurred the same day as the first dose of mRNA-1273. Treatment not reported. Events resolved or resolving. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.