Sex: F
Vaccine: COVID19, COVID19, UNK
Symptoms: COVID-19 immunisation, Coeliac disease, Diabetes mellitus, Inflammation, Interchange of vaccine products
Clinical narrative: Celiac disease; Diabetes; No longer had any strength in her hands; Inflammation; Urticaria; She broke out in a rash at the injection site; Vaccination site erythema; Vaccination site swelling; Interchange of vaccine products; Revaccination with different covid-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of COELIAC DISEASE (Celiac disease) and DIABETES MELLITUS (Diabetes) in an adult 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 products included non-company products TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination and UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    No Medical History information was reported.   On 28-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Oct-2021, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On an unknown date, the patient received dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COELIAC DISEASE (Celiac disease) (seriousness criterion medically significant), DIABETES MELLITUS (Diabetes) (seriousness criterion medically significant), MUSCULAR WEAKNESS (No longer had any strength in her hands), INFLAMMATION (Inflammation), URTICARIA (Urticaria), VACCINATION SITE RASH (She broke out in a rash at the injection site), VACCINATION SITE ERYTHEMA (Vaccination site erythema), VACCINATION SITE SWELLING (Vaccination site swelling), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and COVID-19 IMMUNISATION (Revaccination with different covid-19 vaccine). At the time of the report, COELIAC DISEASE (Celiac disease), DIABETES MELLITUS (Diabetes), MUSCULAR WEAKNESS (No longer had any strength in her hands) and URTICARIA (Urticaria) had not resolved, INFLAMMATION (Inflammation), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and COVID-19 IMMUNISATION (Revaccination with different covid-19 vaccine) outcome was unknown and VACCINATION SITE RASH (She broke out in a rash at the injection site), VACCINATION SITE ERYTHEMA (Vaccination site erythema) and VACCINATION SITE SWELLING (Vaccination site swelling) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medications were reported.  The patient had celiac disease, diabetes and urticaria and suggested it was because of taking different medications. Patient reported that when she got a Pfizer COVID-19 vaccination, patient experienced swelling, redness and a rash for a week. Patient always had inflammation, but that Rinvoq was helping with the inflammation. Patient broke out in a rash at the injection site after getting her first Moderna COVID-19 vaccination so her physician instructed her not to get a second COVID-19 vaccination. That was the only adverse event associated with the COVID-19 vaccination. Patient no longer had any strength in her hands.  It was unknown if she was enrolled in a COVID-19 vaccine trial. Adverse event information provided by her was related to COVID-19 vaccine.  Reporter causality for events celiac disease, diabetes, urticaria was not reported and for events swelling, erythema, rash was no reasonable possibility and for event vaccination site rash was not related and for event inflammation was probable with respect to Rinvoq drug. Reporter causality for events swelling, erythema, rash was possible and for all other events was not reported with respect to Pfizer biontech COVID-19 vaccine.  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 an adult female patient of an unspecified age, with no reported relevant medical history, who experienced the unexpected serious (medically significant) events of Coeliac disease and Diabetes mellitus on unknown dates in the context of receiving a dose of mRNA-1273 vaccine.  Onset latency could not be determined as onset dates of events were not provided. Clinical course and treatment details were not reported. The outcome of events was reported as not resolved. On an unknown date patient received Tozinameran vaccine. Tozinameran and Upadactinib (for rheumatoid arthritis) remain as confounders. The benefit-risk relationship of mRNA-1273 is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 25-Aug-2022: Event hands weakness of added.; Sender's Comments: This spontaneous case concerns an adult female patient of an unspecified age, with no reported relevant medical history, who experienced the unexpected serious (medically significant) events of Coeliac disease and Diabetes mellitus on unknown dates in the context of receiving a dose of mRNA-1273 vaccine.  Onset latency could not be determined as onset dates of events were not provided. Clinical course and treatment details were not reported. The outcome of events was reported as not resolved. On an unknown date patient received Tozinameran vaccine. Tozinameran and Upadactinib (for rheumatoid arthritis) remain as confounders. The benefit-risk relationship of mRNA-1273 is not affected by this report.