Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Mean cell haemoglobin concentration normal, Mean cell haemoglobin increased, Mean cell volume increased, Mean platelet volume normal, Metabolic function test normal
Clinical narrative: This spontaneous consumer report (initial receipt 23-Jul-2015) concerns a 66 year old male patient. The patient stated that he had received flu shot in the past but this was the first time he had a reaction like this. The patient had no medical history and did not take any concomitant medications. On 23-Oct-2014, the patient received Afluria injection (influenza virus vaccine polyvalent, batch number T53008) in the left arm. The patient did not receive any other vaccinations that day. On an unspecified date, two days after the vaccination, the patient experienced weak nerves and muscles. He had generalised weakness throughtout his entire body and all his muscles were "so sore" that his wife had to help him get out of bed in the morning. The patient described the experience as "terrible". About 10 days after the injection, the patient notified his doctor as he was not getting better. The doctor diagnosed him with Guillain-Barre Syndrome and he was told not to have the flu shot again. The patient stated that he could not do anything much for Guillain-Bare treatment besides taking acetylsalicylic acid or ibuprofen for the pain. He further stated that this was something he must suffer through because it does not go away. The patient was currently disabled. He could not work anymore and implied that he was struggling financially. The patient stopped working four months after receiving Afluria. The patient was currently doing physical therapy. He could not lift both arms above his shoulders. His physical therapy focused on his arms at the moment and then they would focus on the legs. The physical therapy maintained the muscles he had left. He did body stretches twice daily but he was not sure if that was helping but it did make his body sore. The overall outcome was reported as permanently disabled. Follow-up (01-Sep-2015): It was reported by the physician that the patient received the flu shot on 23-Oct-2014 at the hospital and not at their office. Follow-up (06-Oct-2015): The patient previously had influenza vaccine in 2008, 2009 and 2012 and tolerated them. The patient had medical history of hyperlipidemia, colonoscopy (in 2011, normal, repeat in 10 years), tobacco use (former smoker for 5-10 years) and no drug use. His concomitant medications included simvastatin, calcium with vitamin D combination, fish oil, colecalciferol, ascorbic acid, multivitamins and sertraline. On 22-Oct-2014, the patient received Afluria. It was reported that within weeks of receiving the vaccination, the patient developed widespread arm and leg weakness. The patient continued to struggle with his strength and stamina. According to the report from on 10-Nov-2014, the patients complained of soreness and weakness in muscles in both arms and legs. The patient received flu vaccine three weeks ago and the symptoms began about five days after vaccination. His neurology examination showed that the primary symptom was weakness and that the patient found it hard to get up from the squatting position. The patient had pain, mild discomfort in the proximal muscles of the arms and legs. He had no tremors. The patient complained of weakness most severe in the larger muscle groups, shoulder and proximal thighs. There was no speech abnormality or visual changes. He underwent examination for vitals which showed weight at 199.4, blood pressure (BP) at 130/82 and heart rate (HR) at 70. His neurology examination showed that the cranial nerves II-XII were normal bilaterally. The motor strength was still very strong in all tested muscles (biceps, triceps, deltoids, hip flexor and hamstrings) but the patient felt he was weaker than normal. His laboratory results showed a normal comprehensive metabolic panel except for albumin which was low at 3.3 g/dl and ALT (alanine aminotransferase) which was low at 15 IU/L. The sedimentation rate was high at 34 mm/hr. His complete blood cell count was normal except red blood cell count that was low at 3.99 M/mm3 and haemoglobin was low at 12.9 g/dl. According to the report from 04-Feb-2015, the patient followed up for GBS after flu shot on 22-Oct-2014. The patient was not bothered with little interest or pleasure in doing things or feeling down or depressed or hopeless. The patient stated that he had profound upper and lower extremity weakness that started 3-4 days of vaccine administration. There were no other corresponding changes from baseline such as fever, cough or change in gastrointestinal baseline. There was no balance or visual disturbance. His weakness was accompanied by moderate pain in the proximal shoulder girdle as well as the legs to a milder degree. The patient stated that his symptoms really did not worsen but had not improved either. There was no change in bowel or bladder function. The patient had no prior history of polyneuropathy symptoms and had never had any significant adverse effects such as this to a pharmacologic treatment. The patient had no fever, chills, rhinorrhoea, cough, headache, weakness, tingling/numbness, visual changes or dizziness. His vitals showed weight at 196, BP at 124/70, HR at 60, height 72.5 and BMI of 26.21. His general examination showed that the patient was alert and conversant with no obvious distress. The HEENT examination was normocephalic and atraumatic. The