Age: 71.0
Sex: F
Vaccine: COVID19, COVID19, UNK
Symptoms: Blood creatinine, Blood creatinine increased, Red blood cell sedimentation rate, Red blood cell sedimentation rate abnormal
Clinical narrative: Shoulders, ankles, elbows and everything were all hot with flare ups; markers for ESR, and CR were more than double what they should be; markers for ESR, and CR were more than double what they should be; 5 days after, I started feeling soreness and it has got progressively worse; 5 days after, I started feeling soreness and it has got progressively worse; This is a spontaneous report from a contactable Nurse, the patient.  A 71-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EL8982), via an unspecified route of administration on 13Jan2021 (at the age of 71-years-old) as a single dose for COVID-19 vaccination and started to receive methotrexate (ACCORD HEALTHCARE, lot number unknown, expiration date 12Nov2021) on an unspecified date (reported as seven years ago) at a dose of 17.5 mg weekly (seven tablets once a week) for Rheumatoid Arthritis. Medical history included rheumatoid arthritis from an unspecified date. Historical vaccinations included "every vaccine known. I've had all my vaccines, flu whatever"  (as reported) on unspecified dates. It was unknown if the patient had received any other vaccinationa in the fourteen days prior to this inoculation. Concomitant medications included folic acid (MANUFACTURER UNKNOWN). On 18Jan2021 (reported as about five days after the shot), the patient had just a little soreness and she thought that was one of the side effects that you have that with the vaccine. So, she didn't worry so much about it. But then it got progressively worse. And by the time just before she was supposed to get the second shot, it was really bad. But she thought that she was still going to get that second shot which was planned for "02Feb2021 or 03Feb2021" (also reported as on 02Feb2021) because she didn't want to not get it.  She was struggling with the pain before she got the second one. She mentioned that by the time she got her second dose, she was in an RA flare. She continued by saying that she had her blood work done, "on Tuesday morning"  because she was due for her RA exam in Mar and it was due, and her markers for ESR, and "CR whatever"  were more than double what they should be. Her Rheumatololgist saw her and when she went to the doctor her shoulders, her ankles, her elbows and everything were all hot with flare ups. Treatment included Prednisone 10mg every day which was given, according to the patient,  in order to "calm down my joints and everything." The action taken with methotrexate was not reported. The clinical outcomes Rheumatoid Arthritis flare up, pain, condition aggravated, ESR increased and CRP increased were reported as unknown.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Rheumatoid arthritis flare up, ESR increased, and CRP increased cannot be excluded.  The case will be reassessed if additional information becomes 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.