chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 8.0
Sex: F
Vaccine: FLUN3
Symptoms: Nocturia, Polydipsia, Polyuria, Type 1 diabetes mellitus, Urine analysis abnormal
Clinical narrative: This is a verbatim narrative as reported to the FDA VAERS: "Onset type I diabetes mellitus 1/7/09. Reviewed hospital records for 10/18-10/22/2008. FINAL DX: new onset type 1 diabetes mellitus; DKA Records reveal patient experienced polyuria, polydipsia, nocturia & weight loss over 6 wk period. Admitted PICU on insulin drip for DKA. Stabilized on sq insulin & d/c to home w/continued diabetes education & management in clinic."
Age: 8.0
Sex: F
Vaccine: FLUN3
Symptoms: Urine ketone body present, Weight decreased
Clinical narrative: This is a verbatim narrative as reported to the FDA VAERS: "Onset type I diabetes mellitus 1/7/09. Reviewed hospital records for 10/18-10/22/2008. FINAL DX: new onset type 1 diabetes mellitus; DKA Records reveal patient experienced polyuria, polydipsia, nocturia & weight loss over 6 wk period. Admitted PICU on insulin drip for DKA. Stabilized on sq insulin & d/c to home w/continued diabetes education & management in clinic."
Age: 26.0
Sex: F
Vaccine: FLUN3
Symptoms: Abortion spontaneous, Maternal exposure during pregnancy, Oligohydramnios, Premature rupture of membranes
Clinical narrative: A serious spontaneous report of oligohydramnios, ruptured membranes, miscarriage and non-serious vaccine administered to a pregnant female has been received from a Physician concerning a 26-Years-old female; subsequent to FLUMIST. This report is from a literature review to characterize reports to VAERS in pregnant women who received seasonal influenza vaccine to assess for potential vaccine safety concerns. No past medical history or concomitant medication were provided for the patient. On an unknown date the patient received FLUMIST when she was 12 weeks pregnant. Approximately four weeks after receiving FLUMIST she presented with oligohydramnios secondary to rupture of membranes for which she was hospitalized. She experienced a miscarriage at 16 weeks and was discharged from the hospital in good condition. The events of miscarriage and vaccine administered to a pregnant female resolved. The outcome of the events of oligohydramnios and ruptured membranes was unknown.
Age: 5.0
Sex: M
Vaccine: FLUN3
Symptoms: Blood glucose increased, Glucose urine present, Pollakiuria, Thirst, Type 1 diabetes mellitus
Clinical narrative: This is a verbatim narrative as reported to the FDA VAERS: "Diagnosed with juvenile onset diabetes mellitus 17 days after live flu vaccine. 1/12/09-records received for DOS 12/14-12/15/08-DC DX: New onset diabetes mellitus, presented with C/O increased thirst, urination, sugar high. 02/01/2010 The original event reported was a temporal association of the FLUMIST and development of Juvenile diabetes."
Age: 38.0
Sex: F
Vaccine: FLUN3
Symptoms: Activities of daily living impaired, Chest X-ray abnormal, Cough, Fatigue, Feeling hot
Clinical narrative: This is a verbatim narrative as reported to the FDA VAERS: "The patient is a 38 year old female. Source of patient information was patient. Source of patient information was medical records. Received second FLUMIST at clinic 10/3/2007. First FLUMIST received 12/6/2006 with common URI symptoms reported lasting 2-3 days that resolved spontaneously. Following receipt of 10/03/2007 FLUMIST, she again experienced some mild URI symptoms (runny nose, body aches) for a few days but was "fine for one week. By 10/11 she felt exhausted, fatigued, tired, had a non-productive cough, congestion, felt warm. She tried to work but went home feeling ill for next 72 hours. She slept for 2 days. On 10/15/07 she went to PCP. A CXR diagnosed pneumonia and she was started on 2 weeks of antibiotics with resolution of medication list reviewed and family history reviewed with patient. No systemic symptoms.
Age: 38.0
Sex: F
Vaccine: FLUN3
Symptoms: Hypersomnia, Pain, Pneumonia, Respiratory tract congestion, Rhinorrhoea
Clinical narrative: This is a verbatim narrative as reported to the FDA VAERS: "The patient is a 38 year old female. Source of patient information was patient. Source of patient information was medical records. Received second FLUMIST at clinic 10/3/2007. First FLUMIST received 12/6/2006 with common URI symptoms reported lasting 2-3 days that resolved spontaneously. Following receipt of 10/03/2007 FLUMIST, she again experienced some mild URI symptoms (runny nose, body aches) for a few days but was "fine for one week. By 10/11 she felt exhausted, fatigued, tired, had a non-productive cough, congestion, felt warm. She tried to work but went home feeling ill for next 72 hours. She slept for 2 days. On 10/15/07 she went to PCP. A CXR diagnosed pneumonia and she was started on 2 weeks of antibiotics with resolution of medication list reviewed and family history reviewed with patient. No systemic symptoms.
Age: 38.0
Sex: F
Vaccine: FLUN3
Symptoms: Upper respiratory tract infection
Clinical narrative: This is a verbatim narrative as reported to the FDA VAERS: "The patient is a 38 year old female. Source of patient information was patient. Source of patient information was medical records. Received second FLUMIST at clinic 10/3/2007. First FLUMIST received 12/6/2006 with common URI symptoms reported lasting 2-3 days that resolved spontaneously. Following receipt of 10/03/2007 FLUMIST, she again experienced some mild URI symptoms (runny nose, body aches) for a few days but was "fine for one week. By 10/11 she felt exhausted, fatigued, tired, had a non-productive cough, congestion, felt warm. She tried to work but went home feeling ill for next 72 hours. She slept for 2 days. On 10/15/07 she went to PCP. A CXR diagnosed pneumonia and she was started on 2 weeks of antibiotics with resolution of medication list reviewed and family history reviewed with patient. No systemic symptoms.
