chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.06
Sex: F
Vaccine: DTAP, HEPA, HPV4, PNC, VARCEL, DTAP, HEPA, HPV4, PNC, VARCEL
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a health professional concerning a 12 month old female with a history of gastrooesophageal reflux disease who on 16-JAN-2008 was vaccinated IM in the right thigh with GARDASIL (659055/1522U) in error. Concomitant therapy included PREVNAR, hepatitis A virus vaccine (unspecified) and diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid. On 16-JAN-2008 the patient experienced vaccine administration in error, inappropriate age and swelling the size of a half-dollar at the injection site. The patient sought unspecified medical attention. The patient's administered in error and inappropriate age and swelling at the injection site persisted. The reporter has requested that MTM from MNSC contact the clinic about his event. Additional information  has been requested. This is in follow-up to report(s) previously submitted on 2/14/2008; 4/7/2008. Information has been received from a health professional concerning a 12 month old female with a history of gastrooesophageal reflux disease who on 16-JAN-2008 was vaccinated IM in the right thigh with GARDASIL (659055/1522U) in error. Concomitant therapy included VARIVAX IM in the right thigh. Other concomitant therapy included PREVNAR, hepatitis A virus vaccine (unspecified) and diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid. On 16-JAN-2008 the patient experienced vaccine administration in error, inappropriate age and swelling the size of a half-dollar at the injection site. The patient sought unspecified medical attention. The patient's administered in error and inappropriate age and swelling at the injection site persisted. Additional information received on B form 13-FEB-2008: Vaccines received on 16-JAN-2008 included: 1. GARDASIL, IM on right thigh, 0 previous. 2. VARIVAX (Merck) (lot reported as 1462u), SQ right thigh, 0 previous. 3. DTaP (U2289AA) (Sanofi), IM on left thigh, 3 previous. 4. HAVRIX (AHAVB217AA) (GSK), IM on left thigh, 0 previous. 5. PREVNAR (B97283A) (Wyeth), IM on left thigh, 3 previous. It was also reported that the patient had a runny nose and cough at the time of vaccination. The patient is adopted. Additional information received from B Form (04-APR-2008): It was reported that the patient was given GARDASIL instead of MMR II that was ordered. This was due to a "software glitch" that showed GARDASIL ordered. It was also reported that the patient experienced a fever on 17-JAN-2008 which lasted approximately 24 hours. The patient has since recovered from the fever, swelling at the injection site, inappropriate age and vaccine administered in error. Additional information is not expected.
Age: 1.06
Sex: F
Vaccine: DTAP, HEPA, HPV4, PNC, VARCEL, DTAP, HEPA, HPV4, PNC, VARCEL
Symptoms: Inappropriate schedule of drug administration, Inappropriate schedule of drug administration, Injection site swelling, Medication error, Pyrexia
Clinical narrative: Information has been received from a health professional concerning a 12 month old female with a history of gastrooesophageal reflux disease who on 16-JAN-2008 was vaccinated IM in the right thigh with GARDASIL (659055/1522U) in error. Concomitant therapy included PREVNAR, hepatitis A virus vaccine (unspecified) and diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid. On 16-JAN-2008 the patient experienced vaccine administration in error, inappropriate age and swelling the size of a half-dollar at the injection site. The patient sought unspecified medical attention. The patient's administered in error and inappropriate age and swelling at the injection site persisted. The reporter has requested that MTM from MNSC contact the clinic about his event. Additional information  has been requested. This is in follow-up to report(s) previously submitted on 2/14/2008; 4/7/2008. Information has been received from a health professional concerning a 12 month old female with a history of gastrooesophageal reflux disease who on 16-JAN-2008 was vaccinated IM in the right thigh with GARDASIL (659055/1522U) in error. Concomitant therapy included VARIVAX IM in the right thigh. Other concomitant therapy included PREVNAR, hepatitis A virus vaccine (unspecified) and diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid. On 16-JAN-2008 the patient experienced vaccine administration in error, inappropriate age and swelling the size of a half-dollar at the injection site. The patient sought unspecified medical attention. The patient's administered in error and inappropriate age and swelling at the injection site persisted. Additional information received on B form 13-FEB-2008: Vaccines received on 16-JAN-2008 included: 1. GARDASIL, IM on right thigh, 0 previous. 2. VARIVAX (Merck) (lot reported as 1462u), SQ right thigh, 0 previous. 3. DTaP (U2289AA) (Sanofi), IM on left thigh, 3 previous. 4. HAVRIX (AHAVB217AA) (GSK), IM on left thigh, 0 previous. 5. PREVNAR (B97283A) (Wyeth), IM on left thigh, 3 previous. It was also reported that the patient had a runny nose and cough at the time of vaccination. The patient is adopted. Additional information received from B Form (04-APR-2008): It was reported that the patient was given GARDASIL instead of MMR II that was ordered. This was due to a "software glitch" that showed GARDASIL ordered. It was also reported that the patient experienced a fever on 17-JAN-2008 which lasted approximately 24 hours. The patient has since recovered from the fever, swelling at the injection site, inappropriate age and vaccine administered in error. Additional information is not expected.
