chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 28.0
Sex: M
Vaccine: SMALL
Symptoms: Albumin urine absent, Anti-GAD antibody negative, Anti-islet cell antibody positive, Asthenia, Blood calcium normal
Clinical narrative: Patient was in his usual state of excellent health until July 2003. Looking back, the first symptoms that the patient can recall are polydipsia and polyuria which began around the end of July 2003. He specifically recalls driving home and drinking "2-3 times as much as normal". At the time, he didn't know what to attribute his thirst to. He recalls stopping to void 6-9 times during that 9 hour drive. He attributed this to his increased fluid intake. Around August 10th, he noted a decrease in his energy level. At that time, he rates his energy level as 40% using a scale of 0 (=no energy/bedridden) to 100 (=baseline energy level). He was flying and his flights were about 14-18 hours long. He would usually stay awake the entire flight. With this particular flight, he could not stay awake even though he had slept well the night before. At the time, he knew something was wrong with him, but didn't know what. Between his initial symptom onset and his initial evaluation in late August, service member began to lose weight, but it was not really noticeable. His baseline weight was around 170-175 pounds. By August 2003, his mother commented on a noticeable weight loss (Since his diagnosis and treatment of diabetes, patient has gradually regained weight and now weighs about 185 pounds.) He did not experience any visual blurring or paresthesias. In late August 2003, service member sought evaluation with the doctor for persistent and worsening symptoms. When he returned to the clinic the following day for lab work, the results were consistent with diabetes with a blood glucose level >200 and positive ketones. He was initially diagnosed as having Type 2 diabetes and an oral agent was initiated. After additional evaluation, he was started on a split mixed insulin regimen. When additional lab results supported the diagnosis of Type 1 diabetes, the oral medication was discontinued. Since then, patient has followed up with an Endocrinologist and he is currently on continuous subcutaneous insulin infusion. Patient has no family history of Type 1 diabetes. He denies symptoms of viral or bacterial infections prior to symptom onset. (He does report during his last trip around 10 August, he did have one emesis after his evening meal; he had no other GI-related or other viral-type symptoms and he was not aware of any other members of his unit experiencing GI-related symptoms.)
Age: 28.0
Sex: M
Vaccine: SMALL
Symptoms: Blood chloride normal, Blood cholesterol normal, Blood cortisol normal, Blood creatine phosphokinase normal, Blood creatinine normal
Clinical narrative: Patient was in his usual state of excellent health until July 2003. Looking back, the first symptoms that the patient can recall are polydipsia and polyuria which began around the end of July 2003. He specifically recalls driving home and drinking "2-3 times as much as normal". At the time, he didn't know what to attribute his thirst to. He recalls stopping to void 6-9 times during that 9 hour drive. He attributed this to his increased fluid intake. Around August 10th, he noted a decrease in his energy level. At that time, he rates his energy level as 40% using a scale of 0 (=no energy/bedridden) to 100 (=baseline energy level). He was flying and his flights were about 14-18 hours long. He would usually stay awake the entire flight. With this particular flight, he could not stay awake even though he had slept well the night before. At the time, he knew something was wrong with him, but didn't know what. Between his initial symptom onset and his initial evaluation in late August, service member began to lose weight, but it was not really noticeable. His baseline weight was around 170-175 pounds. By August 2003, his mother commented on a noticeable weight loss (Since his diagnosis and treatment of diabetes, patient has gradually regained weight and now weighs about 185 pounds.) He did not experience any visual blurring or paresthesias. In late August 2003, service member sought evaluation with the doctor for persistent and worsening symptoms. When he returned to the clinic the following day for lab work, the results were consistent with diabetes with a blood glucose level >200 and positive ketones. He was initially diagnosed as having Type 2 diabetes and an oral agent was initiated. After additional evaluation, he was started on a split mixed insulin regimen. When additional lab results supported the diagnosis of Type 1 diabetes, the oral medication was discontinued. Since then, patient has followed up with an Endocrinologist and he is currently on continuous subcutaneous insulin infusion. Patient has no family history of Type 1 diabetes. He denies symptoms of viral or bacterial infections prior to symptom onset. (He does report during his last trip around 10 August, he did have one emesis after his evening meal; he had no other GI-related or other viral-type symptoms and he was not aware of any other members of his unit experiencing GI-related symptoms.)
