Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Pain, Rheumatoid arthritis
Clinical narrative: Rheumatoid arthritis flare up/patient's toes were bothering; He also experienced achy due to second/experienced achy; had stiffness in toes and feet; 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): 21K-163-4142785-00 (AbbVie).  A 42 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 18Nov2021 (Batch/Lot number: unknown) at the age of 42 years as dose 2, single for covid-19 immunisation; upadacitinib (RINVOQ), oral (Batch/Lot number: unknown) for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Route of administration: Intra-muscular), administration date: 28Oct2021, for Covid-19 immunization. The following information was reported: RHEUMATOID ARTHRITIS (medically significant), outcome "recovered", described as "Rheumatoid arthritis flare up/patient's toes were bothering"; PAIN (non-serious), outcome "unknown", described as "He also experienced achy due to second/experienced achy"; MUSCULOSKELETAL STIFFNESS (non-serious), outcome "unknown", described as "had stiffness in toes and feet". The action taken for upadacitinib was unknown.  The reporter considered "rheumatoid arthritis flare up/patient's toes were bothering", "he also experienced achy due to second/experienced achy" and "had stiffness in toes and feet" related to bnt162b2.  Clinical Course: Pfizer biontech covid-19 vaccine (Tozinameran) was also considered suspect. The patient's toes were bothering, thoughts might be having rheumatoid arthritis flare and had stiffness in toes and feet. He also experienced achy due to second covid shot and just tired due first covid shot. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Product-Reaction level: Causality: Rheumatoid arthritis flare up (10060732) (Rheumatoid arthritis (10039073)) [v.24.1] Action(s) taken with drug : Unknown Causality as per reporter (Drug/Vaccine) : Reasonable possibility Dechallenge : N/A. Causality: Rheumatoid arthritis flare up (10060732) (Rheumatoid arthritis (10039073)) [v.24.1] Action(s) taken with drug : Unknown Causality as per reporter (Drug/Vaccine) : Possible Dechallenge : N/A. Causality for Rinvoq (Upadacitinib): The reporter's causality for the event(s) of rheumatoid arthritis flare due to covid-19 vaccination with Rinvoq (Upadacitinib) was a reasonable possibility. Change History: On 25Jan2022, received updates to event information, reporter opinion of causality, suspect drug information and narrative description. The event of "toes were bothering, thoughts might be having rheumatoid arthritis flare" was amended to "rheumatoid arthritis flare due to covid-19 vaccination".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on temporal association, there is reasonable possibility of causal association between the Reported events and the suspect drug BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer drug 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