Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Fatigue, Osteoarthritis, Rheumatoid arthritis
Clinical narrative: Rheumatoid arthritis flare up of lower back pain and left hip pain; Early stage osteoarthritis; Severe fatigue; Rheumatoid arthritis flare up of lower back pain and left hip pain; Rheumatoid arthritis flare up of lower back pain and left hip pain; Sore arm; FACILITATED COLLECT  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): 22K-163-4250457-00 (AbbVie), US-PFIZER INC-202200230136 (Pfizer).  A 52 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 02Dec2021 (Batch/Lot number: unknown) at the age of 51 years as dose 3 (booster), single, intramuscular, administration date 20Feb2021 (Batch/Lot number: unknown) as dose 2, single and intramuscular, administration date 20Jan2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; upadacitinib (RINVOQ), oral (ongoing) (Lot number: 1154505) for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RHEUMATOID ARTHRITIS (medically significant), outcome "not recovered", OSTEOARTHRITIS (non-serious), outcome "not recovered" and all described as "Early stage osteoarthritis"; VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "unknown", described as "Sore arm"; FATIGUE (non-serious), outcome "unknown", described as "Severe fatigue"; ARTHRALGIA (non-serious), BACK PAIN (non-serious), outcome "unknown" and all described as "Rheumatoid arthritis flare up of lower back pain and left hip pain". The action taken for upadacitinib was unknown. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   The reporter's causality for the event(s) of early stage osteoarthritis and sore arm after receiving covid-19 pfizer brand with rinvoq (upadacitinib) was no reasonable possibility. The reporter's causality for the event(s) of rheumatoid arthritis flare up of lower back pain and left hip pain with rinvoq (upadacitinib) was a reasonable possibility.  The reporter's causality for the event vaccination site pain with Vaccination site pain with pfizer biontech covid-19 vaccine (tozinameran) was a reasonable possibility.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.Suspect Adverse Reaction.; 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 events. 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.