Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Muscle strain, Musculoskeletal pain, Myalgia, Myositis, Nasal congestion
Clinical narrative: Based on follow-up information received on 30 January 2015 the case was medically confirmed and it was upgraded to serious due to important medical event. Initial report received from Consumer on 19 November 2014. A 71-year-old male patient, whose medical history and concomitant medications were not reported, had received an intramuscular dose of FLUZONE HD (Batch number, expiry date, dose number was not reported) in the deltoid on 30 September 2014. On 30 September 2014, the patient had developed fever and muscle aches that spread to entire body. It was reported that the patient was evaluated 4 times by his PCP, once by a neurologist who ruled out GBS. It was also reported that the patient was just received this flu shot and was not offered the regular flu vaccine he always gets each year and never has a problem. Lab investigations were not reported and corrective treatment included steroid twice by rheumatologist. The patient required emergency room or doctor visit. The patient's illness at the time of vaccination, and pre-existing diagnosed allergies and birth defects were denied by reporter. At the time of this report, the outcome of the event was unknown. Follow-up information received from a physician on 30 January 2015. The patient received FLUZONE HD (lot number U5024BA) intramuscularly in the left deltoid on 30 September 2014. On 8 October 2014, the patient visited his physician with complaints of a cough. Vitals signs recorded are Blood pressure 130/80, Pulse rate 89, Oral Temperature 98.5 Degrees F, Height of the patient 5 Ft 8 inch, weight 163 lb, BMI 24.79 KG/M2 and oxygen saturation 97%. He noted that the cough had started 6 days after getting the Flu shot, and had been worsening. The patient also had symptoms of congestion, drainage, low grade fever of 99.9 and nasal congestion. He also complained of decreased range of motion in his right shoulder and left hip. The patient had taken ROBITUSSIN and ALEVE, with no relief. The patient had medical history of Prostate cancer in 2003 and prostate was removed, Achalasia in 2004, the patient had nephrolithiasis in 1984, Colonoscopy in 2007, Gout, Actinic keratosis and hyperlipidemia. The patient had undergone lithotripsy on 1 May 1984, Rotator Cuff repair in left shoulder Jan 2001, Prostate surgery and the prostate removed on 2 Jun 2003. The patient had allergies to CRESTOR, pravastatin and simvastatin. The physical examination of the patient revealed decreased abduction of left shoulder and decreased external rotation and flexion of left hip. At the visit physician prescribed CHERATUSSIN AC 10-100 mg/5 ml syrup. Concomitant medications included the following: Vitamin D-3 2,000 unit PO Cap, OSTEO BI-FLEX 1,500-400-100 mg-unit-mg PO Tab, Omega-3-OHA-EP-Fish Oil 300-1000 mg PO cap, CENTRUM SILVER PO Tab, B complex vitamins PO Tab, Magnesium 250 mg PO Tab, aspirin 81 mg PO tablet, ZYLOPRIM 300 mg PO tablet, COLCRYS 0.6 mg PO tablet, CALCIUM with VITAMIN D PO. The patient diagnosed with cough, right shoulder pain and groin strain. On 21 October 2014, the patient visited to physician for ongoing cough. Vitals signs recorded are Blood pressure 128/60, Pulse rate 86, Oral Temperature 98 Degrees F, Height of the patient 5 Ft 8 inch, weight 164 lb, oxygen saturation 97% and BMI 24.98 KM/M2. The patient also had symptoms of congestion, drainage, low grade fever of 99.9 and nasal congestion. The patient received CHERATUSSIN and ALEVE, with mild relief. He also complained of body aches, "doesn't want to walk due to the pain, denied any actual weakness". A C-reactive protein was 26.6 mg/L, and erythrocyte sedimentation rate was 31 mm/hr. On 19 November 2014, the patient visited to physician for generalized body pain. Vitals signs recorded are Blood pressure 128/70, Pulse rate 97, Oral Temperature 98.1 Degrees F, Height of the patient 5 Ft 8 inch, weight 162 lb, oxygen saturation 98% and BMI 24.69 KG/M2. The patent presented with body aches which he noted had started 3 hours ago after getting the Flu injection. The problem had been worsening. The patient also had symptoms of weakness, low grade fever of 99.5, cough and chills. The patient received TYLENOL and MOTRIN, with mild relief. He had pain in his right shoulder where he was noted to previously have had a rotator cuff tear. He saw a neurologist who didn't feel this was GBS and he also saw his Rheumatologist who gave him a steroid shot. He was having a lot of aches, doesn't want to walk due to pain also denies any actual weakness. At the visit physician prescribed TAMIFLU 75 mg Capsule and MEDROL PAK 4 mg tab. C-reactive protein was 43.4 mg/L, and erythrocyte sedimentation rate was 28 mm/hr. On 8 December 2014, the patient visited to physician for Muscle pain. Vitals signs recorded are Blood pressure 144/76, Pulse rate 70, Oral Temperature 98.2 Degrees F, Height of the patient 5 Ft 8 inch, weight 162 lb, oxygen saturation 97% and BMI 24.69 KG/M2. The Patient presented with body aches which was started 3 hours ago after getting the Flu injection. The problem had been worsening. The patient also had symptoms of weakness, low grade fever of 99.5, cough and chills. The patient felt the best when he was on the Steroids. At the visit physician prescribed OELTASONE 10 mg tablet. The physician assessed myalgia and myositis. C-reactive protein was 59.4 mg/L, and erythrocyte sedimentation rate was 42 mm/hr. On 29 December 2014, the patient visited to physician for follow-up. Vitals signs recorded are Blood pressure 140/82, Pulse rate 98, Oral Temperature 98.3 Degrees F, Height of the patient 5 Ft 8 inch, weight 165 lb, oxygen saturation 96% and BMI 25.19 KG/M2. "Patient is here today to discuss his reaction to the flu shot. He was hospitalized for a few days two weeks ago and wanted to discuss treatment options. He stated the prednisone has helped." On the 10th his prednisone was increased to 40mg. The physician assessed Polymyalgia rheumatic, Gout and Chronic kidney disease (CKD), stage III (moderate) received ZYLOPRIM 100 mg tablet. The patient discontinued with ZYLOPRIM 300 mg PO tablet. List of documents held by sender: Physician office notes, influenza vaccine information, lab records.