Age: 37.0
Sex: M
Vaccine: FLU3
Symptoms: Seasonal allergy, Sensory disturbance, Sleep disorder, Streptococcus test negative, Thyroid function test normal
Clinical narrative: Combined initial and follow up reports received from health authority (DE-PEI-PEI2008012339) on 24 Jun 2010 and 25 Jun 2010 respectively. This patient (a physician working in the as Medicine Director/Occupation Medicine) had medical history of an occupation accident (knee trauma) with incomplete rupture of anterior cruciate ligament and meniscus rupture in right knee in Oct 1995 and was bearing a knee brace. The patient also had pollinosis, arterial hypertension (160/90 mmHg), adiposity the patient was used to regular practice of strenuous sport activities and also family history of carcinoma of prostate (patients father) and osteoporosis (patients mother). The patient was vaccinated with influenza virus vaccine seasonal (manufacturer unknown) (dose and batch number unknown) in Dec 1995. After 10 to 14 days of vaccination, the patient experienced muscle pain in upper legs and later involved lower legs and also upper arm and forearms. Laboratory tests showed progressive increases in creatine kinase (CK), lactate dehydrogenase (LDH), serum glutamic oxaloacetic transaminase (SGOT) and rheumatic factor. Muscle pain was accompanied by muscular weakness and some fibrillation in upper extremities, complaints extended from shoulders to forearms but hand muscles were not affected. Results obtained from differential diagnostic tests done in Feb 1996 excluded hepatitis and human immunodeficiency virus (HIV) infection, borreliosis, and also dysfunction of both thyroid and parathyroid glands. A moderate increase in gamma-globulin fraction in electrophoresis was interpreted as presence of chronic, inflammatory, rheumatic-illness-like process. In May 1996 and in Jun 1996, a marked muscular weakness and was experienced which rapidly induced fatigue, especially after physical activity and thorax, shoulder arms and forearms muscles were most affected. A neurological examination in Jul 1996 assessed the muscle fasciculation as being of benign nature. On 07 May 1997, a 50%-degree of disability (handicapped person) as a consequence of occupational accident was granted, which correlated with granted (established) 50% decrease in working capacity. On 13 Nov 1997, compensation for physical disadvantage G was granted to patient ("G" is given in presence of relevant impairment in walking function). In 1998, transient sensory disturbances were noticed in the affected body regions. On 11 Dec 1998, a clinical examination stated that, the patients clinical signs and symptoms in combination with the observed creatine kinase (CK) elevation are pathognomonic for collagenosis and was accordingly interpreted. Muscle biopsy for confirmation of diagnosis was regarded unnecessary, also because a falsifying impact of ongoing corticosteroid therapy on biopsy results was assumed present. Due to the poor statistical correlation antibody tests were likewise disregarded. The diagnosis of dermato-polymyositis with suspected secondary vasculitis was made and the patient was also diagnosed with vaccination-induced autoimmune disease, mononeuropathy multiplex, inflammation at ankle joint and dorsal part of feet, arterial hypertension, borderline (consecutive to degenerative vascular changes and pollinosis. Consecutive to the progressive impact on respiratory function, utilization of continuous positive airway pressure (C-PAP) mask in the night became necessary from 2001 onwards. In 2001, the patient developed swallowing disorder. Respiratory function clearly worsened since 2005 and immunological examination in May 2006 excluded seropositive chronic polyarthritis as the cause of the increased rheumatic factor levels, CRP (C-reactive protein) and erythrocyte sedimentation rate were clearly increased. Sleep laboratory tests done by specialist physician on 31 May 2006 confirmed severe sleep-related respiratory disorder and increased muscular fatigue in respiratory pump function. The specialist interpreted these results as consecutive to the patients dermato-polymyositis. On 19 May 2006, the patient made a further presentation aiming at obtaining a more favorable decision on his disability degree. The presentation requested the additional consideration of his muscular disease consecutive to vaccination and implied a new assessment. Exam was performed on 09 Jun 2006 and surgical expertise report deals with results of reassessment. The expertise mentions that, an orthopedic expertise on 04 Aug 2003, in which evidently a 50%-degree of disability established and was also considered in the reassessed information. The patient reported in anamnesis that, the continuous positive airway pressure (C-PAP) mask was being additionally utilized at noon-time, i.e. involving further oxygen insufflation. Physical examination of trunk and upper extremities revealed besides underlying adiposity a moderate muscle atrophy, more marked at the level of M.pectoralis major, bilaterally (which partially explained the respiratory impairment). Muscular tone in lower extremities was also reduced. Dysfunction in right knee joint with joint instability, which muscle performance could not fully compensate, correlated with history records. Diagnosis were (1) the expertise