Age: 2.0
Sex: M
Vaccine: FLUN3
Symptoms: Abnormal behaviour, Aggression, Cough, Fatigue, Hypersomnia
Clinical narrative: This is a verbatim narrative as reported to the FDA VAERS: "Behavioral changes. Aggressive. Fatigue-sleeping longer. Re-started napping. Then developed congestion and cough. Sib (+) HINI flu. Treated for sinusitis 11-05-09."
Age: 2.0
Sex: M
Vaccine: FLUN3
Symptoms: Influenza, Influenza virus test positive, Respiratory tract congestion, Sinusitis
Clinical narrative: This is a verbatim narrative as reported to the FDA VAERS: "Behavioral changes. Aggressive. Fatigue-sleeping longer. Re-started napping. Then developed congestion and cough. Sib (+) HINI flu. Treated for sinusitis 11-05-09."
Age: 40.0
Sex: M
Vaccine: FLUN3
Symptoms: Autoantibody positive, Blood glucose increased, Dehydration, Fatigue, Glycosylated haemoglobin increased
Clinical narrative: This is a verbatim narrative as reported to the FDA VAERS. "Pt was in his usual state of excellent health prior to December 2007. He had completed a physical exam in Sept 2007 and had no physical complaints at that time. Pt received FLUMIST vaccine on 14 Nov 2007. He did not receive any other vaccines on that day. He denies any unusual or prolonged reactions within the first week following vaccine receipt. He does not recall any viral-type symptoms just prior to or on the day of vaccine receipt. Sometime in late November or early December 2007, pt noted blurring of his vision. Between December 2007 and the end of January 2008, pt experienced tiredness, increased urination (voiding every 1-2 hours during the day), nocturia (voiding every 2-3 hours throughout the night) and increased thirst (drinking up to 2 quarts of orange juice a day). By mid-January, pt noted numbness and tingling in his fingertips and toes. While in another city on 28 January 2008, pt was seen at a local clinic for dehydration. When he described his symptoms, his blood glucose level was checked and reported to be 432. While at the clinic, he received his several liters of IV fluids. (No documentation of this visit visible to VHC). When pt returned to his city on 5 Feb 2008, he sought medical evaluation. By that time, in addition to the above symptoms worsening, he also had lost 30 lbs since late November 2007. When he was evaluated, his blood glucose level was 326 mg/dL, his UA showed trace positive ketones, and his HgbA1c was 11.6 (4.0-6.0). He was diagnosed with Type 2 diabetes. Between February 2008 and July 2009, pt was tried on a number of combinations of oral diabetes medications. Insulin was initiated in July 2009 and pt was recently changed to an insulin pump. Pt has never experienced ketoacidosis. He has lost neuropathy and diabetic retinopathy. Microalbuminuria was noted on a urine sample in 2008 and pt was subsequently started on Angiotension Receptor Blocker."
Age: 40.0
Sex: M
Vaccine: FLUN3
Symptoms: Hypoaesthesia, Hypoglycaemia, Insulin C-peptide normal, Loss of consciousness, Microalbuminuria
Clinical narrative: This is a verbatim narrative as reported to the FDA VAERS. "Pt was in his usual state of excellent health prior to December 2007. He had completed a physical exam in Sept 2007 and had no physical complaints at that time. Pt received FLUMIST vaccine on 14 Nov 2007. He did not receive any other vaccines on that day. He denies any unusual or prolonged reactions within the first week following vaccine receipt. He does not recall any viral-type symptoms just prior to or on the day of vaccine receipt. Sometime in late November or early December 2007, pt noted blurring of his vision. Between December 2007 and the end of January 2008, pt experienced tiredness, increased urination (voiding every 1-2 hours during the day), nocturia (voiding every 2-3 hours throughout the night) and increased thirst (drinking up to 2 quarts of orange juice a day). By mid-January, pt noted numbness and tingling in his fingertips and toes. While in another city on 28 January 2008, pt was seen at a local clinic for dehydration. When he described his symptoms, his blood glucose level was checked and reported to be 432. While at the clinic, he received his several liters of IV fluids. (No documentation of this visit visible to VHC). When pt returned to his city on 5 Feb 2008, he sought medical evaluation. By that time, in addition to the above symptoms worsening, he also had lost 30 lbs since late November 2007. When he was evaluated, his blood glucose level was 326 mg/dL, his UA showed trace positive ketones, and his HgbA1c was 11.6 (4.0-6.0). He was diagnosed with Type 2 diabetes. Between February 2008 and July 2009, pt was tried on a number of combinations of oral diabetes medications. Insulin was initiated in July 2009 and pt was recently changed to an insulin pump. Pt has never experienced ketoacidosis. He has lost neuropathy and diabetic retinopathy. Microalbuminuria was noted on a urine sample in 2008 and pt was subsequently started on Angiotension Receptor Blocker."