Age: 1.06
Sex: F
Vaccine: DTAP, HEPA, HPV4, PNC, VARCEL, DTAP, HEPA, HPV4, PNC, VARCEL
Symptoms: Swelling, Wrong drug administered
Clinical narrative: Information has been received from a health professional concerning a 12 month old female with a history of gastrooesophageal reflux disease who on 16-JAN-2008 was vaccinated IM in the right thigh with GARDASIL (659055/1522U) in error. Concomitant therapy included PREVNAR, hepatitis A virus vaccine (unspecified) and diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid. On 16-JAN-2008 the patient experienced vaccine administration in error, inappropriate age and swelling the size of a half-dollar at the injection site. The patient sought unspecified medical attention. The patient's administered in error and inappropriate age and swelling at the injection site persisted. The reporter has requested that MTM from MNSC contact the clinic about his event. Additional information  has been requested. This is in follow-up to report(s) previously submitted on 2/14/2008; 4/7/2008. Information has been received from a health professional concerning a 12 month old female with a history of gastrooesophageal reflux disease who on 16-JAN-2008 was vaccinated IM in the right thigh with GARDASIL (659055/1522U) in error. Concomitant therapy included VARIVAX IM in the right thigh. Other concomitant therapy included PREVNAR, hepatitis A virus vaccine (unspecified) and diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid. On 16-JAN-2008 the patient experienced vaccine administration in error, inappropriate age and swelling the size of a half-dollar at the injection site. The patient sought unspecified medical attention. The patient's administered in error and inappropriate age and swelling at the injection site persisted. Additional information received on B form 13-FEB-2008: Vaccines received on 16-JAN-2008 included: 1. GARDASIL, IM on right thigh, 0 previous. 2. VARIVAX (Merck) (lot reported as 1462u), SQ right thigh, 0 previous. 3. DTaP (U2289AA) (Sanofi), IM on left thigh, 3 previous. 4. HAVRIX (AHAVB217AA) (GSK), IM on left thigh, 0 previous. 5. PREVNAR (B97283A) (Wyeth), IM on left thigh, 3 previous. It was also reported that the patient had a runny nose and cough at the time of vaccination. The patient is adopted. Additional information received from B Form (04-APR-2008): It was reported that the patient was given GARDASIL instead of MMR II that was ordered. This was due to a "software glitch" that showed GARDASIL ordered. It was also reported that the patient experienced a fever on 17-JAN-2008 which lasted approximately 24 hours. The patient has since recovered from the fever, swelling at the injection site, inappropriate age and vaccine administered in error. Additional information is not expected.
Age: 0.6
Sex: M
Vaccine: DTAPHEPBIP, PNC, RV5, DTAPHEPBIP, PNC, RV5
Symptoms: Aspiration, Chest X-ray abnormal, Pneumonia, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 7 month old male with no pertinent medical history or drug allergies who on 23-AUG-2007, 24-OCT-2008 was vaccinated PO with his first, second and third (lot# 657983/1243U) 2.0 ml doses of ROTATEQ. Concomitant vaccinations administered on 08-JAN-2008 included a dose of PEDIARIX and a dose of PREVNAR. Upon administration of the third dose, the patient gagged and choked. In January 2008, the patient was also diagnosed with pneumonia. The patient was seen in the physician's office. Lab diagnostic studies included a chest x-ray. The patient was not recovered at the time of this report. There was no product quality report. There was no product quality complaint. Follow-up information from the reporting physician indicated that the patient's chest x-ray (CXR) revealed a right middle lobe pneumonia. The child also experienced tachypnea during the course of the illness. The child was noted to be "doing fine. No fever and no problems eating, drinking or playing." The provided was planning for a repeat CXR and pediatric disease consult with a specialist. Additional information has been requested.
Age: 0.6
Sex: M
Vaccine: DTAPHEPBIP, PNC, RV5, DTAPHEPBIP, PNC, RV5
Symptoms: Chest X-ray abnormal, Choking, Pneumonia, Retching, Tachypnoea
Clinical narrative: Information has been received from a physician concerning a 7 month old male with no pertinent medical history or drug allergies who on 23-AUG-2007, 24-OCT-2008 was vaccinated PO with his first, second and third (lot# 657983/1243U) 2.0 ml doses of ROTATEQ. Concomitant vaccinations administered on 08-JAN-2008 included a dose of PEDIARIX and a dose of PREVNAR. Upon administration of the third dose, the patient gagged and choked. In January 2008, the patient was also diagnosed with pneumonia. The patient was seen in the physician's office. Lab diagnostic studies included a chest x-ray. The patient was not recovered at the time of this report. There was no product quality report. There was no product quality complaint. Follow-up information from the reporting physician indicated that the patient's chest x-ray (CXR) revealed a right middle lobe pneumonia. The child also experienced tachypnea during the course of the illness. The child was noted to be "doing fine. No fever and no problems eating, drinking or playing." The provided was planning for a repeat CXR and pediatric disease consult with a specialist. Additional information has been requested.
