Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Alanine aminotransferase, Anti-cyclic citrullinated peptide antibody, Antibody test, Antineutrophil cytoplasmic antibody, Antinuclear antibody
Clinical narrative: Drug-Induced Lupus; This literature-non-study case was reported in a literature article and describes the occurrence of LUPUS-LIKE SYNDROME (Drug-Induced Lupus) in a 74-year-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.         The patient's past medical history included Proctocolectomy (40 years ago) and End ileostomy (40 years ago). Concurrent medical conditions included Hypertension, Post-traumatic stress disorder and Ulcerative colitis. Concomitant products included AMLODIPINE and CITALOPRAM for an unknown indication.    On an unknown date, the patient received fourth dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced LUPUS-LIKE SYNDROME (Drug-Induced Lupus) (seriousness criteria hospitalization and medically significant). The patient was treated with METHYLPREDNISOLONE (intravenous use) at a dose of 250 milligram every six hours and PREDNISONE (oral use) at a dose of 20 milligram for 6 weeks with a subsequent plan to reduce the dosage by 5 mg each week.. At the time of the report, LUPUS-LIKE SYNDROME (Drug-Induced Lupus) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Alanine aminotransferase (8-40 U/L): 160 U/L on admission and 23 U/L 3 months post discharge. On an unknown date, Anti-cyclic citrullinated peptide antibody: (Negative) <16 (Normal range: Negative: < 20, Weak Positive: 20-39, Moderate Positive: 40-59, Strong Positive >59). On an unknown date, Antibody test: (Negative) Smith-antibody: <1.0 (Normal range: Negative: <1.0), chromatin antibody: >8.0 (Normal range: Negative: <1.0). On an unknown date, Antineutrophil cytoplasmic antibody: (Negative) IBD: Negative, PR-3: <1.0 (Normal: </=1.0), MPO: <1.0 (Normal: </=1.0). On an unknown date, Antinuclear antibody: (Positive) >=1:1280  (Normal values: Negative: <1:40, Low Ab level: 1:40-1:80, Elevated Ab level: >1:80), (Negative) negative ANA during the evaluation of his inflammatory bowel disease., ANA IFA: Positive (Normal: Negative)  ANA Pattern: Nuclear, homogenous, RNP Ab: 1.7, SM/RNP Ab: <1.0 (Normal: Negative: <1.0), (Negative) <1.0 (Normal: Negative: <1.0) and (Negative) <1.0 (Normal: Negative: <1.0). On an unknown date, Aspartate aminotransferase (5-34 U/L): 139 U/L on admission and 14 U/L 3 months post discharge. On an unknown date, Blood albumin (3.4-5 g/dL): 3.1 g/dL on admission. On an unknown date, Blood alkaline phosphatase (40-150 U/L): 498 U/L on admission and 114 U/L 3 months post discharge. On an unknown date, Blood bilirubin: 1.9. On an unknown date, Blood creatinine (0.7-1.3 mg/dl): 2.35 mg/dl on admission   baseline of 1.12 mg/dL and 1.37 mg/dl 3 months post discharge. On an unknown date, Blood culture: Negative. On an unknown date, Body temperature: 103.3 degree F on admission. On an unknown date, C-reactive protein (0-0.5 mg/dl): 16.9 mg/dl on admission and 1.7 mg/dl 3 months post discharge. On an unknown date, Cardiac function test: normalized with no recurrent pericardial effusion. On an unknown date, Chest X-ray: chest x-ray displayed pulmonary infiltrates. On an unknown date, Complement factor C3 (82-185 mg/dl): 135 mg/dl Negative. On an unknown date, Complement factor C4 (15-35 mg/dl): 21 mg/dl Negative. On an unknown date, Computerised tomogram thorax: chest CT revealed a large pericardial effusion. On an unknown date, Dermatologic examination: revealed numerous red, non-blanchable papules and plaques scattered throughout his body. Eruption of papules and plaques on patient's back. and Dermatology evaluation suggested a probable COVID-19 vaccine-related eruption of papules and plaques, clinically resembling pityriasis rosea.. On an unknown date, Double stranded DNA antibody: 6 international unit per millilitre (Negative) Normal range: Negative: </=4 IU/mL, Indeterminate: 5-9 IU/mL, Positive: >/=10 IU/mL. On an unknown date, Hepatitis viral test: Negative. On an unknown date, Histone antibody: (Negative) at three-month follow-up and 9.4 international unit Normal value: Negative: <1.0, Weak Positive: 1.0-1.5, Moderate Positive: 1.6-2.5, Strong Positive: >2.5. On an unknown date, Lipase: 23. On an unknown date, Magnetic resonance cholangiopancreatography: exhibited a normal appearance of intra and extrahepatic bile ducts without obstruction.. On an unknown date, Pericardial excision: Cytology from the pericardial fluid indicated white blood cells with neutrophilic predominance, and pathology of the pericardium showed fibroadipose tissue, suggesting a mixed acute and chronic inflammatory process.. On an unknown date, Physical examination: appeared cachectic, with elevated jugular venous distension, bilateral diminished breath sounds, and diffuse abdominal tenderness.. On an unknown date, Red blood cell sedimentation rate: 50 mm/hr, 70 mm/hr on admission and 3 mm/hr 3 months post discharge. On an unknown date, SARS-CoV-2 test: Positive. On an unknown date, White blood cell count: 7.60 per microlitre.     