Sex: M
Vaccine: PPV
Symptoms: Peripheral swelling, Product administered at inappropriate site, Purulence, Red blood cell sedimentation rate increased, Rotator cuff syndrome
Clinical narrative: Immune-mediated inflammatory reaction/ causing and/or exacerbating an inmmune response; Loss of userange of motion in the right shoulder joint/ decreased mobility; Rotator cuff injury/tear; right shoulder injury; Musculoskeletal injuries; Damage to his nerves and nervous system; Shoulder injury resulting from vaccine administration ("SIRVA"); Pseudoseptic arthritis of the right shoulder/ The patient sustained injury/ Aseptic inflammatory arthritis; Lack of immunity/failed pneumococcal vaccine administration; improper administration of a PNEUMOVAX23 into right shoulder; This initial spontaneous report was received from a lawyer regarding a case in litigation involved a pharmacy, referring to a patient of unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 04-OCT-2018, the patient was vaccinated with pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) in right shoulder for prophylaxis (strength, dose, route of administration, lot#, and expiration date were not reported). The patient sustained injury as a result of alleged improper administration of pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) vaccine (incorrect route of product administration). Also, the patient claimed based on the alleged defective design and manufacture (poor quality product administered, product quality issue, product design issue and manufacturing issue) of the pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23). The outcome of injury was not recovered and for poor quality product administered, product quality issue, product design issue, manufacturing issue and incorrect route of product administration was not reported. The reporter considered injury to be related to pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23).  Follow up (F/U) information was received on 21-OCT-2020, from a lawyer regarding a case in litigation involved a pharmacy, concerning an adult male patient. Pt was prescribed pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) by physician the same date of vaccination. The patient was vaccinated with pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) in the right arm. On the evening of Thursday 04-OCT-2018 (reported as after received the pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23)), the patient suffered a severe and permanent injury to his right arm/shoulder required surgery, inpatient rehabilitation, future care and therapy, and permanent loss of function. The patient began had pain/discomfort in his right shoulder, he called to pharmacy and indicated that shoulder pain was normal and that he should use ice. On Sunday 07-OCT-2018, patient had increased and significant pain and discomfort in his right shoulder and he went to pharmacy where he was advised to take acetaminophen (TYLENOL) and ice. On Monday 08-OCT-2018, he went to a hospital with complaints of inter alia, right upper extremity pain and swelling, upon examination in the Emergency Department (ED), he was found to had swelling in this right deltoid and his acromioclavicular joint was tender to palpation, fluid collection presented in the area of his right shoulder, slight erythematous color of upper arm to clavicle, a laboratory data evidenced an elevated sedimentation rate and c-reactive protein rate. Therefore, an orthopedic surgeon was consulted. It was reported, an aspirated synovial fluid was performed and the fluid was noted to be yellow and turbid and had a white blood cell count of 82000 with 94% polys (neutrophils) and was believed to had septic arthritis, the aspirated synovial fluid was sent to be cultured, but not revealed growth of any bacteria/pathogen. Magnetic resonance imaging (MRI) with and without contrast showed inter alia, a large amount of fluid in the subacromial/subdeltoid burse bursa with less pronounced fluid in the glenohumeral joint and extensive synovial thickening and enhancement that was concerning for post vaccination synovitis. The patient was taken to the operation room this same date, for incision and drainage of superficial and deep abscess and the diagnosis at the time was to be shoulder septic arthritis. During the procedure, physician noted that there were pus collections and a massive rotator cuff tear, following a through irrigation and debridement, a drain was placed and the patient was taken from the operation room with a surgical drain a plan for intravenous (IV) antibiotics, and consulted with an infection disease specialist. Also reported during the surgical procedure, the physician performed 3 wound swabs were taken and sent for routine bacterial culture analysis and after 48 hour, all 3 wound swabs cultures showed no growth of any bacteria/pathogen. The patient hospitalized through 13-OCT-2018 at which time he was discharged to an inpatient rehabilitation facility for further care, management and treatment. On or about 26-OCT-2018, the patient was saw by infectious disease specialist and noted, inter alia, all of the cultures taken were sterile and that the other possible diagnosis was pseudoseptic arthritis of the shoulder, which had been reported followed pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23). It was reported that the right shoulder injury was caused by administered pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) in an improper location (incorrect route of product administration). It was reported the negligence and/or negligent acts, increased the risk of harm and/or proximately caused to suffered the following injuries: pseudoseptic arthritis of the right shoulder, aseptic inflammatory arthritis, immune-mediated inflammatory reaction, increased risk of infection, lack of immunity/failed pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) vaccine administration, rotator cuff injury/tear(s), shoulder injury resulted from vaccine administration, pain and suffering, right shoulder injury, musculoskeletal injuries, caused and/or exacerbated and immune response, loss of used and/or range of motion in the right shoulder joint, needed inpatient hospitalization, surgical intervention, inpatient rehabilitation, IV and oral antibiotic therapy, future care and therapy, physical and emotional suffering, embarrassment and humiliation, needed for additional surgical and/or medical procedures, additional hospitalizations, injuries documented in his medical records, loss of life's pleasure, scarred and deformity, disfigurement, decreased mobility, past medical expenses, damaged to his nerves and nervous system and spousal loss of consortium. The outcome of arthritis, nerve injury, joint range of motion decreased, musculoskeletal injury, limb injury, shoulder injury related to vaccine administration, rotator cuff syndrome, immune-mediated adverse reaction was not recovered and for vaccination failure was not reported. The reporter considered arthritis, nerve injury, joint range of motion decreased, musculoskeletal injury, limb injury, shoulder injury related to vaccine administration, rotator cuff syndrome, immune-mediated adverse reaction and vaccination failure to be related to zoster vaccine live (ZOSTAVAX).