Received Jul 23, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
Eosinophilic granulomatosis with polyangiitis; Myositis; Necrotizing vasculitis; Worsening asthma after vaccination; Worsening asthma after vaccination; This is a literature report for the following literature source(s). A 61-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 02Nov2023 as dose 1 (toppac); single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "eosinophilic asthma" (ongoing); "nonobstructive coronary artery disease" (unspecified if ongoing); "hyperlipidemia" (unspecified if ongoing); "GERD" (unspecified if ongoing); "obesity" (unspecified if ongoing); "myeloproliferative neoplasm" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE, primary immunization, UNKNOWN MANUFACTURER), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE, primary immunization, UNKNOWN MANUFACTURER), for COVID-19 immunization; Covid-19 vaccine (DOSE 1 (BOOSTER), UNKNOWN MANUFACTURER), for COVID-19 immunization. The following information was reported: ASTHMA (hospitalization), CONDITION AGGRAVATED (hospitalization) all with onset Nov2023, latency 2 weeks after the suspect product(s) administration, outcome "recovered" and all described as "Worsening asthma after vaccination"; EOSINOPHILIC GRANULOMATOSIS WITH POLYANGIITIS (hospitalization, medically significant) with onset Dec2023, 1 month after the suspect product(s) administration, outcome "recovered"; MYOSITIS (hospitalization) with onset Dec2023, 1 month after the suspect product(s) administration, outcome "recovered"; VASCULITIS NECROTISING (hospitalization) with onset Dec2023, 1 month after the suspect product(s) administration, outcome "recovered", described as "Necrotizing vasculitis". The patient underwent the following laboratory tests and procedures: Antineutrophil cytoplasmic antibody (0-0.9): Greater than 8, notes: Elevated; Antineutrophil cytoplasmic antibody: Negative; Negative; Negative; Antinuclear antibody: Negative; Biopsy: biopsy findings of vasculitis with, notes: associated myonecrosis (+2 points); Biopsy artery: was without evidence of active vasculitis., notes: performed due to complaints of jaw claudication and left orbital pain; Biopsy muscle: consistent with necrotizing vasculitis with, notes: granulomas containing eosinophils; Hematoxylin and eosin-stained sections, notes: showing presence of a single arteriole showing several surrounding lymphocytes and eosinophils and a multinucleate histocyte; Several small arterioles within the perimysium, notes: show mild to moderate surrounding chronic lymphold inflammation, infiltrating lymphocytes and macrophages within the vascular wall, and patchy fibrinoid necrosis; Blood alkaline phosphatase: Elevated; Blood creatinine: 13736 IU/l, notes: elevated; 4081 IU/l, notes: down-trending; Chest X-ray: Normal; C-reactive protein: Greater than 19; Creatine kinase: within normal limits; Eosinophil count: 54 %, notes: significant eosinophilia; Greater than 10, notes: eosinophilia (+5 points); exam: Eosinophilic fasciitis, notes: was least on the differential as the patient did not have any evidence of fasciitis; significant for tenderness to palpation, notes: over proximal muscle groups bilaterally, upper and lower extremities, without any joint swelling, rashes, scalp tenderness, or enlarged vessels; Magnetic resonance imaging abdominal: diffuse patchy intramuscular edema, notes: and enhancement throughout the anterior and posterior compartments of thigh musculature bilaterally; Magnetic resonance imaging showing edema, notes: in the bilateral erector spinae musculature; Metabolic function test: showed mild elevation in transaminases with, notes: elevated alkaline phosphatase; Red blood cell sedimentation rate: 55, notes: mm/hr; Rheumatoid factor: Negative; Transaminases: mild elevation; Vital signs measurement: stable; White blood cell count: 29800 /mm3, notes: leukocytosis. Therapeutic measures were taken as a result of eosinophilic granulomatosis with polyangiitis, myositis, vasculitis necrotising, asthma, condition aggravated. Clinical course: A 61-year-old male with a history of eosinophilic asthma presented to the office for progressive weakness and diffuse muscle aches in early Jan2024. Other significant past medical history included non-obstructive coronary artery disease, hyperlipidemia, GERD, and obesity. Before this, on 02Nov2023, he took his second booster COVID vaccination (Pfizer-BioNTech, previous vaccinations as well). He