Age: 78.0
Sex: F
Vaccine: COVID19, UNK, UNK
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Dentures were loose and did not fit correctly anymore; Vaccine site itchiness on left arm; Vaccine site redness on left arm; Nausea/feeling like almost want to throw up; Stomach pain; Experienced sebaceous cyst infection on female right breast; This spontaneous case was reported by an other health care professional and describes the occurrence of INFECTED DERMAL CYST (Experienced sebaceous cyst infection on female right breast), ABDOMINAL PAIN UPPER (Stomach pain), DEVICE CONNECTION ISSUE (Dentures were loose and did not fit correctly anymore), VACCINATION SITE PRURITUS (Vaccine site itchiness on left arm) and VACCINATION SITE ERYTHEMA (Vaccine site redness on left arm) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 013M20A) 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) injection for Blood sugar increased.    The patient's past medical history included Allergy, Sebaceous cyst, Denture wearer, Abstains from alcohol, Sebaceous cyst removal, Thyroid operation in 1976, Hip replacement in 2019, Hysterectomy, Gallbladder removal and Bladder neck suspension. Previously administered products included for Plaque psoriasis: ACLOVATE, Clobetasol and Tacrolimus; for Product used for unknown indication: Neosporin, CARDURA, Vasotec, Amlodipine, Diovan, Isoptin, Metformin, Carafate, Januvia, Cardizem, Zitromax and Phenobarbital. Past adverse reactions to the above products included Allergy with Amlodipine, CARDURA, Carafate, Cardizem, Diovan, Isoptin, Januvia, Metformin, Neosporin, Phenobarbital, Vasotec and Zitromax. Concurrent medical conditions included Non-tobacco user, Allergy to antibiotic, Shellfish allergy and Diabetes. Concomitant products included METOPROLOL and NITRIC OXIDE for Blood pressure high, ACARBOSE and GLIMEPIRIDE for Diabetes, FOLIC ACID for Folic acid supplementation, ASCORBIC ACID, BETACAROTENE, CUPRIC OXIDE, TOCOPHERYL ACETATE, ZINC OXIDE (PRESERVISION) for Macular degeneration, METHOTREXATE for Rheumatoid arthritis, LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid operation, VITAMIN D3 for Vitamin D supplementation, AMOXICILLIN for an unknown indication.   On 30-Oct-2020, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram per millilitre. 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 2 dosage form. On an unknown date, the patient started DULAGLUTIDE (TRULICITY) (Subcutaneous) dosage form. On 23-Feb-2021, the patient experienced INFECTED DERMAL CYST (Experienced sebaceous cyst infection on female right breast). In March 2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach pain) and NAUSEA (Nausea/feeling like almost want to throw up). On 25-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (Vaccine site itchiness on left arm) and VACCINATION SITE ERYTHEMA (Vaccine site redness on left arm). On an unknown date, the patient experienced DEVICE CONNECTION ISSUE (Dentures were loose and did not fit correctly anymore). The patient was treated with INSULIN GLARGINE (TOUJEO) ongoing from 26-Apr-2021 at a dose of UNK dosage form; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at a dose of UNK dosage form; FAMOTIDINE (PEPCID [FAMOTIDINE]) ongoing since an unknown date at a dose of UNK dosage form; CLINDAMYCIN ongoing since an unknown date at a dose of UNK dosage form and Rehabilitation therapy for Infected dermal cyst. On 01-Apr-2021, VACCINATION SITE PRURITUS (Vaccine site itchiness on left arm) and VACCINATION SITE ERYTHEMA (Vaccine site redness on left arm) had resolved. In April 2021, ABDOMINAL PAIN UPPER (Stomach pain) and NAUSEA (Nausea/feeling like almost want to throw up) had resolved. At the time of the report, INFECTED DERMAL CYST (Experienced sebaceous cyst infection on female right breast) and DEVICE CONNECTION ISSUE (Dentures were loose and did not fit correctly anymore) outcome was unknown. On 15 Mar 2021, she had a surgery for the removal of her sebaceous cyst infection on her right breast in the dermatologist clinic.    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Blood glucose increased: elevated (High) Elevated.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   On an unknown date patient experienced Dentures were loose and did not fit correctly anymore. In February 2021, the patient experienced trouble with blood sugar/elevated blood sugar. On 23feb2021 the patient experienced sebaceous cyst infection on female right breast. In march 2021, the patient experienced stomach pain and nausea/feeling like almost want to throw up. On 15mar2021 the sebaceous cyst infection on female right breast resolved. On 25 Mar 2021, the patient experienced COVID-19 vaccine site redness on left arm and COVID-19 vaccine site itchiness on left arm. On 01 Apr 2021, the COVID-19 vaccine site redness on left arm and COVID-19 vaccine site itchiness on left arm resolved. In April 2021, the stomach pain and nausea/feeling like almost want to throw up resolved. On 15 mar 2021 she had a surgery for the removal of her sebaceous cyst infection on her right breast in the dermatologist clinic. Sebaceous cyst infection was diagnosed through physical exam by the physician. She did blood sugar monitoring at home since she had diabetes many years ago. She had a denture realignment on 04 May 2021. It was reported that patient drank ginger ale and was watching out what she ate to help manage her nausea and stomach pain.   This case was linked to MOD-2021-130439 (Patient Link).