chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.51
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Sandifer's syndrome, Scan brain
Clinical narrative: INFANTILE SPASMS WITH HYPSARRHYTHMIA CONFIRMED BY PHYSICIAN WITNESS OF EVENT COUPLED WITH EEG FINDINGS DEVELOPED 12 HOURS AFTER VACCINATION.  INITIAL EPISODES WERE FIRST CHARACTERIZED AS DYSTONIA BY HISTORY, THEN SANDIFER SYNDROME.  DIAGNOSIS MADE AFTER AN EVENT WAS WITNESSED IN THE OFFICE.  TREATMENT WAS INITIATED ON 6/28/2007 WITH ACTH WITH RESPONSE NOTED.  PATIENT IS STILL UNDERGOING THERAPY.  7/3/07 Hospital medical records received which reveal patient experienced multiple events of posturing followed by crying.  Episodes recurred & were videotaped multiple times over 4 days.  Seen by PCP who dx on 6/25 as Sandifer Syndrome.  Episodes continued & seen by PCP again on 6/28.  Referred to neurologist where witnessed episode was c/w infantile spasms.  Hospitalized 6/28-6/30/07.  No d/c summary dictated per med records. & ACTH theapy was started.    7/24/07 Received vax record which confirms vax info as reported. 1/11/2010 Infintile seizures/spasms thought to be secondary to DTAP vaccine but some disagreement among neurologist on this theory. Child is still having small brief seizures. 02/02/2010 Persistent infantile spasms; side affets of austism, irritability and obesity 20/2 medication. Developmental delay.
Age: 54.0
Sex: F
Vaccine: TYP
Symptoms: Arthralgia, Dizziness, Fatigue, Headache, Neck pain
Clinical narrative: Extreme fatigue (not experienced before - ongoing), joint pain (both knees, right hip - ongoing), neck pain, dizziness (brief), headache (daily for one week).
Age: 29.0
Sex: M
Vaccine: ANTH
Symptoms: Lip swelling, Urticaria
Clinical narrative: pt received vaccine on 26JUN07. In the evening of 29JUN07, he presented with urticaria including swelling of lower lip. He was given steroids and antihistamines and symptoms resolved. He returned again the following day with similiar episode minus the lip swelling and was encourage to continue to the antihistamines. Symptoms resolve in a couple of hours. He takes no meds. No new foods, bites etc. Its unclear if this could be related to vaccine
Age: 59.0
Sex: F
Vaccine: FLUX
Symptoms: Alanine aminotransferase increased, Anaemia haemolytic autoimmune, Anorexia, Antinuclear antibody increased, Antinuclear antibody positive
Clinical narrative: A  59-year-old Caucasian  woman, previously well, underwent  her first influenza vaccination on November, 11, 2005. She had a previous diagnosis of Systemic Lupus Eryhtematosus (SLE) when she was 42-year-old  with cutaneous and articular involvement treated by a short steroid cycle  eventually leading to a complete remission for the subsequent 14 years. By four weeks  following influenza vaccination, she developed a devastating SLE flare-up including pericarditis, hepatitis, nephritis, pancytopenia and auto-immune haemolytic anemia, coupled with a tremendous increase in autoimmune serology , successfully  cured  with steroids and azathioprine.More in details, she developed pain , redness , swelling and tenderness  on the site of injection, and complained  a worsening  history of  loss of appetite and profound weakness in the subsequent weeks. One month later  she felt  progressively worse and presented at the Hospital for chest pain, palpitation,  pressure, discomfort and shortness of breath . Supraventricular paroxysmal tachycardia was diagnosed (200 bpm)  and adenosine was infused intravenously, with the resolution of the symptoms.  During the following days her conditions deteriorated , with  a quite total loss of appetite . She went again at the Emergency Department ten days later complaining the same symptoms as before. A new episode of  supraventricular tachycardia was diagnosed ( 200 bpm)  and the patient was discharged following carotid sinus massage  on therapy with  oral flecainid. During the following two weeks, because of a continuous weight loss (exceeding 10 Kg over the last two months) due tot a total inappetence and even worsening weakness , she underwent a gastroscopy, which resulted normal, and specialty consultation leaded  to a suspicion of hematological malignancy, due to pancytopenia. The  patient was discharged with a diagnosis of pancytopenia, autoimmune haemolytic anemia,  pericarditis, hepatits and nephritis due to systemic SLE flare-up.  Steroid therapy  and subsequently  azathioprine eventually leaded to a complete clinical and laboratory remission  by three months.