Age: 40.0
Sex: M
Vaccine: FLUN3
Symptoms: Nocturia, Paraesthesia, Pollakiuria, Thirst, Type 2 diabetes mellitus
Clinical narrative: This is a verbatim narrative as reported to the FDA VAERS. "Pt was in his usual state of excellent health prior to December 2007. He had completed a physical exam in Sept 2007 and had no physical complaints at that time. Pt received FLUMIST vaccine on 14 Nov 2007. He did not receive any other vaccines on that day. He denies any unusual or prolonged reactions within the first week following vaccine receipt. He does not recall any viral-type symptoms just prior to or on the day of vaccine receipt. Sometime in late November or early December 2007, pt noted blurring of his vision. Between December 2007 and the end of January 2008, pt experienced tiredness, increased urination (voiding every 1-2 hours during the day), nocturia (voiding every 2-3 hours throughout the night) and increased thirst (drinking up to 2 quarts of orange juice a day). By mid-January, pt noted numbness and tingling in his fingertips and toes. While in another city on 28 January 2008, pt was seen at a local clinic for dehydration. When he described his symptoms, his blood glucose level was checked and reported to be 432. While at the clinic, he received his several liters of IV fluids. (No documentation of this visit visible to VHC). When pt returned to his city on 5 Feb 2008, he sought medical evaluation. By that time, in addition to the above symptoms worsening, he also had lost 30 lbs since late November 2007. When he was evaluated, his blood glucose level was 326 mg/dL, his UA showed trace positive ketones, and his HgbA1c was 11.6 (4.0-6.0). He was diagnosed with Type 2 diabetes. Between February 2008 and July 2009, pt was tried on a number of combinations of oral diabetes medications. Insulin was initiated in July 2009 and pt was recently changed to an insulin pump. Pt has never experienced ketoacidosis. He has lost neuropathy and diabetic retinopathy. Microalbuminuria was noted on a urine sample in 2008 and pt was subsequently started on Angiotension Receptor Blocker."
Age: 40.0
Sex: M
Vaccine: FLUN3
Symptoms: Urine ketone body present, Vision blurred, Weight decreased
Clinical narrative: This is a verbatim narrative as reported to the FDA VAERS. "Pt was in his usual state of excellent health prior to December 2007. He had completed a physical exam in Sept 2007 and had no physical complaints at that time. Pt received FLUMIST vaccine on 14 Nov 2007. He did not receive any other vaccines on that day. He denies any unusual or prolonged reactions within the first week following vaccine receipt. He does not recall any viral-type symptoms just prior to or on the day of vaccine receipt. Sometime in late November or early December 2007, pt noted blurring of his vision. Between December 2007 and the end of January 2008, pt experienced tiredness, increased urination (voiding every 1-2 hours during the day), nocturia (voiding every 2-3 hours throughout the night) and increased thirst (drinking up to 2 quarts of orange juice a day). By mid-January, pt noted numbness and tingling in his fingertips and toes. While in another city on 28 January 2008, pt was seen at a local clinic for dehydration. When he described his symptoms, his blood glucose level was checked and reported to be 432. While at the clinic, he received his several liters of IV fluids. (No documentation of this visit visible to VHC). When pt returned to his city on 5 Feb 2008, he sought medical evaluation. By that time, in addition to the above symptoms worsening, he also had lost 30 lbs since late November 2007. When he was evaluated, his blood glucose level was 326 mg/dL, his UA showed trace positive ketones, and his HgbA1c was 11.6 (4.0-6.0). He was diagnosed with Type 2 diabetes. Between February 2008 and July 2009, pt was tried on a number of combinations of oral diabetes medications. Insulin was initiated in July 2009 and pt was recently changed to an insulin pump. Pt has never experienced ketoacidosis. He has lost neuropathy and diabetic retinopathy. Microalbuminuria was noted on a urine sample in 2008 and pt was subsequently started on Angiotension Receptor Blocker."
Age: 31.0
Sex: M
Vaccine: FLUN3
Symptoms: Anti-GAD antibody negative, Anti-islet cell antibody, Asthenia, Bilirubin urine, Blood glucose increased
Clinical narrative: "This is a verbatim narrative as reported to the FDA VAERS:" "Presented in July 2009 with a 25 pound weight loss and a 2-3 month history of polyuria, polydipsia, weakness, and blurred vision. He was admitted for stabilization and initiation of insulin, and was then transferred back to the medical center. At time of diagnosis, pt's blood sugar level was >500 and pt's A1c was 16.8, without evidence of ketoacidosis. In August 2009, he tested antibody negative for both pancreatic islet cells and GAD-65 antibodies. IA-2 antibodies were not tested. Pt is currently taking bedtime LANTUS with supplemental NOVOLOG taking 1 unit for every 15 grams of CHO, with an insulin sensitivity factor of 42. He has no evidence of diabetes-related complications. Pt denies a history of elevated glucose or blood pressure levels or history of diabetes. He denies any symptoms of acute infections between March 2009 and his diagnosis of T1DM in July."
Age: 31.0
Sex: M
Vaccine: FLUN3
Symptoms: Chromaturia, Glucose urine present, Glycosylated haemoglobin increased, Insulin C-peptide normal, Polydipsia
Clinical narrative: "This is a verbatim narrative as reported to the FDA VAERS:" "Presented in July 2009 with a 25 pound weight loss and a 2-3 month history of polyuria, polydipsia, weakness, and blurred vision. He was admitted for stabilization and initiation of insulin, and was then transferred back to the medical center. At time of diagnosis, pt's blood sugar level was >500 and pt's A1c was 16.8, without evidence of ketoacidosis. In August 2009, he tested antibody negative for both pancreatic islet cells and GAD-65 antibodies. IA-2 antibodies were not tested. Pt is currently taking bedtime LANTUS with supplemental NOVOLOG taking 1 unit for every 15 grams of CHO, with an insulin sensitivity factor of 42. He has no evidence of diabetes-related complications. Pt denies a history of elevated glucose or blood pressure levels or history of diabetes. He denies any symptoms of acute infections between March 2009 and his diagnosis of T1DM in July."