pupils were equal and reactive bilaterally (sclera anicteric). TMs were clear. Nares were patent without discharge. His oropharynx was clear with moist mucus membrane, dentition was good and neck was supple with adenopathy and thyromegaly. Heart was regular with distant tones, chest was clear throughout. The musculoskeletal showed no gross joint or spine deformity. The neurologic examination showed cranial nerves III through XII were intact grossly. There was normal tandem gait. The strength appeared to be symmetrically mildly diminished at 4/5 in the upper and lower extremities, most pronounced with grip strength, forearm extension and wrist extension. He appeared to have no asymmetric muscle wasting or significant large muscle group atrophy. The assessments showed that the patient had GBS, fatigue and malaise and polyneuropathy.  Due to fatigue and malaise, the patient was advised to discontinue simvastatin as this could confound adverse effects. His comprehensive metabolic panel was all normal accept glucose level that was high at 161 mg/dl, sedimentation rate was normal, c-reactive protein was high at 0.8 mg/dl and the complete blood count was normal accept for red cell distribution width (RDW) which was high at 15 %. According to the report from 16-Apr-2015, the patient still complained of having soreness and was having trouble sleeping. The patient had returned from 2 weeks of contract work. Due to his ongoing neuropathy symptoms, he felt that it was difficult to function well. The patient continued to perceive weakness in his arms and specifically had persistent pain in the right shoulder when abducting the shoulder, lying on the shoulder at night or during resistive lifting. The patient felt that lower extremity symptoms had remained stationary and were not all that bad. He did feel generally weak and tired more easily from the routine occupational duties. Patient had no fever or cough, no recent signs of constitutional illness or changes from baseline. His examination showed no chest pain or shortness of breath, no abdominal pain, no headache or tingling/numbness, no cough or chest congestion. He only complained of weakness. His vital signs showed weight at 203.2, BP at 112/70, HR at 64, height at 72.5 and BMI at 27.18. His general examination showed no obvious distress. Neurologic motor exam demonstrated DTRs (deep tendon reflexes) to be 1-2/4 throughout the upper extremities, 2/4 patellar bilaterally and ¼ achilles. The strength was mildly diminished with forward elevation and abduction of the shoulders bilaterally at 4/5 in comparison to 5. There appeared to be mild pectoral atrophy, deltoid and proximal upper extremity musculature appeared to be mildly atrophied. Normal tandem gait was observed. The assessment showed that the patient had rotator cuff syndrome and GBS. The patient received treatment with diclofenac sodium delayed release tablet and sodium (75 mg, 1 tablet orally, 2 times a day for 30 days). The patient was advised to start physical therapy he was highly suspected with rotator cuff injury versus tendonitis compensatory from underlying weakness. The patient was referred to physical therapist for GBS/rotator cuff tendonitis (2x/week for 4 weeks). For the management of GBS, the patient was recommended to start physical therapy, follow sensible dietary intervention and avoid excess high calorie foods, optimize his sleep and stress management. According to the report from 12-May-2015, the patient complained of neuropathy. He continued to have sluggish recovery following Guillain syndrome. General examination showed no obvious distress. The patient's assessment showed GBS and rotator cuff syndrome. According to the report from 23-Jul-2015, the patient complained about being stung by a bee on his left big toe yesterday. Within 10-15 minutes, he felt significant swelling, his groin and axillary regions became swollen and had a sensation of itching and tingling in his inguinal lymph node region. There was no airway or mouth swelling, no cough or light headedness. The patient did have a significant reaction to a bee sting on the left wrist last year. He had been on diphenphydramine for the last 12 hours with limited relief. The patient underwent a plain film X-ray of the right shoulder and neck and was reported to have arthritis. The patient felt that the shoulder mobility and strength was not improving with therapy and continued to experience pain and severely limited abduction. Dermatology examination showed swelling on left great toe. Musculoskeletal examination showed weakness in arms and legs but no myalgia. Neurology examination showed weakness. His vital examinations showed his weight at 207.8, BP at 104/60, HR at 68, height at 72.5 and BMI at 27.79. The general examination showed no obvious distress. Exam of the right shoulder demonstrated no gross atrophy or scabbing to winging. Patient had a positive apprehension test on the right with positive Neer's sign, negative O'Briens maneuver and mildly positive speed test. Yergeson's test was also positive. Examination of the left great toe demonstrated diffused interstitial swelling with small punctuate area of erythema along the tibial nail border. Pain had mild swelling up to the distal ankle. He had no tenderness in the calf or thigh, no inguinal adenopathy was palpable and no evidence of lymphangitis or cellulitis was noted. The assessments included bee sting, rotator cuff syndrome NOS, GBS, fatigue and malaise and hyperlipidaemia. The patient was treated with