tolerated his first two doses and the booster of the COVID vaccination well. His asthma symptoms began worsening two weeks later. His asthma improved; however, a month later, he developed severe muscle aches in proximal muscle groups, mainly involving the neck, bilateral shoulders, hips, biceps, and thighs, with progression over three weeks. He also complained of jaw claudication and left orbital pain. The pain was achy in nature and worse with immobility, with some improvement on movement. No relief with pain medications. He denied weight loss, night sweats, or fevers. On further evaluation, labs revealed leukocytosis 29 800/uL, with significant eosinophilia (54% absolute count), C-reactive protein >19 mg/dL, and erythrocyte sedimentation rate 55 mm/hr. Creatinine kinase levels were elevated to 13,736 U/L. Due to this, he was admitted to the hospital for further workup. On examination, vitals were stable, the patient appeared to be in mild distress due to pain, and the musculoskeletal exam was significant for tenderness to palpation over proximal muscle groups bilaterally, upper and lower extremities, without any joint swelling, rashes, scalp tenderness, or enlarged vessels. Antinuclear antibody testing and rheumatoid factor were negative. A comprehensive metabolic panel showed mild elevation in transaminases with elevated alkaline phosphatase. Anti-nuclear Antibody (ANA) was negative. His anti-myeloperoxidase (MPO) Abs >8 (Elevated, normal 0-0.9), negative proteinase 3 Ab, cytoplasmic antineutrophil antibody, and perinuclear antineutrophil antibody. The differential diagnoses included myeloproliferative neoplasms causing hypereosinophilic syndrome, tissue hypereosinophilia, EGPA, and eosinophilic myositis. Eosinophilic fasciitis was least on the differential as the patient did not have any evidence of fasciitis on exam. Oncology was consulted for any possible underlying myeloproliferative neoplasm causing hyper eosinophilia. They decided to wait for an MRI of the abdomen and lower extremities and a muscle biopsy as scheduled before proceeding with a bone marrow biopsy. Magnetic resonance imaging of the lower extremities revealed diffuse patchy intramuscular edema and enhancement throughout the anterior and posterior compartments of thigh musculature bilaterally, as shown in the images. Left deltoid and quadricep muscle biopsy was consistent with necrotizing vasculitis with granulomas containing eosinophils. Temporal artery biopsy was performed due to complaints of jaw claudication and left orbital pain, but was without evidence of active vasculitis. His chest radiography was normal, and radiographs of sinuses were not obtained. He was diagnosed with EGPA based on ACR/EULAR 2022 diagnostic criteria with long-standing asthma (+3 points), eosinophilia >10% (+5 points), and biopsy findings of vasculitis with associated myonecrosis (+2 points). With consistent biopsy findings and meeting diagnostic criteria for EGPA, further testing with bone marrow biopsy was not pursued. The patient was started on IV methylprednisolone 500 mg on day 1, then 250 mg/day on days 2 and 3. He has significant improvement in symptoms and an improvement in eosinophilia to 16% along with a down-trending CK to 4081U/L. As there is no involvement of CNS, GI, pulmonary, or renal systems, it was classified as non-severe EGPA. Therefore, steroids were tapered down to 60 mg prednisone once daily on discharge. Follow up: About 60 mg of prednisone was continued till he received his first dose of mepolizumab 150 mg/month, 10 days after hospital discharge. Prednisone was tapered starting from 60 mg to 40 mg after 2 weeks. This was further tapered to 32 mg and 16 mg of methylprednisolone in the next month. Mepolizumab dose was increased to 300 mg/month as the patient continued to experience myalgias on prednisone taper. While being on an increased dose of mepolizumab, his dose of methylprednisolone was decreased to 12 mg for 3 weeks, followed by 8 mg for the next 3 weeks and 4 mg for the next 3 weeks. After that, he continued on mepolizumab and was taken off steroids. He has been followed in the clinic for the last 12 months after his discharge. His symptoms of myositis associated with EGPA have not recurred, outpatient Creatine Kinase levels have been within normal limits, and associated symptoms of eosinophilic asthma and chronic rhinosinusitis have also significantly improved. Informed consent was obtained from the patient before writing this