Age: 31.0
Sex: M
Vaccine: FLUN3
Symptoms: Polyuria, Protein urine absent, Specific gravity urine normal, Type 1 diabetes mellitus, Urine ketone body absent
Clinical narrative: "This is a verbatim narrative as reported to the FDA VAERS:" "Presented in July 2009 with a 25 pound weight loss and a 2-3 month history of polyuria, polydipsia, weakness, and blurred vision. He was admitted for stabilization and initiation of insulin, and was then transferred back to the medical center. At time of diagnosis, pt's blood sugar level was >500 and pt's A1c was 16.8, without evidence of ketoacidosis. In August 2009, he tested antibody negative for both pancreatic islet cells and GAD-65 antibodies. IA-2 antibodies were not tested. Pt is currently taking bedtime LANTUS with supplemental NOVOLOG taking 1 unit for every 15 grams of CHO, with an insulin sensitivity factor of 42. He has no evidence of diabetes-related complications. Pt denies a history of elevated glucose or blood pressure levels or history of diabetes. He denies any symptoms of acute infections between March 2009 and his diagnosis of T1DM in July."
Age: 31.0
Sex: M
Vaccine: FLUN3
Symptoms: Urine leukocyte esterase, Urobilinogen urine, Vision blurred, Weight decreased, pH urine normal
Clinical narrative: "This is a verbatim narrative as reported to the FDA VAERS:" "Presented in July 2009 with a 25 pound weight loss and a 2-3 month history of polyuria, polydipsia, weakness, and blurred vision. He was admitted for stabilization and initiation of insulin, and was then transferred back to the medical center. At time of diagnosis, pt's blood sugar level was >500 and pt's A1c was 16.8, without evidence of ketoacidosis. In August 2009, he tested antibody negative for both pancreatic islet cells and GAD-65 antibodies. IA-2 antibodies were not tested. Pt is currently taking bedtime LANTUS with supplemental NOVOLOG taking 1 unit for every 15 grams of CHO, with an insulin sensitivity factor of 42. He has no evidence of diabetes-related complications. Pt denies a history of elevated glucose or blood pressure levels or history of diabetes. He denies any symptoms of acute infections between March 2009 and his diagnosis of T1DM in July."
Age: 3.0
Sex: F
Vaccine: FLUN3
Symptoms: CSF test abnormal, Cataplexy, Cytogenetic analysis abnormal, Hypersomnia, Immunoglobulin therapy
Clinical narrative: "This is a verbatim narrative as reported to the FDA VAERS:" "Narcolepsy and cataplexy. Excessive sleepiness and weight gain. Sleeps 18 hours per day. Hospitalized and treated with IVIG. Now on RITALIN. Hospitalized 3/20/10 to 3/25/10."
Age: 3.0
Sex: F
Vaccine: FLUN3
Symptoms: Narcolepsy, Somnolence, Weight increased
Clinical narrative: "This is a verbatim narrative as reported to the FDA VAERS:" "Narcolepsy and cataplexy. Excessive sleepiness and weight gain. Sleeps 18 hours per day. Hospitalized and treated with IVIG. Now on RITALIN. Hospitalized 3/20/10 to 3/25/10."
Age: 31.0
Sex: M
Vaccine: FLUN3
Symptoms: Abdominal pain, Anti-GAD antibody positive, Anti-islet cell antibody, Asthenia, Blood 25-hydroxycholecalciferol
Clinical narrative: This is a verbatim narrative as reported to the FDA VAERS: "Patient was in his usual state of excellent health prior to May 2010. Patient received Typhoid and Meningococcal vaccine on 9 Feb 2010, and had received an inactivated H1N1 flu vaccine in Jan 2010. He denies any unusual or prolonged reactions within the first week following vaccine receipt. He does not recall any viral-type symptoms just prior to or on the days of vaccine receipt. He completed a physical exam in Feb 2010 and reported feeling well. However, his fasting serum glucose level on 9 Feb 2010 was 211. Sometime in mid-April 2010, patient noted increased thirst and urination and weakness. Between Feb 2010 and time of diagnosis in May 2010, patient lost 25 pounds (BMI 21.62). Also, by the time of diagnosis. Patient complained of abdominal pain and constipation, but denied nausea and/or vomiting. When he sought evaluation on 3 May 2010, his serum glucose level was 258, his HgbA1c was 11.8 and his urine was positive for glucose and ketones. He was hospitalized for 5 days for hydration, electrolyte replacement, and insulin titration, as well as diabetes self management training. He was discharged on once daily LANTUS with additional supplementation for hyperglycemia using NOVOLOG. Since that time, patient has been followed through local health care providers, as well as by Endocrinologist. Patient denies a history of elevated glucose or blood pressure levels or history of hypertension prior to T1DM diagnosis. He does not recall a history of recent infection or symptoms of cough, fever, sinus symptoms, congestion, or diarrhea prior to his diagnosis. He was active with sports and PT and had a normal BMI (23.92) prior to diagnosis. Patient has no family history of diabetes. DX: Type 1 Diabetes Mellitus."
