Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Pain in extremity, Vein disorder
Clinical narrative: Off label use; Did not sweat; Foot felt hot; Vein hardened and protruded; Hot sweat; Burning sensation in leg; Pain in feet , Pain in leg; Redness in foot; Worsened joint knee and pain; Worsened trouble in walking; Back muscle soreness; Chills; Injection site pain; This spontaneous case was reported by a physician and describes the occurrence of OFF LABEL USE (Off label use), HYPOHIDROSIS (Did not sweat), FEELING HOT (Foot felt hot), VEIN DISORDER (Vein hardened and protruded) and HYPERHIDROSIS (Hot sweat) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) injection for Psoriasis and Pustular psoriasis.    The patient's past medical history included Hysterectomy in 1984, Knee surgery NOS in 1987, Discectomy (Surgery Ruptured disc) in 2001 and Discectomy in 2002. Concurrent medical conditions included Tobacco user (10 to 15 cigarettes a day (started 1957) in 1957, Drug allergy (Morphine - Manifests rash/itch) and Contrast media allergy (Contrast dye allergy- manifestation by mucus on throat/ couging/swollen throat/throat started to clog / could not swallow/burning sensation in arms). Concomitant products included METOPROLOL SUCCINATE (TOPROL XL) for Arrhythmia, SERTRALINE HYDROCHLORIDE (ZOLOFT) for Depression, EZETIMIBE (ZETICA) and ALIROCUMAB (PRALUENT) for High cholesterol, HYDROCHLOROTHIAZIDE, LISINOPRIL (ZESTORETIC) for Hypertension, CALCIUM CARBONATE, COLECALCIFEROL (CALTRATE [CALCIUM CARBONATE;COLECALCIFEROL]) and MORPHINE for an unknown indication.   In January 2019, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced INJECTION SITE PAIN (Injection site pain) and CHILLS (Chills). On 11-Apr-2021, the patient experienced MYALGIA (Back muscle soreness). On 12-Apr-2021, the patient experienced GAIT DISTURBANCE (Worsened trouble in walking) and ARTHRALGIA (Worsened joint knee and pain). On an unknown date, the patient experienced OFF LABEL USE (Off label use), HYPOHIDROSIS (Did not sweat), FEELING HOT (Foot felt hot), VEIN DISORDER (Vein hardened and protruded), HYPERHIDROSIS (Hot sweat), BURNING SENSATION (Burning sensation in leg), PAIN IN EXTREMITY (Pain in feet , Pain in leg) and ERYTHEMA (Redness in foot). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form; NAPROXEN SODIUM (ALEVE) at a dose of 1 dosage form and DICLOFENAC SODIUM at a dose of 1 dosage form. On 13-Mar-2021, INJECTION SITE PAIN (Injection site pain) and CHILLS (Chills) had resolved. At the time of the report, OFF LABEL USE (Off label use) had resolved and HYPOHIDROSIS (Did not sweat), FEELING HOT (Foot felt hot), VEIN DISORDER (Vein hardened and protruded), HYPERHIDROSIS (Hot sweat), BURNING SENSATION (Burning sensation in leg), PAIN IN EXTREMITY (Pain in feet , Pain in leg), GAIT DISTURBANCE (Worsened trouble in walking), ERYTHEMA (Redness in foot), ARTHRALGIA (Worsened joint knee and pain) and MYALGIA (Back muscle soreness) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: Initial additional document received on 10-JUN-2021