Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Ear pain, Grip strength decreased, Headache, Pain in extremity
Clinical narrative: Pain in elbow; Trigger finger; Rheumatoid arthritis flare up; Grip strength decreased/could not make fist or grasp or grip/ inability to grip or grasp with her hands; pain in arm; right ear & head pains; right ear & head pains; This is a spontaneous report from a contactable nurse, the patient, and based on information received by Pfizer from Abbvie Pharmacovigilance (Mfr. Control No.: 21K-163-3848385-00). A 63-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EN6207) intramuscular in the right arm on 18Mar2021 at 11:00 (at the age of 63-years-old) as a single dose for COVID-19 immunization; adalimumab (HUMIRA) solution for injection, subcutaneously, from an unspecified date at an unspecified dose and frequency for rheumatoid arthritis (RA). Medical history included polymyalgia rheumatica (PMR), RA, hypothyroidism, anemia. The patient had no known allergies. It was unknown if the patient was enrolled in a COVID-19 vaccine trial. The patient was not diagnosed with COVID-19 prior to the vaccination. Concomitant medications included prednisone, levothyroxine sodium (SYNTHROID), folic acid, calcium carbonate (CAL). The patient did not receive any other vaccinations within 4 weeks of BNT162B2. On 18Mar2021 (within 4 hours of the vaccination), the patient experienced a rheumatoid arthritis flare up. The clinical course was as follows: on 18Mar2021 at 15:00, the patient experienced pain in elbow and finger pain (like trigger finger of both hands). On Mar2021 (within 24 hours), all fingers were involved, the patient's grip strength was decreased (she could not make a fist or grasp or grip/ inability to grip or grasp with her hands) and experienced left wrist pain. On Mar2021 (within 48 hours), the patient experienced finger edema, was still unable to make fist or grasp, experienced painful shooting pains up inner arms, right ear & head pains. The patient increased the prednisone dose to 4 mg daily as treatment for the events. On 21Mar2021 at 11:00 (72 hours after vaccination), the patient continued to experience bilateral arm pains, slight hand grips but could not lift, new right knee and right outer foot pains. On 21Mar2021 (94 hours after vaccination), there was less arm pain and finger edema, continued right ear/head pains. The patient saw the primary physician, there was no ear infection and the physician agreed with the prednisone increase. The physician felt the patient should not take the second vaccine dose and alerted the rheumatologist. On 22Mar2021 (116 hours after vaccination), the patient was able to lift and grasp with both hands, had less ear and arm pain. Since the vaccination, the patient was not tested for COVID-19. The action taken with adalimumab in response to the events was unknown. The reporter's causality for the events trigger finger, inability to grip or grasp with her hands, severe flare of RA symptoms 4 hours post vaccine, pain in arms and elbows, pain in ears was not provided. The clinical outcome of rheumatoid arthritis flare up, trigger finger, "grip strength decreased/could not make fist or grasp or grip/ inability to grip or grasp with her hands", pain in arm, right ear & head pains was resolving; while of pain in elbow was unknown.; Sender's Comments: Based on the information provided by the reporter, it appears unlikely that subject vaccine contributed to the RA flare and other events.  The reported events may likely represent intercurrent medical conditions.   There is limited information provided in this report. This case will be reassessed upon receipt of follow-up information.   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.