Received Mar 11, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 3 | — | — |
antitumor-necrosis-factor-alphainduced tuberculosis-associated IRIS; This is a literature report for the following literature source(s). A 47-year-old male patient received BNT162b2 (BNT162B2 NOS), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's concomitant medications were not reported. The following information was reported: IMMUNE RECONSTITUTION INFLAMMATORY SYNDROME ASSOCIATED TUBERCULOSIS (hospitalization, medically significant), 5 days after the suspect product(s) administration, outcome "recovered", described as "antitumor-necrosis-factor-alphainduced tuberculosis-associated IRIS". The patient with no past medical history developed pain and weakness in his inter-phalangeal and metacarpal-phalangeal joints. On the basis of his symptoms, laboratory testing, and imaging of his hands, he was diagnosed with seronegative rheumatoid arthritis. He was started on biologic treatment with anti-TNF agent adalimumab and methotrexate. Before starting treatment, he had a chest X-ray, which was normal and a test for M. tuberculosis using an interferon gamma release assay, which was also negative. He received two doses of Pfizer mRNA vaccine 4 weeks apart without any complications. Then, 6 months after starting adalimumab, he developed constitutional symptoms including headaches, nocturnal sweats, and low-grade fever. He then developed neck pain and was noted to have bilateral cervical adenopathy noted on exam. Computed tomography (CT) scan of the neck confirmed bilateral cervical adenopathy. His immunosuppressive therapy was stopped. A cervical lymph node biopsy was performed. The histology results were strongly positive for acid-fast bacilli. A diagnosis of tuberculous lymphadenitis was made, and he was started on a four-drug regimen with Isoniazid, Rifampin, Pyrazinamide and Ethambutol. Within 5 days of starting the regimen, he noted a significant improvement in his symptoms. The mycobacterial cultures revealed that the bacillus was susceptible to all the antituberculous drugs. About 2 weeks after starting his antitubercular therapy, he received a dose of previously scheduled COVID mRNA vaccine (third dose of Pfizer mRNA), and 5 days after receiving the vaccine, he developed severe constitutional symptoms including fever, chills, and excessive diaphoresis. He was admitted to the hospital for further evaluation. His exam was unremarkable for any new finding. He was ruled out for sepsis with negative blood cultures and serological testing. Inflammatory markers including ESR and C-reactive protein (CRP) were elevated at 35 mm/hour and 5.33 mg/l. He was diagnosed with antitumor-necrosis-factor-alpha-induced tuberculosis-associated IRIS. Treatment was started with intravenous methylprednisolone 80 mg every 8 hours, with resolution of his symptoms. He was transitioned to oral prednisolone 100 mg twice a day and discharged home 5 days later. His oral steroids were gradually weaned off over the next 3 months. He finished a 12-month course of antitubercular therapy. He had had no recurrent symptoms at 18-month follow-up and was discharged from the infectious disease clinic. He was able to resume therapy with adalimumab after 4 months of antitubercular therapy. The diagnosis of TB-IRIS is based on initial improvement of TB-related symptoms with initiation of TB therapy, paradoxical deterioration of TB related symptoms during TB therapy, and exclusion of other possible causes of clinical deterioration. This patient fulfilled all these criteria. His immune response after receiving COVID vaccine booster may have further contributed to activation of his immune system, resulting in presentation with IRIS. Immune reconstitution inflammatory syndrome should be considered as a differential in patients who develop paradoxical worsening of symptoms with antitubercular therapy in the setting of immune reconstitution. Hyperactive immune response after infection or messenger ribonucleic acid vaccine booster may have contributed to the development of immune reconstitution inflammatory syndrome syndrome in this patient.; Sender's Comments: The event immune reconstitution inflammatory syndrome associated tuberculosis is conservatively assessed as related to the suspect drug BNT162B2 based on plausible temporal association but consider also possible contributory effects from medical history of the patient and/or concomitant medications. 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.
Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none
Test Name: cervical lymph node biopsy; Result Unstructured Data: Test Result:positive for acid-fast bacilli; Test Name: blood cultures; Test Result: Negative ; Comments: ruled out for sepsis; Test Name: chest X-ray; Result Unstructured Data: Test Result:normal; Test Name: Computed tomography (CT) scan of the neck; Result Unstructured Data: Test Result:confirmed bilateral cervical adenopathy; Test Name: C-reactive protein; Result Unstructured Data: Test Result:5.33 mg/l; Test Name: mycobacterial cultures; Result Unstructured Data: Test Result:bacillus was susceptible; Comments: to all the antituberculous drugs; Test Name: test for M. tuberculosis using an interferon gamma release assay; Test Result: Negative ; Test Name: exam; Result Unstructured Data: Test Result:bilateral cervical adenopathy; Test Name: exam; Result Unstructured Data: Test Result:unremarkable for any new finding; Test Name: imaging of his hands; Result Unstructured Data: Test Result:seronegative rheumatoid arthritis; Test Name: ESR; Result Unstructured Data: Test Result:35; Comments: mm/hour; Test Name: serological testing; Test Result: Negative ; Comments: ruled out for sepsis