Age: 1.34
Sex: F
Vaccine: HIBV, MMR
Symptoms: Face oedema, Fatigue, Hypotonia, Irritability, Lethargy
Clinical narrative: Information has been received from a physician concerning a 15 month old female who on 6/7/04 was vaccinated with a dose of MMR (lot # 647277/1035N). On approximately 6/15/04, the patient developed a low grade fever (about 100 F). On approximately 6/17/04, approximately 10 days post vaccination, the patient developed a rash, was very fussy and irritable, and had anxiety. On 6/18/04, the patient was seen by the physician and was still showing signs of irritability and anxiety. The patient's rash and low grade fever had resolved by 6/23/04. The child's mother felt that the child was not the same since being vaccinated with MMR. Follow up information received on 7/8/04 reported that according to the patient's mother, the patient also had crying spells. On 7/8/04, it was reported that although her condition was improving, it was reportedly not back to normal. Follow up information received from the mother reported that her 15 month old daughter was vaccinated on 6/6/04 with MMR. Concomitant therapy that day included HIB conjugate vaccine. On 6/14/04 the patient developed a low grade fever (never more than 100.7 degrees under the arm). On 6/17/04, the patient's fever continued and she also developed a rash started on the face of small red blotches. Subsequently the patient developed fits of discomfort described as always flung her head back, severely arched her back, often moved along the floor on her head, with her back off the ground, pushing with her feet. Her cry was sudden and intense. Eyes shut, sometimes with hands over eyes or on forehead. Always dropped to the floor. Constantly moving, often kicking, not aware of her surroundings/safety. Fits reportedly lasted 2-3 minutes, often one right after the other, with a small recovery time in between. In between the episodes the patient was described as fragile, easily set off, lethargic, with a low appetite, needing more sleep, often disengaged, and more clingy/needy. It was also reported that immediately after her series of fits, she would need to recovery, with milk, nap, or just being held. She was completely worn out. The mother reported that for nine days her daughter had intense crying episodes that appeared to be neurological, according to her pediatrician. The mother reported that the physician believed that what she observed was either due to the MMR vaccine or that it was another virus that had a neurological effect. On 6/17/04, the patient had first fit at 11:00 AM and lasted for about 15-20 minutes. The patient was described as inconsolable - with blue mouth and in the face at times. The fits continued throughout the evening. It was also reported that the patient's face and eyes were swollen. On 6/18/04, the patient's fever was reportedly on and off. The patient's mother gave constant acetaminophen every 4 hours. Subsequently, a rash developed all over her body. Fits occurred throughout morning, at least seven fits over two hours. On 6/19/04 the patient developed a rash slightly darker but not raised and the patient was fussy an hour before bed. On 6/20/04, the patient woke up fussy and was irritable all day. The patient was given acetaminophen. On 6/21/04 the patient had no more rash. The patient continued to be irritable. IT was reported that while drinking bottle immediately after series of fits her eyes moved all over the room and rolled up into corners of eyes 8-10 times. The patient reportedly had four to five fits over30 minutes. The patient's eyes rolled up into corners again while drinking bottle and afterwards in crib - couldn't/wouldn't focus. The patient had periodic fits throughout the evening. On 6/26/04 the patient reportedly would calm down only for a few minutes and then start crying, fidgeting, never opening her eyes and rocking back and forth in stroller. It was reported that the following three days were free of fits. However, her appetite was still low. Between 6/28/04 and 6/30/04 the patient developed a dry cough. The patient was had reportedly very restless nights. It was reported that during the day she was more tired, more short fused. The patient also rubbed her right eye at least five times. It was reported that seems as if vision is bothering her. The patient reportedly crying or whining when rubbing. Between 7/6/04 and7/10/04, for five days, the patient grabbed her left eye in pain, cried and yelled eye. The patient saw a pediatric ophthalmologist on 7/9/04. The patient's mother reported that the physician thinks bacterial. There was reportedly no nerve damage or inflammation. It was also reported that the doctor checked eye and there were no obvious signs of infection. The patient was started on antibiotic and was no longer complaining. The patient had also developed a small hard blister-like bump on foot and two on hand. The patient was irritable all morning and she had episodes of crying and dropping limp. Between 7/11/04 and 7/13/04 the patient had no complaints of eye reportedly all was normal except for continuing dry cough when she sleeps. Follow up information received on 9/13/04 from a neurology fellow who had just finished seeing the patient and the DVD that the mother had made of the child. The physician reported that these were not seizures, but that she probably did have some low-level ADM process which could be secondary to the vaccine or could be due to unrelated viral illness. Additional information has been requested.