Age: 0.3
Sex: U
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Diarrhoea haemorrhagic, Enema administration, Intussusception, Vomiting
Clinical narrative: Information has been received from a nurse practitioner concerning a 16 week old patient with a history of "stomach virus exposure the same week" of vaccination who on 01-FEB-2008 was vaccinated PO with the first 2.0 ml dose of ROTATEQ (lot #657659/0929U).  Concomitant vaccinations administered on that same day included the first dose of PEDIARIX, the first dose of Hib conj vaccine (OMPC) (manufacturer unknown) and the first dose of PREVNAR.  On 01-FEB-2008 the patient experienced "bloody diarrhea."  On 02-FEB-2008 the patient also experienced intussusception and was admitted to the hospital on that same day for 3 days.  An ultrasound showed the intussusception and the patient was administered a "barium enema."  The intussusception "resolved spontaneously, so they did not have to do anything."  The doctor decided not to complete the series of ROTATEQ as of 01-FEB-2008.  On 04-FEB-2008 the patient was discharged from the hospital and recovered from intussusception.  The patient was still having bloody diarrhea and was due into the office on 11-FEB-2008.  There was no product quality complaint.  Additional information has been requested.
Age: 0.3
Sex: U
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Abdominal X-ray, Barium enema, Diarrhoea haemorrhagic, Enema administration, Intussusception
Clinical narrative: Information has been received from a nurse practitioner concerning a 16 week old patient with a history of "stomach virus exposure the same week" of vaccination who on 01-FEB-2008 was vaccinated PO with the first 2.0 ml dose of ROTATEQ (lot #657659/0929U).  Concomitant vaccinations administered on that same day included the first dose of PEDIARIX, the first dose of Hib conj vaccine (OMPC) (manufacturer unknown) and the first dose of PREVNAR.  On 01-FEB-2008 the patient experienced "bloody diarrhea."  On 02-FEB-2008 the patient also experienced intussusception and was admitted to the hospital on that same day for 3 days.  An ultrasound showed the intussusception and the patient was administered a "barium enema."  The intussusception "resolved spontaneously, so they did not have to do anything."  The doctor decided not to complete the series of ROTATEQ as of 01-FEB-2008.  On 04-FEB-2008 the patient was discharged from the hospital and recovered from intussusception.  The patient was still having bloody diarrhea and was due into the office on 11-FEB-2008.  There was no product quality complaint.  Additional information has been requested.
Age: 0.3
Sex: U
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Ultrasound abdomen abnormal
Clinical narrative: Information has been received from a nurse practitioner concerning a 16 week old patient with a history of "stomach virus exposure the same week" of vaccination who on 01-FEB-2008 was vaccinated PO with the first 2.0 ml dose of ROTATEQ (lot #657659/0929U).  Concomitant vaccinations administered on that same day included the first dose of PEDIARIX, the first dose of Hib conj vaccine (OMPC) (manufacturer unknown) and the first dose of PREVNAR.  On 01-FEB-2008 the patient experienced "bloody diarrhea."  On 02-FEB-2008 the patient also experienced intussusception and was admitted to the hospital on that same day for 3 days.  An ultrasound showed the intussusception and the patient was administered a "barium enema."  The intussusception "resolved spontaneously, so they did not have to do anything."  The doctor decided not to complete the series of ROTATEQ as of 01-FEB-2008.  On 04-FEB-2008 the patient was discharged from the hospital and recovered from intussusception.  The patient was still having bloody diarrhea and was due into the office on 11-FEB-2008.  There was no product quality complaint.  Additional information has been requested.
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Blood glucose, Convulsion, Electrocardiogram, Metabolic function test
Clinical narrative: Information has been received from a health professional concerning a female (age not reported) who on an unspecified date was vaccinated with Gardasil injection.  Concomitant therapy included MENACTRA.  Subsequently the patient experienced a seizure like reaction and fainted.  The patient was hospitalized for an unspecified length of time.  On an unspecified date the patient had various test performed, the results were unknown.  At the time of reporting it was unknown if the patient had recovered.  No further information was provided regarding these adverse experiences.  Additional information has been requested.  Seizure and syncope required hospitalization.  This is one of several reports from the same source.
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Convulsion, Syncope
Clinical narrative: Information has been received from a health professional concerning a female (age not reported) who on an unspecified date was vaccinated with Gardasil injection.  Concomitant therapy included MENACTRA.  Subsequently the patient experienced a seizure like reaction and fainted.  The patient was hospitalized for an unspecified length of time.  On an unspecified date the patient had various test performed, the results were unknown.  At the time of reporting it was unknown if the patient had recovered.  No further information was provided regarding these adverse experiences.  Additional information has been requested.  Seizure and syncope required hospitalization.  This is one of several reports from the same source.
Age: 0.3
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC
Symptoms: Activated partial thromboplastin time shortened, Blood urine present, Contusion, Haematochezia, Idiopathic thrombocytopenic purpura
Clinical narrative: This case was reported by a physician and described the occurrence of idiopathic thrombocytopenia purpura in a 4-month-old female subject who was vaccinated with Pediarix (GlaxoSmithKline) for prophylaxis.  Concurrent medical conditions included stuffy nose.  Previous and/or concurrent vaccination included Act-HIB; Sanofi given on 18 January 2008; Prevnar; Wyeth Labs given on 18 January 2008.  On 18 January 2008, the subject received 2nd dose of Pediarix (.5 unknown, intramuscular, left thigh).  At an unspecified time after vaccination with Pediarix, the subject experienced blood in stools, bruising, petechiae and nose bleeds.  The subject was seen in the emergency room and her platelet count was "zero".  The subject was transferred to another hospitals' Intensive Care Unit (ICU).  She was diagnosed with idiopathic thrombocytopenia purpura.  The subject was treated for four days in the ICU with normal immunoglobulin, platelet concentrate and steroid.  On an unknown date, the subject was discharged from the hospital.  At the time of reporting the outcome of the events were unspecified.
