Sex: F
Vaccine: COVID19
Symptoms: Pigmentation disorder, Product administration error, Skin mass, Wrong technique in device usage process
Clinical narrative: There is a small lump under the skin; Big spot in her arm, that's hot and swollen; Big spot in her arm, that's hot and swollen; Big spot in her arm, that's hot and swollen; Big hard lump under the skin; It felt like burning like fire was going down my arm; Probably due to the vaccine being still cold as the vial had just been taken out.Patient called the CDC and found out vial was supposed to stand 15 minutes outside the fridge before being administered; Inappropriate schedule of vaccine administered; The needle spot has a scab on it that is partially gone. They used a large needle instead of a small needle.; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Big spot in her arm, that's hot and swollen), FEELING HOT (Big spot in her arm, that's hot and swollen), PIGMENTATION DISORDER (Big spot in her arm, that's hot and swollen), SKIN MASS (Big hard lump under the skin) and SKIN MASS (There is a small lump under the skin) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004F21A, 010M20A and 0UJ20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Cancer (Cancer- stage 4).   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Aug-2021, the patient experienced BURNING SENSATION (It felt like burning like fire was going down my arm), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and WRONG TECHNIQUE IN DEVICE USAGE PROCESS (The needle spot has a scab on it that is partially gone. They used a large needle instead of a small needle.). 20-Aug-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (Probably due to the vaccine being still cold as the vial had just been taken out.Patient called the CDC and found out vial was supposed to stand 15 minutes outside the fridge before being administered). On 23-Aug-2021, the patient experienced PERIPHERAL SWELLING (Big spot in her arm, that's hot and swollen), FEELING HOT (Big spot in her arm, that's hot and swollen), PIGMENTATION DISORDER (Big spot in her arm, that's hot and swollen) and SKIN MASS (Big hard lump under the skin). On 31-Aug-2021, the patient experienced SKIN MASS (There is a small lump under the skin). On 20-Aug-2021, BURNING SENSATION (It felt like burning like fire was going down my arm), PRODUCT ADMINISTRATION ERROR (Probably due to the vaccine being still cold as the vial had just been taken out.Patient called the CDC and found out vial was supposed to stand 15 minutes outside the fridge before being administered), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and WRONG TECHNIQUE IN DEVICE USAGE PROCESS (The needle spot has a scab on it that is partially gone. They used a large needle instead of a small needle.) had resolved. At the time of the report, PERIPHERAL SWELLING (Big spot in her arm, that's hot and swollen), FEELING HOT (Big spot in her arm, that's hot and swollen), PIGMENTATION DISORDER (Big spot in her arm, that's hot and swollen), SKIN MASS (Big hard lump under the skin) and SKIN MASS (There is a small lump under the skin) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood count: low (Low) low blood counts.         Concomitant medications were not reported.  Patient received the third shot of vaccine on 20-AUG-2021 at noon.  Treatment medications were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 01-Sep-2021: Additional information received and added lab details, new event ( skin mass, wrong technique in device usage process) and additional information in I-narrative supplement.