Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back injury, Fatigue, Immunisation, Intervertebral disc protrusion
Clinical narrative: booster; Rheumatoid arthritis flare; Muscle issues; Whole body had joint pain; Fatigue turned into flare up; Iron deficiency; Sinus infection; Back injury; Blowing out lumbar disks; This is a solicited report received from contactable reporter(s) (Consumer) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4209235-00.  A 33 year-old female patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) at the age of 33 years as dose 3 (booster), single for covid-19 immunisation; upadacitinib (RINVOQ), oral (Batch/Lot number: unknown) for rheumatoid arthritis. Relevant medical history included: "Moderate to severe rheumatoid arthritis" (unspecified if ongoing). Concomitant medication(s) included: MARIJUANA. Vaccination history included: Covid-19 vaccine (Unknown Manufacturer), for COVID-19 immunization. The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "booster"; RHEUMATOID ARTHRITIS (medically significant), outcome "unknown", described as "Rheumatoid arthritis flare"; BACK INJURY (medically significant) with onset 2021, outcome "recovering", described as "Back injury"; INTERVERTEBRAL DISC PROTRUSION (medically significant) with onset 2021, outcome "unknown", described as "Blowing out lumbar disks"; MUSCLE DISORDER (medically significant), outcome "unknown", described as "Muscle issues"; IRON DEFICIENCY (medically significant) with onset 2021, outcome "recovered", described as "Iron deficiency"; SINUSITIS (medically significant) with onset 2021, outcome "recovered", described as "Sinus infection"; ARTHRALGIA (medically significant), outcome "recovered", described as "Whole body had joint pain"; FATIGUE (medically significant), outcome "recovered", described as "Fatigue turned into flare up". The action taken for upadacitinib was unknown. Therapeutic measures were taken as a result of back injury, intervertebral disc protrusion, iron deficiency, sinusitis, arthralgia, fatigue. Additional information: On unknown dates, the patient experienced back injury/blowing out lumbar disks, muscle issues and rheumatoid arthritis flare. In 2021, the patient experienced back injury/blowing out lumbar disks, iron deficiency and sinus infection. On unknown dates, iron deficiency and sinus infection resolved. Pfizer Covid-19 vaccine was also considered suspect. The patient had physical therapy for back injury and had 7 spinal surgeries, 3 fusions. Muscle issues were associated. The patient was moving a student desk that was heavy, blowing out her lumbar disks. She had a laminectomy at the time. L3, L5, and Si joint on right side was fused. The patient was put on muscle relaxer, and medical marijuana sleep. From the booster vaccination, the patient reported that for three or four days, the whole body had joint pain and fatigue turned into flare up. The patient was changing anti-inflammatory from Naproxen to Meloxapram. Fatigue was experienced often. The physician appointments were more frequent due to flare ups and iron deficiency. She was prescribed iron infusion and started in Dec2021 with weekly iron fusion. She was having a sinus infection. Currently on antibiotics.   The reporter's causality for the event(s) of back injury/blowing out lumbar disks onset in 2021, iron deficiency, rheumatoid arthritis flare and sinus infection with Rinvoq (Upadacitinib) was no reasonable possibility.   The reporter's causality for the event(s) of back injury/blowing out lumbar disks unknown onset and muscle issues was not provided. Agency's opinion is that there is no reasonable possibility that the events of back injury/blowing out lumbar disks onset in 2021, back injury/blowing out lumbar disks unknown onset, iron deficiency, muscle issues and rheumatoid arthritis flare are related to Rinvoq (Upadacitinib). Agency's opinion is that the event of sinus infection is not assessable.   The reporter's assessment of the causal relationship of the events with the suspect product BNT162B2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the events immunisation, rheumatoid arthritis, muscle disorder, iron deficiency, sinusitis, arthralgia and fatigue with the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.