Received Nov 24, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (UNKNOWN)) | UNKNOWN MANUFACTURER | 2 | — | — |
Acute tubulointerstitial nephritis; This is a literature report for the following literature source(s). A 12-year-old female patient received BNT162b2 omicron (kp.2) (BNT162B2 OMICRON (KP.2)), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "strep infections" (unspecified if ongoing); "tonsillectomy" (unspecified if ongoing); "adenoidectomy" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 (DOSE 1, SINGLE), for COVID-19 immunisation. Twelve-year-old female presented to the hospital with intermittent fevers, dry cough, sore throat, general malaise, decreased appetite, and weight loss for 2 weeks. There was no history of extra-renal losses, and she had normal urine output. Symptoms started 6 days after receiving the second dose of Pfizer COVID-19 vaccine. Previously, the patient was well except for COVID-19 infection 90 days prior to first dose of the vaccine. Before presenting to the hospital, she tested negative for Group A streptococcus, COVID-19 by polymerase chain reaction (PCR), and influenza at her pediatrician's office. She also tested negative for Epstein Barr Virus, cytomegalovirus, and tick-borne diseases pertinent to the area. She did not report decreased urine output, polyuria, vomiting, or diarrhea. The mother reported that patient took only one dose of Tylenol for fever. Otherwise, no antibiotics or medications were given. Past medical history for her was significant for strep infections and tonsillectomy and adenoidectomy. At the hospital, initial blood pressure was 107/63 mmHg, heart rate was 107 beats per minute, respiratory rate 18 per minute, and pulse ox 100% on room air, and temperature 36.8 centigrade. Patient was noted to be pale appearing, no rashes or joint involvement were appreciated, and otherwise physical exam was normal. Initial laboratory values were remarkable for a non-oliguric acute kidney injury (AKI, with a serum creatinine of 1.59 mg/dL). The rest of comprehensive metabolic panel was unremarkable. Serum creatinine did not improve after 2 fluid boluses. Erythrocyte sedimentation rate was elevated to 107 mm/hr and C-reactive protein to 4.2 mg/dL. Complete blood count had hemoglobin that was low to 11.6 g/dL while white blood cell count and platelets were within normal limits. Full Respiratory Pathogen Panel and COVID-19 by PCR upon admission were negative. Initial urinalysis (UA) was negative for nitrites, leukocyte esterase, protein, blood and glucose, had a specific gravity of 1.004, and had 5 white blood cells. Although there was a history of fever, no fever was noted during admission. However, given the history and the elevated inflammatory markers and AKI, work up for multi-system inflammatory syndrome in children (MISC) was initiated. D-dimer was elevated to 420 ng/dL, PT elevated to 14.4 seconds, and ferritin to 168 ng/mL. There was a largely normal CBC and platelets except for mild anemia (hemoglobin 11.6 g/dL). COVID-19 Antibody nucleocapsid immunoglobulin G was positive. The clinical exam, labs and normal echocardiogram did not support a diagnosis of MIS-C. Antinuclear antibody screen, antidouble- stranded DNA and antineutrophil cytoplasmic antibodies were all normal. Initial laboratory findings and inflammatory markers on admission showed Serum creatinine 1.59 mg/dL (reference range: 0.44-0.77 mg/dL); ESR 107 mm/hr (reference range: 0-20 mm/hr); CRP 4.2 mg/dL (reference range: 0-0.5 mg/dL); Urinalysis Negative for nitrites and leukocyte esterase and positive for many bacteria and 5 WBCs per high; powered field (reference range: 0-2); D-dimer 420 DDU ng/mL (reference range: normal low <230 DDU ng/mL); PT 14.4 seconds (reference range: 10-13.6 seconds); aPTT Within normal limits (33 seconds) (reference range: 25.5-38 seconds); Ferritin 168 ng/mL (reference range: 15.0-150.0 ng/mL); ANA screen, anti-double-stranded DNA and ANCA Negative, 4 IU (reference range: normal low <25 IU), 20 (screening titer is 1:20); Hemoglobin 11.6 g/dL (reference range: 12.0-15.4 