Age: 28.0
Sex: M
Vaccine: SMALL
Symptoms: Blood glucose increased, Blood ketone body present, Blood potassium normal, Blood sodium decreased, Blood thyroid stimulating hormone decreased
Clinical narrative: Patient was in his usual state of excellent health until July 2003. Looking back, the first symptoms that the patient can recall are polydipsia and polyuria which began around the end of July 2003. He specifically recalls driving home and drinking "2-3 times as much as normal". At the time, he didn't know what to attribute his thirst to. He recalls stopping to void 6-9 times during that 9 hour drive. He attributed this to his increased fluid intake. Around August 10th, he noted a decrease in his energy level. At that time, he rates his energy level as 40% using a scale of 0 (=no energy/bedridden) to 100 (=baseline energy level). He was flying and his flights were about 14-18 hours long. He would usually stay awake the entire flight. With this particular flight, he could not stay awake even though he had slept well the night before. At the time, he knew something was wrong with him, but didn't know what. Between his initial symptom onset and his initial evaluation in late August, service member began to lose weight, but it was not really noticeable. His baseline weight was around 170-175 pounds. By August 2003, his mother commented on a noticeable weight loss (Since his diagnosis and treatment of diabetes, patient has gradually regained weight and now weighs about 185 pounds.) He did not experience any visual blurring or paresthesias. In late August 2003, service member sought evaluation with the doctor for persistent and worsening symptoms. When he returned to the clinic the following day for lab work, the results were consistent with diabetes with a blood glucose level >200 and positive ketones. He was initially diagnosed as having Type 2 diabetes and an oral agent was initiated. After additional evaluation, he was started on a split mixed insulin regimen. When additional lab results supported the diagnosis of Type 1 diabetes, the oral medication was discontinued. Since then, patient has followed up with an Endocrinologist and he is currently on continuous subcutaneous insulin infusion. Patient has no family history of Type 1 diabetes. He denies symptoms of viral or bacterial infections prior to symptom onset. (He does report during his last trip around 10 August, he did have one emesis after his evening meal; he had no other GI-related or other viral-type symptoms and he was not aware of any other members of his unit experiencing GI-related symptoms.)
Age: 28.0
Sex: M
Vaccine: SMALL
Symptoms: Blood triglycerides normal, Blood urea normal, Carbon dioxide normal, Creatine urine, Diabetes mellitus
Clinical narrative: Patient was in his usual state of excellent health until July 2003. Looking back, the first symptoms that the patient can recall are polydipsia and polyuria which began around the end of July 2003. He specifically recalls driving home and drinking "2-3 times as much as normal". At the time, he didn't know what to attribute his thirst to. He recalls stopping to void 6-9 times during that 9 hour drive. He attributed this to his increased fluid intake. Around August 10th, he noted a decrease in his energy level. At that time, he rates his energy level as 40% using a scale of 0 (=no energy/bedridden) to 100 (=baseline energy level). He was flying and his flights were about 14-18 hours long. He would usually stay awake the entire flight. With this particular flight, he could not stay awake even though he had slept well the night before. At the time, he knew something was wrong with him, but didn't know what. Between his initial symptom onset and his initial evaluation in late August, service member began to lose weight, but it was not really noticeable. His baseline weight was around 170-175 pounds. By August 2003, his mother commented on a noticeable weight loss (Since his diagnosis and treatment of diabetes, patient has gradually regained weight and now weighs about 185 pounds.) He did not experience any visual blurring or paresthesias. In late August 2003, service member sought evaluation with the doctor for persistent and worsening symptoms. When he returned to the clinic the following day for lab work, the results were consistent with diabetes with a blood glucose level >200 and positive ketones. He was initially diagnosed as having Type 2 diabetes and an oral agent was initiated. After additional evaluation, he was started on a split mixed insulin regimen. When additional lab results supported the diagnosis of Type 1 diabetes, the oral medication was discontinued. Since then, patient has followed up with an Endocrinologist and he is currently on continuous subcutaneous insulin infusion. Patient has no family history of Type 1 diabetes. He denies symptoms of viral or bacterial infections prior to symptom onset. (He does report during his last trip around 10 August, he did have one emesis after his evening meal; he had no other GI-related or other viral-type symptoms and he was not aware of any other members of his unit experiencing GI-related symptoms.)
Age: 28.0
Sex: M
Vaccine: SMALL
Symptoms: Glucose urine present, Glycosylated haemoglobin increased, High density lipoprotein normal, Insulin C-peptide decreased, Laboratory test
Clinical narrative: Patient was in his usual state of excellent health until July 2003. Looking back, the first symptoms that the patient can recall are polydipsia and polyuria which began around the end of July 2003. He specifically recalls driving home and drinking "2-3 times as much as normal". At the time, he didn't know what to attribute his thirst to. He recalls stopping to void 6-9 times during that 9 hour drive. He attributed this to his increased fluid intake. Around August 10th, he noted a decrease in his energy level. At that time, he rates his energy level as 40% using a scale of 0 (=no energy/bedridden) to 100 (=baseline energy level). He was flying and his flights were about 14-18 hours long. He would usually stay awake the entire flight. With this particular flight, he could not stay awake even though he had slept well the night before. At the time, he knew something was wrong with him, but didn't know what. Between his initial symptom onset and his initial evaluation in late August, service member began to lose weight, but it was not really noticeable. His baseline weight was around 170-175 pounds. By August 2003, his mother commented on a noticeable weight loss (Since his diagnosis and treatment of diabetes, patient has gradually regained weight and now weighs about 185 pounds.) He did not experience any visual blurring or paresthesias. In late August 2003, service member sought evaluation with the doctor for persistent and worsening symptoms. When he returned to the clinic the following day for lab work, the results were consistent with diabetes with a blood glucose level >200 and positive ketones. He was initially diagnosed as having Type 2 diabetes and an oral agent was initiated. After additional evaluation, he was started on a split mixed insulin regimen. When additional lab results supported the diagnosis of Type 1 diabetes, the oral medication was discontinued. Since then, patient has followed up with an Endocrinologist and he is currently on continuous subcutaneous insulin infusion. Patient has no family history of Type 1 diabetes. He denies symptoms of viral or bacterial infections prior to symptom onset. (He does report during his last trip around 10 August, he did have one emesis after his evening meal; he had no other GI-related or other viral-type symptoms and he was not aware of any other members of his unit experiencing GI-related symptoms.)
