Age: 60.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Skin burning sensation, Tinnitus
Clinical narrative: burning sensation on his skin is basically from his knees and elbows down; entire body is itchy; skin is hypersensitive; "skin on his legs and arms started to burn" and it got more intense on day 8-10 when it involved his face and back and his whole body; This spontaneous case was reported by a consumer and describes the occurrence of THERMAL BURN ("skin on his legs and arms started to burn" and it got more intense on day 8-10 when it involved his face and back and his whole body), BURNING SENSATION (burning sensation on his skin is basically from his knees and elbows down), PRURITUS (entire body is itchy) and SENSITIVE SKIN (skin is hypersensitive) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011D21A, 013M20A and 041L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, the patient experienced THERMAL BURN ("skin on his legs and arms started to burn" and it got more intense on day 8-10 when it involved his face and back and his whole body) (seriousness criterion medically significant). On an unknown date, the patient experienced BURNING SENSATION (burning sensation on his skin is basically from his knees and elbows down) (seriousness criterion medically significant), PRURITUS (entire body is itchy) (seriousness criterion medically significant) and SENSITIVE SKIN (skin is hypersensitive) (seriousness criterion medically significant). At the time of the report, THERMAL BURN ("skin on his legs and arms started to burn" and it got more intense on day 8-10 when it involved his face and back and his whole body), BURNING SENSATION (burning sensation on his skin is basically from his knees and elbows down), PRURITUS (entire body is itchy) and SENSITIVE SKIN (skin is hypersensitive) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging: normal (normal) normal.         No concomitant medications was given. No treatment medication was given.  On the night after got the booster dose, 26Oct2021, patient "skin on his legs and arms started to burn" and it got more intense on day 8-10 when it involved his face and back and his whole body. patient went to healthcare provider thought that developed a neuropathy. Numerous tests were done and the results came out all fine. patient was referred to a neurologist who examined -tuning fork, vibrations and reaction response of the nerve - no neuropathy was seen.  Patient had MRI of his spinal cord and the result was normal and has a pending electro neuro stimulus test.  neurologist told that in a month or so, the symptoms will dissipate as the mRNA wears off. It clarified that the burning sensation on his skin is basically from his knees and elbows down while his entire body was itchy. Patient skin was hypersensitive - patient has to pat dry his skin after taking a shower because it was hypersensitive.  Company Comment - This case concerns a 60 year old male patient with no relevant medical history, who experienced the serious unexpected events of thermal burn, burning sensation, pruritus and sensitive skin. The events occurred on the same day after the third dose of mRNA-1273 vaccine. The rechallenge was not applicable as there are no plans for future dosing. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-461353 (Patient Link).; Sender's Comments: This case concerns a 60 year old male patient with no relevant medical history, who experienced the serious unexpected events of thermal burn, burning sensation, pruritus and sensitive skin. The events occurred on the same day after the third dose of mRNA-1273 vaccine. The rechallenge was not applicable as there are no plans for future dosing. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.