Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Dermatitis, Pain in extremity, Pruritus, Rash, Urticaria
Clinical narrative: This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DERMATITIS (Both legs and both arms were very inflamed, felt like they were on fire, had pimple sized welts all over), URTICARIA (Both legs and both arms were very inflamed, felt like they were on fire, had pimple sized welts all over), PAIN IN EXTREMITY (Sore Arm), RASH (Rash on legs and arms) and PRURITUS (Very itchy) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination. The patient's past medical history included Non-Hodgkin's lymphoma (Remission). Concomitant products included ATORVASTATIN CALCIUM (LIPITOR), ASPIRIN [ACETYLSALICYLIC ACID], LOSARTAN and TERAZOSIN for an unknown indication. On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore Arm). On 27-Jan-2021, the patient experienced RASH (Rash on legs and arms). On 06-Feb-2021, the patient experienced DERMATITIS (Both legs and both arms were very inflamed, felt like they were on fire, had pimple sized welts all over), URTICARIA (Both legs and both arms were very inflamed, felt like they were on fire, had pimple sized welts all over) and PRURITUS (Very itchy). The patient was treated with CALAMINE, GLYCEROL, ZINC OXIDE (CALAMINE LOTION) at an unspecified dose and frequency; LORATADINE (CLARITIN [LORATADINE]) at an unspecified dose and frequency and FAMOTIDINE (PEPCID AC) at an unspecified dose and frequency. At the time of the report, DERMATITIS (Both legs and both arms were very inflamed, felt like they were on fire, had pimple sized welts all over), URTICARIA (Both legs and both arms were very inflamed, felt like they were on fire, had pimple sized welts all over), PAIN IN EXTREMITY (Sore Arm), RASH (Rash on legs and arms) and PRURITUS (Very itchy) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Treatment for the events included steroid therapy. Patient went to the ER (emergency room) of HMO hospital. No additional information was reported. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 08-Feb-2021 and was forwarded to Moderna on 08-Feb-2021. This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DERMATITIS (Both legs and both arms were very inflamed, felt like they were on fire, had pimple sized welts all over), URTICARIA (Both legs and both arms were very inflamed, felt like they were on fire, had pimple sized welts all over), PAIN IN EXTREMITY (Sore Arm), RASH (Rash on legs and arms) and PRURITUS (Very itchy) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination. The patient's past medical history included Non-Hodgkin's lymphoma (Remission). Concomitant products included ATORVASTATIN CALCIUM (LIPITOR), ASPIRIN [ACETYLSALICYLIC ACID], LOSARTAN and TERAZOSIN for an unknown indication. On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore Arm). On 27-Jan-2021, the patient experienced RASH (Rash on legs and arms). On 06-Feb-2021, the patient experienced DERMATITIS (Both legs and both arms were very inflamed, felt like they were on fire, had pimple sized welts all over), URTICARIA (Both legs and both arms were very inflamed, felt like they were on fire, had pimple sized welts all over) and PRURITUS (Very itchy). The patient was treated with CALAMINE, GLYCEROL, ZINC OXIDE (CALAMINE LOTION) at an unspecified dose and frequency; LORATADINE (CLARITIN [LORATADINE]) at an unspecified dose and frequency and FAMOTIDINE (PEPCID AC) at an unspecified dose and frequency. At the time of the report, DERMATITIS (Both legs and both arms were very inflamed, felt like they were on fire, had pimple sized welts all over), URTICARIA (Both legs and both arms were very inflamed, felt like they were on fire, had pimple sized welts all over), PAIN IN EXTREMITY (Sore Arm), RASH (Rash on legs and arms) and PRURITUS (Very itchy) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Treatment for the events included steroid therapy. Patient went to the ER (emergency room) of HMO hospital. No additional information was reported.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.