Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Injection site induration, Injection site pain, Injection site swelling, Injection site warmth, Musculoskeletal pain
Clinical narrative: Initial and follow-up information has been received from a certified medical assistant (C.N.A.) concerning a 55 year old female smoker (1/2 ppd) with sinusitis, psoriasis, allergy to ibuprofen and tetracycline, rheumatoid arthritis and osteopenia and a history of right wrist distal ulnar resection with radial lunate fusion and extensor tenson realignments (07-APR-2000), unspecified right breast surgery, cesarean section, uterine dilation and curettage and tubal ligation who on 06-NOV-2006 was vaccinated IM in the left arm with a dose of Pneumovax 23 vaccine (lot#651356/0089F). Concomitant therapy included methotrexate, Deldene, trazodone HCl, folic acid, alendronate sodium, hydrochlorothiazide (manufacturer unknown), Allegra and Tricor. On approximately 06-NOV-2006, "within hours of injection", the patient developed redness, swelling "the size of a baseball", and pain at the injection site. On 08-Nov-2006, the patient was seen in the clinic with complaint of fever (temperature 100.4) and rash on her left arm. Upon physical examination, it was noted that the skin on the patient's left upper arm, at the site of vaccination with Pneumovax 23 vaccine, there was "a large area of erythema with induration, very warm to touch in the center, the area was non-erythmatous, but there was a vesicular eruption". The patient was diagnosed with cellulitis, and was treated with dexamethasone, one dose, and was placed on therapy with Augmentin. Instructors were given to the patient to return to the clinic if the condition persisted or worsened. On 15-NOV-2006, the patient was seen in the clinic for follow-up of the left arm cellulitis. Upon physical examination, a large area of induration and swelling was noted, as well as a "middle area of eschar development with some clustering around it". The assessment was acute allergic reaction from Pneumovax 23 vaccine versus cellulitis. The patient was treated for both diagnoses with one dose of Rocephin and dexamethasone. The patient was given instructions to return to the clinic for follow-up in 24 hours. On 16-NOV-2006, the patient returned to the clinic for follow-up, as instructed. Upon physical examination, the lesion on the patient's left upper arm was reported as "looking better". The patient denied pain at the time of examination. The physician's assessment was reported as cellulitis of the left arm, and the patient was treated with another dose of Rocephin and dexamethasone. On 17-NOV-2006, the patient was seen, again, in the clinic for follow-up of cellulitis. Upon physical examination, the lesion on the patient's left upper arm appeared to be healing well, and looked better than the day before. Some slight erythema remained around the wound, which was reported as "non-fluctuant". The patient was treated with a third dose of Rocephin and a fourth dose of dexamethasone, and instructions were given to the patient to take therapy with Tylenol or Motrin for pain, and to return to the clinic the following Monday. On 20-NOV-2006, the patient returned to the clinic, as instructed. The patient complained of left arm/shoulder pain, which was assessed as a one on a scale of one to ten. Upon physical examination, the wound appeared to be healing well, with the injection site reduced to the size of a half dollar, and was covered with a "black scab". The patient was instructed to continue antibiotic therapy for the cellulitis. On 30-NOV-2006, the patient returned to the clinic. The patient denied pain, and, upon physical examination, the wound on the patient's left upper arm continued to appear it be healing "fairly well". The scab was loose "around the images". The patient was instructed to clean the wound daily with Betadine and keep it up open to air. The C.M.A reported that the physician informed the patient that if it did not improve over the following 7 days, he would refer her to a specialist. The patient was scheduled to return to the clinic the following Monday. At the time of this report, the C.M.A. reported that the patient's injection site was not healed,a and the patient was told, "may not completely". It was also reported that the patient may need a skin graft, although was stable at this time. Injection site cellulitis and injection site infection were considered to be disabling and important medical events. Further information is not expected. Follow-up information received on 19-JAN-2007 contained the following adverse experience: upper respiratory infection (onset approximately 08-NOV-2006), which was treated with Sudal, Tussionex and Malex-A.