concluded that 50%-degree of disability fairly reflected the actual condition. With respect to the diagnosis (2), the close temporal relationship to influenza vaccine was underlined and dermatomyositis was regarded as vaccination complication. Worsening of respiratory impairment including the need for regular using of C-PAP mask was assessed in expertise as indicative for a 70%-degree of disability. However, the assessment was regarded in Expertise as still being of transient nature because of the pending evaluation of condition by patient's employer. The Expertise report of 21 Mar2007 was evidently requested by the patient's employer. The expertise was based on all the following: patient's records, the results of an ambulatory examination of 25 Jan 2007 at a hospital and the examination the expert himself performed in Mar 2007 (apparently on 20 Mar 2007). The service requested that the expertise should mainly focus on the analysis of the following two questions: (A) Was dermatomyositis causally related to influenza vaccination? (B) Was dermatomyositis to be considered as vaccination damage fulfilling the criteria of an occupational accident according to section 31 of the law? The physical examination revealed moderate muscular hypotrophy in trunk, shoulders and upper arms with particular impact on M. pectoralis major and M. deltoideus on both sides. Moderate muscular hypotrophy was assessed in upper legs, too, with erythematous spots in both legs and slight ankle edema bilateral (also evident in lower legs), adiposity, supine blood pressure was 160/100 mmHg and other clinical findings were unremarkable. On 06 Feb 2006, the patient's laboratory tests indicated, erythrocyte sedimentation rate (ESR) was 1/4 mm. On 02 May 2006, aspartate aminotransferase (GOT) was 40 U/L, creatinine was 1.3 mg/dL, C-reactive protein was 6.3 mg/dL, erythrocyte sedimentation rate (ESR) was 12/22 mm and rheumatoid factor anti Fc fragment was 230 U/ml. in Mar 2007 creatinine was 1.34 mg/dL, creatine kinase was 371 U/L and rheumatoid factor was 70 U/ml. Normal levels were found for SGOT, myoglobin, total protein, CRP, anti-extractable nuclear antigen (anti-ENA-screen), antinuclear antibodies (ANA), C3/C3c complement, C4 complement, anti-cyclic citrullinated peptides antibody, antistreprotococcal excenzyme antibodies (ASL), and antideoxyribonuclease B (ADNase B). Serum protein electrophoresis was unremarkable. The expertise conclusion was that the underlying condition was rather compatible with polymyositis than with dermatomyositis. The later on appearing sensory disturbance are suggestive of a secondary vasculitis. The questionable diagnostic value of a muscle biopsy when long-lasting corticosteroid therapy was being used had previously been emphasized (examination report of 11 Dec 1998). Likewise, determination of auto-antibodies was not always conclusive because normal levels do not exclude illness in these patients. Autoantibody increases were seen only in par of th population: ANA (50%), anti-Jo 1 (5$ in dermatomyositis, up to 30% in polymyositis), anti-ML2 (10%), anti-PmSci (10%), anti-U 1-RNP (15%), and anti-SRP antibodies (5%). Temporal relationship to influenza vaccine administration, course of symptoms and associated laboratory results let conclude that symptoms were a consequence of vaccination. Other causes appear improbable. Although complications of Influenza vaccination are rather seldom, rheumatic diseases, collagenosis and vasculitis had been described in the literature as case reports. The question whether above diagnosis was to be considered a vaccination damage fulfilling the criteria of an occupational accident according to section 31 of the law was affirmatively answered. The PEI expertise of 01 Sep 2008 was an answer to a request (possibly sent to PEI by patient's employer and evidently signed by a physician). The brief request to PEI asking for a specialized answer stated that the diagnoses listed in the patient's presentation and regarded to be vaccination complications (damage) were as follows: 1) Mixed collagenosis; 2) Polymyositis; 3) Vasculitis, secondary; 4) Sharp syndrome (no further details provided nor differentiation to Mixed collagenosis made). The request letter explicitly stated that the conclusions in above Expertise c). The PEI's answer made considerations on incidences of dermatomyositis and polymyositis in relationship to influenza vaccination presently (Sep 2008) registered in the PEI database and underlined the lack of scientific proof backing-up a causal relationship in (most) literature cases. PEI emphasized that because of the above, diagnostic test should be exhausted in all cases involving these diagnosis, i.e. far beyond the solely consideration of temporal relationship to vaccine. In the present case, a muscle biopsy together with the investigation of autoimmune complexes might have provided a clear hint for a causal relationship. Since this has not been provided, the only remaining alternative was to assess causality to vaccination as possibly related. PEI offered further feed-back if the requesting instance would wish this. The patient received concomitant therapy with Beloc zok mite and Lasix. The patient received treatment with Novalgin, magnesium, dexamethason, diclofenac and ibuprofen. The outcome of the events was not reported.