Sex: F
Vaccine: COVID19
Symptoms: Red blood cell sedimentation rate, SARS-CoV-2 test, Weight
Clinical narrative: Anti-MDA5 dermatomyositis; progressive dyspnea; polyarthralgia; This is a literature report.  A 51-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COVID-19 infection" (unspecified if ongoing), notes: Six months prior; "organizing pneumonia" (unspecified if ongoing); "subsegmental pulmonary embolism" (unspecified if ongoing); "intubation" (unspecified if ongoing), notes: for 4 days. The patient's concomitant medications were not reported. Past drug history included: Methylprednisolone for COVID-19, notes: IV pulse for 1 week; Steroid, notes: oral steroid taper. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunisation. The following information was reported: DERMATOMYOSITIS (medically significant), 7 days after the suspect product(s) administration, outcome "recovered", described as "Anti-MDA5 dermatomyositis"; DYSPNOEA (non-serious), 7 days after the suspect product(s) administration, outcome "recovered", described as "progressive dyspnea"; ARTHRALGIA (non-serious), 7 days after the suspect product(s) administration, outcome "recovered", described as "polyarthralgia". The patient underwent the following laboratory tests and procedures: Antinuclear antibody: negative; Aspartate aminotransferase (normal high range 35): 64 IU/l; Blood creatine phosphokinase: normal; Complement factor: normal; Computerised tomogram thorax: showed significant improvement in the OP pattern p, notes: previously seen; showed a worsening appearance of OP pattern with, notes: mediastinal lymphadenopathy (Fig. 6); C-reactive protein (normal high range 5): 6.8 mg/l; Full blood count: normal; extended myositis panel: strong-positive for anti-MDA5 and anti-Ro52; Metabolic function test: normal; Mycobacterium tuberculosis complex test: negative; physical examination: noteworthy for Gottron's papules over bilateral, notes: MCPs with ulcerations, heliotrope rash, holster sign over bilateral thighs, and Shawl sign which were all suggestive of a dermatomyositis rash (Fig. 6). She also had active synovitis over bilateral knees and wrists; rest of the physical exam was unremarkable; Pulmonary function test: revealed fine crepitations over bilateral mid-to-, notes: lower lobes; which showed a restrictive pattern (FVC 44%, FEV1/, notes: FVC 89%); Red blood cell sedimentation rate (0-20): 73, notes: mm/h, elevated; SARS-CoV-2 test: negative; Weight: loss 13, notes: over 3 months. Therapeutic measures were taken as a result of dermatomyositis, dyspnoea, arthralgia.  Clinical course: The patient developed a photosensitive rash over her face, neck, knuckles, and thighs as well as polyarthralgia and progressive dyspnea 1 week after the 2nd dose of the Pfizer (BNT162b2) COVID-19 vaccine. She received the 1st dose 28 days prior without any complications. Six months prior she was diagnosed with COVID-19 infection complicated by organizing pneumonia (OP) and subsegmental pulmonary embolism. During her hospitalization for COVID-19, she required intubation for 4 days as well as IV pulse methylprednisolone for 1 week. She improved and was able to be discharged on an oral steroid taper with follow-up in the respiratory clinic. A repeat high-resolution CT (HRCT) chest 5 months later showed significant improvement in the OP pattern previously seen. She symptomatically improved over several months and was able to return to her normal routine (until the symptoms after vaccination started). The rash over her bilateral knuckles progressed to painful ulcerative lesions accompanied by fingertip ulcerations. She later developed a loss of appetite with a 13 lb weight loss over 3 months. She denied any muscle weakness or difficulty swallowing. At the time of the rheumatology visit, her physical examination was noteworthy for Gottron's papules over bilateral MCPs with ulcerations, heliotrope rash, holster sign over bilateral thighs, and Shawl sign which were all suggestive of a dermatomyositis rash. She also had active synovitis over bilateral knees and wrists. Lung examination revealed fine crepitations over bilateral mid-to-lower lobes. There was no muscle weakness, peripheral edema, or lymphadenopathy noted. Complement levels were normal. A repeat COVID-19 PCR was also negative. An extended myositis panel was strong-positive for anti-MDA5 and anti-Ro52. A thorough infectious workup was negative including tuberculosis (TB). She was subsequently diagnosed with MDA5-associated CADM with RP-ILD and initiated on prednisolone 1 mg/kg (60 mg daily). Since being diagnosed, she has undergone 4 out of 6 cycles of cyclophosphamide 0.6 g/m2 (monthly) in view of RP-ILD while tapering oral prednisolone. Immunosuppression was held recently in light of a soft tissue infection requiring incision and drainage, however, she has had marked improvement in terms of muscle weakness (MRC score decreased from 4 to currently 1). She is scheduled for repeat HRCT and PFT once her infection resolves.; Sender's Comments: Based on the information in the case report, a possible causal relationship between reported events and suspect drug BNT162B2 cannot be excluded. 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.,Linked Report(s) : US-PFIZER INC-PV202200000729 Same article/drug/event, different patient;