Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Laboratory test abnormal, Pyrexia, Rash
Clinical narrative: Information has been received from a licensed practical nurse concerning a 59 year old female patient a smoker with allergies to morphine and cephalexin and a past medical history of splenectomy, lung cancer and unspecified lung surgery in 2001, who on 4/18/03 was vaccinated IM in the left deltoid with a second dose of pneumococcal vaccine 23 polyvalent (reported lot #624114/0955H not valid for this product). It was noted that the patient was not sure about number of previous doses and reports questionable before 1993 for first dose. Concomitant medication included hydroxyzine hydrochloride and unspecified eye drops. The health professional reported the patient's left arm became so red and swollen she had to go to the emergency room. The reporter indicated no further information could be provided. Follow up information received from a licensed practical nurse and emergency room outpatient records reported the patient went to the emergency room on 4/20/03 at 11:33 AM with a chief complaint of reaction from pneumonia shot on Friday, skin rash and left upper extremity was reported as painful and burning. The emergency record notes the patient's arm was assessed to have redness to the inner aspect of left arm and she was diagnosed with cellulitis of her left arm. A physical examination on 4/20/03 in the emergency room revealed a skin rash to her left arm, and the following body systems, HEENT, neck, respiratory, cardiovascular, abdomen, rectal, neurological/psychological were reported normal. In the emergency room the patient's vital signs were BP165/97, pulse 93, respirations 18, oral temperature 97.7, and oxygen saturation 97%. it was noted a 20 gauge heplock catheter was placed on one attempt at 12:30PM, and the patient was treated with 900mg IV clindamycin at 12:40PM. The patient was given instructions to return every eight hours for two additional doses and reassessment of the left arm cellulitis, and was discharged at 13:25PM. It was reported later on that day, 4/20/03 at 20:56PM, the patient returned for her second dose of treatment with clindamycin. At 21:15 PM her vital signs were recorded as BP 154/82, heart rate 88, respirations 20, and temperature 97.9. At 21:23 PM it was reported the redness and swelling had decreased from the morning assessment, and at 21:39 PM the patient stated, much better, less red, less tender. It was noted at 21:26 PM the patient received a second dose 900mg dose of IV clindamycin. It was indicated in the emergency room record that medication would probably be switched to oral after next dose. At 22:01, the patient was given discharge instructions and sent home. On 4/21/03 at 06:08AM the patient returned to the emergency room for her scheduled third dose of clindamycin 900mg IV. Her vital signs on 4/21/03 at 06:08AM were BP 127/87, heart rate 74, respirations 16, and temperature 97.1. The patient rated her pain 0-1. An admission progress note from 06:08AM on 4/21/03 indicated her right forearm IV was painful, and also noted, there was a decreased redness to her left bicep from the previous assessment on the evening of 4/20/03, and the redness had virtually resolved. She was reported awake alert and oriented times three. It was also note that one last dose of IV clindamycin would be given and then she would be started on a 5 day course of oral clindamycin. At 6:11AM the patient received her third dose of IV clindamycin 900mg. The IV catheter was removed at 06:50 AM. The emergency physician indicated the patient's reaction was possibly caused by pneumococcal vaccine 23 polyvalent. The patient was instructed to return to the emergency room if symptoms increased, and was discharged to home. Subsequently, the patient recovered. Upon internal review cellulitis was determined to be an other important medical event (OMIC). Follow up information was received on 6/11/03 which pertained  to an event that occurred three days after administration of pneumococcal vaccine 23 polyvalent. The information included the following adverse experience: right forearm IV painful (4/21/03). No further information is expected.