Age: 31.0
Sex: M
Vaccine: FLUN3
Symptoms: Blood cholesterol normal, Blood glucose abnormal, Blood glucose increased, Blood triglycerides increased, Constipation
Clinical narrative: This is a verbatim narrative as reported to the FDA VAERS: "Patient was in his usual state of excellent health prior to May 2010. Patient received Typhoid and Meningococcal vaccine on 9 Feb 2010, and had received an inactivated H1N1 flu vaccine in Jan 2010. He denies any unusual or prolonged reactions within the first week following vaccine receipt. He does not recall any viral-type symptoms just prior to or on the days of vaccine receipt. He completed a physical exam in Feb 2010 and reported feeling well. However, his fasting serum glucose level on 9 Feb 2010 was 211. Sometime in mid-April 2010, patient noted increased thirst and urination and weakness. Between Feb 2010 and time of diagnosis in May 2010, patient lost 25 pounds (BMI 21.62). Also, by the time of diagnosis. Patient complained of abdominal pain and constipation, but denied nausea and/or vomiting. When he sought evaluation on 3 May 2010, his serum glucose level was 258, his HgbA1c was 11.8 and his urine was positive for glucose and ketones. He was hospitalized for 5 days for hydration, electrolyte replacement, and insulin titration, as well as diabetes self management training. He was discharged on once daily LANTUS with additional supplementation for hyperglycemia using NOVOLOG. Since that time, patient has been followed through local health care providers, as well as by Endocrinologist. Patient denies a history of elevated glucose or blood pressure levels or history of hypertension prior to T1DM diagnosis. He does not recall a history of recent infection or symptoms of cough, fever, sinus symptoms, congestion, or diarrhea prior to his diagnosis. He was active with sports and PT and had a normal BMI (23.92) prior to diagnosis. Patient has no family history of diabetes. DX: Type 1 Diabetes Mellitus."
Age: 31.0
Sex: M
Vaccine: FLUN3
Symptoms: Glucose urine present, Glycosylated haemoglobin increased, High density lipoprotein increased, Hyperglycaemia, Insulin C-peptide decreased
Clinical narrative: This is a verbatim narrative as reported to the FDA VAERS: "Patient was in his usual state of excellent health prior to May 2010. Patient received Typhoid and Meningococcal vaccine on 9 Feb 2010, and had received an inactivated H1N1 flu vaccine in Jan 2010. He denies any unusual or prolonged reactions within the first week following vaccine receipt. He does not recall any viral-type symptoms just prior to or on the days of vaccine receipt. He completed a physical exam in Feb 2010 and reported feeling well. However, his fasting serum glucose level on 9 Feb 2010 was 211. Sometime in mid-April 2010, patient noted increased thirst and urination and weakness. Between Feb 2010 and time of diagnosis in May 2010, patient lost 25 pounds (BMI 21.62). Also, by the time of diagnosis. Patient complained of abdominal pain and constipation, but denied nausea and/or vomiting. When he sought evaluation on 3 May 2010, his serum glucose level was 258, his HgbA1c was 11.8 and his urine was positive for glucose and ketones. He was hospitalized for 5 days for hydration, electrolyte replacement, and insulin titration, as well as diabetes self management training. He was discharged on once daily LANTUS with additional supplementation for hyperglycemia using NOVOLOG. Since that time, patient has been followed through local health care providers, as well as by Endocrinologist. Patient denies a history of elevated glucose or blood pressure levels or history of hypertension prior to T1DM diagnosis. He does not recall a history of recent infection or symptoms of cough, fever, sinus symptoms, congestion, or diarrhea prior to his diagnosis. He was active with sports and PT and had a normal BMI (23.92) prior to diagnosis. Patient has no family history of diabetes. DX: Type 1 Diabetes Mellitus."
Age: 31.0
Sex: M
Vaccine: FLUN3
Symptoms: Pollakiuria, Thirst, Type 1 diabetes mellitus, Urine analysis abnormal, Urine ketone body present
Clinical narrative: This is a verbatim narrative as reported to the FDA VAERS: "Patient was in his usual state of excellent health prior to May 2010. Patient received Typhoid and Meningococcal vaccine on 9 Feb 2010, and had received an inactivated H1N1 flu vaccine in Jan 2010. He denies any unusual or prolonged reactions within the first week following vaccine receipt. He does not recall any viral-type symptoms just prior to or on the days of vaccine receipt. He completed a physical exam in Feb 2010 and reported feeling well. However, his fasting serum glucose level on 9 Feb 2010 was 211. Sometime in mid-April 2010, patient noted increased thirst and urination and weakness. Between Feb 2010 and time of diagnosis in May 2010, patient lost 25 pounds (BMI 21.62). Also, by the time of diagnosis. Patient complained of abdominal pain and constipation, but denied nausea and/or vomiting. When he sought evaluation on 3 May 2010, his serum glucose level was 258, his HgbA1c was 11.8 and his urine was positive for glucose and ketones. He was hospitalized for 5 days for hydration, electrolyte replacement, and insulin titration, as well as diabetes self management training. He was discharged on once daily LANTUS with additional supplementation for hyperglycemia using NOVOLOG. Since that time, patient has been followed through local health care providers, as well as by Endocrinologist. Patient denies a history of elevated glucose or blood pressure levels or history of hypertension prior to T1DM diagnosis. He does not recall a history of recent infection or symptoms of cough, fever, sinus symptoms, congestion, or diarrhea prior to his diagnosis. He was active with sports and PT and had a normal BMI (23.92) prior to diagnosis. Patient has no family history of diabetes. DX: Type 1 Diabetes Mellitus."
