Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pneumonitis, Rash macular
Clinical narrative: mixed connective tissue disease; Swelling of knees; Swelling of feet; Neck pain; Hand pain; Lung inflammation; Red blotches; This is a solicited report based on the information received by Pfizer  (Mfr. Control No.: 21K-163-4113622-00). A contactable consumer (patient) reported for a 40-year-old female patient that received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in Feb2021 (at the age of 40-years-old) (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunization; and upadacitinib (RINVOQ), oral from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at unspecified dose for moderate to severe rheumatoid arthritis. Medical history included arms tingling, breathing issues, joint knee pain, lupus, neck hurting and rheumatoid arthritis in the C1 to C6 and neck rheumatoid arthritis; all from 2014 to an unknown date; and suspected covid-19 from 2019 (pending clarification). Concomitant medications included gabapentin; methotrexate; and prednisone; all taken for an unspecified indication from Jun2021 to Aug2021. In Jan2021, patient received 1st dose COVID-19 Vaccine manufactured by Pfizer/BioNTech (at the age of 40-years-old) for COVID-19 immunization. The patient had blood test in Oct2014 and Oct2021 both with unknown results. The action taken in response to the event for upadacitinib was unknown. The outcome of the event mixed connective tissue disease was not recovered. The outcome of the remaining events was unknown.  Solicited report by a consumer of an adult female with events of non-serious MIXED CONNECTIVE TISSUE DISEASE, SWOLLEN KNEES, SWOLLEN FEET, HANDS HURT, NECK HURT, RED OR REDDISH BROWN PATCHES APPEARED OVER NECK AND FACE, LUNGS GOT INFLAMED and POSSIBLE COVID with RINVOQ (UPADACITINIB). The patient had a relevant medical history of ARMS TINGLING, BREATHING ISSUES, JOINT KNEE PAIN, LUPUS, NECK HURTING and RHEUMATOID ARTHRITIS IN THE C1 TO C6 AND NECK. On unknown dates, the patient experienced MIXED CONNECTIVE TISSUE DISEASE, SWOLLEN KNEES, SWOLLEN FEET, HANDS HURT, NECK HURT, RED OR REDDISH BROWN PATCHES APPEARED OVER NECK AND FACE, LUNGS GOT INFLAMED and POSSIBLE COVID. PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) was also considered suspect.  In 2019 (pending clarification), the patient got bad due to thought it was COVID. She had mixed connective tissue disease, cold and numb fingers or toes, muscle and joint pain, swollen knees and feet, hurt hands, hips and neck. She had red or reddish-brown patches can appear over the necks and face and lungs got inflamed in which Jun2021, was the last time patient had it. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. In Jan2021, patient received 1st dose COVID-19 Vaccine manufactured by Pfizer/BioNTech.  In Feb2021, patient received 2nd dose COVID-19 Vaccine manufactured by Pfizer/BioNTech. The reporter's causality for the event(s) of mixed connective tissue disease with RINVOQ (UPADACITINIB) was no reasonable possibility. The reporter's causality for the event(s) of SWOLLEN KNEES, SWOLLEN FEET, HANDS HURT, NECK HURT, RED OR REDDISH BROWN PATCHES APPEARED OVER NECK AND FACE, LUNGS GOT INFLAMED and POSSIBLE COVID was not provided. The reporter's causality for the events mixed connective tissue disease, swelling of knees, swelling of feet, hand pain, neck pain, red blotches, lung inflammation, and suspected COVID-19 with BNT162B2 was possible.  In 2014, the patient started Lupus, arms tingling, breathing issues, neck hurting, joint knee pain and rheumatoid arthritis in the C1 to C6 and neck also.  The lot number for the vaccine, BNT162B2 was not provided and will be requested during follow-up.; Sender's Comments: Based on the information in the case report, a possible causal association between the events and suspect drug BNT162B2 cannot be excluded.  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.