Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Skin burning sensation, Skin exfoliation, Vaccination site erythema, Vaccination site reaction
Clinical narrative: skin was burning; skin is falling off near the elbow of the left arm; blister; redness from injection site to elbow; covid arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE ERYTHEMA (redness from injection site to elbow), VACCINATION SITE REACTION (covid arm) and BLISTER (blister) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0271321A and 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Apr-2021, the patient experienced VACCINATION SITE ERYTHEMA (redness from injection site to elbow) (seriousness criterion medically significant) and VACCINATION SITE REACTION (covid arm) (seriousness criterion medically significant). On 19-Apr-2021, the patient experienced BLISTER (blister) (seriousness criterion medically significant). On 20-Apr-2021, the patient experienced SKIN BURNING SENSATION (skin was burning) and SKIN EXFOLIATION (skin is falling off near the elbow of the left arm). At the time of the report, VACCINATION SITE ERYTHEMA (redness from injection site to elbow), VACCINATION SITE REACTION (covid arm) and BLISTER (blister) outcome was unknown and SKIN BURNING SENSATION (skin was burning) and SKIN EXFOLIATION (skin is falling off near the elbow of the left arm) had not resolved.            No concomitant medications were provided by the reporter.  Patient reported that she  saw her dermatologist. She reported that the blisters were cut open and the dermatologist prescribed Mupirocin 2% ointment.  This case concerns a 60-year-old female with a serious unexpected event of vaccination site reaction, vaccination site erythema, blister, and nonserious unexpected skin burning sensation and skin exfoliation. Event onset 2 days after second dose mRNA-1273. Events ongoing. 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.   This case was linked to MOD-2021-080031 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: Additional event details provided. On 21-Apr-2021: Follow-up contained no new information.; Sender's Comments: This case concerns a 60-year-old female with a serious unexpected event of vaccination site reaction, vaccination site erythema, blister, and nonserious unexpected skin burning sensation and skin exfoliation. Event onset 2 days after second dose mRNA-1273. Events ongoing. 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.