g/dL); Platelet count 325 K/uL (reference range: 150-350 K/uL); WBC count 6.95 K/uL (reference range: 4.80-10.80 K/uL); SARS-CoV-2 IgG antibody assay (CMIA) Positive. Fevers up to 38.8°C started on the fourth hospital day. A repeat COVID-19 PCR was negative. Renal bladder ultrasound revealed normal sized kidneys with increased echogenicity consistent with medical renal disease. Chest X-ray was normal. Computed tomography scan of the neck, chest, and abdomen without intravenous (IV) contrast were performed for concern for malignancy and all were normal. Blood and urine cultures were negative. Patient had normal urine output throughout her hospital stay. Serum creatinine rose to 3.26 mg/dL. Initial UA was negative for glucose. However, subsequent UAs revealed glucosuria (with 50 mg/dL that later increased to greater than 500 mg/dL). Renal biopsy was performed and revealed diffuse and severe acute TIN predominant with eosinophils and neutrophils. Subsequently the patient received pulse methylprednisolone (30 mg/kg) IV for 3 days after which serum creatinine decreased to 2.67 mg/dL. Subsequently, the patient was treated with oral prednisone 60 mg daily for 6 weeks followed by a slow taper. The patient was also evaluated by ophthalmology while on high dose steroids to rule out uveitis. She had a normal eye exam. Glucosuria resolved after a few weeks on steroids and serum creatinine normalized to 0.7 mg/dL. After discontinuation of steroids, serum creatinine worsened. Treatment was initiated with mycophenolate mofetil (MMF), which has been suggested as a therapy for TIN that is not responsive to steroids. With MMF, serum creatinine has decreased to <0.7 mg/dL. The patient remained on MMF for a year, and afterwards MMF was tapered. One year after MMF was discontinued, UA was persistently negative for both blood and protein, urine protein/creatinine ratio <0.2 mg/dL. Kidney function was also normal one year after MMF discontinuation. The patient currently has been lost to follow-up.; Sender's Comments: The event tubulointerstitial nephritis is conservatively assessed as related to the suspect drug BNT162B2 OMICRON (KP.2) 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.
Medical History/Concurrent Conditions: Adenoidectomy; Streptococcal infection; Tonsillectomy
Test Name: aPTT; Test Result: 33 s; Comments: Within normal limits; Test Name: ANCA; Result Unstructured Data: Test Result:20; Comments: screening titer is 1:20; Test Name: antineutrophil cytoplasmic; Result Unstructured Data: Test Result:normal; Test Name: Antinuclear antibody screen; Result Unstructured Data: Test Result:normal; Test Name: Antinuclear antibody screen; Test Result: Negative ; Test Name: Renal biopsy; Result Unstructured Data: Test Result:revealed diffuse and severe acute TIN predominant; Comments: with eosinophils and neutrophils; Test Name: Serum creatinine; Test Result: 1.59 mg/dl; Test Name: Serum creatinine; Result Unstructured Data: Test Result:did not improve mg/dl; Comments: after 2 fluid boluses; Test Name: Serum creatinine; Test Result: 3.26 mg/dl; Comments: rose; Test Name: Serum creatinine; Test Result: 2.67 mg/dl; Comments: decreased; Test Name: Serum creatinine; Result Unstructured Data: Test Result:normalized to 0.7 mg/dl; Test Name: Serum creatinine; Result Unstructured Data: Test Result:worsened mg/dl; Comments: After discontinuation of steroids; Test Name: Serum creatinine; Result Unstructured Data: Test Result:decreased to less than 7 mg/dl; Test Name: Blood culture; Test Result: Negative ; Test Name: glucose; Test Result: 50 mg/dl; Test Name: glucose; Result Unstructured Data: Test Result:later increased to greater than 500 mg/dl; Comments: glucosuria; Test Name: glucose; Result Unstructured Data: Test Result:glucosuria resolved mg/dl; Test Name: initial blood pressure; Result Unstructured Data: Test Result:107/63 mmHg; Test Name: Body temperature; Result Unstructured Data: Test Result:intermittent fevers Centigrade; Test Name: Body temperature; Result Unstructured Data: Test Result:36.8 Centigrade; Test Name: Body temperature; Result Unstructured