Age: 28.0
Sex: M
Vaccine: SMALL
Symptoms: Low density lipoprotein normal, Pollakiuria, Polydipsia, Polyuria, Somnolence
Clinical narrative: Patient was in his usual state of excellent health until July 2003. Looking back, the first symptoms that the patient can recall are polydipsia and polyuria which began around the end of July 2003. He specifically recalls driving home and drinking "2-3 times as much as normal". At the time, he didn't know what to attribute his thirst to. He recalls stopping to void 6-9 times during that 9 hour drive. He attributed this to his increased fluid intake. Around August 10th, he noted a decrease in his energy level. At that time, he rates his energy level as 40% using a scale of 0 (=no energy/bedridden) to 100 (=baseline energy level). He was flying and his flights were about 14-18 hours long. He would usually stay awake the entire flight. With this particular flight, he could not stay awake even though he had slept well the night before. At the time, he knew something was wrong with him, but didn't know what. Between his initial symptom onset and his initial evaluation in late August, service member began to lose weight, but it was not really noticeable. His baseline weight was around 170-175 pounds. By August 2003, his mother commented on a noticeable weight loss (Since his diagnosis and treatment of diabetes, patient has gradually regained weight and now weighs about 185 pounds.) He did not experience any visual blurring or paresthesias. In late August 2003, service member sought evaluation with the doctor for persistent and worsening symptoms. When he returned to the clinic the following day for lab work, the results were consistent with diabetes with a blood glucose level >200 and positive ketones. He was initially diagnosed as having Type 2 diabetes and an oral agent was initiated. After additional evaluation, he was started on a split mixed insulin regimen. When additional lab results supported the diagnosis of Type 1 diabetes, the oral medication was discontinued. Since then, patient has followed up with an Endocrinologist and he is currently on continuous subcutaneous insulin infusion. Patient has no family history of Type 1 diabetes. He denies symptoms of viral or bacterial infections prior to symptom onset. (He does report during his last trip around 10 August, he did have one emesis after his evening meal; he had no other GI-related or other viral-type symptoms and he was not aware of any other members of his unit experiencing GI-related symptoms.)
Age: 28.0
Sex: M
Vaccine: SMALL
Symptoms: Type 1 diabetes mellitus, Urine analysis abnormal, Urine ketone body present, Vomiting, Weight decreased
Clinical narrative: Patient was in his usual state of excellent health until July 2003. Looking back, the first symptoms that the patient can recall are polydipsia and polyuria which began around the end of July 2003. He specifically recalls driving home and drinking "2-3 times as much as normal". At the time, he didn't know what to attribute his thirst to. He recalls stopping to void 6-9 times during that 9 hour drive. He attributed this to his increased fluid intake. Around August 10th, he noted a decrease in his energy level. At that time, he rates his energy level as 40% using a scale of 0 (=no energy/bedridden) to 100 (=baseline energy level). He was flying and his flights were about 14-18 hours long. He would usually stay awake the entire flight. With this particular flight, he could not stay awake even though he had slept well the night before. At the time, he knew something was wrong with him, but didn't know what. Between his initial symptom onset and his initial evaluation in late August, service member began to lose weight, but it was not really noticeable. His baseline weight was around 170-175 pounds. By August 2003, his mother commented on a noticeable weight loss (Since his diagnosis and treatment of diabetes, patient has gradually regained weight and now weighs about 185 pounds.) He did not experience any visual blurring or paresthesias. In late August 2003, service member sought evaluation with the doctor for persistent and worsening symptoms. When he returned to the clinic the following day for lab work, the results were consistent with diabetes with a blood glucose level >200 and positive ketones. He was initially diagnosed as having Type 2 diabetes and an oral agent was initiated. After additional evaluation, he was started on a split mixed insulin regimen. When additional lab results supported the diagnosis of Type 1 diabetes, the oral medication was discontinued. Since then, patient has followed up with an Endocrinologist and he is currently on continuous subcutaneous insulin infusion. Patient has no family history of Type 1 diabetes. He denies symptoms of viral or bacterial infections prior to symptom onset. (He does report during his last trip around 10 August, he did have one emesis after his evening meal; he had no other GI-related or other viral-type symptoms and he was not aware of any other members of his unit experiencing GI-related symptoms.)
Age: 35.0
Sex: M
Vaccine: FLUX
Symptoms: Clostridial infection, Guillain-Barre syndrome, Neuropathy peripheral, Pneumothorax
Clinical narrative: Guillain Barre, 2.5 month hospitalization complicated by pneumothorax/C. Difficile and subsequent long term neuropathy.
Age: 0.34
Sex: M
Vaccine: PNC13, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Erythema, Irritability, Oedema peripheral, Screaming, Skin warm
Clinical narrative: Crying, excessive, redness & swelling at injection site after 3 hours.
Age: 0.34
Sex: M
Vaccine: PNC13, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Crying, Injection site erythema, Injection site swelling
Clinical narrative: Crying, excessive, redness & swelling at injection site after 3 hours.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, HEPA, HPV4, MNQ, TDAP
Symptoms: Injection site pain, Injection site reaction, Rash macular
Clinical narrative: Macular erythema with tenderness at immunization site measuring 8x5 mm (R) and 4.5x5 mm (L) arm. No wheezing both lungs clear. Rx = cold compress PRN; BENADRYL cap 25mg q6h PRN; TYLENOL or ibuprofen PRN for pain; RTC if it gets worse or having problems breathing.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, VARCEL
Symptoms: Induration, Injection site erosion, Injection site erythema
Clinical narrative: Left arm w/ 4 cm area of erythema, excoriated with several breaks in the skin. Area of induration noted that is 2.5cm in diameter, no fluctuance non tender to palpate. No streaking noted.