Age: 31.0
Sex: M
Vaccine: FLUN3
Symptoms: Weight decreased
Clinical narrative: This is a verbatim narrative as reported to the FDA VAERS: "Patient was in his usual state of excellent health prior to May 2010. Patient received Typhoid and Meningococcal vaccine on 9 Feb 2010, and had received an inactivated H1N1 flu vaccine in Jan 2010. He denies any unusual or prolonged reactions within the first week following vaccine receipt. He does not recall any viral-type symptoms just prior to or on the days of vaccine receipt. He completed a physical exam in Feb 2010 and reported feeling well. However, his fasting serum glucose level on 9 Feb 2010 was 211. Sometime in mid-April 2010, patient noted increased thirst and urination and weakness. Between Feb 2010 and time of diagnosis in May 2010, patient lost 25 pounds (BMI 21.62). Also, by the time of diagnosis. Patient complained of abdominal pain and constipation, but denied nausea and/or vomiting. When he sought evaluation on 3 May 2010, his serum glucose level was 258, his HgbA1c was 11.8 and his urine was positive for glucose and ketones. He was hospitalized for 5 days for hydration, electrolyte replacement, and insulin titration, as well as diabetes self management training. He was discharged on once daily LANTUS with additional supplementation for hyperglycemia using NOVOLOG. Since that time, patient has been followed through local health care providers, as well as by Endocrinologist. Patient denies a history of elevated glucose or blood pressure levels or history of hypertension prior to T1DM diagnosis. He does not recall a history of recent infection or symptoms of cough, fever, sinus symptoms, congestion, or diarrhea prior to his diagnosis. He was active with sports and PT and had a normal BMI (23.92) prior to diagnosis. Patient has no family history of diabetes. DX: Type 1 Diabetes Mellitus."
Age: 33.0
Sex: M
Vaccine: FLUN3
Symptoms: Anti-GAD antibody positive, Anti-IA2 antibody, Anti-islet cell antibody, Blood glucose increased, Blood pH decreased
Clinical narrative: This is a verbatim narrative as reported to the FDA VAERS: "Currently a 33-year-old M. Patient history reveals patient first reported symptoms of hyperglycemia around mid-December while at work, but no records are available from that visit. Pt then presented to office on 20 Dec 2006. (Glucose level was 262 and HgbA1c was 12.1). At that time, he reported approximately 4-week of polyuria, polydipsia, blurred vision, and weight loss (approximately 10-15 pounds over previous month). (This note is not visible in electronic medical records, but lab result dates and other notes from his medical records support this history). While on vacation, on 31 Dec 2006, pt sought evaluation at clinic for continued weight loss and new onset nausea and vomiting. His presenting BG level was 521 and his pH per ABG was 7.25 and UA with positive ketones and glucose. He was admitted to clinic for 5 days with diagnosis of Diabetic Ketoacidosis (DKA). In early Jan 2007, his C-peptide level was 0.6. Daily LANTUS with supplemental Aspart were initiated. Pt received diabetes self management education, he was followed up through Internal Medicine and Endocrinology at hospital."
Age: 33.0
Sex: M
Vaccine: FLUN3
Symptoms: Diabetic ketoacidosis, Glucose urine present, Glycosylated haemoglobin increased, Hyperglycaemia, Insulin C-peptide decreased
Clinical narrative: This is a verbatim narrative as reported to the FDA VAERS: "Currently a 33-year-old M. Patient history reveals patient first reported symptoms of hyperglycemia around mid-December while at work, but no records are available from that visit. Pt then presented to office on 20 Dec 2006. (Glucose level was 262 and HgbA1c was 12.1). At that time, he reported approximately 4-week of polyuria, polydipsia, blurred vision, and weight loss (approximately 10-15 pounds over previous month). (This note is not visible in electronic medical records, but lab result dates and other notes from his medical records support this history). While on vacation, on 31 Dec 2006, pt sought evaluation at clinic for continued weight loss and new onset nausea and vomiting. His presenting BG level was 521 and his pH per ABG was 7.25 and UA with positive ketones and glucose. He was admitted to clinic for 5 days with diagnosis of Diabetic Ketoacidosis (DKA). In early Jan 2007, his C-peptide level was 0.6. Daily LANTUS with supplemental Aspart were initiated. Pt received diabetes self management education, he was followed up through Internal Medicine and Endocrinology at hospital."
Age: 33.0
Sex: M
Vaccine: FLUN3
Symptoms: Nausea, Polydipsia, Polyuria, Urine ketone body present, Vision blurred
Clinical narrative: This is a verbatim narrative as reported to the FDA VAERS: "Currently a 33-year-old M. Patient history reveals patient first reported symptoms of hyperglycemia around mid-December while at work, but no records are available from that visit. Pt then presented to office on 20 Dec 2006. (Glucose level was 262 and HgbA1c was 12.1). At that time, he reported approximately 4-week of polyuria, polydipsia, blurred vision, and weight loss (approximately 10-15 pounds over previous month). (This note is not visible in electronic medical records, but lab result dates and other notes from his medical records support this history). While on vacation, on 31 Dec 2006, pt sought evaluation at clinic for continued weight loss and new onset nausea and vomiting. His presenting BG level was 521 and his pH per ABG was 7.25 and UA with positive ketones and glucose. He was admitted to clinic for 5 days with diagnosis of Diabetic Ketoacidosis (DKA). In early Jan 2007, his C-peptide level was 0.6. Daily LANTUS with supplemental Aspart were initiated. Pt received diabetes self management education, he was followed up through Internal Medicine and Endocrinology at hospital."
Age: 33.0
Sex: M
Vaccine: FLUN3
Symptoms: Vomiting, Weight decreased
Clinical narrative: This is a verbatim narrative as reported to the FDA VAERS: "Currently a 33-year-old M. Patient history reveals patient first reported symptoms of hyperglycemia around mid-December while at work, but no records are available from that visit. Pt then presented to office on 20 Dec 2006. (Glucose level was 262 and HgbA1c was 12.1). At that time, he reported approximately 4-week of polyuria, polydipsia, blurred vision, and weight loss (approximately 10-15 pounds over previous month). (This note is not visible in electronic medical records, but lab result dates and other notes from his medical records support this history). While on vacation, on 31 Dec 2006, pt sought evaluation at clinic for continued weight loss and new onset nausea and vomiting. His presenting BG level was 521 and his pH per ABG was 7.25 and UA with positive ketones and glucose. He was admitted to clinic for 5 days with diagnosis of Diabetic Ketoacidosis (DKA). In early Jan 2007, his C-peptide level was 0.6. Daily LANTUS with supplemental Aspart were initiated. Pt received diabetes self management education, he was followed up through Internal Medicine and Endocrinology at hospital."