Age: 0.3
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC
Symptoms: Intensive care, International normalised ratio, Petechiae, Platelet count decreased, Urine analysis abnormal
Clinical narrative: This case was reported by a physician and described the occurrence of idiopathic thrombocytopenia purpura in a 4-month-old female subject who was vaccinated with Pediarix (GlaxoSmithKline) for prophylaxis.  Concurrent medical conditions included stuffy nose.  Previous and/or concurrent vaccination included Act-HIB; Sanofi given on 18 January 2008; Prevnar; Wyeth Labs given on 18 January 2008.  On 18 January 2008, the subject received 2nd dose of Pediarix (.5 unknown, intramuscular, left thigh).  At an unspecified time after vaccination with Pediarix, the subject experienced blood in stools, bruising, petechiae and nose bleeds.  The subject was seen in the emergency room and her platelet count was "zero".  The subject was transferred to another hospitals' Intensive Care Unit (ICU).  She was diagnosed with idiopathic thrombocytopenia purpura.  The subject was treated for four days in the ICU with normal immunoglobulin, platelet concentrate and steroid.  On an unknown date, the subject was discharged from the hospital.  At the time of reporting the outcome of the events were unspecified.
Age: 0.3
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC
Symptoms: White blood cell count increased
Clinical narrative: This case was reported by a physician and described the occurrence of idiopathic thrombocytopenia purpura in a 4-month-old female subject who was vaccinated with Pediarix (GlaxoSmithKline) for prophylaxis.  Concurrent medical conditions included stuffy nose.  Previous and/or concurrent vaccination included Act-HIB; Sanofi given on 18 January 2008; Prevnar; Wyeth Labs given on 18 January 2008.  On 18 January 2008, the subject received 2nd dose of Pediarix (.5 unknown, intramuscular, left thigh).  At an unspecified time after vaccination with Pediarix, the subject experienced blood in stools, bruising, petechiae and nose bleeds.  The subject was seen in the emergency room and her platelet count was "zero".  The subject was transferred to another hospitals' Intensive Care Unit (ICU).  She was diagnosed with idiopathic thrombocytopenia purpura.  The subject was treated for four days in the ICU with normal immunoglobulin, platelet concentrate and steroid.  On an unknown date, the subject was discharged from the hospital.  At the time of reporting the outcome of the events were unspecified.
Age: 0.3
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC
Symptoms: Contusion, Epistaxis, Haematochezia, Idiopathic thrombocytopenic purpura, Immunoglobulins
Clinical narrative: This case was reported by a physician and described the occurrence of idiopathic thrombocytopenia purpura in a 4-month-old female subject who was vaccinated with Pediarix (GlaxoSmithKline) for prophylaxis.  Concurrent medical conditions included stuffy nose.  Previous and/or concurrent vaccination included Act-HIB; Sanofi given on 18 January 2008; Prevnar; Wyeth Labs given on 18 January 2008.  On 18 January 2008, the subject received 2nd dose of Pediarix (.5 unknown, intramuscular, left thigh).  At an unspecified time after vaccination with Pediarix, the subject experienced blood in stools, bruising, petechiae and nose bleeds.  The subject was seen in the emergency room and her platelet count was "zero".  The subject was transferred to another hospitals' Intensive Care Unit (ICU).  She was diagnosed with idiopathic thrombocytopenia purpura.  The subject was treated for four days in the ICU with normal immunoglobulin, platelet concentrate and steroid.  On an unknown date, the subject was discharged from the hospital.  At the time of reporting the outcome of the events were unspecified.
Age: 0.3
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC
Symptoms: Intensive care, Petechiae, Platelet count decreased, Transfusion
Clinical narrative: This case was reported by a physician and described the occurrence of idiopathic thrombocytopenia purpura in a 4-month-old female subject who was vaccinated with Pediarix (GlaxoSmithKline) for prophylaxis.  Concurrent medical conditions included stuffy nose.  Previous and/or concurrent vaccination included Act-HIB; Sanofi given on 18 January 2008; Prevnar; Wyeth Labs given on 18 January 2008.  On 18 January 2008, the subject received 2nd dose of Pediarix (.5 unknown, intramuscular, left thigh).  At an unspecified time after vaccination with Pediarix, the subject experienced blood in stools, bruising, petechiae and nose bleeds.  The subject was seen in the emergency room and her platelet count was "zero".  The subject was transferred to another hospitals' Intensive Care Unit (ICU).  She was diagnosed with idiopathic thrombocytopenia purpura.  The subject was treated for four days in the ICU with normal immunoglobulin, platelet concentrate and steroid.  On an unknown date, the subject was discharged from the hospital.  At the time of reporting the outcome of the events were unspecified.