Age: 59.0
Sex: F
Vaccine: FLUX
Symptoms: Aspartate aminotransferase increased, Asthenia, Blood creatinine decreased, Blood creatinine normal, Blood lactate dehydrogenase increased
Clinical narrative: A  59-year-old Caucasian  woman, previously well, underwent  her first influenza vaccination on November, 11, 2005. She had a previous diagnosis of Systemic Lupus Eryhtematosus (SLE) when she was 42-year-old  with cutaneous and articular involvement treated by a short steroid cycle  eventually leading to a complete remission for the subsequent 14 years. By four weeks  following influenza vaccination, she developed a devastating SLE flare-up including pericarditis, hepatitis, nephritis, pancytopenia and auto-immune haemolytic anemia, coupled with a tremendous increase in autoimmune serology , successfully  cured  with steroids and azathioprine.More in details, she developed pain , redness , swelling and tenderness  on the site of injection, and complained  a worsening  history of  loss of appetite and profound weakness in the subsequent weeks. One month later  she felt  progressively worse and presented at the Hospital for chest pain, palpitation,  pressure, discomfort and shortness of breath . Supraventricular paroxysmal tachycardia was diagnosed (200 bpm)  and adenosine was infused intravenously, with the resolution of the symptoms.  During the following days her conditions deteriorated , with  a quite total loss of appetite . She went again at the Emergency Department ten days later complaining the same symptoms as before. A new episode of  supraventricular tachycardia was diagnosed ( 200 bpm)  and the patient was discharged following carotid sinus massage  on therapy with  oral flecainid. During the following two weeks, because of a continuous weight loss (exceeding 10 Kg over the last two months) due tot a total inappetence and even worsening weakness , she underwent a gastroscopy, which resulted normal, and specialty consultation leaded  to a suspicion of hematological malignancy, due to pancytopenia. The  patient was discharged with a diagnosis of pancytopenia, autoimmune haemolytic anemia,  pericarditis, hepatits and nephritis due to systemic SLE flare-up.  Steroid therapy  and subsequently  azathioprine eventually leaded to a complete clinical and laboratory remission  by three months.
Age: 59.0
Sex: F
Vaccine: FLUX
Symptoms: Cardiolipin antibody negative, Chest discomfort, Chest pain, Complement factor C3 decreased, Complement factor C4 decreased
Clinical narrative: A  59-year-old Caucasian  woman, previously well, underwent  her first influenza vaccination on November, 11, 2005. She had a previous diagnosis of Systemic Lupus Eryhtematosus (SLE) when she was 42-year-old  with cutaneous and articular involvement treated by a short steroid cycle  eventually leading to a complete remission for the subsequent 14 years. By four weeks  following influenza vaccination, she developed a devastating SLE flare-up including pericarditis, hepatitis, nephritis, pancytopenia and auto-immune haemolytic anemia, coupled with a tremendous increase in autoimmune serology , successfully  cured  with steroids and azathioprine.More in details, she developed pain , redness , swelling and tenderness  on the site of injection, and complained  a worsening  history of  loss of appetite and profound weakness in the subsequent weeks. One month later  she felt  progressively worse and presented at the Hospital for chest pain, palpitation,  pressure, discomfort and shortness of breath . Supraventricular paroxysmal tachycardia was diagnosed (200 bpm)  and adenosine was infused intravenously, with the resolution of the symptoms.  During the following days her conditions deteriorated , with  a quite total loss of appetite . She went again at the Emergency Department ten days later complaining the same symptoms as before. A new episode of  supraventricular tachycardia was diagnosed ( 200 bpm)  and the patient was discharged following carotid sinus massage  on therapy with  oral flecainid. During the following two weeks, because of a continuous weight loss (exceeding 10 Kg over the last two months) due tot a total inappetence and even worsening weakness , she underwent a gastroscopy, which resulted normal, and specialty consultation leaded  to a suspicion of hematological malignancy, due to pancytopenia. The  patient was discharged with a diagnosis of pancytopenia, autoimmune haemolytic anemia,  pericarditis, hepatits and nephritis due to systemic SLE flare-up.  Steroid therapy  and subsequently  azathioprine eventually leaded to a complete clinical and laboratory remission  by three months.
Age: 59.0
Sex: F
Vaccine: FLUX
Symptoms: Condition aggravated, Coombs direct test positive, DNA antibody positive, Dyspnoea, Gamma-glutamyltransferase increased
Clinical narrative: A  59-year-old Caucasian  woman, previously well, underwent  her first influenza vaccination on November, 11, 2005. She had a previous diagnosis of Systemic Lupus Eryhtematosus (SLE) when she was 42-year-old  with cutaneous and articular involvement treated by a short steroid cycle  eventually leading to a complete remission for the subsequent 14 years. By four weeks  following influenza vaccination, she developed a devastating SLE flare-up including pericarditis, hepatitis, nephritis, pancytopenia and auto-immune haemolytic anemia, coupled with a tremendous increase in autoimmune serology , successfully  cured  with steroids and azathioprine.More in details, she developed pain , redness , swelling and tenderness  on the site of injection, and complained  a worsening  history of  loss of appetite and profound weakness in the subsequent weeks. One month later  she felt  progressively worse and presented at the Hospital for chest pain, palpitation,  pressure, discomfort and shortness of breath . Supraventricular paroxysmal tachycardia was diagnosed (200 bpm)  and adenosine was infused intravenously, with the resolution of the symptoms.  During the following days her conditions deteriorated , with  a quite total loss of appetite . She went again at the Emergency Department ten days later complaining the same symptoms as before. A new episode of  supraventricular tachycardia was diagnosed ( 200 bpm)  and the patient was discharged following carotid sinus massage  on therapy with  oral flecainid. During the following two weeks, because of a continuous weight loss (exceeding 10 Kg over the last two months) due tot a total inappetence and even worsening weakness , she underwent a gastroscopy, which resulted normal, and specialty consultation leaded  to a suspicion of hematological malignancy, due to pancytopenia. The  patient was discharged with a diagnosis of pancytopenia, autoimmune haemolytic anemia,  pericarditis, hepatits and nephritis due to systemic SLE flare-up.  Steroid therapy  and subsequently  azathioprine eventually leaded to a complete clinical and laboratory remission  by three months.
