Age: 57.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Prothrombin time prolonged, Pulmonary function test normal, Pyrexia, Red blood cell count normal, Red blood cell sedimentation rate normal
Clinical narrative: Based on the follow up information received on 19-Feb-2015, the case is now medically confirmed. Initial unsolicited report received from a non healthcare professional (corrected) on 14 May 2014. A 57-year-old male patient had received a dose of FLUZONE, (batch number UH486AA, dose number and route of vaccination not reported) in left deltoid on 18 November 2011. The patient's illness at the time of vaccination was not reported and had no known allergies. On 18 November 2011, same day after vaccination, the patient presented fever, joint pain, muscle fatigue, muscle spasms and muscle atrophy. Corrective treatment and laboratory details were not reported. At the time of this report the outcome was unknown. Documents held by sender: none. Follow up information received on 19-Feb-2015, from a physician. The patient had received FLUZONE vaccine in the left arm. Expiry date for the vaccine is 30-Jun-2012. The patient had a medical history of acute upper respiratory infections of unspecified site, vertigo, acute bronchitis, extrinsic asthma unspecified, allergic rhinitis cause unspecified, spasm of muscle, acute pharyngitis, lumbago and sciatica. There were no known allergies. The prescriptions included ZITHROMAX Z-PAK 250 mg Tab, take 2 tablets (500 mg) by oral route daily for 1 day then 1 tablet (250 mg) by oral route once daily for 4 days, diagnosis description: Acute Pharyngitis. LIDODERM 5% (700 Mg/Patch) adhesive patch, apply 1 patch by transdermal route once daily (may wear up to 12 hours). SKELAXIN 800 mg tab, take 1 tablet (25 mg) by oral route once daily. TOPROL XL 25mg 24 hour tab, take 1 tablet (25 mg) by oral route once daily. Follow-up information received from a physician on 17 June 2015. Medical history included diabetes, heart disease, lump in left arm, lipomas were prominent (painful on manipulation), exercise intolerance, back issues, bone marrow biopsy (1996), right pleural effusion (1997), calf tightness (1999), hay fever allergy, skin allergy to bandages, gastroesophageal reflux disease, two thyroid nodules, thoracentesis (revealed due to high eosinophils), hernia repairs when the patient was a baby, tonsillectomy when the patient was a child. Family history included mother's death at the age of 67 due to atherosclerotic heart disease, diabetic, elevated blood pressure and congestive failure, father's death at the age of 81 due to heart disease, one brother and sister had cardiac disease, CPT II deficiency in one son, two other sons had anaphylactic allergies. Social history included alcohol assessment which was reported as low risk, tobacco assessment and substance abuse assessment was reported as never. It was reported that the patient had GI upset while on Levofloxacin during a visit of 06 March 2014 and stomach issues while on LEVAQUIN during a visit on 21 April 2014 at 13:06 hours. Concomitant medications included CYMBALTA 60 mg daily, FLOMAX 4 mg, DEXTRIN 60 mg daily as needed, NASONEX 2 sprays to each nostril daily, SINGULAIR 10mg daily, TYLENOL 2 tablets every 4 hours as needed for pain control, Vitamin C 500 mg once daily, Aspirin 81 mg daily, Azithromycin 250 mg tablets (uses 500 mg) once daily as needed, DEXILANT 60 mg daily, ADVIL 400 mg every 6 hours as needed for pain control or fever control, Acidophilus one capsule daily, FLOMAX 0.4mg tablets once daily, prednisone 10 mg as needed, CoQ-10, ADVIL, KLONIPIN, Magnesium and ANDROGEL. On 06 March 2014 (date of visit), it was reported that the patient was on following medications- Acidophilus 1 capsule orally three times a day, ADVIL 400 mg (take 2 tablets of 200 mg) orally as needed, ALLEGRA 180 mg orally one time daily, Aspirin baby 81 mg orally one time daily, DEXILANT 60 mg capsule orally one time daily, FLOMAX 0.4 mg orally once a day, Magnesium 750 mg orally, METAMUCIL 5 ml orally once a day as needed, NASONEX 50 mcg (actuation spray 2 sprays) nasally once a day, SINGULAIR 10 mg tablet orally every