Age: 35.0
Sex: F
Vaccine: FLUN3
Symptoms: Chest pain, Chills, Dizziness, Fatigue, Feeling abnormal
Clinical narrative: "This is a verbatim narrative as reported to the FDA VAERS:" "Within a few hours of receiving the FLUMIST, I started to have an achy head and became very sensitive to light. I stayed at work until 4:30pm and went home to rest. I felt terrible until I went to bed that evening at 10pm. The next few days I had sinus drip in the back of my throat and on Thursday October 14th around 6:10PM, I started to get chills all over my body. Within an hour I was visibly shaking uncontrollably and started to get a fever. It was 98.8 degrees. I took TYLENOL and some over the counter herbal remedies. I went to bed around 11pm and slept for 13 hours. When I woke up, my fever was reduced, but I have large red raised welts over my entire chest and torso. I have since found out they are hives. I was in bed for about 48 hours, exhausted, hot and extremely dizzy. It was hard to walk to the bathroom. My chest and torso and pelvis hurt really badly as well and were sensitive to the touch, everything felt swollen and bruised. I started to feel a bit better by the third day, but still feel a little achy and I'm still quite dizzy and very tired."
Age: 35.0
Sex: F
Vaccine: FLUN3
Symptoms: Feeling hot, Gait disturbance, Headache, Hyperaesthesia, Hypersomnia
Clinical narrative: "This is a verbatim narrative as reported to the FDA VAERS:" "Within a few hours of receiving the FLUMIST, I started to have an achy head and became very sensitive to light. I stayed at work until 4:30pm and went home to rest. I felt terrible until I went to bed that evening at 10pm. The next few days I had sinus drip in the back of my throat and on Thursday October 14th around 6:10PM, I started to get chills all over my body. Within an hour I was visibly shaking uncontrollably and started to get a fever. It was 98.8 degrees. I took TYLENOL and some over the counter herbal remedies. I went to bed around 11pm and slept for 13 hours. When I woke up, my fever was reduced, but I have large red raised welts over my entire chest and torso. I have since found out they are hives. I was in bed for about 48 hours, exhausted, hot and extremely dizzy. It was hard to walk to the bathroom. My chest and torso and pelvis hurt really badly as well and were sensitive to the touch, everything felt swollen and bruised. I started to feel a bit better by the third day, but still feel a little achy and I'm still quite dizzy and very tired."
Age: 35.0
Sex: F
Vaccine: FLUN3
Symptoms: Pain, Pelvic pain, Photophobia, Pyrexia, Swelling
Clinical narrative: "This is a verbatim narrative as reported to the FDA VAERS:" "Within a few hours of receiving the FLUMIST, I started to have an achy head and became very sensitive to light. I stayed at work until 4:30pm and went home to rest. I felt terrible until I went to bed that evening at 10pm. The next few days I had sinus drip in the back of my throat and on Thursday October 14th around 6:10PM, I started to get chills all over my body. Within an hour I was visibly shaking uncontrollably and started to get a fever. It was 98.8 degrees. I took TYLENOL and some over the counter herbal remedies. I went to bed around 11pm and slept for 13 hours. When I woke up, my fever was reduced, but I have large red raised welts over my entire chest and torso. I have since found out they are hives. I was in bed for about 48 hours, exhausted, hot and extremely dizzy. It was hard to walk to the bathroom. My chest and torso and pelvis hurt really badly as well and were sensitive to the touch, everything felt swollen and bruised. I started to feel a bit better by the third day, but still feel a little achy and I'm still quite dizzy and very tired."
Age: 35.0
Sex: F
Vaccine: FLUN3
Symptoms: Tremor, Urticaria
Clinical narrative: "This is a verbatim narrative as reported to the FDA VAERS:" "Within a few hours of receiving the FLUMIST, I started to have an achy head and became very sensitive to light. I stayed at work until 4:30pm and went home to rest. I felt terrible until I went to bed that evening at 10pm. The next few days I had sinus drip in the back of my throat and on Thursday October 14th around 6:10PM, I started to get chills all over my body. Within an hour I was visibly shaking uncontrollably and started to get a fever. It was 98.8 degrees. I took TYLENOL and some over the counter herbal remedies. I went to bed around 11pm and slept for 13 hours. When I woke up, my fever was reduced, but I have large red raised welts over my entire chest and torso. I have since found out they are hives. I was in bed for about 48 hours, exhausted, hot and extremely dizzy. It was hard to walk to the bathroom. My chest and torso and pelvis hurt really badly as well and were sensitive to the touch, everything felt swollen and bruised. I started to feel a bit better by the third day, but still feel a little achy and I'm still quite dizzy and very tired."
Age: 26.0
Sex: M
Vaccine: FLUN3
Symptoms: Arthritis, Chest pain, Diabetes mellitus, Dyspnoea, Pneumonia
Clinical narrative: This is a verbatim narrative as reported to the FDA VAERS: "Rash started out on left leg, spread to right leg and then all over the body. Treated twice over the course of month with allergy medication, topical solution and prednisone. Pneumonia lasted for month, then had difficulty breathing, shortness of breath, chest pains, arthritis diagnosed, and diabetes diagnosed."
Age: 26.0
Sex: M
Vaccine: FLUN3
Symptoms: Rash generalised
Clinical narrative: This is a verbatim narrative as reported to the FDA VAERS: "Rash started out on left leg, spread to right leg and then all over the body. Treated twice over the course of month with allergy medication, topical solution and prednisone. Pneumonia lasted for month, then had difficulty breathing, shortness of breath, chest pains, arthritis diagnosed, and diabetes diagnosed."