Age: 0.3
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC
Symptoms: Contusion, Epistaxis, Haematochezia, Idiopathic thrombocytopenic purpura, Petechiae
Clinical narrative: This case was reported by a physician and described the occurrence of idiopathic thrombocytopenia purpura in a 4-month-old female subject who was vaccinated with Pediarix (GlaxoSmithKline) for prophylaxis.  Concurrent medical conditions included stuffy nose.  Previous and/or concurrent vaccination included Act-HIB; Sanofi given on 18 January 2008; Prevnar; Wyeth Labs given on 18 January 2008.  On 18 January 2008, the subject received 2nd dose of Pediarix (.5 unknown, intramuscular, left thigh).  At an unspecified time after vaccination with Pediarix, the subject experienced blood in stools, bruising, petechiae and nose bleeds.  The subject was seen in the emergency room and her platelet count was "zero".  The subject was transferred to another hospitals' Intensive Care Unit (ICU).  She was diagnosed with idiopathic thrombocytopenia purpura.  The subject was treated for four days in the ICU with normal immunoglobulin, platelet concentrate and steroid.  On an unknown date, the subject was discharged from the hospital.  At the time of reporting the outcome of the events were unspecified.
Age: 0.3
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC
Symptoms: Platelet count decreased
Clinical narrative: This case was reported by a physician and described the occurrence of idiopathic thrombocytopenia purpura in a 4-month-old female subject who was vaccinated with Pediarix (GlaxoSmithKline) for prophylaxis.  Concurrent medical conditions included stuffy nose.  Previous and/or concurrent vaccination included Act-HIB; Sanofi given on 18 January 2008; Prevnar; Wyeth Labs given on 18 January 2008.  On 18 January 2008, the subject received 2nd dose of Pediarix (.5 unknown, intramuscular, left thigh).  At an unspecified time after vaccination with Pediarix, the subject experienced blood in stools, bruising, petechiae and nose bleeds.  The subject was seen in the emergency room and her platelet count was "zero".  The subject was transferred to another hospitals' Intensive Care Unit (ICU).  She was diagnosed with idiopathic thrombocytopenia purpura.  The subject was treated for four days in the ICU with normal immunoglobulin, platelet concentrate and steroid.  On an unknown date, the subject was discharged from the hospital.  At the time of reporting the outcome of the events were unspecified.
Age: 0.3
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC
Symptoms: Blood urine present, Contusion, Haematocrit, Haemoglobin, Idiopathic thrombocytopenic purpura
Clinical narrative: This case was reported by a physician and described the occurrence of idiopathic thrombocytopenia purpura in a 4-month-old female subject who was vaccinated with Pediarix (GlaxoSmithKline) for prophylaxis.  Concurrent medical conditions included stuffy nose.  Previous and/or concurrent vaccination included Act-HIB; Sanofi given on 18 January 2008; Prevnar; Wyeth Labs given on 18 January 2008.  On 18 January 2008, the subject received 2nd dose of Pediarix (.5 unknown, intramuscular, left thigh).  At an unspecified time after vaccination with Pediarix, the subject experienced blood in stools, bruising, petechiae and nose bleeds.  The subject was seen in the emergency room and her platelet count was "zero".  The subject was transferred to another hospitals' Intensive Care Unit (ICU).  She was diagnosed with idiopathic thrombocytopenia purpura.  The subject was treated for four days in the ICU with normal immunoglobulin, platelet concentrate and steroid.  On an unknown date, the subject was discharged from the hospital.  At the time of reporting the outcome of the events were unspecified.
Age: 0.3
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC
Symptoms: Immunoglobulins, Intensive care, International normalised ratio, Petechiae, Platelet count decreased
Clinical narrative: This case was reported by a physician and described the occurrence of idiopathic thrombocytopenia purpura in a 4-month-old female subject who was vaccinated with Pediarix (GlaxoSmithKline) for prophylaxis.  Concurrent medical conditions included stuffy nose.  Previous and/or concurrent vaccination included Act-HIB; Sanofi given on 18 January 2008; Prevnar; Wyeth Labs given on 18 January 2008.  On 18 January 2008, the subject received 2nd dose of Pediarix (.5 unknown, intramuscular, left thigh).  At an unspecified time after vaccination with Pediarix, the subject experienced blood in stools, bruising, petechiae and nose bleeds.  The subject was seen in the emergency room and her platelet count was "zero".  The subject was transferred to another hospitals' Intensive Care Unit (ICU).  She was diagnosed with idiopathic thrombocytopenia purpura.  The subject was treated for four days in the ICU with normal immunoglobulin, platelet concentrate and steroid.  On an unknown date, the subject was discharged from the hospital.  At the time of reporting the outcome of the events were unspecified.
Age: 0.3
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC
Symptoms: Prothrombin time, Red blood cells urine positive, Respiratory tract congestion, Transfusion, Urine analysis abnormal
Clinical narrative: This case was reported by a physician and described the occurrence of idiopathic thrombocytopenia purpura in a 4-month-old female subject who was vaccinated with Pediarix (GlaxoSmithKline) for prophylaxis.  Concurrent medical conditions included stuffy nose.  Previous and/or concurrent vaccination included Act-HIB; Sanofi given on 18 January 2008; Prevnar; Wyeth Labs given on 18 January 2008.  On 18 January 2008, the subject received 2nd dose of Pediarix (.5 unknown, intramuscular, left thigh).  At an unspecified time after vaccination with Pediarix, the subject experienced blood in stools, bruising, petechiae and nose bleeds.  The subject was seen in the emergency room and her platelet count was "zero".  The subject was transferred to another hospitals' Intensive Care Unit (ICU).  She was diagnosed with idiopathic thrombocytopenia purpura.  The subject was treated for four days in the ICU with normal immunoglobulin, platelet concentrate and steroid.  On an unknown date, the subject was discharged from the hospital.  At the time of reporting the outcome of the events were unspecified.
