8/29/11 Child was seen for a Well Check Up. Wt. 90 1/2 lbs. Ht. 62 1/2" BMI 16, Temperature 98.5, B.P. 80/40, Pulse 78, RR 20. Pertinent findings were vision acuity of 20/70 ou, child was referred to an Ophthalmologist, poor fine & gross motor coordination, and a speech problem in which child had problems pronouncing the letter "s". Child was referred to the school board program that evaluates children with motor and speech delay. Mom and I had a long discussion regarding immunizations, but not limited to an article I gave her. Mom gave permission for the child to receive a MENVEO vaccination, after we discussed the pros and cons of the vaccine. A sibling who was also examined received a Tdap vaccine. Approximately 20 minutes after child left the office she returned with Mom. Mom said child started to complain of pain in the arm in which she received the injection. The child developed bizarre behavior of crying and laughing at the same time, repeating "I'm ok", tearing tissues, and persistent voluntary movements of her trunk and extremities. Child responded to instructions. Whenever she said, I'm ok; mom repeated "no you are not." Child would not allow mom to touch her. Child continued with this bizarre behavior in the office, for about 1/2 hour. Her pulse rate was 132, B.P. was 100/60, respiratory rate was 42, and pulse ox was 96%. I had child breathe into a paper bag without any change in her symptoms. I called 911 and had her transported to Emergency Room. I contacted Novartis the company that manufactures and distributes MENVEO, and was referred to someone. She told me that she was a pharmacist in their medical division. She said that she did not know of any reports of similar behavior following MENVEO administration. She had no suggestion on how to respond. Mom wanted proof that the child received MENVEO. We showed Mom the empty vial with the lot # that matched the Lot # she signed for on our Vaccine Administration Sheet. I later contacted ER, and spoke with the pediatrician who saw her. He said they did a drug screen which was negative, and child calmed down and appeared normal on discharge. He said child's dad gave the history that child had similar behavior in the past. Mom did not give this history. Parents have recently separated and are planning a divorce, (Mom gave me this history when child was in the office). Mom told me that there was a lot of stress in the house. Child has a past history of a head injury at age 3 (three) months, had a MRI scan which revealed frontal and occipital injury. Child had an abnormal EEG. Child has been followed since that time. Child was diagnosed as Obsessive-Compulsive in 2006, and had been under the care of a psychologist. Child has a history of speech problems, and still has problems pronouncing the letter "s". Child has fine motor coordination problems, cannot snap her fingers and has had O/T. We contacted our Novartis rep. We asked him to pick up the empty vial, and have it checked by the company. He promised to come by within 48 hours, as he was currently out of town. 8/31/11 Child returned to the office with her dad. Child had no recall of events from the time she left the office on 8/29/11 until she left the ER on the same day. Dad stated that child was in the ER for about 2 (two) hours before her mental status returned to normal. Child has been ok since, but complained of pain and swelling in her left arm. She said the symptoms were improving, and her arm was better today than yesterday. On physical exam the only remarkable finding was redness and slight swelling of her left upper arm. Dad stated that child had a similar episode after the last vaccination she received. He said that he took her to the ER, and they referred her to another ER. The last immunization she received in this office prior to the one on 8/29/11 was on 8/20/2010 (Tdap). I contacted the hospital and they had no record of an ER visit on that date. Dad felt he had a copy of the ER record at home, and said he would share it with me. He felt the episode occurred in 2009. There is no record of the child being seen for a well check or receiving an immunization in this office in 2009.