Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: hands were so inflamed and red; hands were so inflamed and red; i could not open and close them; Hives became blisters/hives turned to oozing blisters; Blisters became extremely itchy / it still is flaring up and itching like crazy/hands with the terribly itchy bumps/they were so itchy/never experienced anything so itchy; One hive broke out on right thumb/Both hands developed bunches of giant red hives from top of hand to knuckles/hives on right hand/developed on left hand/spread throughout the top of both hands; Patient is concerned for her health; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (One hive broke out on right thumb/Both hands developed bunches of giant red hives from top of hand to knuckles/hives on right hand/developed on left hand/spread throughout the top of both hands), BLISTER (Hives became blisters/hives turned to oozing blisters), PRURITUS (Blisters became extremely itchy / it still is flaring up and itching like crazy/hands with the terribly itchy bumps/they were so itchy/never experienced anything so itchy), ANXIETY (Patient is concerned for her health) and INFLAMMATION (hands were so inflamed and red) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Medical History information was not reported.  Concomitant products included LEVOTHYROXINE for an unknown indication.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced URTICARIA (One hive broke out on right thumb/Both hands developed bunches of giant red hives from top of hand to knuckles/hives on right hand/developed on left hand/spread throughout the top of both hands). On 15-Apr-2021, the patient experienced BLISTER (Hives became blisters/hives turned to oozing blisters) and PRURITUS (Blisters became extremely itchy / it still is flaring up and itching like crazy/hands with the terribly itchy bumps/they were so itchy/never experienced anything so itchy). In April 2021, the patient experienced ANXIETY (Patient is concerned for her health). On an unknown date, the patient experienced INFLAMMATION (hands were so inflamed and red), ERYTHEMA (hands were so inflamed and red) and MUSCULOSKELETAL DISORDER (i could not open and close them). At the time of the report, URTICARIA (One hive broke out on right thumb/Both hands developed bunches of giant red hives from top of hand to knuckles/hives on right hand/developed on left hand/spread throughout the top of both hands), BLISTER (Hives became blisters/hives turned to oozing blisters), INFLAMMATION (hands were so inflamed and red), ERYTHEMA (hands were so inflamed and red) and MUSCULOSKELETAL DISORDER (i could not open and close them) outcome was unknown and PRURITUS (Blisters became extremely itchy / it still is flaring up and itching like crazy/hands with the terribly itchy bumps/they were so itchy/never experienced anything so itchy) and ANXIETY (Patient is concerned for her health) had not resolved.            Concomitant medicine included levothyroxine.  Treatment medications included 3 strengths of Steroid creams, Betamethasone Diproprionate,  can start oral prednisone if needed and Benadryl.   Action taken with mRNA-1273 in response to the event was not applicable  Based on the current available information and temporal association between the use of the product and the start dates of the event, a causal relationship cannot be excluded.   This case was linked to US-MODERNATX, INC.-MOD-2021-084082 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: Events of aggravation and pictures of reactions on hand attached, the outcome of event "Blisters became extremely itchy / it still is flaring up and itching like crazy/hands with the terribly itchy bumps"was updated as still not recovered. On 24-May-2021: follow up contain Vaccine Hypersensitivity/Anaphylaxis; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-084082:Case for dose 1