hour, TYLENOL 325 mg tablet orally as needed. On 21 April 2014 (date of visit), it was reported that the patient was on Acidophilus 1 capsule orally one time daily, Aspirin enteric coated low strength tablet 81 mg 1 tablet every morning (stopped on 17 June 2012), ADVIL 200 mg tablet 3 tablets orally two times a day as needed (was taking 1-2 times per week while playing golf), ALLEGRA 1 tablet orally one time daily, Azelastine 0.05 percent (1 drop ophthalmic as needed for allergies), calcium 600 (1-2 tablets) orally one time daily, coconut oil topically one time daily. Coenzyme Q-10 tablet by oral route (200-400 mg) daily, CYMBALTA 30 mg (enteric coated) 1 capsule orally every morning, DEXILANT 60 mg 1 capsule orally one time daily, FLOMAX 0.4 mg capsule sustained release 24 hour 1 capsule orally at bedtime, GAMMAGARD liquid injection 120 mg intravenously once a month, METAMUCIL powder 1 tablespoon daily by oral route, NASONEX 50 mcg (actuation spray 2 sprays nasally every evening as needed), Prednisone 750 mg, SYSTANE balance 1 drop ophthalmic as needed for allergy symptoms, TYLENOL extra strength 500 mg tablet orally as needed for neck pain, Vitamin D3 1000 unit tablet (1 tablet) orally one time daily, Vitamin D3 2000 unit tablet (1 tablet) orally every morning. On 02 July 2014 (date of visit), it was reported that the patient was on DEXILANT 80 mg capsule orally from 03 November 2012 to 02 July 2014, Fluconazole 100 mg tablet orally from 04 July 2013 to 02 July 2014, Fluticasone propionate 50 mcg/actuation from 04 July 2013 to 02 July 2014, Montelukast sodium 10 mg tablet orally from 27 September 2012 to 02 July 2014. It was reported that the patient had sigmoidoscopy and esophagogastroduodenopathy on 16 March 2015 (age at the time of procedure was 61 years). On 18 November 2011, the patient became febrile with fever (102.5 to 103) / fever till 103 at night after vaccination. On an unspecified date, two to three weeks after vaccination, the patient had difficulty writing/finger cramping with problems writing, cramping pain in hands, weakness of forearm and hands/weakness of the arms and legs, shoulder weakness. On an unspecified date in 2011, one month after vaccination, the patient developed mild Guillain-Barre syndrome which might be evolved due to chronic inflammatory neuropathy, Lyme disease and Babesia infections (latency unknown). On an unspecified date in 2011, the patient had atrophy in his feet and in areas of shoulders, scapulae and interosal muscles of hands and calves, fasciculations and muscle discomfort following prolonged activity and exercise, easy muscle fatigability, generalized fatigue, generalized joint achiness, muscle soreness. On an unknown date, the patient had shortness of breath, flattening of the throat, hissing in his ears, chronic fatigue syndrome, mild sensory or sensory predominant peripheral neuropathy/stocking-glove sensory loss, joint pain, numbness in his hands/numbness in hands and feet, benign fasciculation syndrome/muscle twitching, difficulty walking/difficulty climbing the stairs, jaw stiffness, hissing in the ears, obstructive sleep apnea, in situ melanoma of skin,, actinic keratosis / left ear and left temple, amyotrophic lateral sclerosis/ progressive muscular atrophy, arthropathy, anxiety, anterior chest wall pain, asthma, cervical disc disease, chronic allergic rhinitis/ rhinitis NOS, constipation, dyspnea, erectile dysfunction, generalised spinal muscular atrophy of late onset, gastroesophageal reflux disease, insomnia, multiple thyroid nodules, obesity, muscular fatigue, myalgia, myositis, myoglobinuria, urinary frequency and urgency, pain in right neck, decreased reflexes in the upper extremities, autoimmune motor sensory neuropathy, head movements abnormal, factor XI deficiency. It was reported that muscle biopsy showed mild non-specific findings (i.e rare atrophic fibres, highly atrophic nuclear cluster fibres, possible mild increase in small droplets and small number of COX-deficient fibres). On an unknown date, the patient was diagnosed with sensory polyneuropathy. In February 2012, the patient was diagnosed with idiopathic sensory neuropathy. In