Age: 60.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Drug hypersensitivity, Fatigue, Inappropriate schedule of drug administration, Incorrect route of drug administration, Joint swelling
Clinical narrative: Information has been received from a male (age not reported) with a history of chronic bronchitis and no drug reactions/allergies who in approximately February 2007, "about 45 days ago" was vaccinated with first dose of Pneumovax 23.  Concomitant therapy included ibuprofen and aspirin.  In approximately February 2007 after the first dose of vaccine, the patient developed a staph infection and sought medical attention.  He had to visit the emergency room (ER).  The consumer also reported that he also experienced "itching inside his body internally", a low grade fever as well as sweating uncontrollably.  He was prescribed AUGMENTIN by the ER physician to treat his symptoms.  At the time of reporting, the patient had not recovered.  On 13-MAR-2007, the patient was given a second dose of Pneumovax 23 instead of a TB test that he was scheduled to receive.  Additional information has been requested. This is in follow-up to report (s) previously submitted on 7/30/2007. Initial and follow-up information has been received from a 60 year old female, psych tech with allergy to ALVELOX, with chronic obstructive pulmonary disease (COPD), chronic bronchitis, smoker, back pain, and a history of a tonsillectomy and who in approximately February 2007, "about 45 days ago" was vaccinated intramuscularly with the first dose of PNEUMOVAX vaccine. Concomitant therapy included ibuprofen and aspirin. In approximately February 2007 after the first dose of vaccine, the patient developed a staph infection and sought medical attention. He had to visit the emergency room (ER). The consumer also reported that he also experienced "itching inside of his body internally", a low grade fever as well as sweating uncontrollably. He was prescribed amoxicillin (+) AUGMENTIN by the ER physician to treat his symptoms. At the time of reporting, the patient had not recovered. On 13-MAR-2007, the patient was given intradermally, a second dose of PNEUMOVAX vaccine instead of TB test that he was scheduled to receive. Additional information was received from the patient. The patient reported he was required to receive a PPD test to determine if he had been exposed to tuberculosis or had TB because he works in a hospital. On 13-MAR-2007, immediately after the PPD was administered by the nurse, his left arm, at the injection site, turned red. After work he went to bed and approximately 7-8 hours later when he awoke his arm was swollen and red. That evening at work he showed his arm to a different nurse who felt that the patient had an infection. She marked "the infection" so she could observe if it was getting worse. At 04:15 AM he had a red streak from the injection site to almost his arm pit. He was immediately sent to the ER where he was diagnosed with staph infection. He was prescribed cephalexin  500 mg and he returned to work. The hospital medical doctor stopped the cephalexin and prescribed SEPTRA 800-160 tablets. My body rejected the sulfamethozazole (+) trimethoprim almost immediately. He went home and continued to feel worse so he returened to the emergency room. Sulfamethoxazole (+) trimethoprim was stopped and he was given AUGMENTIN 75 mg. His body seemed to accept the AUGMENTIN. He returned to work. Three days later, he saw the nurse who administered the innoculation. The nurse told him that she had made a terrible mistake and had given him PNEUMOVAX vaccine intradermally instead of the "TB serum". Since all this happened, his pre-existing (COPD) chronic bronchitis has worsened. His physician felt that it was due in part to the staph infection and weakned immune system that was fighting the staph. The patient reported he was never prescribed PNEUMOVAX vaccine. He was at the hospital 3 to 4 months before the incident on a COPD related matter and the doctor who saw him suggested that he received the vaccination. So he got it and had no reaction to it at all. The only thing it did was give him peace of mind. The outcome of the events was not reported. Information has been received from medical records conderning a 60 year old male, psych technician, smoked one pack per day, now down to 3/4 pack per day with chronic bronchitis and chronic obstructive pulmonary disease (COPD) and no history of drug reactions/allergies with a history of low back pain who in approximately February 2007, "about 45 days ago" was vaccinated with the first dose of PNEUMOVAX vaccine. Concomitant therapy included ibuprofen and aspirin. The patient was seen in the Emergency Room on 14-MAR-2007, with the chief complaint of infection in the left forearm. The patient's blood pressure was 155/91 and oxygen saturation was 92 %. The patient had redness covering a 10 centimeter (cm) circular area in the upper volar forearm and had a red streak that was about 2.5 cm wid going up the anterior medial left upper arm. The patient was