Age: 23.0
Sex: M
Vaccine: FLUN3
Symptoms: Anti-islet cell antibody, Antibody test negative, Arthralgia, Arthroscopic surgery, Bacillus test positive
Clinical narrative: This is a verbatim narrative as reported to the FDA VAERS: "Patient was in his usual state of good health prior to Dec 2010. Looking back, patient recalls developing symptoms of hyperglycemia sometime around November 2010 while stationed. He experienced symptoms of polyuria, polydipsia, fatigue, polyphagia and an approximately 15-pound weight loss over -30-day period. Around 10 Dec 2010, patient also began experiencing nausea and vomiting which gradually increased to the point of not being able to keep anything down by 18 Dec and led him to seek evaluation. At that time, a glucose level of 327, positive urine ketones and ketoacidosis led to his diagnosis of T1DM and he was hospitalized in the ICU for 3 days. During his admission, insulin was initiated, as well as diabetes self management training. He was discharged on once daily LANTUS with additional premeal NOVOLOG and supplementation for hyperglycemia using NOVOLOG. Since diagnosis, patient has been followed through a local Endocrinologist, as well as local medical providers. Patient received FLUMIST on Oct 2010 and H1N1 vaccine in Aug 2010, and his most recent Anthrax vaccine was received in Dec 2009. He denies any unusual or prolonged reactions within the first week following vaccine receipt. Patient does not recall any viral-type symptoms just prior to or on the days of vaccine receipt. Patient does not recall a history of infection or symptoms of cough, fever, sinus symptoms, congestion or diarrhea prior to his diagnosis of T1DM. Patient reports a history of a glucose in the 200s prior to his arthroscopic knee surgery in late Oct. He denies a previous history of elevated glucose or blood pressure levels or history of hypertension. He was had not been as active over the past year due to knee pain and surgery. He has no family Hx of T1DM."
Age: 23.0
Sex: M
Vaccine: FLUN3
Symptoms: Blood culture positive, Blood glucose increased, Chest X-ray normal, Fatigue, Glycosylated haemoglobin increased
Clinical narrative: This is a verbatim narrative as reported to the FDA VAERS: "Patient was in his usual state of good health prior to Dec 2010. Looking back, patient recalls developing symptoms of hyperglycemia sometime around November 2010 while stationed. He experienced symptoms of polyuria, polydipsia, fatigue, polyphagia and an approximately 15-pound weight loss over -30-day period. Around 10 Dec 2010, patient also began experiencing nausea and vomiting which gradually increased to the point of not being able to keep anything down by 18 Dec and led him to seek evaluation. At that time, a glucose level of 327, positive urine ketones and ketoacidosis led to his diagnosis of T1DM and he was hospitalized in the ICU for 3 days. During his admission, insulin was initiated, as well as diabetes self management training. He was discharged on once daily LANTUS with additional premeal NOVOLOG and supplementation for hyperglycemia using NOVOLOG. Since diagnosis, patient has been followed through a local Endocrinologist, as well as local medical providers. Patient received FLUMIST on Oct 2010 and H1N1 vaccine in Aug 2010, and his most recent Anthrax vaccine was received in Dec 2009. He denies any unusual or prolonged reactions within the first week following vaccine receipt. Patient does not recall any viral-type symptoms just prior to or on the days of vaccine receipt. Patient does not recall a history of infection or symptoms of cough, fever, sinus symptoms, congestion or diarrhea prior to his diagnosis of T1DM. Patient reports a history of a glucose in the 200s prior to his arthroscopic knee surgery in late Oct. He denies a previous history of elevated glucose or blood pressure levels or history of hypertension. He was had not been as active over the past year due to knee pain and surgery. He has no family Hx of T1DM."
Age: 23.0
Sex: M
Vaccine: FLUN3
Symptoms: Hyperglycaemia, Hyperphagia, Intensive care, Ketoacidosis, Laboratory test normal
Clinical narrative: This is a verbatim narrative as reported to the FDA VAERS: "Patient was in his usual state of good health prior to Dec 2010. Looking back, patient recalls developing symptoms of hyperglycemia sometime around November 2010 while stationed. He experienced symptoms of polyuria, polydipsia, fatigue, polyphagia and an approximately 15-pound weight loss over -30-day period. Around 10 Dec 2010, patient also began experiencing nausea and vomiting which gradually increased to the point of not being able to keep anything down by 18 Dec and led him to seek evaluation. At that time, a glucose level of 327, positive urine ketones and ketoacidosis led to his diagnosis of T1DM and he was hospitalized in the ICU for 3 days. During his admission, insulin was initiated, as well as diabetes self management training. He was discharged on once daily LANTUS with additional premeal NOVOLOG and supplementation for hyperglycemia using NOVOLOG. Since diagnosis, patient has been followed through a local Endocrinologist, as well as local medical providers. Patient received FLUMIST on Oct 2010 and H1N1 vaccine in Aug 2010, and his most recent Anthrax vaccine was received in Dec 2009. He denies any unusual or prolonged reactions within the first week following vaccine receipt. Patient does not recall any viral-type symptoms just prior to or on the days of vaccine receipt. Patient does not recall a history of infection or symptoms of cough, fever, sinus symptoms, congestion or diarrhea prior to his diagnosis of T1DM. Patient reports a history of a glucose in the 200s prior to his arthroscopic knee surgery in late Oct. He denies a previous history of elevated glucose or blood pressure levels or history of hypertension. He was had not been as active over the past year due to knee pain and surgery. He has no family Hx of T1DM."