Age: 71.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Asthenia, Biopsy prostate, Colonoscopy abnormal, Immediate post-injection reaction, Injection site nodule
Clinical narrative: This is a spontaneous report from a contactable consumer, from a contactable physician and from a contactable nurse who reported on behalf of the physician. A 71-year-old male patient received on 18Nov2014 at around 15:30 first dose of PREVNAR 13 (Batch/Lot J23863, Exp 30Nov2015) intramuscular in right deltoid at 0.5 ml single (over age 65); on the same date he also received FLUZONE (Lot U1198AD) intramuscular on left deltoid (number of previous doses was reported as <4). Medical history included Dupuytren's contracture in the hand (he did not take any medication for Dupuytren's contracture), ongoing acute foot pain, acute recurrent maxillary sinusitis; amnesia memory loss; arm weakness; benign pigmented nevus; chemical conjunctivitis; hematuria; hemorrhoids; infectious eczematoid dermatitis; injury of the ulnar nerve; male erectile disorder, marital problem, mixed hyperlipidemia, neck pain, prediabetes, prostate cancer diagnosed Jan2000 - had radical prostatectomy 2/2000 (Gleason score 6; PSA at diagnosis 6.3), seborrheic dermatitis of the scalp, tension type headache (occipital, muscular tension), tooth pain, ulnar nerve lesion, ulnar nerve palsy, vertigo, injury of deltoid region, sciatica, history of sprain of ankle (L ankle sprain Achilles strain), tinea corporis, rotator cuff tendonitis (improving) and transurethral resection of prostate (TURP) 29Nov2001. Past surgical history included colonoscopy (fiberoptic) 1 polyp of unknown pathology on 27Jan2009 and repeated it in 2014. The patient's concomitant medications included: aspirin 81 mg oral 1 tablet daily; Omega-3 1000 mg oral 1 capsule twice daily; pomegranate extract powder 800 mg twice daily; soy isoflavones 0.5 capsule twice daily; vitamin D3 10000 unit oral capsule; hydrocortisone 2.5 % external cream to apply sparingly to affected area twice daily; CLARITIN 10 mg oral 1 tablet at bedtime; reservatrol capsule; CIALIS 20 mg oral 1 tablet daily 1 hour before needed; AVODART 0.5 mg oral alternate day (3 capsule); creatine 5000 mg oral; ubiquinol 100 mg oral capsule; metformin HCl 500 mg oral 1 tablet twice daily; CRESTOR 20 mg oral tablet. The patient five or six years before this report received as immunization a dose of PREVNAR. On 18Nov2014 immediately after injection, the patient started experiencing a severe pain in arm, it continued to sore and aches a lot, and two of days after the vaccination it got worse and symptoms progressed: patient had knot at site and loss of strength and cannot raise arm above shoulder height. The patient mentioned that when he tried to raise his arm about to his head it "stretched and straighten his muscles". The patient then said the pain did not go away, it was constant, not greater then prior. The physician visited the patient for arm pain on 01Dec2014: he referred right arm swelling and lab tests showed: Blood pressure (BP) 110/62 mmHg, Heart rate (HR) 70 b/min, Respiratory rate: 18 r/min, temperature: 98 F, Height: 71.5 in, Weight: 176 lb, BMI: 24.21 kg/m2, BSA Calculate: 2.01. Physical Examination: well appearing and no acute distress, right arm upper large 5 cm area of firmness that was tender to palpation; Hand normal in strength, wrist and forearm normal; elbow normal; right shoulder lower than left, painful movement with extension, abduction and overhead raising; weakness observed upper arm. Prescribed prednisone 20 mg oral 3 tablet daily after meals for three days then 2 days for three days then 1 daily for three days if needed. Planned to make an appointment with physical therapy and consider neurologic exam/studies. The physician visited the patient for arm pain on 10Dec2014. The patient referred pain in arm better, but no longer needs pain meds to sleep. Arm was still swollen but improved, he could lift arm to 90 degree to perpendicular from body (previously 45 degree). The area was painful to touch. No radiating pain and no shooting pain. Vital signs on 10Dec2014 at 12:21 PM showed BP: 128/68 mmHg and Respiratory rate: 18 r/min. Physical examination: well appearing and no acute distress, right arm still has large 5 cm area of firmness in deltoid region, but no longer tender to palpation; no palpable calcifications/bony lesions, and it moved independent of bone beneath; active motion stops due to pain/stiffness at 90-100 degrees; hand, wrist and forearm with normal strength and sense, reflexes normal, pulses normal; shoulder: non tender at joint shoulder; no redness/swelling; left upper extremity (LUE) and neck normal. Planned therapy: walked down and arranged appointment in the next few weeks with goals of increasing mobility, decreasing inflammation; used NSAID during the prednisone therapy with food. The physician reported allergy to PREVNAR 13. The events recovered on 14Jan2015. The event did not result in an emergency room or doctor visit. The physician previously reported this adverse event to doctor (VARS) to manufacturer. The physician was provided with the information regarding the adverse events by the patient and could confirm the occurrence of the events reported by the patient. Follow-up (28Jan2015): New information received from a contactable physician includes: PREVNAR 13 manufacturer, Batch/Lot expiration date, anatomical location, route; no PREVNAR 13 previous doses; concomitant medications; no emergency room or doctor visit; medical history; Past surgical history, Concurrent conditions; course of events; physician visit; lab tests; Planned therapy; reporter informed regarding the adverse events; reporter confirmation; physician reported adverse event to doctor (VARS). Follow-up (09Mar2015): New information received from a contactable nurse who reported on behalf of the physician includes: vaccine details, concomitant vaccine.