Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy breast, Catheterisation cardiac, Myalgia, Rash papular, Skin lesion
Clinical narrative: Chilblain-like lesions; Muscle aches; Warm reddened skin/self diagnosed warm red rash on upper left arm/warm reddened skin with slight bumpy rash appeared; Bumpy rash/ slight bumpy rash appeared; itchy at the injection site/Itching; rash at the injection site/self diagnosed warm red rash on upper left arm/warm reddened skin with slight bumpy rash appeared; Itchy red rash at injection site/self diagnosed warm red rash on upper left arm; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE WARMTH (Warm reddened skin/self diagnosed warm red rash on upper left arm/warm reddened skin with slight bumpy rash appeared), RASH PAPULAR (Bumpy rash/ slight bumpy rash appeared), SKIN LESION (Chilblain-like lesions), VACCINATION SITE PRURITUS (itchy at the injection site/Itching) and VACCINATION SITE RASH (rash at the injection site/self diagnosed warm red rash on upper left arm/warm reddened skin with slight bumpy rash appeared) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Bunionectomy (Also in 1970) in 1987, Hysterectomy in 1999, Cholecystectomy in 2004, Parathyroidectomy in 2004, Bladder suspension in 2007, Fracture repair in 2010, Fusion cervical spine in 2012, Cardiac pacemaker insertion on 28-Feb-2019, Cardioversion (Also on 21-JUN-2018, 01-MAR-2019, 18-JUL-2019, and 03-SEP-2019.) on 22-May-2018, Cardiac ablation (Also on 03-AUG-2018, and 29-AUG-2019.) on 24-Apr-2018 and Lumpectomy on 23-Dec-2020. Concurrent medical conditions included Cardiovascular disease, unspecified (Ongoing since 2017 - persistent atrial fibrillation /flutter - AV Node ablation and pacemaker.), Sulfonamide allergy (Early 1970s -1980s, red rash (reaction to Declostatin,swollen thumb with warm red rash)), Drug allergy (Declostatin, Early 1970s -1980s, red rash (reaction to Declostatin,swollen thumb with warm red rash)), Drug allergy (Allergy to Erythromycin.), Drug allergy (Allergy to Hydrochlorothiazide.), Drug allergy (Allergy to Niacin), Drug allergy (approximately in 2013, legs ached Allergy to Vytorin.) since 2013, Drug allergy (Extreme dizziness and irregular heartbeat) since 2019, Drug allergy (In 1970s.), Vitamin D low, Type 2 diabetes mellitus, Hypothyroidism, Heart disorder, Cardiac arrhythmia, Blood cholesterol abnormal, Bowel discomfort, Atrial fibrillation since 2017, Atrial flutter since 2017 and Type 2 diabetes mellitus. Concomitant products included RIVAROXABAN (XARELTO) for Anticoagulant therapy, CURCUMA LONGA, PIPER NIGRUM (TURMERIC & BLACK PEPPAR) and CURCUMIN for Antiinflammatory therapy, PRAVASTATIN for Blood cholesterol abnormal, PLANTAGO OVATA (METAMUCIL FIBRE THERAPY) for Bowel discomfort, METOPROLOL SUCCINATE for Cardiac arrhythmia, SITAGLIPTIN PHOSPHATE (JANUVIA) and METFORMIN HCL from 16-Mar-2020 to an unknown date for Diabetes, AZILSARTAN MEDOXOMIL, CHLORTALIDONE (EDARBYCLOR) from 16-Mar-2020 to an unknown date for Heart disorder, LEVOTHYROXINE SODIUM (LEVOTHYROXIN) for Hypothyroidism, LORATADINE for Runny nose, CHOLECALCIFEROL for Vitamin D, UBIDECARENONE (COQ10 [UBIDECARENONE]) and AMOXICILLIN for an unknown indication.    On 03-Feb-2021 at 1:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Warm reddened skin/self diagnosed warm red rash on upper left arm/warm reddened skin with slight bumpy rash appeared) and VACCINATION SITE PRURITUS (itchy at the injection site/Itching). 16-Feb-2021, the patient experienced RASH PAPULAR (Bumpy rash/ slight bumpy rash appeared) and VACCINATION SITE ERYTHEMA (Itchy red rash at injection site/self diagnosed warm red rash on upper left arm). 16-Feb-2021, the patient experienced VACCINATION SITE RASH (rash at the injection site/self diagnosed warm red rash on upper left arm/warm reddened skin with slight bumpy rash appeared). On an unknown date, the patient experienced SKIN LESION (Chilblain-like lesions) and MYALGIA (Muscle aches). On 28-Feb-2021, VACCINATION SITE WARMTH (Warm reddened skin/self diagnosed warm red rash on upper left arm/warm reddened skin with slight bumpy rash appeared), RASH PAPULAR (Bumpy rash/ slight bumpy rash appeared), VACCINATION SITE PRURITUS (itchy at the injection site/Itching), VACCINATION SITE RASH (rash at the injection site/self diagnosed warm red rash on upper left arm/warm reddened skin with slight bumpy rash appeared) and VACCINATION SITE ERYTHEMA (Itchy red rash at injection site/self diagnosed warm red rash on upper left arm) had resolved. At the time of the report, SKIN LESION (Chilblain-like lesions) and MYALGIA (Muscle aches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2010, Catheterisation cardiac: unknown (Inconclusive) unknown. On 11-Sep-2020, Biopsy breast: unknown (Inconclusive) unknown.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered VACCINATION SITE WARMTH (Warm reddened skin/self diagnosed warm red rash on upper left arm/warm reddened skin with slight bumpy rash appeared), RASH PAPULAR (Bumpy rash/ slight bumpy rash appeared), VACCINATION SITE PRURITUS (itchy at the injection site/Itching), VACCINATION SITE RASH (rash at the injection site/self diagnosed warm red rash on upper left arm/warm reddened skin with slight bumpy rash appeared) and VACCINATION SITE ERYTHEMA (Itchy red rash at injection site/self diagnosed warm red rash on upper left arm) to be possibly related. No further causality assessments were provided for SKIN LESION (Chilblain-like lesions) and MYALGIA (Muscle aches).    On 20-FEB-2021,  patient stated she still had rash but it was not itching. The rash was localized. The event did not cause patient to seek any medical care. The patient did not had any other symptoms. She had not taken any medicine or applied any creams. She was just letting it run its course. She was schedule for second dose on 03-MAR-2021. The patient had atrio-ventricular node ablation on 26 -SEP-2019. No treatment details were not reported.   This case was linked to MOD-2021-255792 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Events Muscle aches, raised rash, feeling of warmth, vaccination site erythema added.patient ethnic group is updated. patient medical history is added.adverse event start date added. email id added. Rash at injection site, duration of days added. Chilblain-like lesions added. On 13-Jul-2021: Follow up received information about concomitant medications added, patient history updated, event dates, outcome updated, causality updated.