Age: 9.0
Sex: M
Vaccine: HEPA, PNC, PPV
Symptoms: Weight decreased
Clinical narrative: On 03/16/2001, this child was vaccinated with a 2nd dose of pneumococcal vaccine 23 polyvalent. It was noted that on 06/02/00, the patient received a 1st dose of pneumococcal vaccine 23 polyvalent. On 06/16/01, three months after the 2nd vaccination, the patient was diagnosed with graves disease. Unspecified medical attention sought. Upon internal review, Graves Disease was considered an other important medical event. F/U info from the pt's endocrinologist indicated that he did not think there was an association between the Graves disease and the pneumococcal vaccine (manufacturer unknown). Additional info has been requested. F/U states that information has been received from a consumer concerning her 10 year old son with no known drug allergies, a history of ear infections and varicella (1996) and a family history of thyroid diseases (dad, thyroiditis) who on 6/2/00 was vaccinated in the left leg with a 1st dose of pneumococcal vaccine 23 polyvalent (lot 469402 invalid lot for this product). The mother reported the vaccine to be "pneumococcal" vaccine and the physician calls it "23 valent pneumococcal vaccine". Medical records received stated that the dose given on 6/2/00 was Streptococcus pneumonia vaccine (Prevnar) (lot 469402). Concomitant medication included a dose in the right arm of Hep-B (lot 633866/1958J). There was no illness at the time of vax. On 3/15/01, the child was seen for a well visit. The physician reported that he had been encouraging the family to have the child lose some weight. On this visit, the child had reported that he had taken up 4 different sports and had a 10lb weight loss. The physician reported, and medical records confirmed, that on 3/16/01, the pt received a dose in the left arm of Prevnar (lot 474724), a dose in the left arm of Hep-A (lot 637331/1358L) and a tetanus shot in the right arm (lot U0375AA). It was reported that sometime in 10/00, the parents started noticing weight loss on the child. The weight loss continued until 5/01 when the child was looking ill. He had blood tests done and in 5/01, the pt was dx'd with Graves disease. The child was seen by an endocrinologist on 5/15/01 for the new onset Graves disease. The endocrinologist reported that in the fall of 2000, the child starting eating and drinking a lot and had a lot of weight loss. He had gone from 98lbs to 85lbs and had an elevated heart rate. Other than being a little more active and having a tremor, he did not have any significant problems. He took only vitamins and had no other medical problems. His physical exam was normal except for fine tremor to his hands when they are stretched with his fingers spread and an "impressive" thyroid. It was reported that the pt's free T4 was at 5.7. TSM suppressed to 0.1 and his SMAC-23 was normal. The child was being started on propranolol (Inderal) (10mg Q8 hr) and methimazole (Tapazole) (10mg TID) and had labs scheduled for the following week. F/U info from the pt's endocrinologist indicated that he did not think there was an association between the Graves disease and the pneumococcal vaccine. F/U info from a physician indicated that the childs's mother requested that he receive the pneumococcal vaccine because he had a history of multiple ear infections. It was also reported that the mother requested the Hep-A vaccine for travel purposes. The physician indicated that the pt was doing fine and that the endocrinologist thought the child would go into a complete remission. The reporter felt the pt's experience was disabling.