Age: 59.0
Sex: F
Vaccine: FLUX
Symptoms: Haemoglobin decreased, Hepatitis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: A  59-year-old Caucasian  woman, previously well, underwent  her first influenza vaccination on November, 11, 2005. She had a previous diagnosis of Systemic Lupus Eryhtematosus (SLE) when she was 42-year-old  with cutaneous and articular involvement treated by a short steroid cycle  eventually leading to a complete remission for the subsequent 14 years. By four weeks  following influenza vaccination, she developed a devastating SLE flare-up including pericarditis, hepatitis, nephritis, pancytopenia and auto-immune haemolytic anemia, coupled with a tremendous increase in autoimmune serology , successfully  cured  with steroids and azathioprine.More in details, she developed pain , redness , swelling and tenderness  on the site of injection, and complained  a worsening  history of  loss of appetite and profound weakness in the subsequent weeks. One month later  she felt  progressively worse and presented at the Hospital for chest pain, palpitation,  pressure, discomfort and shortness of breath . Supraventricular paroxysmal tachycardia was diagnosed (200 bpm)  and adenosine was infused intravenously, with the resolution of the symptoms.  During the following days her conditions deteriorated , with  a quite total loss of appetite . She went again at the Emergency Department ten days later complaining the same symptoms as before. A new episode of  supraventricular tachycardia was diagnosed ( 200 bpm)  and the patient was discharged following carotid sinus massage  on therapy with  oral flecainid. During the following two weeks, because of a continuous weight loss (exceeding 10 Kg over the last two months) due tot a total inappetence and even worsening weakness , she underwent a gastroscopy, which resulted normal, and specialty consultation leaded  to a suspicion of hematological malignancy, due to pancytopenia. The  patient was discharged with a diagnosis of pancytopenia, autoimmune haemolytic anemia,  pericarditis, hepatits and nephritis due to systemic SLE flare-up.  Steroid therapy  and subsequently  azathioprine eventually leaded to a complete clinical and laboratory remission  by three months.
Age: 59.0
Sex: F
Vaccine: FLUX
Symptoms: Nephritis, Neutrophil count increased, Neutrophil count normal, Palpitations, Pancytopenia
Clinical narrative: A  59-year-old Caucasian  woman, previously well, underwent  her first influenza vaccination on November, 11, 2005. She had a previous diagnosis of Systemic Lupus Eryhtematosus (SLE) when she was 42-year-old  with cutaneous and articular involvement treated by a short steroid cycle  eventually leading to a complete remission for the subsequent 14 years. By four weeks  following influenza vaccination, she developed a devastating SLE flare-up including pericarditis, hepatitis, nephritis, pancytopenia and auto-immune haemolytic anemia, coupled with a tremendous increase in autoimmune serology , successfully  cured  with steroids and azathioprine.More in details, she developed pain , redness , swelling and tenderness  on the site of injection, and complained  a worsening  history of  loss of appetite and profound weakness in the subsequent weeks. One month later  she felt  progressively worse and presented at the Hospital for chest pain, palpitation,  pressure, discomfort and shortness of breath . Supraventricular paroxysmal tachycardia was diagnosed (200 bpm)  and adenosine was infused intravenously, with the resolution of the symptoms.  During the following days her conditions deteriorated , with  a quite total loss of appetite . She went again at the Emergency Department ten days later complaining the same symptoms as before. A new episode of  supraventricular tachycardia was diagnosed ( 200 bpm)  and the patient was discharged following carotid sinus massage  on therapy with  oral flecainid. During the following two weeks, because of a continuous weight loss (exceeding 10 Kg over the last two months) due tot a total inappetence and even worsening weakness , she underwent a gastroscopy, which resulted normal, and specialty consultation leaded  to a suspicion of hematological malignancy, due to pancytopenia. The  patient was discharged with a diagnosis of pancytopenia, autoimmune haemolytic anemia,  pericarditis, hepatits and nephritis due to systemic SLE flare-up.  Steroid therapy  and subsequently  azathioprine eventually leaded to a complete clinical and laboratory remission  by three months.
Age: 59.0
Sex: F
Vaccine: FLUX
Symptoms: Pericarditis, Platelet count decreased, Serum ferritin increased, Supraventricular tachycardia, Systemic lupus erythematosus
Clinical narrative: A  59-year-old Caucasian  woman, previously well, underwent  her first influenza vaccination on November, 11, 2005. She had a previous diagnosis of Systemic Lupus Eryhtematosus (SLE) when she was 42-year-old  with cutaneous and articular involvement treated by a short steroid cycle  eventually leading to a complete remission for the subsequent 14 years. By four weeks  following influenza vaccination, she developed a devastating SLE flare-up including pericarditis, hepatitis, nephritis, pancytopenia and auto-immune haemolytic anemia, coupled with a tremendous increase in autoimmune serology , successfully  cured  with steroids and azathioprine.More in details, she developed pain , redness , swelling and tenderness  on the site of injection, and complained  a worsening  history of  loss of appetite and profound weakness in the subsequent weeks. One month later  she felt  progressively worse and presented at the Hospital for chest pain, palpitation,  pressure, discomfort and shortness of breath . Supraventricular paroxysmal tachycardia was diagnosed (200 bpm)  and adenosine was infused intravenously, with the resolution of the symptoms.  During the following days her conditions deteriorated , with  a quite total loss of appetite . She went again at the Emergency Department ten days later complaining the same symptoms as before. A new episode of  supraventricular tachycardia was diagnosed ( 200 bpm)  and the patient was discharged following carotid sinus massage  on therapy with  oral flecainid. During the following two weeks, because of a continuous weight loss (exceeding 10 Kg over the last two months) due tot a total inappetence and even worsening weakness , she underwent a gastroscopy, which resulted normal, and specialty consultation leaded  to a suspicion of hematological malignancy, due to pancytopenia. The  patient was discharged with a diagnosis of pancytopenia, autoimmune haemolytic anemia,  pericarditis, hepatits and nephritis due to systemic SLE flare-up.  Steroid therapy  and subsequently  azathioprine eventually leaded to a complete clinical and laboratory remission  by three months.