manuscript. Discussion: Eosinophilic granulomatosis with polyangiitis, previously known as Churg-Strauss, is a subtype of ANCA-associated vasculitis characterized by necrotizing granulomatous vasculitis of the small and medium vessel arteries. Patients classically present with long-standing asthma and peripheral eosinophilia, and 30%-40% of patients have p-ANCA positivity. The mean age of diagnosis is 50 years, with equal distribution between both genders. Eosinophilic granulomatosis with polyangiitis is postulated to progress through 3 stages. Initially, an allergic prodromal phase with chronic sinusitis and asthma, which lasts for months to years, followed by an eosinophilic phase with peripheral eosinophilia and initiation of multi-organ involvement, usually involving the lung, GI tract, and cardiac tissues. The last is the vasculitis phase, which is sometimes associated with paradoxical improvement of asthma and usually presents with constitutional symptoms associated with peripheral neuropathy, usually presenting as mononeuritis multiplex, renal, and skin involvement. This is where the patient has a unique presentation; he had long-standing asthma followed by a likely trigger of the mRNA vaccine and a rapid presentation of EGPA vasculitis with mainly myositis component without significant involvement of lung, neural, cardiac, renal, or skin. A PubMed search with keywords "EGPA" AND "COVID-19 vaccine" resulted in 7 searches, out of which 4 case reports were of new onset of EGPA after COVID mRNA vaccines. For this patient, an initial pulse dose of steroids was used with a taper, and mepolizumab was tried to maintain remission. Mepolizumab is a targeted monoclonal antibody against IL-5. It was initially used for severe eosinophilic asthma, but later the MIRRA (Mepolizumab in Relapsing or Refractory EGPA) trial revealed the benefits for EGPA patients. Most of the case reports mentioned above have adequate clinical response, except the case report of Mahdi et al, where neural involvement was difficult to treat and required multiple trials of treatment. Different environmental factors can trigger EGPA such as medications, infections, allergens, and vaccines. The development of EGPA primarily involves Th2 activation, followed by Th1 and Th17 activation, and a reduced Treg response. As the disease advances, B-cell participation leads to the production of MPO antibodies and positivity for p-ANCA. COVID m-RNA vaccine encodes for the spike protein (S2-P), which is then produced by the host cells, leading to the development of both T and B-cell responses. The potential for the influenza vaccine to induce vasculitis, including large, medium, and small vessel vasculitis, has been investigated. Machado et al studied the vaccine registry of COVID-19 vaccines in rheumatological diseases; the results were largely positive, with very few rare adverse effects. Given the infrequency of EGPA and the recent introduction of mRNA vaccines for COVID-19, there is a pressing need for increased reporting of such clinical occurrences. This would not only spur further research but also aid in the development of clinical guidelines for individuals predisposed to rheumatological diseases. Given that individuals with rheumatic diseases were initially excluded from vaccine development trials, case reports play a crucial role in post-market surveillance within these patient populations. The biological plausibility of cross-reactivity or rapid activation of immune cells with B-cell and T-cell response and the temporal relationship between new mRNA vaccines and the rapid onset of EGPA is hypothesis-generating but does not establish causality.; Sender's Comments: A reasonable temporal relationship was observed between suspect product administration and worsening of asthma occurring approximately two weeks post-vaccination; therefore, a causal relationship cannot be excluded and the events of asthma/condition aggravated are considered related. However, the subsequently reported eosinophilic granulomatosis with polyangiitis (EGPA), myositis, and necrotizing vasculitis occurred in the setting of long-standing eosinophilic asthma with biopsy-confirmed EGPA and characteristic clinical and laboratory findings, providing a more likely alternative etiology. Therefore, Eosinophilic granulomatosis with polyangiitis, myositis, and necrotizing vasculitis are considered Not Related to suspect product. 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.