Age: 0.3
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC
Symptoms: White blood cell count
Clinical narrative: This case was reported by a physician and described the occurrence of idiopathic thrombocytopenia purpura in a 4-month-old female subject who was vaccinated with Pediarix (GlaxoSmithKline) for prophylaxis.  Concurrent medical conditions included stuffy nose.  Previous and/or concurrent vaccination included Act-HIB; Sanofi given on 18 January 2008; Prevnar; Wyeth Labs given on 18 January 2008.  On 18 January 2008, the subject received 2nd dose of Pediarix (.5 unknown, intramuscular, left thigh).  At an unspecified time after vaccination with Pediarix, the subject experienced blood in stools, bruising, petechiae and nose bleeds.  The subject was seen in the emergency room and her platelet count was "zero".  The subject was transferred to another hospitals' Intensive Care Unit (ICU).  She was diagnosed with idiopathic thrombocytopenia purpura.  The subject was treated for four days in the ICU with normal immunoglobulin, platelet concentrate and steroid.  On an unknown date, the subject was discharged from the hospital.  At the time of reporting the outcome of the events were unspecified.
Age: 25.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Feeling hot, Rash generalised, Skin warm
Clinical narrative: Information has been received from a licensed practical nurse concerning a 25 year old female with no pertinent medical history or drug reactions/allergies who on 20-JUL-2007 was vaccinated with a first dose of Gardasil.  Concomitant therapy included LOESTRIN.  On 21-JAN-2008 the patient received a second dose of Gardasil (lot# 659653/1448U) 0.5 mL IM.  On 22-JAN-2008 the patient developed a rash all over the body.  Medical attention was sought.  The office has ruled out other factors except for Gardasil.  The patient was instructed to take BENADRYL.  At the time of reporting the patient had not recovered and will be seen at the office on 23-JAN-2008.  No other details were given.  Additional information has been requested. Inital and follow-up information has been received  from a licensed practical nurse concerning a 25 year old female with no illness at the time of vaccination, no pertinent medical history or drug reactions/allergies who on 20-JUL-2007 was vaccinated with a first dose of HPV vaccine. On an unspecified date the patient was vaccinated with a second dose of HPV vaccine. On 21-JAN-2008 the patient received a third dose of HPV vaccine (lot #659651/1448U) 0.5mL IM at 5:18 PM in the left arm. On 22-JAN-2008 the patient developed a rash all over the body. The office has ruled out other factors except for HPV vaccine. The patient was advised over the phone to take BENADRYL. At the time of reporting the patient had not recovered and will be seen at the office on 23-JAN-2208. The patient hadno relief and given a steroid taper and EPIPEN injection at another facility. On 01-FEB-2008 the patient was seen again and the rash was gone and the taper was done. The patient had recovered on 01-FEB-2008. Additional information is not expected.
Age: 25.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Rash generalised
Clinical narrative: Information has been received from a licensed practical nurse concerning a 25 year old female with no pertinent medical history or drug reactions/allergies who on 20-JUL-2007 was vaccinated with a first dose of Gardasil.  Concomitant therapy included LOESTRIN.  On 21-JAN-2008 the patient received a second dose of Gardasil (lot# 659653/1448U) 0.5 mL IM.  On 22-JAN-2008 the patient developed a rash all over the body.  Medical attention was sought.  The office has ruled out other factors except for Gardasil.  The patient was instructed to take BENADRYL.  At the time of reporting the patient had not recovered and will be seen at the office on 23-JAN-2008.  No other details were given.  Additional information has been requested. Inital and follow-up information has been received  from a licensed practical nurse concerning a 25 year old female with no illness at the time of vaccination, no pertinent medical history or drug reactions/allergies who on 20-JUL-2007 was vaccinated with a first dose of HPV vaccine. On an unspecified date the patient was vaccinated with a second dose of HPV vaccine. On 21-JAN-2008 the patient received a third dose of HPV vaccine (lot #659651/1448U) 0.5mL IM at 5:18 PM in the left arm. On 22-JAN-2008 the patient developed a rash all over the body. The office has ruled out other factors except for HPV vaccine. The patient was advised over the phone to take BENADRYL. At the time of reporting the patient had not recovered and will be seen at the office on 23-JAN-2208. The patient hadno relief and given a steroid taper and EPIPEN injection at another facility. On 01-FEB-2008 the patient was seen again and the rash was gone and the taper was done. The patient had recovered on 01-FEB-2008. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ, HPV4, MNQ, HPV4, MNQ
Symptoms: Activities of daily living impaired, Antinuclear antibody negative, Arthralgia, Culture throat negative, Dysgraphia
Clinical narrative: Information has been received from a registered nurse concerning a 16 year old female with an amoxicillin allergy who on 20-NOV-2007 was vaccinated intramuscularly with a 0.5 ml first dose of Gardasil (lot 659437/1266U).  On 22-JAN-2008, the patient was vaccinated intramuscularly with a 0.5 ml second dose of Gardasil (lot 659657/1487U) and concomitantly vaccinated with a dose of MENACTRA.  On 27-JAN-2008, the patient developed joint pain affecting her hands, elbows, and feet and swelling to her toes, knees and ankles.  The patient was seen by the office and was being treated with prednisone.  Laboratory evaluations revealed complete blood count, sedimentation rate, and antinuclear antibody test were within normal limits.  The patient had not recovered at the time of reporting.  The patient's joint pain in hands, elbows, and feet and swelling to her toes, knees, and ankles were considered to be disabling by the reporter as "the patient had difficulty using a pencil and had missed school."  Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ, HPV4, MNQ, HPV4, MNQ