Age: 59.0
Sex: F
Vaccine: FLUX
Symptoms: Ultrasound kidney normal, Urine analysis abnormal, Weight decreased, White blood cell count decreased, White blood cell count increased
Clinical narrative: A  59-year-old Caucasian  woman, previously well, underwent  her first influenza vaccination on November, 11, 2005. She had a previous diagnosis of Systemic Lupus Eryhtematosus (SLE) when she was 42-year-old  with cutaneous and articular involvement treated by a short steroid cycle  eventually leading to a complete remission for the subsequent 14 years. By four weeks  following influenza vaccination, she developed a devastating SLE flare-up including pericarditis, hepatitis, nephritis, pancytopenia and auto-immune haemolytic anemia, coupled with a tremendous increase in autoimmune serology , successfully  cured  with steroids and azathioprine.More in details, she developed pain , redness , swelling and tenderness  on the site of injection, and complained  a worsening  history of  loss of appetite and profound weakness in the subsequent weeks. One month later  she felt  progressively worse and presented at the Hospital for chest pain, palpitation,  pressure, discomfort and shortness of breath . Supraventricular paroxysmal tachycardia was diagnosed (200 bpm)  and adenosine was infused intravenously, with the resolution of the symptoms.  During the following days her conditions deteriorated , with  a quite total loss of appetite . She went again at the Emergency Department ten days later complaining the same symptoms as before. A new episode of  supraventricular tachycardia was diagnosed ( 200 bpm)  and the patient was discharged following carotid sinus massage  on therapy with  oral flecainid. During the following two weeks, because of a continuous weight loss (exceeding 10 Kg over the last two months) due tot a total inappetence and even worsening weakness , she underwent a gastroscopy, which resulted normal, and specialty consultation leaded  to a suspicion of hematological malignancy, due to pancytopenia. The  patient was discharged with a diagnosis of pancytopenia, autoimmune haemolytic anemia,  pericarditis, hepatits and nephritis due to systemic SLE flare-up.  Steroid therapy  and subsequently  azathioprine eventually leaded to a complete clinical and laboratory remission  by three months.
Age: 18.0
Sex: F
Vaccine: TD
Symptoms: Arthralgia, Diarrhoea, Dizziness, Fatigue, Myalgia
Clinical narrative: Within 10 minutes of vaccination I started to feel very dizzy, then collapsed in the doctor's office and needed to be revived. I was sick for several months following vaccination with chronic fatigue, bouts of diarhhea, constant joint and muscle pain. I also lost a considerable amount of body weight within 1 month of vaccination, for no explainable reason.
Age: 18.0
Sex: F
Vaccine: TD
Symptoms: Syncope, Weight decreased
Clinical narrative: Within 10 minutes of vaccination I started to feel very dizzy, then collapsed in the doctor's office and needed to be revived. I was sick for several months following vaccination with chronic fatigue, bouts of diarhhea, constant joint and muscle pain. I also lost a considerable amount of body weight within 1 month of vaccination, for no explainable reason.
Age: 3.0
Sex: M
Vaccine: VARCEL
Symptoms: Anorexia, Body temperature increased, Chapped lips, Conjunctivitis, Dehydration
Clinical narrative: Information has been received from VAERS concerning a 3 year old male with a history of a cold and ear infection that he "just got over" who on 06-JAN-1998 was vaccinated in the "L" with a dose of Varivax (lot # 622625/0085E). Concomitant therapy included amoxicillin/clavulanate potassium (AUGMENTIN). On 10-JAN-1998 the patient developed a fever of 103.5, the patient was given acetaminophen, the MD was then notified that the patient had a high temp 103-104 with the acetaminophen. It was reported that the patient's ear and throat looked infected. The patient would not eat and was drinking very little. The patient's eyes were pink, his lips were dry and cracked. The patient was admitted to the hospital (it was also reported that the patient was not hospitalized) with a diagnosis of Kawasaki Disease (the patient's symptoms included anorexia, conjunctivitis, dehydration, ear discharge, pharyngitis, dry skin and vasculitis). Subsequently the patient recovered. No further information was provided. The patient's Kawasaki Disease was considered serious for hospitalization and life threatening. A lot check has been requested. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released by the regulatory agency. No further information is available.
