Age: 4.0
Sex: M
Vaccine: MMR, IPV, MMR, PNC
Symptoms: Glucose urine absent, Glycosylated haemoglobin, Protein urine present, Urine ketone body absent
Clinical narrative: Initial report was received on 19 December 2011 from another manufacturer (manufacturer control number WAES 1110USA00820). The following is verbatim from the report: "Information has been received from a physician concerning an approximately 4 year old male patient who on 09-AUG-2007 was vaccinated with the first dose of MMR II (Lot number 656033/0280U, Exp. Date: 02-FEB-2009) and on 05-MAY-2010 received the second dose of MMR II (Lot number 664655/0640Y, Exp. Date: May-2011). The physician reported that "few months" after the second dose was given (approximately August 2010), the patient was diagnosed with insulin dependent diabetes. The patient was hospitalized at the time of the diagnosis. Insulin was given as a treatment for the experience. At the time of the report, the patient was still insulin dependent diabetic. Information was received from a physician and medical records regarding a 4 year old male patient (44 inches, 41 pounds) with no illness reported at time of vaccination, who on 09-AUG-2007 was vaccinated with a first dose of MMR II (Lot number 656033/0280U) and on 05-MAY-2010 received the second dose of MMR II (Lot number 664655/0640Y) into the right arm. Concomitant vaccinations received were PREVNAR (Wyeth) (Lot #E4913) given intramuscularly in the left arm, and IPOL (Sanofi-Pasteur) given intramuscularly in the left arm. On 29-SEP-2010, the patient developed diabetes mellitus, Type I. The patient required hospitalization. On 02-JUN-2011, the patient's overall control of his diabetes had been excellent and his HbA1C was almost in the normal range. The patient was not on any other medication besides his insulin. His blood sugars were checked five to eight times per day. The patient's mother stated that he was able to feel his low blood sugars when they reached the 70's and 80's. At that time he usually complained of feeling hungry. His mother checked his ketones on a daily basis and she denied having seen ketonuria during the last month. She stated that he was not having polyuria, polydipsia, nocturia, or enuresis. The patient was on an insulin regimen that included LEVEMIR and NOVOLOG. He took 2 units of LEVEMIR at dinnertime and NOVOLOG according to sliding scales. On 05-OCT-2011, the patient was seen in follow-up. The patient's blood glucose was high overnight. Assessment: type I diabetes, uncontrolled. On 02-NOV-2011, the patient was on antibiotics for an ear infection. The patient's blood glucose was running low in the mornings. Assessment: Type 1 diabetes, uncontrolled. The patient was reported as unrecovered as Type I dependent diabetic is a "lifelong illness". This is one of several reports from the same source. All available medical records will be provided upon request. Additional information has been requested." List of documents held by sender: None.    Initial report was received on 19 December 2011 from another manufacturer (manufacturer control number WAES 1110USA00820). The following is verbatim from the report: "Information has been received from a physician concerning an approximately 4 year old male who on 09-AUG-2007 was vaccinated with the first dose of MMR II (Lot number 656033/0280U, Exp. Date: 02-FEB-2009) and on 05-MAY-2010 received the second dose of MMR II (Lot number 664655/0640Y, Exp. Date: May-2011). The physician reported that "few months" after the second dose was given (approximately August 2010), the patient was diagnosed with insulin dependent diabetes. The patient was hospitalized at the time of the diagnosis. Insulin was given as a treatment for the experience. At the time of the report, the patient was still insulin dependent diabetic. Information was received from a physician and medical records regarding a 4 year old male patient (44 inches, 41 pounds) with no illness reported at time of vaccination, who on 09-AUG-2007 was vaccinated with a first dose of MMR II (Lot number 656033/0280U) and on 05-MAY-2010 received the second dose of MMR II (Lot number 664655/0640Y) into the right arm. Concomitant vaccinations received were PREVENAR 13 (Wyeth) (Lot #E4913) given intramuscularly in the left arm, and IPOL (Sanofi-Pasteur) given intramuscularly in the left arm. On 29-SEP-2010, the patient developed diabetes mellitus, Type I. The patient required hospitalization. On 02-JUN-2011, the patient's overall control of his diabetes had been excellent and his HbA1C was almost in the normal range. The patient was not on any other medications besides his insulin. His blood sugars were checked five to eight times per day. The patient's mother stated that he was able to feel his low blood sugars when they reached the 70's and 80's. At that time he usually complained of feeling hungry. His mother checked his ketones on a daily basis and she denied having seen ketonuria during the last month. She stated that he was not having polyuria, polydipsia, nocturia, or enuresis. The patient was on an insulin regimen that included LEVEMIR and NOVOLOG. He took 2 units of LEVEMIR at dinnertime and NOVOLOG according to sliding scales. On 05-OCT-2011, the patient was seen in follow-up. The patient's blood glucose was high overnight. Assessment: type I diabetes, uncontrolled. On 02-NOV-2011, the patient was on antibiotics for an ear infection. The patient's blood glucose was running low in the mornings. Assessment: Type 1 diabetes, uncontrolled. The patient was reported as unrecovered as Type I dependent diabetic is a "lifelong illness." This is one of several reports from the same source. All available medical records will be provided upon request. Additional information has been requested." List of documents held by sender: None.