Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Skin irritation
Clinical narrative: Irritated inside of the left arm after first shot; Wakes up in the middle of the night after first shot; Red  marks on the inside of the left arm after first shot; Fever (102 F) after first shot; Chills after first shot after first shot; This spontaneous case was reported by a consumer and describes the occurrence of SKIN IRRITATION (Irritated inside of the left arm after first shot), POOR QUALITY SLEEP (Wakes up in the middle of the night after first shot), ERYTHEMA (Red  marks on the inside of the left arm after first shot), PYREXIA (Fever (102 F) after first shot) and CHILLS (Chills after first shot after first shot) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008B21A and 001C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced SKIN IRRITATION (Irritated inside of the left arm after first shot), POOR QUALITY SLEEP (Wakes up in the middle of the night after first shot), ERYTHEMA (Red  marks on the inside of the left arm after first shot), PYREXIA (Fever (102 F) after first shot) and CHILLS (Chills after first shot after first shot). The patient was treated with HYDROXYZINE HCL ongoing since an unknown date at a dose of 50 mg. On 01-Apr-2021, SKIN IRRITATION (Irritated inside of the left arm after first shot), POOR QUALITY SLEEP (Wakes up in the middle of the night after first shot), PYREXIA (Fever (102 F) after first shot) and CHILLS (Chills after first shot after first shot) had resolved. At the time of the report, ERYTHEMA (Red  marks on the inside of the left arm after first shot) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Body temperature: high (High) High- 102 degree farenheit.         Patient visited 3 doctors, Dermatologist, Allergist and Internist. She took 3 course of Steroids and Hydroxyzine HCL tab 50mg.  No concomitant medications were provided by reporter.  company comment: This case concerns a 63 year old female with no reported medical history, who experienced non-serious, unexpected events of erythema, skin Irritation and poor quality of sleep. The events occurred on the same day after first dose of mRNA -1273 vaccine. The patient has been having red and irritating marks on his left arm after the first vaccine, she has seen several  specialists doctors and has visited the emergency room but the redness is ongoing.  Patient took 3 course of steriods and anti-histamine. The re-challenge  is not applicable since the patient was treated for the events. The benefit -risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a 63 year old female with no reported medical history, who experienced non-serious, unexpected events of erythema, skin Irritation and poor quality of sleep. The events occurred on the same day after first dose of mRNA -1273 vaccine. The patient has been having red and irritating marks on his left arm after the first vaccine, she has seen several  specialists doctors and has visited the emergency room but the redness is ongoing.  Patient took 3 course of steriods and anti-histamine. The re-challenge  is not applicable since the patient was treated for the events. The benefit -risk relationship of mRNA-1273 is not affected by this report.