Age: 51.0
Sex: F
Vaccine: PPV
Symptoms: Injection site infection, Injection site oedema, Injection site pain, Necrosis, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 51 year old white female homemaker with no prior medical history and no known allergies who on 8/27/02 was vaccinated with a first 0.5ml dose of pneumococcal vaccine 23 polyvalent. *Concomitant medication included hormone replacement therapy.* The PT was reported as well as the time of vaccination. On 8/27/02, following vaccination, the pt developed redness and swelling to the right deltoid area at the injection site. On 8/31/02, the pt phoned the physician to report that her arm was swollen and tender. The physician reported to the pt that he "thought that she was probably just having a local reaction, and that she should just take some [acetaminophen] and that if her arm was not feeling better that he would see her on Monday." On Monday 9/2/02 (also reported as 9/3/02), *the pt was still experiencing fierce pain and discomfort.* The PT presented to the physician's office with an abscess that measured 15cm on the deltoid, pain and an infection in the right deltoid. *The PT's husband reported that at this time, the infected arm was twice the size of a grapefruit and another pus pocket was forming. The PT's husband reported that "the original pus pocket was beginning to run and a smelly ugly color pus was coming out. At this point, my wife was in the uttermost pain and a fear of losing her arm came into the picture."* The abscess had already started to drain and the pt was admitted to the hospital, started on IV antibiotics, and had a surgical consult. The surgeon performed an (I & D) Incision and Drain of the abscess, and drained a moderate amount of pus. Cultures from the drainage were done and came back as sterile. *The PT was hospitalized for 3 days and recovered on 9/25/02.* The reporting physician "has not heard from or seen the pt so he is assuming that she followed up with the surgeon." It was noted that the experience was still being treated; however, it was also noted that the experience "abated." The reporting physician felt that the *PT's abscess* was an other important medical events. *The PT's husband reported that he felt the "vaccine was the cause". No further info has been requested.* Follow up information received from the patient and her spouse in the form of a letter (dated 11/11/02) and operative reports indicated that since they had first contacted the company, unfortunately there have been alot of major medical problems. The patient's husband wrote, my wife has had to return to surgery four more times in the last month and still it is unknown if there will be further procedures to follow. The husband further writes, on 10/7/02 my wife was still experiencing fierce amounts of pain, discomfort, and the infection was spreading. We returned to the doctor's office where she was immediately placed into the hospital and the second surgery was performed. On 10/10 the procedure was surgically repeated. On 10/14 she went back into the operating room for closure of the open wound; resulting with an 10/24 reopening of the wound and the procedure performed again. My wife has been in the upmost pain and fear of disfigurement, scarring and the loss of and/or the use of her arms and fingers. She is very depressed, scared and worried. The operative report, dated 10/7/02, indicated that following vaccination in the right shoulder in early September 2002, the patient had developed two abscesses and that those abscesses were drained previously. Assessment revealed that the entire shoulder overlying the deltoid is erythematous, very tense and very tender. The patient had been started on IV antibiotics that morning. The patient underwent an incision and drainage of the right shoulder abscess. The procedure detail revealed that purulent fluid was drained from the abscess and that cultures were taken. The wound was irrigated and then packed with wet-to-dry Karlix roll, a sterile dressing was placed and the patient was taken to the recovery room in good condition. The operative report dated 10/10/02 indicated that while hospitalized wound care continued, but the patient developed some area that needed further drainage and debridgement. The patient underwent repeat debridgement of this right shoulder wound, sharp debridement and pulse lavage with 3 liters normal saline. The wound was packed with wet-to-dray Kerlix roll and a sterile dressing was placed. The patient was taken to the recovery room then back up to the floor and was to be discharged in the morning with local wound care and plans for her return on 10/14/02 for primary wound closure. The operative report dated 10/14/02 indicated that when the patient was admitted on 10/7/02 she had erythema and fluctuance in the right shoulder along with cellulitis. The patient underwent a delayed primary closure and debridement with pulse lavage. The wound was infiltrated with 0.25% of bupivacaine hydrochloride and dressed with xeroform gauze, 4x4's and paper tape. The patient was to be discharged to home with PO pain medication and was to follow up in two weeks for suture removal. Additional information is expected. Follow up information was received in the form of operative reports and a lab report. The operative report dated 10/24/02 indicated that the patient returned to the hospital to the emergency room, on an unspecified date, with increased pain and erythema, edema; appears to be infected again. The patient was taken to the operating room on 10/24/02 with the preoperative diagnosis of recurrent right shoulder/right deltoid abscess. She underwent an incision and drainage of the previously closed surgical wound at the right shoulder, the inferior aspect of the wound. The most inferior stitches had been removed in the office the day before and another stitch was removed. There was some purulent drainage noted which was irrigated out and blunt dissection to break up the loculations. The report also noted that, it feels like there is a small abscess that is just deep to the fascia in the IM and also just above the fascia underneath the SC tissue. The wound was packed with wet to dry Kerlix roll and a sterile dressing was applied. IV antibiotics were continued and the patient was admitted for pain control. The discharge date was 10/25/02. The operative report dated 11/1/02 indicated that the patient had been admitted, on an unspecified date, to obtain blood test and an MRI scan. The MRI scan showed deep penetration of the abscess in several cavities into the deltoid muscle but no penetration into the humerus or invasion of the neurovascular bundle around the surgical neck. On 11/1/02 the preoperative diagnosis was noted as infection of the deltoid muscle, and the patient underwent an irrigation and debridement of deltoid muscle and wound vac replacement. Operative findings noted that the patient had a modest amount of necrotic muscle but nothing approaching the axillary neurovascular bundle or the humerus itself. Three liters of antibiotic saline were lavaged into the wound. The wound was covered with an appropriately shaped sponge with a vacuum assisted closure device. The patient was returned to the floor to begin empiric antibiotics. The lab report, dated 11/1/02, indicated: specimen type-SURG PATH: specimen-right deltoid muscle; final diagnosis: skeletal muscle-suppurative necrosis. Small fragment of acutely inflamed granulation. Additional information is expected. A 15-day follow up report received 02/05/2003 adds: (Pt has) an allergy to penicillin.