Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Pain in extremity, Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: injection site warm to feel of touch.; dizzy / felt lightheaded; Left arm injection site had redness / redness in her left arm; soreness at the injection site.; Injection site was red and raised, / bump at the injection site; soreness of her left arm; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE WARMTH (injection site warm to feel of touch.), DIZZINESS (dizzy / felt lightheaded), VACCINATION SITE ERYTHEMA (Left arm injection site had redness / redness in her left arm), VACCINATION SITE PAIN (soreness at the injection site.) and VACCINATION SITE SWELLING (Injection site was red and raised, / bump at the injection site) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A, 013L20A, 003C21A and 042J21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Disease Crohns (since age 20 years before the patients first dose of the Moderna covid-19 vaccine.).   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Mar-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (injection site warm to feel of touch.), DIZZINESS (dizzy / felt lightheaded), VACCINATION SITE ERYTHEMA (Left arm injection site had redness / redness in her left arm), VACCINATION SITE PAIN (soreness at the injection site.), VACCINATION SITE SWELLING (Injection site was red and raised, / bump at the injection site) and PAIN IN EXTREMITY (soreness of her left arm). At the time of the report, VACCINATION SITE WARMTH (injection site warm to feel of touch.), DIZZINESS (dizzy / felt lightheaded), VACCINATION SITE ERYTHEMA (Left arm injection site had redness / redness in her left arm), VACCINATION SITE PAIN (soreness at the injection site.), VACCINATION SITE SWELLING (Injection site was red and raised, / bump at the injection site) and PAIN IN EXTREMITY (soreness of her left arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was reported. It was reported that after first dose patient had soreness of left arm, was dizzy, redness in left arm, injection site warm to feel of touch, lightheaded. After the second dose the patient also had soreness and a bump at the injection site. Injection site was red and raised, soreness of left arm and was dizzy. Left arm injection site had redness,and was warm to feel of touch.The patient was lightheaded. After the third dose patient also had redness and soreness at the injection site soreness of left arm, dizzy ,left arm injection site was warm to feel of touch and felt lightheaded. After the fourth dose patient had redness and soreness at the injection site.The injection site was warm at the injection site. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-721271 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-721271:(Bivalent Dose)