Symptoms: Full blood count normal, Pharyngolaryngeal pain, Red blood cell sedimentation rate normal
Clinical narrative: Information has been received from a registered nurse concerning a 16 year old female with an amoxicillin allergy who on 20-NOV-2007 was vaccinated intramuscularly with a 0.5 ml first dose of Gardasil (lot 659437/1266U).  On 22-JAN-2008, the patient was vaccinated intramuscularly with a 0.5 ml second dose of Gardasil (lot 659657/1487U) and concomitantly vaccinated with a dose of MENACTRA.  On 27-JAN-2008, the patient developed joint pain affecting her hands, elbows, and feet and swelling to her toes, knees and ankles.  The patient was seen by the office and was being treated with prednisone.  Laboratory evaluations revealed complete blood count, sedimentation rate, and antinuclear antibody test were within normal limits.  The patient had not recovered at the time of reporting.  The patient's joint pain in hands, elbows, and feet and swelling to her toes, knees, and ankles were considered to be disabling by the reporter as "the patient had difficulty using a pencil and had missed school."  Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ, HPV4, MNQ, HPV4, MNQ
Symptoms: Activities of daily living impaired, Antinuclear antibody negative, Arthralgia, Full blood count normal, Joint swelling
Clinical narrative: Information has been received from a registered nurse concerning a 16 year old female with an amoxicillin allergy who on 20-NOV-2007 was vaccinated intramuscularly with a 0.5 ml first dose of Gardasil (lot 659437/1266U).  On 22-JAN-2008, the patient was vaccinated intramuscularly with a 0.5 ml second dose of Gardasil (lot 659657/1487U) and concomitantly vaccinated with a dose of MENACTRA.  On 27-JAN-2008, the patient developed joint pain affecting her hands, elbows, and feet and swelling to her toes, knees and ankles.  The patient was seen by the office and was being treated with prednisone.  Laboratory evaluations revealed complete blood count, sedimentation rate, and antinuclear antibody test were within normal limits.  The patient had not recovered at the time of reporting.  The patient's joint pain in hands, elbows, and feet and swelling to her toes, knees, and ankles were considered to be disabling by the reporter as "the patient had difficulty using a pencil and had missed school."  Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ, HPV4, MNQ, HPV4, MNQ
Symptoms: Oedema peripheral, Red blood cell sedimentation rate normal
Clinical narrative: Information has been received from a registered nurse concerning a 16 year old female with an amoxicillin allergy who on 20-NOV-2007 was vaccinated intramuscularly with a 0.5 ml first dose of Gardasil (lot 659437/1266U).  On 22-JAN-2008, the patient was vaccinated intramuscularly with a 0.5 ml second dose of Gardasil (lot 659657/1487U) and concomitantly vaccinated with a dose of MENACTRA.  On 27-JAN-2008, the patient developed joint pain affecting her hands, elbows, and feet and swelling to her toes, knees and ankles.  The patient was seen by the office and was being treated with prednisone.  Laboratory evaluations revealed complete blood count, sedimentation rate, and antinuclear antibody test were within normal limits.  The patient had not recovered at the time of reporting.  The patient's joint pain in hands, elbows, and feet and swelling to her toes, knees, and ankles were considered to be disabling by the reporter as "the patient had difficulty using a pencil and had missed school."  Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ, HPV4, MNQ, HPV4, MNQ
Symptoms: Arthralgia, Gait disturbance
Clinical narrative: Information has been received from a registered nurse concerning a 16 year old female with an amoxicillin allergy who on 20-NOV-2007 was vaccinated intramuscularly with a 0.5 ml first dose of Gardasil (lot 659437/1266U).  On 22-JAN-2008, the patient was vaccinated intramuscularly with a 0.5 ml second dose of Gardasil (lot 659657/1487U) and concomitantly vaccinated with a dose of MENACTRA.  On 27-JAN-2008, the patient developed joint pain affecting her hands, elbows, and feet and swelling to her toes, knees and ankles.  The patient was seen by the office and was being treated with prednisone.  Laboratory evaluations revealed complete blood count, sedimentation rate, and antinuclear antibody test were within normal limits.  The patient had not recovered at the time of reporting.  The patient's joint pain in hands, elbows, and feet and swelling to her toes, knees, and ankles were considered to be disabling by the reporter as "the patient had difficulty using a pencil and had missed school."  Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ, HPV4, MNQ, HPV4, MNQ
Symptoms: Arthralgia, Gait disturbance, Pain in extremity
Clinical narrative: Information has been received from a registered nurse concerning a 16 year old female with an amoxicillin allergy who on 20-NOV-2007 was vaccinated intramuscularly with a 0.5 ml first dose of Gardasil (lot 659437/1266U).  On 22-JAN-2008, the patient was vaccinated intramuscularly with a 0.5 ml second dose of Gardasil (lot 659657/1487U) and concomitantly vaccinated with a dose of MENACTRA.  On 27-JAN-2008, the patient developed joint pain affecting her hands, elbows, and feet and swelling to her toes, knees and ankles.  The patient was seen by the office and was being treated with prednisone.  Laboratory evaluations revealed complete blood count, sedimentation rate, and antinuclear antibody test were within normal limits.  The patient had not recovered at the time of reporting.  The patient's joint pain in hands, elbows, and feet and swelling to her toes, knees, and ankles were considered to be disabling by the reporter as "the patient had difficulty using a pencil and had missed school."  Additional information has been requested.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, RV5
