Age: 4.0
Sex: F
Vaccine: PPV
Symptoms: Oedema peripheral, Pain in extremity
Clinical narrative: Information has been received from a pharmacist concerning her 4 year old female daughter with a history of asthma and allergic rhinitis, who on 24-JUL-2007 was vaccinated intramuscularly in the right leg with a 0.5 mL first dose of pneumococcal 23v polysaccharide vaccine (Lot # unknown), and on 19-FEB-2008 was inadvertently vaccinated intramuscularly in the left leg with 0.5 mL second dose of pneumococcal 23v polysaccharide vaccine (Lot # unknown) by mistake. Concomitant therapy included FLOVENT, SINGULAIR, and VENTILAN (as needed). It was reported that the patient was experiencing pain in her left leg the day after the second dose was administered. The pain had increased over 48 hours and the patient displayed an unwillingness to move her leg. The patient was scheduled to be examined on 21-FEB-2008 by her physician. The patient's pain in her leg persisted. Follow up information has been received from a physician who reported that the patient came, was seen in the office on 21-FEB-2008 for a local reaction. It was reported that on 19-FEB-2008 the patient had been seen for an asthma and allergic rhinitis recheck. As she has chronic lung disease (asthma). Pneumococcal 23v polysaccharide vaccine was recommended. The patient was a little bit anxious about her shot. The longer she waits, the more upset she would be. The nurse wanted to get over with it. The nurse gave the patient the pneumococcal 23v polysaccharide vaccine and then entered the MCIR and updated the immunization sheet in the chart. Looking back, she saw that the child had received pneumococcal 23v polysaccharide vaccine on 27-JUL-2007. Hence, it was not necessary for us to give the 2nd dose of pneumococcal 23v polysaccharide vaccine. The mother was given a copy of the MCIR on that day. The mother stated that "on 20-FEB-2008 the patient's left thigh swelled up and was red'" and "she called the physician's office and spoke with one of the nurse's." The mother said that "the nurse felt that the booster dose was needed." The mother said that "she felt that her concerns were not addressed." She also stated that "she had missed work a couple of days because her daughter could not got to school, because she "was not able to walk" and "the daughter had cellulitis." The mother reported that the patient did not have a fever and that "the redness reduced and the swelling also got better a little bit." The patient was bearing weight but she was not taking too may steps. During the examination by the physician, the patient was alert and comfortable when she was on the examination table. When the physician pressed the thigh compared to the injection area and she denied any tenderness. The physician noted definite swelling of the left thigh compared to the right thigh. When the knee joint moved, the patient had slight pain at the terminal extension. No definite tenderness of the joint. She was able to bear weight and take small steps but she would not walk as she walks usually. The physician did not notice any evidence of infection. No other systemic signs. The patient was not in any distress. The physician informed the mother that local reactions have been seen with some of th immunizations. Similar type reaction have been seen with DTAP. The physician informed the mother that this type of reaction can happen even with the first dose of the shot. However, the physician told the parents that the patient did not need the second dose of pneumococcal 23v polysaccharide vaccine as she was not immunosuppressed. The physician apologized for the error which occurred through this office. The physician diagnosed the patient with a local reaction at the injection site and recommended TYLENOL or MOTRIN, and leg elevation. The physician advised to give some more time and follow up if there was any worsening of the symptoms. The father indicated that he wanted us to look at two process issues, #1 checking the immunization schedule prior to administering vaccines, #2 the nurse should look into the parents more thoroughly and discuss with the physician and then get back to the parents. The physician told the father that both of the things he mentioned are legitimate and, the father was told it will be looked into. The physician has already spoken with the administering nurse about the error, which occurred by administering the second dose of the vaccine when it was not necessary. Both of the parent thanked the physician for accommodating them. The physician told the father based on the discussion with the administering nurse, the office is planning on not billing them for the office visit or the vaccine. Out the time of the report the outcome of the patient was unknown. No further information is available.