Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site warmth
Clinical narrative: Information has been received by a drug wholesaler representative concerning three patients who on 20-JAN-2009 were vaccinated with a dose of PNEUMOVAX.  On an unknown date, the patients experienced several swelling in the arm where vaccine was administered.  Follow up information was received on 02-MAR-2009, from a physician via medical record concerning a patient who is a pleasant 67 year old female with no history of prior vaccine reactions or allergies, who in 2001 received the first dose of PNEUMOVAX vaccine and on 16-JAN-2009 (previously reported as 20-JAN-2009) was vaccinated subcutaneously with the second dose of PNEUMOVAX vaccine (Lot 659922/1667U) in the right triceps.  Concomitant therapies included NEXIUM, simvastatin (MSD) and alendronate sodium (MSD).  On 17-JAN-2009, within 24 hours of vaccination, the patient developed redness, erythema, swelling, tenderness, and warmth of the right arm centered about the olecranon area extending proximally about 10 cm and distally at 20 cm to 30 cm, 50% to 80% circumferential overlying the extensor surface and admitted into hospital on 18-JAN-2009.  The patient was seen in urgent care the following day and was started on levofloxacin I.V. and P.O.  Despite this, the area of redness, pain, and swelling continued to expand, and she presented to the emergency department for evaluation on 18-JAN-2009.  Findings were compatible with a cellulitis and she was admitted for inpatient management of cellulitis failing outpatient therapy.  Hospital course: The patient was admitted to inpatient unit.  She was treated with heat and elevation.  She was started on vancomycin parenterally.  She was given a total of 48 hours of IV vancomycin, and physical symptoms rapidly improved on initiation of vancomycin, and physical exam was almost entirely normal at the time of discharge.  There was a minimal residual tenderness and soft tissue swelling about the olecranon area only without any significant warmth or erythema remaining.  She never had much in the way of systemic symptoms and a detailed neuromuscular exam distally in the hand and wrist was normal at the time of discharge.  The reporting physician investigated with the patient the possible causes for this episode.  Clinically by exam and response to vancomycin, this was a quite classic cellulitis.  A temporal association with PNEUMOVAX vaccine would suggest that this was someway implicated.  However, rapid progression was not compatible with a contaminated needle stick.  In fact, the patient described a very good sterile technique being used at the time of injection.  The injection site was located somewhat distal to usual position roughly 10 cm proximal to the olecranon over the extensor surface at the arm.  The needle stick site itself was entirely clean, intact, and uninvolved without any purulence or signs of specific involvement.  It was almost entirely nonvisible at the time of discharge.  This was circled in ink to facilitate identification at followup, but this was not compatible with typical portal of entry from a skin break.  The cellulitis actually appeared to be centered about the olecranon as above.  She did have mildly dry skin but it was not deeply fissured.  It was certainly possible that this was just a normal cutaneous pathogen which she translocated through her mild xerodermatitis.  That would certainly fit as needle stick was at the far proximal margin of cellulitis.  However, the time course of symptoms arising shortly after vaccination in the same arm, although not exactly centered on areas unusual.  Certainly erythema, warmth, and local swelling had been associated with vaccine reactions secondary to amnestic response on an immune-mediated basis rather than infectious.  Clinical appearance in response to antibiotics was classic for cellulitis.  The appearance was not typical for an immune-mediated reaction on exam, and again it was not centered at the site of the injection and had difficulty blaming this on allergic reaction to PNEUMOVAX vaccine or it components but the physician could not exclude this.  The reporting physician instructed the patient, that she should consider herself allergic to PNEUMOVAX vaccine and avoid future doses.  Physician asked the pharmacy at the hospital to list the patient as potentially allergic.  It was certainly possible that this could simply have been a contaminated vial of PNEUMOVAX vaccine with some bacterial overgrowth.  However, the reporting physician was unaware of any reports of this from the manufacturer.  The responsible physician had been contacted along with other patients who had received vaccination from this same lot and had not similar or, in fact any local reaction.  So this was doubtful as well.  At the time of discharge on 20-JAN-2009, the patient presented as good with discharge exam almost entirely normal.  At the time of reporting the patient was instructed to continue monitoring the elbow for any signs of recurrent infectious process, and to seek medical attention immediately if that occurs.  Otherwise, she would have a follow-up appointment for recheck in 1 to 2 weeks with the primary care team.  The discharged medications included: oral DURICEF 1000 mg twice a day for 10 days.  1 Oral SEPTRA DS twice a day for 10 days.  Acidophilus/OTC probiotic tablets 2 with meals and 1 at bedtime (since the patient was concerned with the yeast infections after antimicrobial therapy).  Oral DIFLUCAN 150 mg single dose P.R.N. for persistent candida vaginitis symptoms following completion of antibiotic therapy.  NEXIUM 40 mg daily, ZOCOR one q.p.m. continued previous dosage, FOSAMAX 70 mg weekly, presumed one week following the completion of antibiotics.  There was no further information concerning the other two patients reported initially.  This is one of several reports from the same source.