Age: 38.0
Sex: M
Vaccine: ANTH
Symptoms: Anti-GAD antibody negative, Anti-islet cell antibody, Autoantibody negative, Glycosylated haemoglobin increased, Insulin C-peptide normal
Clinical narrative: Dx with DM Type I on 25 Jan 12. In 2010 pt began to notice a gradual wt. loss, increase thirst, and urination. He initially thought it was related stress. His wt went from 180 to 150 in Jan 2011.
Age: 38.0
Sex: M
Vaccine: ANTH
Symptoms: Pollakiuria, Thirst, Type 1 diabetes mellitus, Weight decreased
Clinical narrative: Dx with DM Type I on 25 Jan 12. In 2010 pt began to notice a gradual wt. loss, increase thirst, and urination. He initially thought it was related stress. His wt went from 180 to 150 in Jan 2011.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest discomfort, Dizziness
Clinical narrative: Information has been received from a registered pharmacist concerning a female patient in her "70s" who in approximately February 2012, was vaccinated with a dose of 0.65 mL ZOSTAVAX (Merck) (Lot# not reported) subcutaneously. In approximately February 2012, the patient experienced dizziness and chest-tightening after being vaccinated with ZOSTAVAX (Merck) and was hospitalized in an unspecified  hospital (duration and location unspecified). The patient was anxious before getting the vaccination. The AE was improved on therapy. Subsequently, the patient recovered from dizziness and chest-tightening on an unspecified date. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Coma, Syncope
Clinical narrative: Information has been received from a retired physician concerning a female patient (young girl) (age unknown) who on an unknown date was vaccinated with a dose of GARDASIL (lot number, dose and route not reported). The physician stated that he knew that the patient had a reaction to GARDASIL. On an unknown date, the patient fainted in the office (name of the office unspecified) and later was hospitalized, released (date unspecified). At the time of reporting, the patient had not recovered and was hospitalized and in coma. Coma was considered to be immediately life-threatening and disabling per retired physician. No further information is available.
Age: 0.2
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Cellulitis, Crying, Hypersensitivity, Injection site erythema, Injection site swelling
Clinical narrative: Initial report was received on 07 March 2012 from a health care professional. A two-month-old male patient had received on 02 March 2012 the following vaccines: a first dose intramuscular right thigh injection of PENTACEL, lot number C4061AB; dose two intramuscular left thigh injection for Hep B, lot number 1482AA (manufacturer not reported); a first dose intramuscular left thigh injection of PREVNAR 13, Pfizer lot number 918172 and a first oral dose of Rotavirus, lot number 1457AA (manufacturer not reported) and 24 hours after vaccination, experienced uncontrollable crying, increased swelling, redness to the right thigh and the area was hot to the touch. The patient was taken to the ER (emergency room) and was hospitalized for two days for observation. Laboratory findings included an increased white blood cell count (wbc). The patient's diagnosis was "cellulitis versus allergic reaction". Treatments were not reported. No further information was available at the time of the report. The patient's outcome was recovered (date not reported). Documents held by sender: none.
Age: 0.2
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Injection site warmth, White blood cell count increased
Clinical narrative: Initial report was received on 07 March 2012 from a health care professional. A two-month-old male patient had received on 02 March 2012 the following vaccines: a first dose intramuscular right thigh injection of PENTACEL, lot number C4061AB; dose two intramuscular left thigh injection for Hep B, lot number 1482AA (manufacturer not reported); a first dose intramuscular left thigh injection of PREVNAR 13, Pfizer lot number 918172 and a first oral dose of Rotavirus, lot number 1457AA (manufacturer not reported) and 24 hours after vaccination, experienced uncontrollable crying, increased swelling, redness to the right thigh and the area was hot to the touch. The patient was taken to the ER (emergency room) and was hospitalized for two days for observation. Laboratory findings included an increased white blood cell count (wbc). The patient's diagnosis was "cellulitis versus allergic reaction". Treatments were not reported. No further information was available at the time of the report. The patient's outcome was recovered (date not reported). Documents held by sender: none.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Burning sensation, Erythrodermic psoriasis, Gait disturbance, Oedema peripheral, Pruritus generalised
Clinical narrative: Initial case received from a health care professional, who was the patient, on 12 March 2012. A 67-year-old male patient received a left deltoid intramuscular injection of FLUZONE, sanofi pasteur Inc. lot number UT481AB, on 31 October 2011. The patient, also a cardiologist, did not report any past medical history; however, the patient took concomitant medication, COZAAR for the past eight years. The patient denied any illness at time of vaccination, denied any known drug allergies, and denied adverse event following prior vaccinations. On a day in November 2011, one week after vaccination, the patient experienced hand/face swelling and burning and developed a rash over his entire body that was biopsied as Erythrodermic Psoriasis, which persists to date. He had lost control of body temperature and experienced generalized itching and shedding of skin, which made walking difficult. The patient required doctor visit and medication, HUMIRA to treat the adverse event. The patient's outcome was not reported. Documents held by sender: None.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Rash generalised, Skin exfoliation, Swelling face
Clinical narrative: Initial case received from a health care professional, who was the patient, on 12 March 2012. A 67-year-old male patient received a left deltoid intramuscular injection of FLUZONE, sanofi pasteur Inc. lot number UT481AB, on 31 October 2011. The patient, also a cardiologist, did not report any past medical history; however, the patient took concomitant medication, COZAAR for the past eight years. The patient denied any illness at time of vaccination, denied any known drug allergies, and denied adverse event following prior vaccinations. On a day in November 2011, one week after vaccination, the patient experienced hand/face swelling and burning and developed a rash over his entire body that was biopsied as Erythrodermic Psoriasis, which persists to date. He had lost control of body temperature and experienced generalized itching and shedding of skin, which made walking difficult. The patient required doctor visit and medication, HUMIRA to treat the adverse event. The patient's outcome was not reported. Documents held by sender: None.