diagnosed with cellulitis of the left forearm with left angitis post TB injection. The patient was placed on cephalexin 500 mg two, oral (P.O.) every (q) 8 hours (hr), elevated arm, and apply warm packs, TYLENOL, 500 mg for pain and ibuprofen 800 mg q 8 hr for pain if needed. Information has been received from medical records from 17-MAR-2007, the patient went to the ER with generalized pruritic and red, splotchy rash on his extremities. The patient was treated with SEPTRA for cellulitis on the left arm. The patient reported using his inhaler regularly for increased congestion and wheezing. The patient continued to smoke. The patient was diagnosed with probable allergic reaction to SEPTRA, persistent cellulitis of left arm and exacerbation of COPD possibly due to SEPTRA allergy and persistent cellulitis. SEPTRA was discontinued. The patient was started on prednisone 40 mg p.o.,  resume ADVAIR. The patient was to follow-up with physician if his conditioned worsened. Information received from medical records from 08-APR-2007, the patient visited the physician and complained of persistent itching, with no visible rash and generalized joint aches and wrist swelling following the sulfa reaction and reportedly as well as severe local reaction to the PNEUMOVAX vaccine. A prescription of prednisone was prescribed. The patient was scheduled for a follow-up visit in 2 1/2 weeks. Information has been received from medical records from 26-APR-2007, the patient complained of generalized stiffness and muscle and joint aches and was fatigued and required increased sleep requirement. He had some loose stools but had returned to normal bowel and bladder habits. The patient's left forearm had recovered without abnormalities identified. The patient was diagnosed with myalgias/arthralgias and increased fatigue. Information has been received from medical records from 09-MAY-2007, the patient complained of shortness of breath which had progressed over the past three months. The patient stated that the shortness of breath may be related to the PNEUMOVAX vaccine. The patient complained of dark yellow-to-pink tinged urine for the past two weeks with some colicky-type pain in the bilateral lower flank area. The patient had a urinalysis and a urine screen. The patient had rhinitis and was instructed to use NASONEX. Information received from medical records on 04-JUN-2007 indicated that the patient visited the physician with complaints of shortness of breath (SOB). The physician reported the patient had bilateral wheezes and productive cough with blood pressure of 140/86 mm Hg. It was reported that the patient's chronic bronchitis with exacerbation was slowly improving. The physician listed the following medications, LEVAQUIN, WELLBUTRIN, SPIRIVA. On 13-JUN-2007, the patient visited the physician with complaints of SOB with exertion. It was reported that the patient was recovering, slowly from streptococcal pneumonia. The patient reported that he had not smoked for 14 days. Upon physical examination the patient's oxygen saturation was 98% on room air, 88% after walking up stairs, which decreased to 87% on room air. After a 5 minute recovery oxygen saturation returned to 93%. On 05-JUL-2007, the patient visited the physician the physician documented oxygen desaturation when walking up one flight of stairs. The physician did not think the patient would be able to return to his job as a psych technician in particular his duties involving doing what the patient described as "taken downs". The physician could not determine how much of his disability is due to his pre-existing chronic obstructive pulmonary disease and how much is due to his recent injury. The physician requested that the patient be evaluated by a pulmunologist with an occupational medicine practice. The patient was seen by the physician on 18-JUL-2007 with complaints of SOB. The patient stated he was not using ADVAIR but was using SPIRIVA. The patient had exacerbation of chronic obstructive pulmonary disease secondary to external allergens specifically smoking and forest fires. The patient was treated with DUONEB and given an intramuscular injection of 40 mg of KENALOG. The patient was given a new prescription for ADVAIR. The patient was to follow-up with the physician if there was no improvement. The physician determined the patient's exacerbation of chronic obstructive disease to be disabling. This is a consolidation of two reports concerning the same patient. It has been determined that WAES # 0709USA02171 is a duplicate of WAES # 0704USA00735. Therefore WAES # 0709USA02171 is being deleted from our files and the reports consolidated into WAES # 0704USA00735. Additional information has been requested. This is in consolidation of two reports concerning the same patient. It has been determined that WAES # 0709USA02171 is a duplicate of WAES # 0704USA00735. Therefore WAES # 0709USA02171 is being deleted from our files and the reports consolidated into WAES # 0704USA00735. All available medical records will be provided upon request.