May 2012, the patient had significant exercise intolerance, difficulty walking and shortness of breath. In July 2012, the patient had atrophy, fasciculations, crunchy toes (kind of tightness), mild diffuse atrophy of the musculature of the pelvis, thighs and lower legs. In October 2013, the patient had marked exercise intolerance. In November 2012, the patient was diagnosed with motor neuron disease. On an unspecified date in 2013, the patient was diagnosed with chronic inflammatory demyelinating polyradiculoneuropathy. Other laboratory investigations included Electromyography (EMG) which showed a sensory polyneuropathy, MRI of legs that showed atrophy in his calf muscles, brain MRI which showed small vascular malformation right frontal lobe, Partial thromboplastin time was abnormal, creatinine kinase: high. Laboratory investigations included blood DNA analysis which showed CPT II deficiency, aspartate aminotransferase (AST): 60, alanine aminotransferase (ALT): 78, lactate: 2.7 mm, serum creatinine kinase (CK): 3280 u/l. On an unknown date, the patient had blood pressure: 124/80, pulse: 80, respirations: 16. In 2012, the patient had ELISA testing for Lyme which was normal. On 31 January 2012, the patient had Western blot test which showed several IgG and IgM antibodies. In July 2012, creatinine kinase was 1450 (elevated). In October 2012, creatinine kinase was 1500 after exercise. In November 2012, Lyme western blot test was positive. In September 2013, the Lyme antibody, Western blot, Complete blood count (CBC), blood metabolic profile (BMP), rheumatoid factor (RF), thyroid stimulating hormone (TSH), angiotensin-converting enzyme (ACE), C-Reactive protein test (CRP), erythrocyte sedimentation rate (ESR), anti-nuclear antibody (ANA) were normal. On 06 March 2014, blood pressure: 130/83, pulse rate: 77, temperature: 98.1 Fahrenheit. On 21 April 2014 at 12:44 hours, body surface area (BSA): 2.4991 square meter, body mass index (BMI): 34.55 kg per square meter, blood pressure: 125/72 mmHg (single reading, left arm sitting), pulse rate: 77 per minute. On 14 April 2014 at 13:26 hours, the following tests were performed- sodium level: 141, potassium level: 4.0, chloride level: 101, CO2 level: 25, glucose level: 73 mg/dL, BUN: 12 mg/dL, creatinine: 1.24 mg/dl, BUN/Creatinine ratio: 10, eGFR: 72, eGFR Non: 62, calcium level: 9.1 mg/dL, bilirubin total: 0.6 mg/dL, alkaline phosphatase: 59 IU/L, AST/SGOT: 16 IU/L, ALT/SGPT: 23 IU/L, protein total: 7.6, albumin level: 4.2, globulin: 3.4, A/G ratio: 1.2, vitamin K1 level: 2.73 ng/ml (high), albumin electro: 3.8, globulin electro: 3.6, A/G ratio electro: 1.0, alpha 1: 0.2, alpha 2: 0.6, beta 1: 0.9, gamma: 2.1 (high), M-Spike: not observed, total creatinine kinase: 91 U/L, thyroglobulin Ab: 36.0 IU/mL (high), thyroid peroxidase Ab (TPO): 70 IU/ml (high), urine microalbumin: less than 3.0 ug/mL, urine protein: less than 4.0 ug/mL, urine albumin: 100.0 percent, urine alpha 1: 0.0 percent, urine alpha 2: 0.0 percent, urine beta: 0.0 percent, urine gamma: 0.0 percent, U M Spike: not observed, WBC: 4.4 x 10E9/UL, RBC: 5.19 x 10E6/UL, Hgb: 15.2, Hct: 44.9 percent, MCV: 87 fL, MCH: 29.3 pg, MCHC: 33.9, RDW: 14.0 percent, platelet: 157 x 10E3/UL, auto lymph: 31 percent, auto neut: 56 percent, immature granulocytes: 4 percent, auto monocytes: 8 percent, auto eosinophils: 1 percent, auto basophils: 0 percent, lymphocytes: 1.4 x 10E3/UL, neutrophils: 2.5 x 10E3/UL, monocytes: 0.4 x 10E3/UL, eosinophils: 0.0 x 10E3/UL, basophils: 0.0 x 10E3/UL, NRBC: not valued, immature cells: not valued, Aba immature gran: 0.2 x 10E3/UL (high), hematology comments: not valued, PT: 10.1 seconds, PT: 12.6 seconds, INR: 1.0 ratio, INR: 1.0, APTT: 46.6 seconds (high), APTT: 34 seconds (high), APTT 1:1 NP: 33.6 seconds, APTT 1:1 NP: 64.1, APTT 1:1 saline: 64.1, thrombin time: 19.4 seconds, factor VIII: 249 percent, von Willebrand factor Ag: 343 percent, von Willebrand factor activity: 289 percent, urinalysis color: yellow, urinalysis appear: clear, urinalysis pH: 6.5, urinalysis specific gravity: 1.009, urinalysis glucose: negative, urinalysis glucose conf: not valued, urinalysis bilirubin: negative, urinalysis ketones: negative, urinalysis blood: negative, urinalysis protein: negative, urinalysis nitrite: negative, urinalysis urobilinogen: 0.2, urinalysis WBC est: negative, dRWT Sorn: 51.6 seconds, dRWT confirmation: TNP seconds, dRWT ratio: TNP ratio, platelet neutralization: 0.6 seconds, hexagonal phospholipid neutralization: 0 seconds, B2-Glycoprotein IgA: less than 10, B2-Glycoprotein IgG: less than 10, B2 Glycoprotein IgM: less than 10, Anticardiolipin IgG: less than 10, Anticardiolipin IgM: less than 10. On 25 April 2014, urine organic acid, acylcarnitine panel, methylmalonic acid, p-ANCA, c-ANCA, myeloperoxidase, and PR3, TSH, serum protein, immunofixation, pyruvate, B12, folate, hemoglobin A1C, respiratory and cardiac response to exercise were normal, lactate: 1.2 and creatinine kinase: 193 and the values after exercise were 6.9 and 205 respectively which was within normal limits, pulmonary function testing revealed normal spirometry, normal maximal respiratory pressures and normal diffusion capacity. On 29 April 2015 at 13:05 hours, the following test were performed- C-Reactive protein (CRP): 3.5 mg/L, total CK: 138 U/L, cholesterol: 195 mg/dl, HDL: 53 mg/dl, LDL calcium: 109 mg/dL (high), VLDL: 33 mg/dl (high), triglyceride: 167 mg/dL (high), lipid comment: not valued, sedimentation rate: 5 mm/hr, ANA: negative, Sjogren's Anti SS-A: 0.3, Sjogren's Anti SS-B: less than 0.2, Anti-Jo-1: less than 0.2, rheum fact interp: 8.3 IU/mL. On 03 May 2014, Biodex test was normal. On 03 June 2015 at 10:37 hours, the patient's vital signs such as systolic blood pressure: 122 mmHg, diastolic blood pressure: 74 mmHg, mean arterial pressure: 90 mmHg checked and body surface area (BSA): 2.56 square meter, body mass index: 32.86 kg/square meter. On 21 May 2014 at 9:51 hours, myotonic dystrophy type 2 found negative, muscle-specific receptor tyrosine kinase (MuSK) found negative, elevated LFT's with normal bilirubin, lactate: 2.7, complete blood count (CBC) was normal, creatinine kinase was 3280. The patient was prescribed with ALLEGRA 180 mg tablet orally (30 tablets, 0 refills) daily; DEXILANT 60 mg capsule (delayed release) orally (30 capsules, 0 refills) daily; Aspirin 81 mg tablet orally (30 tablets, 0 refills). The corrective treatment also included Probiotic formula 1 capsule orally (0 refills) daily; tamsulosin 0.4 mg 1 capsule daily by oral route (0 refills), L-carnitine 330 mg three times a day. The patient was treated with antibiotics for Babesia infections, BACTRIM 2 tablets by oral route every 12 hours for Lyme disease, and with aspirin and TYLENOL for fever. In February 2012, the patient began taking B6 at 100 mg daily and stopped in May 2012 as B6 level was elevated. In July 2012, the patient was treated with prednisone 60 mg for creatinine kinase elevation. In October 2012, the patient was prescribed with prednisone 60 mg daily for 10 days for creatinine kinase elevation. The patient was treated with Doxycycline and Azithromycin from January 2011 to June 2013. From 10 September 2013, the patient was treated with Intravenous immunoglobulin (IVIG) [5 monthly infusions 120 gm]. The patient had stopped from February - June 2014. Upon medical review, the case was considered as serious due to important medical event: sensory polyneuropathy; muscle atrophy in his feet and in areas of shoulders; scapulae and interosal muscles of hands and calves; muscle spasms; muscle fatigue; joint pain; muscle soreness; muscle pain in chest and in back / anterior chest wall pain / finger cramping / cramping pain in hands; generalized fatigue; chronic fatigue syndrome; mild sensory or sensory predominant peripheral neuropathy / autoimmune motor sensory neuropathy; numbness in hands and feet; benign fasciculation syndrome / muscle twitching; difficulty walking; jaw stiffness; myositis, arthropathy; weakness of forearm and hands / weakness of the arms and legs, shoulder weakness; decreased reflexes in the upper extremities; myoglobinuria; urinary frequency and urgency; urinary urgency; Guillain-Barre syndrome; in situ melanoma of skin; Lyme disease / Babesia infection. Documents held by sender: None.