epinephrine (intramuscular, 0.3 mg, 0 mg, once 1 dose) for the bee sting. The patient was advised to avoid future influenza vaccinations. As the patient had ongoing fatigue and nocturnal snoring and gasping, he was recommended overnight oximetry. The patient was recommended to re-start on low-dose simvastatin (20 mg, daily) due to hyperlipidaemia. The patient had verbally reported that LDL was high. The patient reported that he underwent carotid sonogram which was reported normal after the C-spine X-ray showed evidence of calcification on plain film finding. According to the report from 22-Aug-2015, the patient's recent blood work showed stable findings with the exception of cholesterol being elevated with LDL at 160. The patient had been off the statin therapy per the physician's advice and had significant myopathy symptoms related presumptively to GBS. The patient had adopted a fairly sensible low-cholesterol diet. His carotid sonogram showed no significant carotid plaquing or thickening. The CRP level was 1.3. His right shoulder continued to be problematic. MRI confirmed presence of a partial-thickness supraspinatus and subcapularis tear with no labral tear noted. From the musculoskeletal examination, the patient complaint of back pain (upper, constant). The neurology examination showed weakness. The patient felt weak in his legs. There was no tingling/numbness. The ophthalmology showed no change in vision. His vitals showed weight at 205.2, BP at 106/68, HR at 68, height at 72.5 and BMI at 27.44. The general examination showed somewhat restricted affect. Exam of the right shoulder demonstrated no gross deformity, swelling or scapular winging. The assessments showed rotator cuff rupture, GBS, hyperlipidemia and osteoarthritis of spine nos. The treatments for rotator cuff rupture included corticosteroid injection. For GBS, the patient was recommended to stay on statin therapy due to his persistent muscle symptoms. For hyperlipidemia, the patient continued on low-dose cholesterol diet and fish oil supplements. The patient's right shoulder was prepped with sterile betadine. Using aseptic technique, 3 cc of 2% plain lidocaine was delivered to subacromial space followed by 60 mg triamcinolone which was tolerated well. According to the report from 22-Sep-2015, the patient reported lump on his shoulder. The patient had ongoing difficulty with arthralgias, myalgias and right-sided shoulder pain. The patient had nice therapeutic response to corticosteroid injection in the right shoulder about a month ago, but his symptoms were recurring. The patient also had synovial swelling. The pain across the upper back and shoulder girdle bilaterally was pronounced at times and kept him from sleeping well at night. He used ibuprofen (1 or 2 tablets daily). Additionally, the patient preferred to stay off the statin therapy during his ongoing difficulty from GBS and did not have good control on lipid profile. The constitutional, musculoskeletal and neurology examination showed generalised weakness, fatigue, joint pain, joint stiffness and back pain. His vitals showed weight at 207.2, BP at 118/60, HR at 56, height at 72.5 and BMI at 27.71. The general examination of right shoulder showed swelling over the right a.c. joint consistent with a synovial cyst. The assessments showed Guillain-Barre disease, pain in thoracic spine, rotator cuff rupture, hyperlipidaemia and synovial cyst nos. For the pain in thoracic spine, the patient received gabapentin capsules (300 mg, 1 capsule, oral, 3-4 times a day, 30 days, 60).  For the synovial cysts, the physician stated that it likely reflected underlying changes at the a.c joint and considered therapeutic aspiration versus surgical excision based on orthopaedics opinion. The outcome was reported as permanently disabled. Reporter's Comments: The reporter stated the events were related to the Afluria. The reporter assessed the causality for the events as probable to the use of Afluria. Sender's Comments: Company comments: Seriousness: Serious. Disability Listedness: Listed. According to the CSL Inactivated Influenza Virus Vaccine CCDS, all events are listed. According to the US Afluria PI, GBS is listed. Causality: Possible. Time to onset 2 days. GBS is a class effect of Influenza vaccine in general. Of note, patient had tolerated vaccination in past. Company comments 19-Oct-2015: Seriousness: Serious. Permanent disability. Listedness: Unlisted. Assessment according to the CCSI for CSL Inactivated Influenza Virus Vaccine and the Afluria Product Information. Events and diagnostic findings  surrounding the diagnosis of GBS, such as weakness, disability, muscular discomfort, increased CRP, are considered listed. Unlisted events include rotator cuff syndrome and its accompanying symptoms, diagnostics, and physical examination results, as well as spinal osteoarthritis and its accompanying findings. Causality: Possible. The overall causality is based on the evolution of symptoms relating to the diagnosis of GBS. There is temporal relationship as well as medical confirmation of the diagnosis. GBS is a known class effect for influenza vaccines. No data was provided on any preceding viral illnesses which may also be causative. The patient's clinical course also showed several other pathologies which are considered unrelated to the vaccine such as rotator cuff syndrome, dyslipidemia after discontinuation of simvastatin, spinal osteoarthritis, swelling of groin and axillary regions months after the vaccination. Causality: Possible.