Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy to arthropod sting, Arthropod sting, COVID-19, Device electrical finding, Thyroid disorder
Clinical narrative: Thyroid disorder; Device electrical finding/electrical issues in pacemaker; Allergic reaction to bee sting/ALLERGIC TO BEES with RINVOQ; Bee sting/STUNG by Bee; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of THYROID DISORDER (Thyroid disorder) and DEVICE ELECTRICAL FINDING (Device electrical finding/electrical issues in pacemaker) in a 61-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.    The patient's past medical history included Thyroidectomy NOS since April 2021. Family history included Cancer. Concurrent medical conditions included Non-tobacco user, Abstains from alcohol, Cancer and Rheumatoid arthritis.   In 2020, the patient started UPADACITINIB (RINVOQ) (Oral) 15 milligram once a day. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2020, the patient experienced DEVICE ELECTRICAL FINDING (Device electrical finding/electrical issues in pacemaker) (seriousness criterion medically significant), ALLERGY TO ARTHROPOD STING (Allergic reaction to bee sting/ALLERGIC TO BEES with RINVOQ), ARTHROPOD STING (Bee sting/STUNG by Bee) and COVID-19 (COVID-19). In April 2021, the patient experienced THYROID DISORDER (Thyroid disorder) (seriousness criterion medically significant). At the time of the report, THYROID DISORDER (Thyroid disorder) was resolving and DEVICE ELECTRICAL FINDING (Device electrical finding/electrical issues in pacemaker), ALLERGY TO ARTHROPOD STING (Allergic reaction to bee sting/ALLERGIC TO BEES with RINVOQ), ARTHROPOD STING (Bee sting/STUNG by Bee) and COVID-19 (COVID-19) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       It was reported as there was no Illicit drug use   It was unknown if patient was enrolled in a COVID-19 Vaccine Trial  On Apr-2021, the patient had thyroid surgery, second COVID vaccine cause electrical issues. In May 2021, the patient had pacemaker placed. She also contracted COVID. Patient told she didn't think Rinvoq caused her tumor in thyroid.  The reporter causality DEVICE ELECTRICAL FINDING (Device electrical finding/electrical issues in pacemaker), COVID-19 (COVID-19), ALLERGY TO ARTHROPOD STING (Allergic reaction to bee sting/ALLERGIC TO BEES with RINVOQ) and ARTHROPOD STING (Bee sting/STUNG by Bee) and THYROID DISORDER (Thyroid disorder) were not reported with RINVOQ.   No concomitant medications were reported.  No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in  Company comment: This spontaneous case concerns a 61 year old female patient with relevant medical history of cancer (reported as third step cancer) , who experienced the unexpected serious (other medically significant) events of Thyroid disorder and Device electrical finding (reported as electrical issues in pacemaker) and unexpected non serious AESI of COVID 19, unknown days after receiving the second dose of mRNA-1273 vaccine in the COVID-19 vaccination series. The patient received the first dose with the same vaccine on an unknown date. Medical history of cancer and the ongoing pandemic of COVID 19 could be risk factors for the event COVID 19. No information on exact date of the events, detailed clinical course, relevant investigations, treatment was available in the report. The event Thyroid disorder was resolving and COVID 19 had resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 61 year old female patient with relevant medical history of cancer (reported as third step cancer) , who experienced the unexpected serious (other medically significant) events of Thyroid disorder and Device electrical finding (reported as electrical issues in pacemaker) and unexpected non serious AESI of COVID 19, unknown days after receiving the second dose of mRNA-1273 vaccine in the COVID-19 vaccination series. The patient received the first dose with the same vaccine on an unknown date. Medical history of cancer and the ongoing pandemic of COVID 19 could be risk factors for the event COVID 19. No information on exact date of the events, detailed clinical course, relevant investigations, treatment was available in the report. The event Thyroid disorder was resolving and COVID 19 had resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report.