Age: 34.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Activities of daily living impaired, Cellulitis, Erythema, Injection site erythema, Nausea
Clinical narrative: This medically confirmed spontaneous report (initial receipt 06-MAR-2012) concerns a 34 year old female patient with a medical history of asthma. She was also a smoker and had allergies to penicillins, latex and adhesive bandage. The patient was concomitantly taking asthma medications. On 01-MAR-2012, the patient received a flu vaccine (manufacturer unspecified). On the same day the patient also received a 0.5 mL dose of co-suspect medication PNEUMOVAX 23 (batch 1489AA, exp 05/2012) intramuscularly at an unspecified site. On 02-Mar-2012, the day after vaccination, the patient reported redness at the injection site (unspecified site). On 03-Mar-2012, the patient had nausea and emesis. On 04-Mar-2012, the patient went to the local ER (emergency room) with pain, swelling, redness and heat which went down to her unspecified arm to her elbow. She was diagnosed with cellulitis. Treatment included steroids, unspecified antibiotics and pain medication. The patient still has pain and redness but the event is somewhat resolving. Reporter comment: The patient has missed work due to significant disability or incapacity. The patient required intervention to prevent serious criteria (went to ER).
Age: 34.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Oedema peripheral, Pain in extremity, Skin warm, Vomiting
Clinical narrative: This medically confirmed spontaneous report (initial receipt 06-MAR-2012) concerns a 34 year old female patient with a medical history of asthma. She was also a smoker and had allergies to penicillins, latex and adhesive bandage. The patient was concomitantly taking asthma medications. On 01-MAR-2012, the patient received a flu vaccine (manufacturer unspecified). On the same day the patient also received a 0.5 mL dose of co-suspect medication PNEUMOVAX 23 (batch 1489AA, exp 05/2012) intramuscularly at an unspecified site. On 02-Mar-2012, the day after vaccination, the patient reported redness at the injection site (unspecified site). On 03-Mar-2012, the patient had nausea and emesis. On 04-Mar-2012, the patient went to the local ER (emergency room) with pain, swelling, redness and heat which went down to her unspecified arm to her elbow. She was diagnosed with cellulitis. Treatment included steroids, unspecified antibiotics and pain medication. The patient still has pain and redness but the event is somewhat resolving. Reporter comment: The patient has missed work due to significant disability or incapacity. The patient required intervention to prevent serious criteria (went to ER).
Sex: M
Vaccine: DT
Symptoms: Brain scan abnormal, Central nervous system lesion, Chronic fatigue syndrome, Dizziness, Feeling abnormal
Clinical narrative: Initial report was received 08 March 2012 from a consumer, who is also the patient. A male patient (age and date of birth not reported) who had cellulitis of the foot (cause unknown) at the time of vaccination, had received an intramuscular injection of DECAVAC, lot number U369BA (lot number invalid) on 01 August 2011. The patient had been taking KEFLEX and BACTRIM concomitantly. On 10 August 2011 (also reported as 10 days later), the patient reported "feeling weird" which resulted in blurred vision, paresthesia, left arm paralysis, trouble walking and dizziness. He was evaluated by several neurologists and rheumatologists, also reported as 19 doctors. He received spinal taps and brain scans (unspecified) which showed a 1cm brain lesion on the temporal lobe. The patient was diagnosed with Chronic Fatigue Syndrome and Sjogren's Syndrome five months post vaccination. Outcome was not reported. Documents held by sender: None.
Sex: M
Vaccine: DT
Symptoms: Gait disturbance, Lumbar puncture abnormal, Monoplegia, Paraesthesia, Sjogren's syndrome
Clinical narrative: Initial report was received 08 March 2012 from a consumer, who is also the patient. A male patient (age and date of birth not reported) who had cellulitis of the foot (cause unknown) at the time of vaccination, had received an intramuscular injection of DECAVAC, lot number U369BA (lot number invalid) on 01 August 2011. The patient had been taking KEFLEX and BACTRIM concomitantly. On 10 August 2011 (also reported as 10 days later), the patient reported "feeling weird" which resulted in blurred vision, paresthesia, left arm paralysis, trouble walking and dizziness. He was evaluated by several neurologists and rheumatologists, also reported as 19 doctors. He received spinal taps and brain scans (unspecified) which showed a 1cm brain lesion on the temporal lobe. The patient was diagnosed with Chronic Fatigue Syndrome and Sjogren's Syndrome five months post vaccination. Outcome was not reported. Documents held by sender: None.