Age: 3.0
Sex: M
Vaccine: VARCEL
Symptoms: Diet refusal, Dry skin, Ear infection, Echocardiogram, Electrocardiogram
Clinical narrative: Information has been received from VAERS concerning a 3 year old male with a history of a cold and ear infection that he "just got over" who on 06-JAN-1998 was vaccinated in the "L" with a dose of Varivax (lot # 622625/0085E). Concomitant therapy included amoxicillin/clavulanate potassium (AUGMENTIN). On 10-JAN-1998 the patient developed a fever of 103.5, the patient was given acetaminophen, the MD was then notified that the patient had a high temp 103-104 with the acetaminophen. It was reported that the patient's ear and throat looked infected. The patient would not eat and was drinking very little. The patient's eyes were pink, his lips were dry and cracked. The patient was admitted to the hospital (it was also reported that the patient was not hospitalized) with a diagnosis of Kawasaki Disease (the patient's symptoms included anorexia, conjunctivitis, dehydration, ear discharge, pharyngitis, dry skin and vasculitis). Subsequently the patient recovered. No further information was provided. The patient's Kawasaki Disease was considered serious for hospitalization and life threatening. A lot check has been requested. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released by the regulatory agency. No further information is available.
Age: 3.0
Sex: M
Vaccine: VARCEL
Symptoms: Fluid intake reduced, Kawasaki's disease, Lip dry, Ocular hyperaemia, Pharyngitis
Clinical narrative: Information has been received from VAERS concerning a 3 year old male with a history of a cold and ear infection that he "just got over" who on 06-JAN-1998 was vaccinated in the "L" with a dose of Varivax (lot # 622625/0085E). Concomitant therapy included amoxicillin/clavulanate potassium (AUGMENTIN). On 10-JAN-1998 the patient developed a fever of 103.5, the patient was given acetaminophen, the MD was then notified that the patient had a high temp 103-104 with the acetaminophen. It was reported that the patient's ear and throat looked infected. The patient would not eat and was drinking very little. The patient's eyes were pink, his lips were dry and cracked. The patient was admitted to the hospital (it was also reported that the patient was not hospitalized) with a diagnosis of Kawasaki Disease (the patient's symptoms included anorexia, conjunctivitis, dehydration, ear discharge, pharyngitis, dry skin and vasculitis). Subsequently the patient recovered. No further information was provided. The patient's Kawasaki Disease was considered serious for hospitalization and life threatening. A lot check has been requested. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released by the regulatory agency. No further information is available.
Age: 3.0
Sex: M
Vaccine: VARCEL
Symptoms: Pyrexia, Vasculitis
Clinical narrative: Information has been received from VAERS concerning a 3 year old male with a history of a cold and ear infection that he "just got over" who on 06-JAN-1998 was vaccinated in the "L" with a dose of Varivax (lot # 622625/0085E). Concomitant therapy included amoxicillin/clavulanate potassium (AUGMENTIN). On 10-JAN-1998 the patient developed a fever of 103.5, the patient was given acetaminophen, the MD was then notified that the patient had a high temp 103-104 with the acetaminophen. It was reported that the patient's ear and throat looked infected. The patient would not eat and was drinking very little. The patient's eyes were pink, his lips were dry and cracked. The patient was admitted to the hospital (it was also reported that the patient was not hospitalized) with a diagnosis of Kawasaki Disease (the patient's symptoms included anorexia, conjunctivitis, dehydration, ear discharge, pharyngitis, dry skin and vasculitis). Subsequently the patient recovered. No further information was provided. The patient's Kawasaki Disease was considered serious for hospitalization and life threatening. A lot check has been requested. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released by the regulatory agency. No further information is available.
Age: 0.92
Sex: M
Vaccine: FLU3, RV5, FLU3, RV5
Symptoms: Abdominal X-ray, Abdominal pain upper, Barium enema, Blood chloride, Blood creatinine
Clinical narrative: Information has been received from the FDA (VAERS # 278155) through the CDC concerning an 11-month-old male with no history/pre-existing conditions who on 13-DEC-2006 was vaccinated with a third dose of Rotateq (Lot # 655863/1034F). Concomitant therapy that day included a second dose of Fluzone (Lot # 42174RA). The second dose of Rotateq (Lot # 654665/1017F) and the first dose of Fluzone (Lot # KU2174KA) were given on an unknown date. On 15-APR-2007, 113 post vaccination, the patient experienced intussusception. Follow up information received from the FDA (VAERS # 278155) through the CDC indicated that on 16-APR-2007, the patient had acute vomiting and stomach pains. He was seen in the ER screaming with a fever and diarrhea. A paralytic ilius was questioned, and GI was consulted. They indicated biliuos emesis and concern for intussusception. Films and KUB were normal status post enema with good results. The patient recovered. Laboratory data included: WBC=11.45; hemaglobin=11.5; hematocrit=34.2; platelets=431; CRP=1.0; NA=138; potassium=4.4; chloride=99; CO2=18; glucose=91; BUN=10; creatinine=0.4; LFTs=normal. A standard lot check investigation was performed for Lot # 655863/1034F). All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigations was performed. The testing performed on the batch prior to release met all release specifications. The lot met requirements of the Center for Biologics Evaluation and Research and was released.  Upon internal review, intussusception was considered to be an other important medical event. Additional information has been requested. VAERS # 278155
Age: 0.92
Sex: M