For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   The co-suspect product included non-company product unspecified monoclonal antibody infusion (unknown route) at an unspecified dose as an immunotherapy. Patient presented with chest pressure, abdominal pain, a non-painful, non-pruritic diffuse rash, and malaise. The patient reported that these symptoms started five weeks ago when he tested positive for COVID-19 and experienced mild constitutional symptoms, including headache and fatigue.  Two days after the initial positive test, the patient received a monoclonal antibody infusion. Two weeks following the immunotherapy infusion, he received his fourth COVID-19 vaccine. Over the next three weeks, he developed anorexia and a 15-pound weight loss, with no associated nausea, vomiting, and dysphagia. Upon admission, he presented with a fever, tachycardia, and tachypnea.  Dermatology evaluation suggested a probable COVID-19 vaccine-related eruption of papules and plaques, clinically resembling pityriasis rosea.  After ruling out infectious and malignant etiologies, the diagnosis of Drug-Induced Lupus (DIL) became top differential.  A three-month follow-up revealed complete resolution of symptoms: cutaneous papules and plaques had entirely disappeared, liver enzymes returned to normal limits, cardiac function normalized with no recurrent pericardial effusion, and anti-Histones antibodies were negative.  Company Comment: This is a literature non-study case concerning a 74-year-old, male patient with a history of Proctocolectomy (40 years ago) and End ileostomy (40 years ago) due to Ulcerative colitis and concurrent medical conditions of Hypertension and Post-traumatic stress disorder, who experienced the serious (due to medically significant and hospitalization) unexpected, event of Lupus-like syndrome. The event occurred approximately three weeks after a dose of SPIKEVAX COVID-19 VACCINE NOS, administered as a fourth dose of COVID-19 vaccination schedule. Reportedly, the patient presented with chest pressure, abdominal pain, a non-painful, non-pruritic diffuse rash, and malaise to the hospital. The patient reported that these symptoms started five weeks prior to admission when he tested positive for COVID-19 and experienced mild constitutional symptoms, including headache and fatigue. Two days after the initial positive test, the patient received a monoclonal antibody infusion. Two weeks following the immunotherapy infusion, he received his fourth COVID-19 vaccine. Over the three following weeks, he developed anorexia and a 15-pound weight loss, with no associated nausea, vomiting, and dysphagia. The patient's home medications included amlodipine and citalopram. Upon admission, he presented with a fever (103.3°F), tachycardia, and tachypnea. On physical examination, he appeared cachectic, with elevated jugular venous distension, bilateral diminished breath sounds, and diffuse abdominal tenderness. Skin examination revealed numerous red, non-blanchable papules and plaques scattered throughout his body. Relevant laboratory results revealed a WBC of 7.60/µL, creatinine 2.35 mg/dL (baseline of 1.12 mg/dL), CRP 16.9 mg/dL, ESR 50 mm/hr, Lipase 23, ALT 160 U/L, AST 139 U/L, ALP 498 U/L, Total Bilirubin 1.9, and albumin 3.1 g/dL. A chest x-ray displayed pulmonary infiltrates, and a chest CT revealed a large pericardial effusion. Viral hepatitis serologies returned negative. Magnetic resonance cholangiopancreatography exhibited a normal appearance of intra and extrahepatic bile ducts without obstruction. Due to concerns about progressive hemodynamic changes, a pericardial window was performed. Cytology from the pericardial fluid indicated white blood cells with neutrophilic predominance, and pathology of the pericardium showed fibroadipose tissue, suggesting a mixed acute and chronic inflammatory process. Dermatology evaluation suggested a probable COVID-19 vaccine-related eruption of papules and plaques, clinically resembling pityriasis rosea. Blood cultures remained negative. The unexplained, systemic processes raised concerns about a systemic autoimmune etiology. Rheumatological testing revealed a positive ANA of 1:1280 with a homogenous pattern, Anti-Histones 9.4 U, and Anti-RNP antibodies 1.7. However, results for anti-CCP antibody, C3 and C4 complement, ANCA (IBD, PR-3, MPO), Smith-antibody antibody, dsDNA antibody, chromatin antibody, anti-SSA, and Anti-SSB antibody were all negative. Given these findings, concerns for an autoimmune process emerged, leading to the initiation of IV methylprednisolone at 250 mg every six hours. After ruling out infectious and malignant etiologies, Drug Induced Lupus was stated as diagnosis. The patient was discharged with an oral prednisone taper, commencing at 20 mg for six weeks, with a subsequent plan to reduce the dosage by 5 mg each week. A three-month follow-up revealed complete resolution of symptoms: cutaneous papules and plaques had entirely disappeared, liver enzymes returned to normal limits, cardiac function normalized with no recurrent pericardial effusion, and anti-Histones antibodies were negative. The outcome of the event was reported as recovered. Previous COVID-19 infection and monoclonal antibody infusion might be confounders.  The benefit-risk relationship of SPIKEVAX COVID-19 VACCINE NOS vaccine is not affected by this report.