Sex: M
Vaccine: DT
Symptoms: Vision blurred
Clinical narrative: Initial report was received 08 March 2012 from a consumer, who is also the patient. A male patient (age and date of birth not reported) who had cellulitis of the foot (cause unknown) at the time of vaccination, had received an intramuscular injection of DECAVAC, lot number U369BA (lot number invalid) on 01 August 2011. The patient had been taking KEFLEX and BACTRIM concomitantly. On 10 August 2011 (also reported as 10 days later), the patient reported "feeling weird" which resulted in blurred vision, paresthesia, left arm paralysis, trouble walking and dizziness. He was evaluated by several neurologists and rheumatologists, also reported as 19 doctors. He received spinal taps and brain scans (unspecified) which showed a 1cm brain lesion on the temporal lobe. The patient was diagnosed with Chronic Fatigue Syndrome and Sjogren's Syndrome five months post vaccination. Outcome was not reported. Documents held by sender: None.
Age: 42.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Vitiligo
Clinical narrative: Patient reports a rapid onset of progressive vitiligo. Following a 3-part course of GARDASIL, per dosing schedule. Condition persists. Patient is in treatment through a number of modalities. Sx began within 2-3 weeks of administration of the vaccine.
Age: 50.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site pain, Musculoskeletal pain, Pain in extremity
Clinical narrative: Patient was seen 3/15/12 - complained his (R) shoulder & arm has been hurting since the injection. No swelling no redness} constant pain bicep head.
Age: 29.0
Sex: M
Vaccine: FLUX
Symptoms: Anti-GAD antibody positive, Anti-insulin antibody, Anti-islet cell antibody, Antibody test negative, Blood glucose increased
Clinical narrative: Reports history of polyuria, polydipsia, fatigue and intermittent visual changes dating back to the summer of 2005. Initially, he did not necessarily feel sick, but noted he was not feeling himself. Symptoms gradually increased and in March 2006, he sought evaluation. Records review reveals he presented on 17 March 2006 with a serum glucose level of 487 and negative urine Ketones. He was diagnosed with Type 2 diabetes and started on METFORMIN. His blood glucose levels were in good control on oral agents and meal planning for about 7-9 months. After persistent suboptimal glycemic control despite adjustments in oral agents, positive Gad-65 antibodies and several low C-peptide levels, his diabetes was reclassified as Latent Autoimmune Diabetes in Adults (LADA) in February 2007. Prior to diagnosis of diabetes, he denies a history of elevated glucose or blood pressure levels or history of hypertension. He does not recall a history of a recent infection or symptoms of cough, fever, sinus symptoms, congestion or diarrhea prior to his diagnosis. He was active and met weight and PT requirements prior to diagnosis. He has no family Hx of T1 DM. He is on status after undergoing a medical board in 2007. He is currently controlling his diabetes using an insulin pump and continuous glucose monitor. He denies long-term diabetes-related complications except for for peripheral neuropathy. He also has had chronic problems with onychomycosis since being diagnosed with diabetes.
Age: 29.0
Sex: M
Vaccine: FLUX
Symptoms: Diabetic neuropathy, Fatigue, Feeling abnormal, Insulin C-peptide decreased, Latent autoimmune diabetes in adults
Clinical narrative: Reports history of polyuria, polydipsia, fatigue and intermittent visual changes dating back to the summer of 2005. Initially, he did not necessarily feel sick, but noted he was not feeling himself. Symptoms gradually increased and in March 2006, he sought evaluation. Records review reveals he presented on 17 March 2006 with a serum glucose level of 487 and negative urine Ketones. He was diagnosed with Type 2 diabetes and started on METFORMIN. His blood glucose levels were in good control on oral agents and meal planning for about 7-9 months. After persistent suboptimal glycemic control despite adjustments in oral agents, positive Gad-65 antibodies and several low C-peptide levels, his diabetes was reclassified as Latent Autoimmune Diabetes in Adults (LADA) in February 2007. Prior to diagnosis of diabetes, he denies a history of elevated glucose or blood pressure levels or history of hypertension. He does not recall a history of a recent infection or symptoms of cough, fever, sinus symptoms, congestion or diarrhea prior to his diagnosis. He was active and met weight and PT requirements prior to diagnosis. He has no family Hx of T1 DM. He is on status after undergoing a medical board in 2007. He is currently controlling his diabetes using an insulin pump and continuous glucose monitor. He denies long-term diabetes-related complications except for for peripheral neuropathy. He also has had chronic problems with onychomycosis since being diagnosed with diabetes.
Age: 29.0
Sex: M
Vaccine: FLUX
Symptoms: Onychomycosis, Polydipsia, Polyuria, Type 2 diabetes mellitus, Urine ketone body absent
Clinical narrative: Reports history of polyuria, polydipsia, fatigue and intermittent visual changes dating back to the summer of 2005. Initially, he did not necessarily feel sick, but noted he was not feeling himself. Symptoms gradually increased and in March 2006, he sought evaluation. Records review reveals he presented on 17 March 2006 with a serum glucose level of 487 and negative urine Ketones. He was diagnosed with Type 2 diabetes and started on METFORMIN. His blood glucose levels were in good control on oral agents and meal planning for about 7-9 months. After persistent suboptimal glycemic control despite adjustments in oral agents, positive Gad-65 antibodies and several low C-peptide levels, his diabetes was reclassified as Latent Autoimmune Diabetes in Adults (LADA) in February 2007. Prior to diagnosis of diabetes, he denies a history of elevated glucose or blood pressure levels or history of hypertension. He does not recall a history of a recent infection or symptoms of cough, fever, sinus symptoms, congestion or diarrhea prior to his diagnosis. He was active and met weight and PT requirements prior to diagnosis. He has no family Hx of T1 DM. He is on status after undergoing a medical board in 2007. He is currently controlling his diabetes using an insulin pump and continuous glucose monitor. He denies long-term diabetes-related complications except for for peripheral neuropathy. He also has had chronic problems with onychomycosis since being diagnosed with diabetes.
