Age: 77.0
Sex: M
Vaccine: PPV
Symptoms: Asthenia, Chills, Convulsion, Fatigue, Injection site oedema
Clinical narrative: Information has been received from a licensed practical nurse concerning a 77 year old male with mild reactive airway disease, diabetes, sinusitis and a history of a CABG in 1998 who on 10/10/03 was vaccinated  IM from a multidose vial with a first 0.5ml dose of pneumococcal 23v polysaccharide vaccine (643784/0676M). Concomitant medication included Combivent 2 puffs as needed, Celebrex 200mg daily, Flonase prn, Advair inhaler, Altace 5mg daily, Demadex 20mg daily, simvastatin 80mg every evening, potassium, insulin human, insulin human isophane, and montelukast sodium 30mg daily. The pt had no previous reactions following prior vaccinations. It was reported that the pt did not have any problems in the office after he received the vaccine. On 10/10/03, eight hours post-vaccination, after dinner that night, while at home playing bridge, the pt developed what he described as severe chills, "convulsions," weakness, fatigue and swelling in the arm where he had received the vaccine. It was also reported that the pt's arm was hot to the touch. His family called 911 and the pt was seen in the ER. It was also reported that the nurse could not tell from the pt's chart if he was taken to the ER or if he was just treated by the EMT's at his home. The ENT's that treated the pt said that he had a "reaction to the shot of Pneumovax." The pt was not treated with any antibiotics or other prescription drugs. No diagnostic lab tests were performed. The pt's physician noted that he had been a pt there since 1993 and wanted an investigation done into this lot number. On 10/13/03 the pt was seen in the office for an appointment and that he was recovering and was "feeling fine." Subsequently, the pt recovered. No product quality complaint was involved. The records of testing prior to the release of this lot have been checked by Quality Assurance and found to be satisfatory. The lot complies with the standards and was released. Upon internal review, "convulsions" was determined to be an other important medical event (OMIC). Additional info has been requested. Follow up on 11/17/2003: "Information has been received from a licensed practical nurse concerning a retired 77 year old white male with moderate to severe COPD, clinically stable with improved tolerance for symptoms, (also reported as mild reactive airway disease), chronic cytopenia, insulin-dependent diabetes mellitus, atherosclerotic heart disease, sinusitis, in process of completely a rehabilitation program, and a history of CABG in 1998 who on the morning of 10/10/2003 was vaccinated IM in the left deltoid from a multidose vial with the first known 0.5mL dose of pneumococcal 23v polysaccharide vaccine (Lot # 643784/0676M).  Concomitant medication included albuterol sulfate (+) ipratropium bromide (Combivent) 2 puffs as needed, celecoxib (Celebrex) 200mg daily, fluticasone propionate (Flonase) prn, fluticasone propionate (+) salmeterol xinafoate (Advair) inhaler, ramipril (Altace) 5mg daily, torsemide (Demadex) 20mg daily, simvastatin (MSD) 80mg every evening, potassium (unspecified), insulin human (Humulin R), insulin human isophane (Humulin N), and montelukast sodium (MSD) 10mg daily.  There was no known acute illness at the time of vaccination.  The patient had no previous reactions following prior vaccinations.  It was reported that the paitne did not have any problems in the office after he received the vaccine.  On 10/10/2003, approximately eight hours post-vaccination, after dinner that night, while at home playing bridge, the patient developed severe chills, "convulsions" (also described as seizure-like reaction), increasing weakness, fatigue, swelling in the left arm, tenderness at the injection site, the arm was hot to the touch and the patient reported that he felt "quite ill".  His family called 911.  The EMT's that treated the patient said that he had had a "reaction to the shot Pneumovax."  It was reported that although considerations were made for the ER evaluation, after sometime with the medics, and with the likelihood of a reaction to the pneumococcal 23v polysaccharide vaccine, the patient felt that an emergency room evaluation was not warranted as he was feeling better.  The patient was not treated with any antibiotics or other prescription drugs.  No diagnostic lab tests were performed.  On the morning of 10/11/2003 it was reported that the patient was feeling better.  He was instructed that if he had recurrent symptoms, he should contact the physician's office promptly for re-evaluation.  Over the next 48 hours the patient continued to feel poorly and had occasional chills.  On 10/13/2003 the patient recovered.  It was also reported that the patient would be leaving for a trip out of town in a few days, and the physician "made clear to him" that should he continue to have chills or feel poorly, then antibiotics would probably be warranted and he should get back to the physician.  No product quality complaint was involved.  The patient's physician noted that he had been a patient there since 1993 and wanted an investigation done into this lot number.  The records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory.  The lot complies with the standards of the Center for Biologics Evaluation and Research and was released.  Upon internal review, "convulsions" (also described as seizure-like reaction) was determined to be an other important medical event.  No further information is expected."