Age: 63.0
Sex: M
Vaccine: PPV
Symptoms: Nasal congestion, Pain, Pyrexia
Clinical narrative: Information has been received from a 62 year old male patient who on 9/10/03 was vaccinated with a IM first dose of pneumococcal 23v polysaccharide vaccine (lot # 645255/1212M). Concomitant therapy included rofecoxib, fluticasone propionate (+) salmeterol xinafoate prn and cetirizine hydrochloride. On 9/10/03, the patient reported soreness at site (also reported as swollen arm and tenderness at the site of injection) and within 8 hours, he had a fever of 105 degrees F, a severe headache and myalgia. Follow up information was received from the physician concerning an adverse event to pneumococcal 23v polysaccharide vaccine. The patient was a 62 year old male who had a first visit with pulmonary medicine in October 2000, a medical history of CREST syndrome, mild pulmonary fibrosis and a CT scan that showed interstitial fibrosis in October 2002. On 9/10/03 (also reported as 9/9/03), the patient was vaccinated with an IM first dose of pneumococcal 23v polysaccharide vaccine (lot number 645255/1212M) because of his underlying CREST syndrome associated with mild pulmonary fibrosis. The patient called the medical office the following day to say that the was running a temperature of up to 101 degrees or 102 degrees and was feeling malaise and tiredness as well as chest tightness. At that time, the patient was instructed to take analgesic medication, also noted as acetaminophen, to rest and that the reactions were generally short lived and flu-like and should subside within two to three days. Later that day, the patient was seen by his primary care physician because of persistence of his fever, generalized malaise and discomfort. The physician felt that this might be a flu like illness or a bronchitis and he was treated with moxifloxacin hydrochloride. However, the patient continued to have a temperature that he recorded up to 103 degrees, achiness, malaise and associated some shortness of breath for seven days following the injection. After seven days, the patient again called the reporting physician feeling somewhat better. The patient then, however, had another episode of fever and generalized body aches, which worsened for an additional three days (also reported as extended over the weekend). The patient was seen again, by his primary physician who felt that he was dehydrated in addition to having had multiple complaints of fever, achiness, chest tightness and congestion. The physician mentioned that as part of the patient's symptomatology, he experienced a great deal of chest tightness and actual breathlessness. It was noted that the patient was not hospitalized and was given an IV drip of 2 liters for dehydration in the office and subsequently, had improved. On 9/17/03, the patient reported to the physician that he was concerned not only about the reaction but the fact that his chest felt somewhat tighter and he was not breathing as well as prior to the vaccination. Lab diagnostic tests included biochemical screening tests which were negative, a white blood cell count which was normal, pulmonary function studies, and a chest x-rays before and after the problem subsided that were unchanged and did not show any acute-type changes (previously reported as there were no diagnostic lab studies completed). It was also noted that on 9/19/03, his temperature was 99.7 (also reported as temperature had subsided). The patient's last visit with pulmonary medicine was on 9/23/03 and the physician documented that his lungs were clear, his ENT exam was negative, he no longer had a fever and he was feeling a little better. It was noted that the patient was recovering with sequelae, still had a headache, myalgia and was practically completely recovered. The physician also felt that the worse part of the patient's symptoms had abated and mentioned that he would like for the patient to call him back to see if his breathing returned to normal. There was no product quality complaint involved. The reporter expressed a concern of the particular lot of vaccine and mentioned that he put the vial of pneumococcal 23v polysaccharide vaccine aside that was given to the patient. The records of testing prior to release of this lot have been checked and found to be satisfactory. The lot complies with the standards and was released. Upon internal medical review, dyspnoea, dehydration and chest tightness were considered other important medical events (OMIC). This is a consolidation of two reports concerning the same patient.  Follow up on 11/25/2003: "Follow up information was received from the physician which indicated that the patient was last seen on 09/23/2003 and was "essentially recovered from reaction."  Upon internal medical review, dyspnea, dehydration, and chest tightness were considered other important medical events (OMIC).  No further information is expected."