Age: 29.0
Sex: M
Vaccine: FLUX
Symptoms: Visual impairment
Clinical narrative: Reports history of polyuria, polydipsia, fatigue and intermittent visual changes dating back to the summer of 2005. Initially, he did not necessarily feel sick, but noted he was not feeling himself. Symptoms gradually increased and in March 2006, he sought evaluation. Records review reveals he presented on 17 March 2006 with a serum glucose level of 487 and negative urine Ketones. He was diagnosed with Type 2 diabetes and started on METFORMIN. His blood glucose levels were in good control on oral agents and meal planning for about 7-9 months. After persistent suboptimal glycemic control despite adjustments in oral agents, positive Gad-65 antibodies and several low C-peptide levels, his diabetes was reclassified as Latent Autoimmune Diabetes in Adults (LADA) in February 2007. Prior to diagnosis of diabetes, he denies a history of elevated glucose or blood pressure levels or history of hypertension. He does not recall a history of a recent infection or symptoms of cough, fever, sinus symptoms, congestion or diarrhea prior to his diagnosis. He was active and met weight and PT requirements prior to diagnosis. He has no family Hx of T1 DM. He is on status after undergoing a medical board in 2007. He is currently controlling his diabetes using an insulin pump and continuous glucose monitor. He denies long-term diabetes-related complications except for for peripheral neuropathy. He also has had chronic problems with onychomycosis since being diagnosed with diabetes.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Deafness unilateral, Decreased appetite, Ear infection viral, Mobility decreased
Clinical narrative: Initial report received from a health care professional on 12 March 2012. This reporter also reported another adverse event, which was captured in case number 2012-02847. A 68-year-old male patient received an intramuscular left deltoid injection of FLUZONE, sanofi pasteur Inc. lot number UT474AB, on 17 October 2011. On 21 October 2011, the patient started with symptoms of body aches and pain and could not get out of bed for five days. He could barely eat. The patient developed loss of hearing in the right ear. The patient had a magnetic resonance imaging (MRI) of the brain which was interpreted as "OK". He was seen by his physician who diagnosed him with a viral infection behind the ear drum which caused nerve damage. The patient's hearing will not return. The outcome was reported as recovered. Documents held by sender: None.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Nerve injury, Nuclear magnetic resonance imaging brain normal, Pain
Clinical narrative: Initial report received from a health care professional on 12 March 2012. This reporter also reported another adverse event, which was captured in case number 2012-02847. A 68-year-old male patient received an intramuscular left deltoid injection of FLUZONE, sanofi pasteur Inc. lot number UT474AB, on 17 October 2011. On 21 October 2011, the patient started with symptoms of body aches and pain and could not get out of bed for five days. He could barely eat. The patient developed loss of hearing in the right ear. The patient had a magnetic resonance imaging (MRI) of the brain which was interpreted as "OK". He was seen by his physician who diagnosed him with a viral infection behind the ear drum which caused nerve damage. The patient's hearing will not return. The outcome was reported as recovered. Documents held by sender: None.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Injection site erythema, Injection site pruritus, Injection site swelling, Pain
Clinical narrative: Received vaccine on 3/2 called 3/4 with itching, pain, swelling, and redness to injection site. Saw Dr. 3/5 dx cellulitis. Pt went to Urgent Care 3/5 at 1:11 and referred to ER. Seen again in office 3/7 for ER. f/u cellulitis.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Swelling
Clinical narrative: Approx 2 hours after receiving PNEUMOVAX, pt reports swelling (7 inches) & redness 4 x 4 in which is present today.
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Local reaction
Clinical narrative: Localized vaccine reaction on pt's right anterior thigh. Redness, hard lump. Dtap vaccine administered on 3-07-12 at 4:45 pm. Pt. F/U with provider 3-09-12.
Age: 0.18
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1
Symptoms: Decreased appetite, Haematochezia, Irritability, Occult blood
Clinical narrative: Following vaccine administration, patient was noted to be fussier than normal, not eating as well; 3 days later, mom noticed a small amount of blood in a soft stool. No fevers/URI symptoms/constipation. Tx: Avoidance of dairy/soy in mom's diet (breastfeeding)/NUTRAMIGEN supplementation. Monitoring further bloody stools/abdomen changes.
Age: 10.0
Sex: F
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Chills, Dizziness, Pain, Pain in extremity, Syncope
Clinical narrative: 10 mins after BOOSTRIX, MENACTRA, Hep A, Varicella vaccines - felt dizzy & fainted (vasovagal syncope). Recovered 1-2 mins. 2 hours later came back in office w/ chills & shooting pain legs = gave MOTRIN, slowly recovered 30 mins - 1 hour.