Vaccine: FLU3, RV5, FLU3, RV5
Symptoms: Blood glucose, Blood potassium, Blood urea, C-reactive protein increased, Carbon dioxide normal
Clinical narrative: Information has been received from the FDA (VAERS # 278155) through the CDC concerning an 11-month-old male with no history/pre-existing conditions who on 13-DEC-2006 was vaccinated with a third dose of Rotateq (Lot # 655863/1034F). Concomitant therapy that day included a second dose of Fluzone (Lot # 42174RA). The second dose of Rotateq (Lot # 654665/1017F) and the first dose of Fluzone (Lot # KU2174KA) were given on an unknown date. On 15-APR-2007, 113 post vaccination, the patient experienced intussusception. Follow up information received from the FDA (VAERS # 278155) through the CDC indicated that on 16-APR-2007, the patient had acute vomiting and stomach pains. He was seen in the ER screaming with a fever and diarrhea. A paralytic ilius was questioned, and GI was consulted. They indicated biliuos emesis and concern for intussusception. Films and KUB were normal status post enema with good results. The patient recovered. Laboratory data included: WBC=11.45; hemaglobin=11.5; hematocrit=34.2; platelets=431; CRP=1.0; NA=138; potassium=4.4; chloride=99; CO2=18; glucose=91; BUN=10; creatinine=0.4; LFTs=normal. A standard lot check investigation was performed for Lot # 655863/1034F). All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigations was performed. The testing performed on the batch prior to release met all release specifications. The lot met requirements of the Center for Biologics Evaluation and Research and was released.  Upon internal review, intussusception was considered to be an other important medical event. Additional information has been requested. VAERS # 278155
Age: 0.92
Sex: M
Vaccine: FLU3, RV5, FLU3, RV5
Symptoms: Diarrhoea, Ileus paralytic, Intussusception, Laboratory test, Liver function test
Clinical narrative: Information has been received from the FDA (VAERS # 278155) through the CDC concerning an 11-month-old male with no history/pre-existing conditions who on 13-DEC-2006 was vaccinated with a third dose of Rotateq (Lot # 655863/1034F). Concomitant therapy that day included a second dose of Fluzone (Lot # 42174RA). The second dose of Rotateq (Lot # 654665/1017F) and the first dose of Fluzone (Lot # KU2174KA) were given on an unknown date. On 15-APR-2007, 113 post vaccination, the patient experienced intussusception. Follow up information received from the FDA (VAERS # 278155) through the CDC indicated that on 16-APR-2007, the patient had acute vomiting and stomach pains. He was seen in the ER screaming with a fever and diarrhea. A paralytic ilius was questioned, and GI was consulted. They indicated biliuos emesis and concern for intussusception. Films and KUB were normal status post enema with good results. The patient recovered. Laboratory data included: WBC=11.45; hemaglobin=11.5; hematocrit=34.2; platelets=431; CRP=1.0; NA=138; potassium=4.4; chloride=99; CO2=18; glucose=91; BUN=10; creatinine=0.4; LFTs=normal. A standard lot check investigation was performed for Lot # 655863/1034F). All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigations was performed. The testing performed on the batch prior to release met all release specifications. The lot met requirements of the Center for Biologics Evaluation and Research and was released.  Upon internal review, intussusception was considered to be an other important medical event. Additional information has been requested. VAERS # 278155
Age: 0.92
Sex: M
Vaccine: FLU3, RV5, FLU3, RV5
Symptoms: Platelet count, Pyrexia, Screaming, Vomiting, White blood cell count
Clinical narrative: Information has been received from the FDA (VAERS # 278155) through the CDC concerning an 11-month-old male with no history/pre-existing conditions who on 13-DEC-2006 was vaccinated with a third dose of Rotateq (Lot # 655863/1034F). Concomitant therapy that day included a second dose of Fluzone (Lot # 42174RA). The second dose of Rotateq (Lot # 654665/1017F) and the first dose of Fluzone (Lot # KU2174KA) were given on an unknown date. On 15-APR-2007, 113 post vaccination, the patient experienced intussusception. Follow up information received from the FDA (VAERS # 278155) through the CDC indicated that on 16-APR-2007, the patient had acute vomiting and stomach pains. He was seen in the ER screaming with a fever and diarrhea. A paralytic ilius was questioned, and GI was consulted. They indicated biliuos emesis and concern for intussusception. Films and KUB were normal status post enema with good results. The patient recovered. Laboratory data included: WBC=11.45; hemaglobin=11.5; hematocrit=34.2; platelets=431; CRP=1.0; NA=138; potassium=4.4; chloride=99; CO2=18; glucose=91; BUN=10; creatinine=0.4; LFTs=normal. A standard lot check investigation was performed for Lot # 655863/1034F). All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigations was performed. The testing performed on the batch prior to release met all release specifications. The lot met requirements of the Center for Biologics Evaluation and Research and was released.  Upon internal review, intussusception was considered to be an other important medical event. Additional information has been requested. VAERS # 278155
Age: 0.92
Sex: M
Vaccine: FLU3, RV5, FLU3, RV5
Symptoms: Abdominal pain upper, Blood chloride normal, Blood creatinine normal, Blood glucose abnormal, Blood potassium normal
