Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Headache, Palpitations, Rheumatoid arthritis
Clinical narrative: This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4203909-00 (RA). A 54 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date May2021 (Batch/Lot number: unknown) as dose 1, single for Covid-19 immunisation; upadacitinib (RINVOQ), oral since 01Nov2021 (ongoing) (Batch/Lot number: unknown) for rheumatoid arthritis. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: RHEUMATOID ARTHRITIS (medically significant) with onset 2022, outcome "unknown", described as "RHEUMATOID ARTHRITIS FLARE"; BLOOD PRESSURE INCREASED (non-serious) with onset 2021, outcome "not recovered", described as "blood pressure had been higher than usual/Her most recent blood pressure reading were 132/88 and 155/100/ Increased blood pressure"; PALPITATIONS (non-serious) with onset Nov2021, outcome "not recovered", described as "HEART PALPITATIONS OCCASIONALLY"; SINUS PAIN (non-serious), outcome "unknown", described as "Sinus pain"; HEADACHE (non-serious), outcome "unknown", described as "HEADACHES". The event "rheumatoid arthritis flare" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: blood pressure measurement: (Dec2021) 132/88; (Dec2021) 155/100. The action taken for upadacitinib was dosage not changed. Causality for Rinvoq (upadacitinib): The reporter's causality for the event(s) of increased blood pressure, heart palpitations occasionally, sinus pain, headaches and rheumatoid arthritis flare was not provided. Causality for Pfizer BioNTech Covid-19 vaccine (tozinameran): The reporter's causality for the event(s) of increased blood pressure was possible, heart palpitations occasionally, sinus pain, headaches and rheumatoid arthritis flare was not related. Follow-up (09Mar2022): This is a solicited Follow-up report based on information received by Pfizer (Manufacturer Control Number: 21K-163-4203909-00). Updated information included: patient demographics, event information, reporter opinion of causality, suspect drug information and narrative description. 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 Limited information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported event. The case will be reassessed once new information is available. 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.