Symptoms: Barium enema abnormal, Irritability, Vomiting
Clinical narrative: Information has been received from a physician concerning an 8 month old male who on 12-JUL-2007, 12-SEP-2007 and 14-NOV-2007 was vaccinated PO with his first, second and third 2.0 ml doses of Rotateq (not lot# available).  On 13-JAN-2008 two months after vaccination, the patient's mother called that after hours physician to report that the patient experienced vomiting and was irritable.  The physician advised the patient's mother to take the patient to the ER.  The patient was admitted to the hospital for 3 days and was diagnosed with intussusception.  The patient was given a barium enema as an intervention which was successful.  The patient was discharged from the hospital on 15-JAN-2008.  On 16-JAN-2008 the patient came into the physician's office was noted to be eating well and did not have any symptoms since then.  On approximately 16-JAN-2008 the patient was recovered.  The patient was scheduled for a well visit on 13-FEB-2008.  It was also noted that "it was life-threatening because intussusception can be fatal."  There was no product quality complaint.  Intussusception was considered to be immediately life-threatening and an other important medical event (intervention) by the reporter.  Additional information has been requested.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, RV5
Symptoms: Abdominal X-ray, Barium enema, Enema administration, Intussusception, Irritability
Clinical narrative: Information has been received from a physician concerning an 8 month old male who on 12-JUL-2007, 12-SEP-2007 and 14-NOV-2007 was vaccinated PO with his first, second and third 2.0 ml doses of Rotateq (not lot# available).  On 13-JAN-2008 two months after vaccination, the patient's mother called that after hours physician to report that the patient experienced vomiting and was irritable.  The physician advised the patient's mother to take the patient to the ER.  The patient was admitted to the hospital for 3 days and was diagnosed with intussusception.  The patient was given a barium enema as an intervention which was successful.  The patient was discharged from the hospital on 15-JAN-2008.  On 16-JAN-2008 the patient came into the physician's office was noted to be eating well and did not have any symptoms since then.  On approximately 16-JAN-2008 the patient was recovered.  The patient was scheduled for a well visit on 13-FEB-2008.  It was also noted that "it was life-threatening because intussusception can be fatal."  There was no product quality complaint.  Intussusception was considered to be immediately life-threatening and an other important medical event (intervention) by the reporter.  Additional information has been requested.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, RV5
Symptoms: Vomiting
Clinical narrative: Information has been received from a physician concerning an 8 month old male who on 12-JUL-2007, 12-SEP-2007 and 14-NOV-2007 was vaccinated PO with his first, second and third 2.0 ml doses of Rotateq (not lot# available).  On 13-JAN-2008 two months after vaccination, the patient's mother called that after hours physician to report that the patient experienced vomiting and was irritable.  The physician advised the patient's mother to take the patient to the ER.  The patient was admitted to the hospital for 3 days and was diagnosed with intussusception.  The patient was given a barium enema as an intervention which was successful.  The patient was discharged from the hospital on 15-JAN-2008.  On 16-JAN-2008 the patient came into the physician's office was noted to be eating well and did not have any symptoms since then.  On approximately 16-JAN-2008 the patient was recovered.  The patient was scheduled for a well visit on 13-FEB-2008.  It was also noted that "it was life-threatening because intussusception can be fatal."  There was no product quality complaint.  Intussusception was considered to be immediately life-threatening and an other important medical event (intervention) by the reporter.  Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Haemorrhage, Head injury, Syncope
Clinical narrative: Pt collapsed on floor, hit back of head.  Pt quickly alert.  Kept head flat, immobilized.  Paramedics called.  Sent to ER due to head trauma (bleeding).
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Muscle spasms
Clinical narrative: Very severe spasm/cramps from waist down in both legs, thighs, calves and feet.  Reaction was delayed until 12 hours after booster shot was administered.
Age: 27.0
Sex: F
Vaccine: ANTH
Symptoms: Fluctuance, Incisional drainage, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Pt presented for medical care related to her anthrax vaccination that she received on 17 Feb 08, prior to deploying.  Previous to this, for both of her two (2) anthrax shots, she developed large local reactions requiring incise and drainage per the pt.  Today she notes that, after receiving the vaccine, she had developed a large swelling of the area that was very painful to even light touch.  She noted that this was different from the first two in that it developed so quickly.  She denied any difficulties breathing or other rash.  Upon examination, the area of vaccination (right mid-lateral upper arm just ont he lateral border of the biceps) was extremely indurated with swelling measuring about 12cm in diameter and raised approximately 1 cm.  There was some fluctuance, warmth, and extreme tenderness.  The area was incised but only bloody return.  Cultures were not available to rule out cellulitis and the patient was started on Cipro for possible cellulitis (pt is PCN-allergic).