Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: This is a solicited report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4342045-00 (RA). A 56-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) intramuscular for Covid-19 immunisation; upadacitinib (RINVOQ), (Batch/Lot number: unknown), oral for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COELIAC DISEASE (medically significant), outcome "not recovered", described as "celiac disease"; DIABETES MELLITUS (medically significant), outcome "not recovered", described as "Diabetes"; URTICARIA (non-serious), outcome "not recovered"; VACCINATION SITE SWELLING (non-serious), outcome "recovered"; VACCINATION SITE ERYTHEMA (non-serious), outcome "recovered"; VACCINATION SITE RASH (non-serious), outcome "recovered". The action taken for upadacitinib was unknown. Additional information: Solicited report by a consumer of a 62-year-old female with events of non-serious Celiac disease, Diabetes, Urticaria and swelling, Redness and a rash from Covid-19 vaccination Rinvoq (UPADACITINIB). There was no reported medical history. Pfizer BioNTech Covid-19 Vaccine (TOZINAMERAN) was also considered suspect. The patient had celiac disease, diabetes, and urticaria and suggested it was because of taking different medications. She did not say Rinvoq was one of them. She reported that when she got a Pfizer Covid vaccination, she experienced swelling, redness, and a rash for a week. She did not take any other COVID vaccinations. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Causality for Rinvoq (UPADACITINIB): The reporter's causality for the event(s) of Celiac disease, Diabetes, Urticaria was not provided. The reporter's causality for the event(s) of swelling, Redness and a rash from Covid vaccination unknown onset, swelling, Redness and a rash from Covid vaccination unknown onset and swelling, Redness and a rash from Covid vaccination. Unknown onset with Rinvoq (UPADACITINIB) was no reasonable possibility. The reporter's assessment of the causal relationship of "celiac disease", "diabetes" and "urticaria" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. The reporter considered "vaccination site swelling", "vaccination site erythema" and "vaccination site rash" related to BNT162b2. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.