Age: 35.0
Sex: F
Vaccine: FLUX, TDAP
Symptoms: Injection site erythema, Oedema peripheral, Pain in extremity
Clinical narrative: Tdap given (L) deltoid IM on 3/7/12 - pain & redness after a few hrs. 3/8/12 Redness & swelling extended downward to elbow - took ibuprofen. 3/9/12 Soreness today redness reduced to a round 3 x 3 cm reaction at injection site.
Age: 0.35
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Diarrhoea, Enema administration, Lethargy, Vomiting
Clinical narrative: Pt rec. immunizations on 2/29/2012 & on 3/4 developed signs & sxs of abdominal obstruction (? intussusception). Had vomiting & diarrhea, lethargy. Was sent from rural outside hospital to another hospital - had enema and no obvious radiological finding of obstruction. Was d/c home - doing well now.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Muscular weakness, Vaccination site pain, X-ray
Clinical narrative: Stated vaccination site was painful immediately after injection and that her arm was very weak.
Age: 18.0
Sex: M
Vaccine: HEPA, MNQ, TDAP
Symptoms: Fall, Neurological examination normal, Syncope
Clinical narrative: After receiving 3 vaccines pt. fainted - this occurred 10 minutes after receiving vaccines. Pt was standing with his mother about 5 minutes after receiving vaccines. Nurse was making next appointment & Pt fell while nurse was talking to Mom. VS & Neuro checked - normal. Pupils equal & reactive. Mom stayed after 1/2 hr & then took pt to MD to be checked.
Age: 30.0
Sex: F
Vaccine: HEP
Symptoms: Erythema, Pruritus, Pyrexia, Rash maculo-papular, Skin lesion
Clinical narrative: Macular, papular skin lesion at abdomen and lower limbs, itch; erythema and fever.
Age: 30.0
Sex: F
Vaccine: HEP
Symptoms: Toxic skin eruption
Clinical narrative: Macular, papular skin lesion at abdomen and lower limbs, itch; erythema and fever.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site reaction, Rash erythematous
Clinical narrative: Patient presented 3/11/12 with itching, red rash at injection site. (Dark red rash of 1.5", light red rash of 6" diameter). Counseled to use hydrocortisone & BENADRYL.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Pain in extremity, Vaccination site warmth
Clinical narrative: Severe pain in right arm. Numbness in fingers. Vaccination area was warm/hot.
Age: 8.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling, heat at site of INFLUENZA vaccine given on 3/6/12. Given Rx: AUGMENTIN x 10 days.
Age: 0.51
Sex: M
Vaccine: DTAPIPVHIB, FLU3, PNC, RV5
Symptoms: Blister, Pallor, Pyrexia, Rash, Rash papular
Clinical narrative: Blanching papular rash over trunk, chest, abdomen, back; few (?) blister on hand. (+) Fever began 3/5/2012 evening. Rash began 1-2 days later. Of note goes to day care w/exposure to hand foot mouth disease.
Age: 0.25
Sex: F
Vaccine: DTAPIPV, HIBV, PNC13
Symptoms: Crying
Clinical narrative: "Hysterical crying from the time they left the clinic until she went to bed."
Age: 4.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Mother described onset of swelling and redness at the site of injection of DTAP (left thigh). Area of swelling is slightly larger than a quarter. Denies other symptoms, including fever. This RN advices watching and waiting, as symptoms were listed as a common reaction for this vaccine.
Age: 19.0
Sex: F
Vaccine: FLU3, HEP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Patient came to clinic on 03-07-12 for private pay Hep B and flu vaccine. Client was given adult Hep B which is for age 20 years and up when the client is only age 19 years, 5 months. No adverse reactions.
Age: 61.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Abdominal discomfort, Chills, Diarrhoea, Middle insomnia, Vaccination complication
Clinical narrative: Patient called office to report 3-15-12, 12:44 pm. Reported Rec'd Shingles and Tdap vaccines on 3-13-12. Patient believes he had a reaction to vaccine. Incident reported - Patient woke up in middle of night for two hours had extreme stomach upset and diarrhea followed by chills. Symptoms subsided. No fever. VIS stated to call provider to report reaction.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Generalised erythema, Induration, Injection site erythema, Injection site swelling
Clinical narrative: Mild redness at inj site on 3/13. On 3/15 redness and swelling have spread beyond inj site. 3/16 extensive spread of erythema, swelling, now itchy, hot, firm to touch and tender. Dx cellulitis, received rx.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Skin warm, Swelling, Tenderness
Clinical narrative: Mild redness at inj site on 3/13. On 3/15 redness and swelling have spread beyond inj site. 3/16 extensive spread of erythema, swelling, now itchy, hot, firm to touch and tender. Dx cellulitis, received rx.
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Erythema, Oedema peripheral
Clinical narrative: L. arm: localized erythema and swelling 24 hours after vaccine treated with BENADRYL, Ibuprofen, hydrocortisone cream.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, HEPA, HPV4, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: Fainted after 3 min.
Age: 4.0
Sex: M
Vaccine: FLUN3
Symptoms: Guillain-Barre syndrome, Lumbar puncture abnormal, Nuclear magnetic resonance imaging abnormal
Clinical narrative: Guillain Barre Syndrome.
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA, IPV, VARCEL
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Itching. Redness. Swelling.