Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Nodule
Clinical narrative: Nodule; Allergic reaction to bee sting; Allergy to antibiotic; Calcium increased; Cardiac pacemaker insertion; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of NODULE (Nodule), ALLERGY TO ARTHROPOD STING (Allergic reaction to bee sting), DRUG HYPERSENSITIVITY (Allergy to antibiotic), BLOOD CALCIUM INCREASED (Calcium increased) and CARDIAC PACEMAKER INSERTION (Cardiac pacemaker insertion) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.  Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.  Concurrent medical conditions included Diabetes mellitus, Bee sting hypersensitivity, Allergic reaction to antibiotics and Rheumatoid arthritis. Concomitant products included SEMAGLUTIDE (OZEMPIC) for Diabetes mellitus, WARFARIN SODIUM (COUMADIN) for an unknown indication.  On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) 1 dosage form. On 18-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On 08-May-2021, the patient experienced CARDIAC PACEMAKER INSERTION (Cardiac pacemaker insertion) (seriousness criterion medically significant). On an unknown date, the patient experienced NODULE (Nodule) (seriousness criterion medically significant), ALLERGY TO ARTHROPOD STING (Allergic reaction to bee sting) (seriousness criterion medically significant), DRUG HYPERSENSITIVITY (Allergy to antibiotic) (seriousness criterion medically significant) and BLOOD CALCIUM INCREASED (Calcium increased) (seriousness criterion medically significant). At the time of the report, NODULE (Nodule), ALLERGY TO ARTHROPOD STING (Allergic reaction to bee sting), DRUG HYPERSENSITIVITY (Allergy to antibiotic), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and BLOOD CALCIUM INCREASED (Calcium increased) outcome was unknown and CARDIAC PACEMAKER INSERTION (Cardiac pacemaker insertion) had resolved.  DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood calcium: 300 No units.  It was reported that on an unspecified date the patient experienced allergies to bee stings, allergies to most antibiotics, diabetic, calcium level went up and nodules. On 08 May 2021, the patient had to put in a pacemaker due to the Moderna vaccine. She was diabetic and had been taking ozempic for four years. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Causality of rinvoq with respect to pacemaker put in, allergies to bee stings, allergies to most antibiotics, diabetic, calcium level went up and nodules were reported as not provided and no reasonable possibility respectively. Causality for Moderna with respect to Cardiac pacemaker insertion was possible and calcium increased were reported as not reported. No treatment medication was reported.  Company comment: This is an spontaneous case concerning a 62-years-old female patient with medical history of Diabetes mellitus, moderate to severe reumathoid arthritis, concomitant products as SEMAGLUTIDE, WARFARIN and UPADACITINIB who experienced the unexpected events (seriousness criterion medically significant) of Cardiac pacemaker insertion, nodule, allergy to arthropod sting, drug hypersensitivity, blood calcium increased and other expected event in the context of the 3rd. dose of mRNA-1273 vaccine.  As the primary schedule was inadequate, the expected event of Inappropriate schedule of vaccine administration beginning the date of the 2nd. dose; the other events occurred on unknown date. As diagnosis results, on unknown date blood calcium levels went up to 300. The medical history of diabetes and warfarin treatment (suggestive of increase cardiovascular risk) could be a contributor of Cardiac pacemaker insertion event and the blood calcium levels event to nodule event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: COMPANY COMMENT: -This is an spontaneous case concerning a 62-years-old female patient with medical history of Diabetes mellitus, moderate to severe reumathoid arthritis, concomitant products as SEMAGLUTIDE, WARFARIN and UPADACITINIB who experienced the unexpected events (seriousness criterion medically significant) of Cardiac pacemaker insertion, nodule, allergy to arthropod sting, drug hypersensitivity, blood calcium increased and other expected event in the context of the 3rd.  dose of  mRNA-1273 vaccine.  As the primary schedule was inadequate, the expected event of Inappropriate schedule of vaccine administration beginning the date of the 2nd. dose; the other events occurred on unknown date. As diagnosis results, on unknown date blood calcium levels went up to 300. The medical history of diabetes and warfarin treatment (suggestive of increase cardiovascular risk) could be a contributor of  Cardiac pacemaker insertion event and the blood calcium levels event to nodule event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.