Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy skin, Full blood count normal, Laboratory test, Oedema peripheral, Skin reaction
Clinical narrative: generalized skin reaction; bilateral leg edema; This literature-non-study case was reported in a literature article and describes the occurrence of SKIN REACTION (generalized skin reaction) and OEDEMA PERIPHERAL (bilateral leg edema) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   LITERATURE REFERENCE:     The patient's past medical history included Hemodialysis (Patient made significant improvement post start of hemodialysis (HD).). Concurrent medical conditions included Hypertension, Diabetes mellitus, Systemic lupus erythematosus (in remission) and Chronic kidney disease stage 5.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SKIN REACTION (generalized skin reaction) (seriousness criterion hospitalization) and OEDEMA PERIPHERAL (bilateral leg edema) (seriousness criterion hospitalization). At the time of the report, SKIN REACTION (generalized skin reaction) and OEDEMA PERIPHERAL (bilateral leg edema) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Biopsy skin: abnormal (abnormal) revealed epidermal necrosis, neutrophilic spongiosis & negative DIF. On an unknown date, Full blood count normal: normal (normal) CBC was normal. On an unknown date, Laboratory test: negative (Negative) negative for active immunological, autoimmune or other dermatologic disease..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered SKIN REACTION (generalized skin reaction) and OEDEMA PERIPHERAL (bilateral leg edema) to be related.    Concomitant product use was not provided by the reporter.    Skin manifestations included generalized macular & blistering lesions, painful ruptured vesicles & skin weeping.  Patient denied oral or genital ulcers, new onset diarrhea, new medication, new sexual contact or recent travel.  Case was considered to be related to cutaneous complication of COVID vaccine in patients with ESRD.  Patient made significant improvement post start of hemodialysis (HD), oral & topical steroid.  Author concluded that associated factors may be related to difference in vaccine response in renal patients, alteration of immunogenic reaction in uremic environment or progression due to delayed healing & concomitant presence of edema in setting of inadequate dialysis. Clinical trials for Moderna vaccine didn't include participants with renal disease & hence insufficient to determine the pharmacology & side effect profile in this population.  Company comment: This is a literature case concerning a 76 years old, female patient with clinical history of Hemodialysis Hypertension, Diabetes mellitus, Systemic lupus erythematosus and Chronic kidney disease stage 5 who experienced the unexpected events of SKIN REACTION and OEDEMA PERIPHERAL  The events occurred unknown days after the first dose of Moderna Covid 19 vaccine. The rechallenge was not applicable since only information about the first dose was disclosed The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2021-380843 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 11-Nov-2021: Follow up received by safety on 11-NOV-2021 has Email with administration received from team and contain non-significant information.; Sender's Comments: This is a literature case concerning a 76 years old, female patient with clinical history of Hemodialysis Hypertension, Diabetes mellitus, Systemic lupus erythematosus and Chronic kidney disease stage 5 who experienced the unexpected events of SKIN REACTION and OEDEMA PERIPHERAL  The events occurred unknown days after the first dose of Moderna Covid 19 vaccine. The rechallenge was not applicable since only information about the first dose was disclosed The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.