Data: Test Result:no fever was noted during admission Centigrade; Test Name: Body temperature; Result Unstructured Data: Test Result:38.8 Centigrade; Comments: started on the fourth hospital day; Test Name: Chest X-ray; Result Unstructured Data: Test Result:normal; Test Name: Computed tomography scan of the abdomen; Result Unstructured Data: Test Result:normal; Test Name: Computed tomography scan of the neck; Result Unstructured Data: Test Result:normal; Test Name: Computed tomography scan of the chest; Result Unstructured Data: Test Result:normal; Test Name: CRP; Test Result: 4.2 mg/dl; Test Name: urine culture; Test Result: Negative ; Test Name: cytomegalovirus; Test Result: Negative ; Test Name: anti-double-stranded DNA; Result Unstructured Data: Test Result:normal iU; Test Name: anti-double-stranded DNA; Test Result: 4 [iU]; Test Name: normal echocardiogram; Result Unstructured Data: Test Result:did not support a diagnosis of MIS-C; Test Name: Epstein Barr Virus; Test Result: Negative ; Test Name: D-dimer; Result Unstructured Data: Test Result:420 ng/dL; Comments: elevated DDU; Test Name: CBC; Result Unstructured Data: Test Result:largely norma; Test Name: hemoglobin; Result Unstructured Data: Test Result:11.6 g/dl; Comments: low; Test Name: hemoglobin; Result Unstructured Data: Test Result:11.6 g/dl; Comments: mild anemia; Test Name: heart rate; Result Unstructured Data: Test Result:107; Comments: Units: beats per minute; Test Name: inflammatory markers; Result Unstructured Data: Test Result:elevated; Test Name: clinical lab; Result Unstructured Data: Test Result:did not support a diagnosis of MIS-C; Test Name: Initial laboratory values; Result Unstructured Data: Test Result:remarkable; Test Name: labs; Result Unstructured Data: Test Result:did not support a diagnosis of MIS-C; Test Name: comprehensive metabolic panel; Result Unstructured Data: Test Result:unremarkable; Test Name: eye exam; Result Unstructured Data: Test Result:normal; Test Name: pulse ox; Test Result: 100 %; Comments: on room air; Test Name: physical exam; Result Unstructured Data: Test Result:normal; Test Name: platelets; Result Unstructured Data: Test Result:within normal limits x10 3/mm3; Test Name: platelets; Result Unstructured Data: Test Result:325 x10 3/mm3; Test Name: PT; Test Result: 14.4 s; Test Name: Erythrocyte sedimentation rate; Result Unstructured Data: Test Result:107; Comments: elevated Units: mm/hr; Test Name: Kidney function; Result Unstructured Data: Test Result:normal; Test Name: Full Respiratory Pathogen Panel; Test Result: Negative ; Test Name: respiratory rate; Result Unstructured Data: Test Result:18; Comments: Units: per minute; Test Name: COVID-19 Antibody nucleocapsid immunoglobulin G; Test Result: Positive ; Test Name: COVID-19; Test Result: Negative ; Test Name: COVID-19; Test Result: Negative ; Test Name: COVID-19; Test Result: Negative ; Comments: A repeat COVID-19 PCR; Test Name: ferritin; Result Unstructured Data: Test Result:168 ng/ml; Test Name: specific gravity; Result Unstructured Data: Test Result:1.004; Test Name: Group A streptococcus; Test Result: Negative ; Test Name: Renal bladder ultrasound; Result Unstructured Data: Test Result:revealed normal sized kidneys with increased; Comments: echogenicity consistent with medical renal disease; Test Name: urine output; Result Unstructured Data: Test Result:normal; Test Name: urine protein/creatinine ratio; Result Unstructured Data: Test Result:less than 0.2; Test Name: weight; Result Unstructured Data: Test Result:loss; Test Name: WBC count; Result Unstructured Data: Test Result:6.95 x10 3/mm3; Test Name: while white blood cell count; Result Unstructured Data: Test Result:within normal limits; Test Name: white blood cells; Result Unstructured Data: Test Result:5; Test Name: urinalysis; Result Unstructured Data: Test Result:negative for nitrites, leukocyte esterase; Comments: protein, blood and glucose, had a specific gravity of 1.004, and had 5 white blood cells; Test Name: urinalysis; Result Unstructured Data: Test Result:persistently negative for both blood and protein