Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Blood glucose increased, Blood test, Device connection issue, Infected dermal cyst
Clinical narrative: Device connection fit issue; stomach pain; nausea; Infected sebaceous cyst; postoperative pain; blood sugar increased; This spontaneous case was reported by a consumer and describes the occurrence of INFECTED DERMAL CYST (Infected sebaceous cyst) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect products included non-company products ADALIMUMAB (HUMIRA) for Psoriatic arthritis and DULAGLUTIDE (TRULICITY) for Blood sugar increased.    The patient's past medical history included Thyroidectomy NOS in 1976, Total hip replacement in 2019, Hysterectomy, Gallbladder removal and Bladder repair. Previously administered products included for Plaque psoriasis: Aclovate, Clobetasol and Tacrolimus; for Product used for unknown indication: phenobarbital, Neosporin, Cardura, Vasotec, amlodipine, diovan, isoptin, Metformin, Carafate, januvia, CARDIZEM [DILTIAZEM] and ZITROMAX. Concurrent medical conditions included Sebaceous cyst since 2020, Denture wearer, Non-tobacco user, Abstains from alcohol, Drug allergy, Drug allergy, Drug allergy, Drug allergy, Drug allergy, Drug allergy, Drug allergy, Drug allergy, Drug allergy, Drug allergy, Drug allergy, Drug allergy and Shellfish allergy. Concomitant products included METOPROLOL and NITRIC OXIDE for Blood pressure high, ACARBOSE and GLIMEPIRIDE for Diabetes, ASCORBIC ACID, BETACAROTENE, CUPRIC OXIDE, TOCOPHERYL ACETATE, ZINC OXIDE (PRESERVISION) for Macular degeneration, AMOXICILLIN for Prophylaxis, METHOTREXATE SODIUM (METHOTREXAT [METHOTREXATE SODIUM]) for Rheumatoid arthritis, FOLIC ACID and VITAMIN D3 for Supplementation therapy, LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder.   On 30-Oct-2020, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. In February 2021, the patient started DULAGLUTIDE (TRULICITY) (Subcutaneous) 40 milligram. On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Apr-2021, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 40 milligram. In February 2021, the patient experienced PROCEDURAL PAIN (postoperative pain) and BLOOD GLUCOSE INCREASED (blood sugar increased). On 23-Feb-2021, the patient experienced INFECTED DERMAL CYST (Infected sebaceous cyst) (seriousness criterion medically significant). In March 2021, the patient experienced ABDOMINAL PAIN UPPER (stomach pain) and NAUSEA (nausea). On an unknown date, the patient experienced DEVICE CONNECTION ISSUE (Device connection fit issue). The patient was treated with INSULIN GLARGINE (TOUJEO) on 26-Apr-2021 for Blood sugar abnormal, at an unspecified dose and frequency; GINGER ROOT [ZINGIBER OFFICINALE RHIZOME] for Nausea and Stomach pain, at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency; CORTISONE at an unspecified dose and frequency; FAMOTIDINE (PEPCID [FAMOTIDINE]) at an unspecified dose and frequency and CLINDAMYCIN at an unspecified dose and frequency. On 15-Mar-2021, INFECTED DERMAL CYST (Infected sebaceous cyst) had resolved. In April 2021, ABDOMINAL PAIN UPPER (stomach pain) and NAUSEA (nausea) had resolved. At the time of the report, PROCEDURAL PAIN (postoperative pain), DEVICE CONNECTION ISSUE (Device connection fit issue) and BLOOD GLUCOSE INCREASED (blood sugar increased) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Pathology test: benign (Inconclusive) Benign sebaceous cyst. On an unknown date, Blood test: trouble with blood sugar (Inconclusive) trouble with blood sugar.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included a surgery for the removal of sebaceous cyst infection on patient's right breast in the dermatologist clinic on 15 Mar 2021.  Based on reporter's causality and lack of information regarding the events, the events are assessed as unlikely related to mRNA-1273.   This case was linked to MOD-2021-131000 (Patient Link).; Sender's Comments: Based on reporter's causality and lack of information regarding the events, the events are assessed as unlikely related to mRNA-1273.