Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Inappropriate schedule of product administration, Urticaria, Vaccination site pruritus
Clinical narrative: headache; fatigue; Administered out of the window of time between both doses; had a rash and still has red spots (not many) on both arms but more around frontal body (chest area) as it started with a tiny needle size red dot then got bigger; has different temperature swollen arm of injection; itch on upper arm near injection site area; a couple of hives and itch on upper arm near injection site; Injection site rash; swollen arm at injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of URTICARIA (had a rash and still has red spots (not many) on both arms but more around frontal body (chest area) as it started with a tiny needle size red dot then got bigger), VACCINATION SITE WARMTH (has different temperature swollen arm of injection), VACCINATION SITE PRURITUS (itch on upper arm near injection site area), VACCINATION SITE URTICARIA (a couple of hives and itch on upper arm near injection site) and VACCINATION SITE RASH (Injection site rash) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016B21A and 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Sinus infection.   On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021 at 12:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced URTICARIA (had a rash and still has red spots (not many) on both arms but more around frontal body (chest area) as it started with a tiny needle size red dot then got bigger), VACCINATION SITE WARMTH (has different temperature swollen arm of injection), VACCINATION SITE PRURITUS (itch on upper arm near injection site area), VACCINATION SITE URTICARIA (a couple of hives and itch on upper arm near injection site), VACCINATION SITE RASH (Injection site rash) and VACCINATION SITE SWELLING (swollen arm at injection site). 06-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Administered out of the window of time between both doses). On 05-May-2021, the patient experienced HEADACHE (headache) and FATIGUE (fatigue). The patient was treated with METHYLPREDNISOLONE for Vaccination site swelling, at an unspecified dose and frequency and LEVOCETIRIZINE at an unspecified dose and frequency. On 06-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Administered out of the window of time between both doses) had resolved. At the time of the report, URTICARIA (had a rash and still has red spots (not many) on both arms but more around frontal body (chest area) as it started with a tiny needle size red dot then got bigger), VACCINATION SITE WARMTH (has different temperature swollen arm of injection) and VACCINATION SITE SWELLING (swollen arm at injection site) had resolved and VACCINATION SITE PRURITUS (itch on upper arm near injection site area), VACCINATION SITE URTICARIA (a couple of hives and itch on upper arm near injection site), VACCINATION SITE RASH (Injection site rash), HEADACHE (headache) and FATIGUE (fatigue) outcome was unknown.            No concomitant medications were provided by the reporter.   This case was linked to MOD-2021-067643 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Apr-2021: Follow-up document was received. Reporter address, email id, vaccine information (lot/batch number, administration site), patient demographics and medical history and vaccination details were added. It contains significant information. On 19-Apr-2021: Follow-up document was received. New events and treatment medications were added. It contains significant information. On 19-May-2021: Follow-up was received. Allergy was included in patient's relevant medical history.New events fatigue and headache were added. Outcome of event swollen arm, red dot was updated to recovered. Reporter's causality for swollen arm, red dot was updated to possible. It contains significant information.