Initial report received from a healthcare professional on 26 March 2013. A 75 year-old-male patient, who has no known allergies and concomitant medications were not reported, had received intramuscular dose of FLUZONE HD vaccine, batch number: U4496AA (dose number and anatomical site of administration were not reported, expiry date: 04 May 2013) on 27 September 2012 at 11.39 AM. The patient had no illness at the time of vaccination. It was reported that several months ago, after receiving FLUZONE HD vaccine, the patient experienced pain all over the body, stiffness and myalgia. Severity was reported as severe. The corrective treatment and laboratory investigations were not reported. At the time of this report, the outcome was not reported. Documents held by sender: none. Follow up information received from healthcare professional on 01 July 2013. The patients concomitant medications included amlodipine, finasteride, FLOMAX, magnesium chloride, multivitamin, selenium, vitamin B6, vitamin D3, vitamin E, VYTORIN, and zinc gluconate. Patient's had no known drug allergies and no other allergies like iodine, latex, food and eggs. Patient had received flu shot vaccine on 01 October 2005, 12 October 2007, 05 January 2009, 14 September 2010, 14 October 2010 and patient also received high risk flu shot vaccine intramuscular in left deltoid region on 17 October 2011 and 27 September 2013, had received PNEUMOVAX vaccine and tetanus toxoid vaccine on 04 April 2007, had received ZOSTAVAX vaccine on 04 January 2010 all vaccines batch number were not reported. Examination on 27 September 2012, the patients blood pressure was 138/82, pulse was 76 temperature 95.8, weight 174 lbs. The patient was assessed to have renal insufficiency, benign hyperplasia of prostate, disorder of bone and cartilage, hyperlipidemia and hypertension. Constitutional the patient was not in distress. Examination on 10 September 2012, the patient presented with hypertension, hyperlipidemia, nephrolithiasis, skin basal cell carcinoma (2007), colon polyps (1195), BPH, normocytic anemia (2008), vitamin D deficiency 2012. Patient denies drinking, has history of smoking cigar for 30-35 years. The patient smokes 1 pack per day for 20-25 years and quit smoking in 1972. The patient takes less than 2 caffeinated drinks per day. The patients blood pressure was 136/78, pulse was 90 temperature 97.0, weight 173 lbs, BMI (basal metabolic index) 28.41 and height 65.5 inches. The patient had no allergy to eggs, food, iodine and latex. With Zung depression assessment, clinical global impression was: Within normal range, no psychopathology. The patient was advice to continued amlodipine VYTORIN, tamsulosin 0.4 mcg 24 hour QHS and vitamin D3. The patient had received dose of FLUZONE HD vaccine in left deltoid region. Examination on 26 March 2013: The patient had sudden onset of moderate right flank pain, nausea and vomiting. Patient had severe myalgia all over body with stiffness. The patient was recovering from right flank pain, nausea and vomiting. On 17 June 2013 patient was improving from myalgia and stiffness. The same day, the blood pressure was 138/84 and pulse was 68. 17 June 2013, the dose of vitamin D3 1000 units 1 PO QD dose was changed.