Clinical narrative: Information has been received from the FDA (VAERS # 278155) through the CDC concerning an 11-month-old male with no history/pre-existing conditions who on 13-DEC-2006 was vaccinated with a third dose of Rotateq (Lot # 655863/1034F). Concomitant therapy that day included a second dose of Fluzone (Lot # 42174RA). The second dose of Rotateq (Lot # 654665/1017F) and the first dose of Fluzone (Lot # KU2174KA) were given on an unknown date. On 15-APR-2007, 113 post vaccination, the patient experienced intussusception. Follow up information received from the FDA (VAERS # 278155) through the CDC indicated that on 16-APR-2007, the patient had acute vomiting and stomach pains. He was seen in the ER screaming with a fever and diarrhea. A paralytic ilius was questioned, and GI was consulted. They indicated biliuos emesis and concern for intussusception. Films and KUB were normal status post enema with good results. The patient recovered. Laboratory data included: WBC=11.45; hemaglobin=11.5; hematocrit=34.2; platelets=431; CRP=1.0; NA=138; potassium=4.4; chloride=99; CO2=18; glucose=91; BUN=10; creatinine=0.4; LFTs=normal. A standard lot check investigation was performed for Lot # 655863/1034F). All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigations was performed. The testing performed on the batch prior to release met all release specifications. The lot met requirements of the Center for Biologics Evaluation and Research and was released.  Upon internal review, intussusception was considered to be an other important medical event. Additional information has been requested. VAERS # 278155
Age: 0.92
Sex: M
Vaccine: FLU3, RV5, FLU3, RV5
Symptoms: Blood sodium normal, Blood urea normal, C-reactive protein normal, Diarrhoea, Enema administration
Clinical narrative: Information has been received from the FDA (VAERS # 278155) through the CDC concerning an 11-month-old male with no history/pre-existing conditions who on 13-DEC-2006 was vaccinated with a third dose of Rotateq (Lot # 655863/1034F). Concomitant therapy that day included a second dose of Fluzone (Lot # 42174RA). The second dose of Rotateq (Lot # 654665/1017F) and the first dose of Fluzone (Lot # KU2174KA) were given on an unknown date. On 15-APR-2007, 113 post vaccination, the patient experienced intussusception. Follow up information received from the FDA (VAERS # 278155) through the CDC indicated that on 16-APR-2007, the patient had acute vomiting and stomach pains. He was seen in the ER screaming with a fever and diarrhea. A paralytic ilius was questioned, and GI was consulted. They indicated biliuos emesis and concern for intussusception. Films and KUB were normal status post enema with good results. The patient recovered. Laboratory data included: WBC=11.45; hemaglobin=11.5; hematocrit=34.2; platelets=431; CRP=1.0; NA=138; potassium=4.4; chloride=99; CO2=18; glucose=91; BUN=10; creatinine=0.4; LFTs=normal. A standard lot check investigation was performed for Lot # 655863/1034F). All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigations was performed. The testing performed on the batch prior to release met all release specifications. The lot met requirements of the Center for Biologics Evaluation and Research and was released.  Upon internal review, intussusception was considered to be an other important medical event. Additional information has been requested. VAERS # 278155
Age: 0.92
Sex: M
Vaccine: FLU3, RV5, FLU3, RV5
Symptoms: Haematocrit normal, Haemoglobin increased, Ileus paralytic, Inappropriate schedule of drug administration, Intussusception
Clinical narrative: Information has been received from the FDA (VAERS # 278155) through the CDC concerning an 11-month-old male with no history/pre-existing conditions who on 13-DEC-2006 was vaccinated with a third dose of Rotateq (Lot # 655863/1034F). Concomitant therapy that day included a second dose of Fluzone (Lot # 42174RA). The second dose of Rotateq (Lot # 654665/1017F) and the first dose of Fluzone (Lot # KU2174KA) were given on an unknown date. On 15-APR-2007, 113 post vaccination, the patient experienced intussusception. Follow up information received from the FDA (VAERS # 278155) through the CDC indicated that on 16-APR-2007, the patient had acute vomiting and stomach pains. He was seen in the ER screaming with a fever and diarrhea. A paralytic ilius was questioned, and GI was consulted. They indicated biliuos emesis and concern for intussusception. Films and KUB were normal status post enema with good results. The patient recovered. Laboratory data included: WBC=11.45; hemaglobin=11.5; hematocrit=34.2; platelets=431; CRP=1.0; NA=138; potassium=4.4; chloride=99; CO2=18; glucose=91; BUN=10; creatinine=0.4; LFTs=normal. A standard lot check investigation was performed for Lot # 655863/1034F). All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigations was performed. The testing performed on the batch prior to release met all release specifications. The lot met requirements of the Center for Biologics Evaluation and Research and was released.  Upon internal review, intussusception was considered to be an other important medical event. Additional information has been requested. VAERS # 278155
Age: 0.92
Sex: M
Vaccine: FLU3, RV5, FLU3, RV5
Symptoms: Liver function test normal, Platelet count increased, Pyrexia, Screaming, Urinary system X-ray
Clinical narrative: Information has been received from the FDA (VAERS # 278155) through the CDC concerning an 11-month-old male with no history/pre-existing conditions who on 13-DEC-2006 was vaccinated with a third dose of Rotateq (Lot # 655863/1034F). Concomitant therapy that day included a second dose of Fluzone (Lot # 42174RA). The second dose of Rotateq (Lot # 654665/1017F) and the first dose of Fluzone (Lot # KU2174KA) were given on an unknown date. On 15-APR-2007, 113 post vaccination, the patient experienced intussusception. Follow up information received from the FDA (VAERS # 278155) through the CDC indicated that on 16-APR-2007, the patient had acute vomiting and stomach pains. He was seen in the ER screaming with a fever and diarrhea. A paralytic ilius was questioned, and GI was consulted. They indicated biliuos emesis and concern for intussusception. Films and KUB were normal status post enema with good results. The patient recovered. Laboratory data included: WBC=11.45; hemaglobin=11.5; hematocrit=34.2; platelets=431; CRP=1.0; NA=138; potassium=4.4; chloride=99; CO2=18; glucose=91; BUN=10; creatinine=0.4; LFTs=normal. A standard lot check investigation was performed for Lot # 655863/1034F). All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigations was performed. The testing performed on the batch prior to release met all release specifications. The lot met requirements of the Center for Biologics Evaluation and Research and was released.  Upon internal review, intussusception was considered to be an other important medical event. Additional information has been requested. VAERS # 278155
