Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered at inappropriate site, Vaccination site mass, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Patient fore arm itch really bad; Patient fore arm swollen; there was a huge lump of about 4 inches by 4 inches/currently lump is gone but it feels weird like a little lump if he rubbed with his finger; Patient had administration error and was injected under the skin in the fore arm instead of the shoulder; This spontaneous case was reported by a patient family member or friend and describes the occurrence of VACCINATION SITE PRURITUS (Patient fore arm itch really bad), VACCINATION SITE SWELLING (Patient fore arm swollen), VACCINATION SITE MASS (there was a huge lump of about 4 inches by 4 inches/currently lump is gone but it feels weird like a little lump if he rubbed with his finger) and PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Patient had administration error and was injected under the skin in the fore arm instead of the shoulder) in a 54-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7165B) for COVID-19 vaccination.     Patient did not have any allergy. Patient did not have COVID positive test or diagnosis. Patient did not have medical history relating to mentioned AE and both acute and chronic illnesses at the time of vaccination.     On 21-Sep-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 21-Sep-2022, the patient experienced VACCINATION SITE PRURITUS (Patient fore arm itch really bad), VACCINATION SITE SWELLING (Patient fore arm swollen), VACCINATION SITE MASS (there was a huge lump of about 4 inches by 4 inches/currently lump is gone but it feels weird like a little lump if he rubbed with his finger) and PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Patient had administration error and was injected under the skin in the fore arm instead of the shoulder). At the time of the report, VACCINATION SITE PRURITUS (Patient fore arm itch really bad), VACCINATION SITE SWELLING (Patient fore arm swollen) and VACCINATION SITE MASS (there was a huge lump of about 4 inches by 4 inches/currently lump is gone but it feels weird like a little lump if he rubbed with his finger) was resolving and PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Patient had administration error and was injected under the skin in the fore arm instead of the shoulder) outcome was unknown.            Patient had previous doses of Moderna covid-19 vaccine -1st dose on 17-Mar-2021 (route intramuscular and lot 038A21A), 2nd dose on 19-Apr-2021 (route unknown and lot 017B21A) and 1st booster dose on 21-Sep-2021 (route unknown and lot 048F21A).  Patient was not under any concomitant or regular medication.  No other vaccines given within 1 month prior to Moderna COVID-19 vaccine. Patient did not experience a similar event in the past. Symptoms were improving. Currently lump was gone but it felt weird like a little lump if patient rubbed with the finger.  Patient did not take any treatment.   This case was linked to MOD-2022-662412 (Patient Link).