Eosinophilic asthma
Medical History/Concurrent Conditions: GERD; Hyperlipidemia; Myeloproliferative neoplasm; Nonobstructive coronary artery disease; Obesity
Test Name: Anti-myeloperoxidase (MPO) Abs; Result Unstructured Data: Test Result:Greater than 8; Comments: Elevated; Test Name: cytoplasmic antineutrophil antibody; Test Result: Negative ; Test Name: perinuclear antineutrophil antibody; Test Result: Negative ; Test Name: proteinase 3 Ab; Test Result: Negative ; Test Name: Antinuclear antibody (ANA); Test Result: Negative ; Test Name: biopsy findings; Result Unstructured Data: Test Result:biopsy findings of vasculitis with; Comments: associated myonecrosis (+2 points); Test Name: Temporal artery biopsy; Result Unstructured Data: Test Result:was without evidence of active vasculitis.; Comments: performed due to complaints of jaw claudication and left orbital pain; Test Name: Left deltoid and quadricep muscle biopsy; Result Unstructured Data: Test Result:consistent with necrotizing vasculitis with; Comments: granulomas containing eosinophils.; Test Name: muscle biopsy; Result Unstructured Data: Test Result:Hematoxylin and eosin-stained sections; Comments: showing presence of a single arteriole showing several surrounding lymphocytes and eosinophils and a multinucleate histocyte.; Test Name: muscle biopsy; Result Unstructured Data: Test Result:Several small arterioles within the perimysium; Comments: show mild to moderate surrounding chronic lymphold inflammation, infiltrating lymphocytes and macrophages within the vascular wall, and patchy fibrinoid necrosis.; Test Name: Alkaline phosphatase; Result Unstructured Data: Test Result:Elevated; Test Name: Creatinine kinase levels; Result Unstructured Data: Test Result:13736 IU/l; Comments: elevated; Test Name: Creatinine kinase levels; Result Unstructured Data: Test Result:4081 IU/l; Comments: down-trending; Test Name: chest radiography; Result Unstructured Data: Test Result:Normal; Test Name: C-reactive protein; Result Unstructured Data: Test Result:Greater than 19 mg/dl; Test Name: Creatine Kinase levels; Result Unstructured Data: Test Result:within normal limits; Test Name: absolute count; Test Result: 54 %; Comments: significant eosinophilia; Test Name: absolute count; Result Unstructured Data: Test Result:Greater than 10 %; Comments: eosinophilia (+5 points); Test Name: exam; Result Unstructured Data: Test Result:Eosinophilic fasciitis; Comments: was least on the differential as the patient did not have any evidence of fasciitis.; Test Name: musculoskeletal exam; Result Unstructured Data: Test Result:significant for tenderness to palpation; Comments: over proximal muscle groups bilaterally, upper and lower extremities, without any joint swelling, rashes, scalp tenderness, or enlarged vessels.; Test Name: Magnetic resonance imaging of the lower extremities; Result Unstructured Data: Test Result:diffuse patchy intramuscular edema; Comments: and enhancement throughout the anterior and posterior compartments of thigh musculature bilaterally.; Test Name: Magnetic resonance imaging of the lower extremities; Result Unstructured Data: Test Result:Magnetic resonance imaging showing edema; Comments: in the bilateral erector spinae musculature.; Test Name: comprehensive metabolic panel; Result Unstructured Data: Test Result:showed mild elevation in transaminases with; Comments: elevated alkaline phosphatase.; Test Name: erythrocyte sedimentation rate; Result Unstructured Data: Test Result:55; Comments: mm/hr; Test Name: Rheumatoid factor; Test Result: Negative ; Test Name: Transaminases; Result Unstructured Data: Test Result:mild elevation; Test Name: vitals; Result Unstructured Data: Test Result:stable; Test Name: White blood cell count; Result Unstructured Data: Test Result:29800 /mm3; Comments: leukocytosis