Age: 0.92
Sex: M
Vaccine: FLU3, RV5, FLU3, RV5
Symptoms: Vomiting, White blood cell count increased
Clinical narrative: Information has been received from the FDA (VAERS # 278155) through the CDC concerning an 11-month-old male with no history/pre-existing conditions who on 13-DEC-2006 was vaccinated with a third dose of Rotateq (Lot # 655863/1034F). Concomitant therapy that day included a second dose of Fluzone (Lot # 42174RA). The second dose of Rotateq (Lot # 654665/1017F) and the first dose of Fluzone (Lot # KU2174KA) were given on an unknown date. On 15-APR-2007, 113 post vaccination, the patient experienced intussusception. Follow up information received from the FDA (VAERS # 278155) through the CDC indicated that on 16-APR-2007, the patient had acute vomiting and stomach pains. He was seen in the ER screaming with a fever and diarrhea. A paralytic ilius was questioned, and GI was consulted. They indicated biliuos emesis and concern for intussusception. Films and KUB were normal status post enema with good results. The patient recovered. Laboratory data included: WBC=11.45; hemaglobin=11.5; hematocrit=34.2; platelets=431; CRP=1.0; NA=138; potassium=4.4; chloride=99; CO2=18; glucose=91; BUN=10; creatinine=0.4; LFTs=normal. A standard lot check investigation was performed for Lot # 655863/1034F). All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigations was performed. The testing performed on the batch prior to release met all release specifications. The lot met requirements of the Center for Biologics Evaluation and Research and was released.  Upon internal review, intussusception was considered to be an other important medical event. Additional information has been requested. VAERS # 278155
Age: 0.67
Sex: M
Vaccine: DTAP, IPV, PNC, RV5, RV5, DTAP, IPV, PNC, RV5
Symptoms: Intussusception
Clinical narrative: Information has been received from the FDA (VAERS # 278302) through the CDC concerning an 8-month-old male who on 24-MAR-2007 was vaccinated with a third dose of Rotateq (Lot # 655865/1109F). Concomitant therapy included a second dose of Daptacel (Lot # 0249U0A), a second dose of Ipol (Lot # Z0240), and a second dose of Prevnar) (Lot # 808672E). On 30-APR-2007, 37 days post vaccination, the patient experienced intussusception. An air enema was done. Follow up information received from the FDA (VAERS # 278302) through the CDC indicated that the patient experienced vomiting, decreased oral intake, abdominal pain, and intermittent lethargy. He was admitted to the hospital from 30-APR-2007 to 03-MAY-2007 (4 days). He was treated with IVF for dehydration. A surgical consult was done. The intussusception was successfully reduced. He was observed status post reduction and progressed well. The final diagnosis was vomiting (resolved) and intussusception s/p reduction with air contrast enema. It was noted that the patient had otitis media days prior to admittance (on 22-APR-2007). Laboratory data included: NA=130, K=3; CO2=22; guaiac + stools; KUB and air contrast enema revealed intussusception was successfully reduced by air contrast enema; stool and urine culture were negative. The patient recovered. A standard lot check investigation was performed for Lot # 655865/1109F. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biological Evaluation and Research and was released. The events were considered to be life-threatening by the reporter. Additional information has been requested. VAERS # 278302
Age: 0.67
Sex: M
Vaccine: DTAP, IPV, PNC, RV5, RV5, DTAP, IPV, PNC, RV5
Symptoms: Abdominal pain, Barium double contrast, Blood potassium decreased, Blood potassium normal, Blood sodium decreased
Clinical narrative: Information has been received from the FDA (VAERS # 278302) through the CDC concerning an 8-month-old male who on 24-MAR-2007 was vaccinated with a third dose of Rotateq (Lot # 655865/1109F). Concomitant therapy included a second dose of Daptacel (Lot # 0249U0A), a second dose of Ipol (Lot # Z0240), and a second dose of Prevnar) (Lot # 808672E). On 30-APR-2007, 37 days post vaccination, the patient experienced intussusception. An air enema was done. Follow up information received from the FDA (VAERS # 278302) through the CDC indicated that the patient experienced vomiting, decreased oral intake, abdominal pain, and intermittent lethargy. He was admitted to the hospital from 30-APR-2007 to 03-MAY-2007 (4 days). He was treated with IVF for dehydration. A surgical consult was done. The intussusception was successfully reduced. He was observed status post reduction and progressed well. The final diagnosis was vomiting (resolved) and intussusception s/p reduction with air contrast enema. It was noted that the patient had otitis media days prior to admittance (on 22-APR-2007). Laboratory data included: NA=130, K=3; CO2=22; guaiac + stools; KUB and air contrast enema revealed intussusception was successfully reduced by air contrast enema; stool and urine culture were negative. The patient recovered. A standard lot check investigation was performed for Lot # 655865/1109F. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biological Evaluation and Research and was released. The events were considered to be life-threatening by the reporter. Additional information has been requested. VAERS # 278302