Age: 61.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Vaccination site pain
Clinical narrative: Rheumatoid arthritis flare up; Sore arm; Vaccination site pain; Booster; left wrist were swollen; Lot of stress; This is a solicited report received from marketing program 'Facilitated Collect' via a contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4157981-00 (Agency).  A 61 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 18Oct2021 (Batch/Lot number: unknown) at the age of 61 years as dose 3 (booster), single for covid-19 immunisation; upadacitinib (RINVOQ), oral (ongoing) (Batch/Lot number: 1154508) for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st Dose, Route of administration: Intramuscular), administration date: 20Mar2021, when the patient was 61 years old, for COVID-19 Immunization; Bnt162b2 (2nd Dose, Route of administration: Intramuscular), administration date: 17Apr2021, when the patient was 61 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 18Oct2021, outcome "unknown", described as "Booster"; RHEUMATOID ARTHRITIS (medically significant), outcome "not recovered", described as "Rheumatoid arthritis flare up"; STRESS (non-serious) with onset 2021, outcome "unknown", described as "Lot of stress"; PAIN IN EXTREMITY (non-serious) with onset 18Oct2021, outcome "recovered" (Oct2021), described as "Sore arm"; VACCINATION SITE PAIN (non-serious) with onset 18Oct2021, outcome "recovered" (Oct2021), described as "Vaccination site pain"; JOINT SWELLING (non-serious) with onset 2021, outcome "unknown", described as "left wrist were swollen". The action taken for upadacitinib was dosage not changed.  Additional information: It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Causality as per reporter: Possible.  Follow-up(17Dec2021):This is a follow up solicited report based on the information received by Pfizer from Agency. (MFR Control No: 21K-163-4197847-00). A contactable 61-year-old female consumer (patient) reported for herself that: Updated information: 3rd dose administration date added, Lot number for RINVOQ added, New events were added, Event details updated. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial; Adverse event information provided by patient not related to covid vaccine.  Causality for RINVOQ(UPADACITINIB): The reporter's causality for the event(s) of RHEUMATOID ARTHRITIS FLARE UP with RINVOQ(UPADACITINIB) was a reasonable possibility; for the event Vaccination site pain, the causality as per reporter (Drug/Vaccine): No Reasonable possibility. Action(s) taken with drug: Dose Not Changed. The reporter's causality for the event(s) of PFIZER BOOSTER CAUSED SORE ARM with RINVOQ(UPADACITINIB) was no reasonable possibility.  Causality for PFIZER BIONTECH COVID-19 VACCINE(TOZINAMERAN)(TOZINAMERAN): The Causality as per reporter for the event Rheumatoid arthritis flare up (Rheumatoid arthritis) was Not Reported; The Causality as per reporter for the event Vaccination site pain was Not Related.  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, a contributory effect of the vaccine BNT162B2 to the reported events cannot be ruled out. 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.