chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Nausea, Syncope
Clinical narrative: Information has been received from a physician concerning a female patient "in her teens" who on approximately 25-FEB-2008 was vaccinated with a second dose of Gardasil.  On approximately 25-FEB-2008, "about a month ago," the patient passed out and hit her head.  The patient had a laceration from the fall which required stitches.  Subsequently, the patient recovered.  No product quality complaint was involved.  Additional information has been requested.  This is in follow-up to report(s) previously submitted on 4/14/2008.  Information has been received from a physician and a registered nurse concerning a 13 year old female patient with no medical history reported, who on 23-FEB-2008 at 09:34 am was vaccinated intramuscularly into the left arm with the first dose of GARDASIL (Lot # 659655/1486U).  On 23-FEB-2008 at 09:40 am, the patient experienced nausea, syncope and passed out.  Due to the syncope, the patient hit her head in the bathroom and was sent to the emergency room for stitches for a laceration.  Subsequently, the patient recovered.  No product quality complaint was involved.  Additional information is not expected.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Head injury, Laceration, Loss of consciousness, Nausea, Suture insertion
Clinical narrative: Information has been received from a physician concerning a female patient "in her teens" who on approximately 25-FEB-2008 was vaccinated with a second dose of Gardasil.  On approximately 25-FEB-2008, "about a month ago," the patient passed out and hit her head.  The patient had a laceration from the fall which required stitches.  Subsequently, the patient recovered.  No product quality complaint was involved.  Additional information has been requested.  This is in follow-up to report(s) previously submitted on 4/14/2008.  Information has been received from a physician and a registered nurse concerning a 13 year old female patient with no medical history reported, who on 23-FEB-2008 at 09:34 am was vaccinated intramuscularly into the left arm with the first dose of GARDASIL (Lot # 659655/1486U).  On 23-FEB-2008 at 09:40 am, the patient experienced nausea, syncope and passed out.  Due to the syncope, the patient hit her head in the bathroom and was sent to the emergency room for stitches for a laceration.  Subsequently, the patient recovered.  No product quality complaint was involved.  Additional information is not expected.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a female patient "in her teens" who on approximately 25-FEB-2008 was vaccinated with a second dose of Gardasil.  On approximately 25-FEB-2008, "about a month ago," the patient passed out and hit her head.  The patient had a laceration from the fall which required stitches.  Subsequently, the patient recovered.  No product quality complaint was involved.  Additional information has been requested.  This is in follow-up to report(s) previously submitted on 4/14/2008.  Information has been received from a physician and a registered nurse concerning a 13 year old female patient with no medical history reported, who on 23-FEB-2008 at 09:34 am was vaccinated intramuscularly into the left arm with the first dose of GARDASIL (Lot # 659655/1486U).  On 23-FEB-2008 at 09:40 am, the patient experienced nausea, syncope and passed out.  Due to the syncope, the patient hit her head in the bathroom and was sent to the emergency room for stitches for a laceration.  Subsequently, the patient recovered.  No product quality complaint was involved.  Additional information is not expected.
Age: 0.5
Sex: F
Vaccine: RV5
Symptoms: Intussusception, Vomiting projectile
Clinical narrative: Information has been received from a nurse practitioner concerning her 6-month-old granddaughter with no pertinent medical history and no drug reactions/allergies who was vaccinated PO with the second dose of Rotateq.  There was no concomitant medication.  Subsequently, three weeks post vaccination, the patient experienced projectile vomiting and intussusception and was hospitalized.  She was hospitalized for 2 days.  On approximately 04-APR-2008, the patient developed "similar symptoms" but has not required hospitalization and has not been diagnosed with intussusception.  No additional information is available.  There was no product quality complaint.  Additional information has been requested.
Age: 0.33
Sex: F
Vaccine: RV5
Symptoms: Intussusception, Surgery
Clinical narrative: Information has been received from a physician concerning a 4 month old female with a family history of intussusception who on 10-JAN-2008 was vaccinated with a dose of ROTATEQ.  Subsequently the patient experienced intussusception and was hospitalized.  On 06-APR-2008 the patient had surgery, but the present status was unknown.  There was no product quality complaint.  Intussusception was also considered to be immediately life-threatening and an other important medical event (surgery).  Additional information has been requested.
Age: 0.54
Sex: M
Vaccine: DTAPHEPBIP, PNC, RV5
Symptoms: Abnormal behaviour, Intussusception, Irritability, Surgery
Clinical narrative: Information has been received from a physician concerning a 6 month old male who on 16-NOV-2007, 25-JAN-2008 and 20-MAR-2008 was vaccinated PO with his first, second and third 2.0 ml dose of Rotateq. On 20-MAR-2008 after vaccination, the baby was acting strange and irritable and was taken by the parents to a hospital emergency room twice. Both times the baby was sent home with no conclusive diagnosis. The symptoms continued and the parents called the physician and the baby was taken to a different hospital. The patient was admitted to the hospital and underwent surgery for intussusception. On 08-APR-2008 the patient was seen for follow-up after hospitalization. The outcome was unknown. There was no product quality complaint. Intussusception was also considered to be an other important medical event (surgery) by the physician. Additional information has been requested.  9/22/09 Vaccine records received. According to records doses of rotavirus vaccine were administered IM in thigh.   9/25/09 Hopsital records received DOS 3/30/2008 to 4/2/08. Assessment: Incarcerated, strangulated, intussusception (ileoileal). Patient was seen in ER and discharged, returned with worsening pain, decreased PO intake, persistant vomiting and bloody diarrhea, increased lethargy. Abdomen distended. Unable to reduce intussusception with air contrast enema. Admitted to PICU after distal ileal resection and appendectomy.  ICD-9 Codes: 560.0 Intussusception, 557. Ac Vasc Insuff Intestine.
Sex: U
Vaccine: RV5
Symptoms: Intussusception, Surgery
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated PO with a 2.0 ml dose of ROTATEQ (no lot# provided).  Subsequently the patient experienced intussusception.  The patient sought unspecified medical attention and underwent "surgery."  The physician did not mention which dose of the series the experience occurred after.  The outcome was unknown.  There was no product quality complaint.  Intussusception was also considered to be an other important medical event (surgery) by the physician.  Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Haematochezia
Clinical narrative: Information has been received from a nurse practitioner concerning an infant who in August 2007, was vaccinated PO with the first dose of Rotateq.  In August 2007, the patient experienced bloody stools.  The patient sought unspecified medical attention and was treated with Lactobacillus.  Subsequently, the patient recovered.  There was no product quality complaint.  Upon internal review, bloody stool(s) was determined to be an other important medical event.  This is one of several reports from the same source.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Blood pressure increased, Bronchospasm, Chest X-ray normal, Computerised tomogram abnormal
Clinical narrative: Information has been received from a physician, concerning a 14 year old female with no pertinent medical history, who on 22-NOV-2007 was vaccinated IM with the first dose, 0.5 ml, of GARDASIL (lot # 659435/1265U). Concomitant therapy included a dose of influenza virus vaccine (manufacturer unspecified). On 11-JAN-2008, the patient had a physical, and had no symptoms. On 15-FEB-2008, she was seen in the office by another physician, with complaints of 2 weeks (onset 01-FEB-2008) of vomiting, diarrhea, low grade fevers and abdominal pain; the reporting physician also noted the patient had tiredness, and fainting spells. On 19-FEB-2008, an ultrasound of the abdomen and upper right quadrant to rule out gallstones, was negative. A computed axial tomography (CAT) scan to rule out a cyst.  A complete blood count (CBC), and a urinalysis were normal. A laparoscopy of the pelvis was also normal. On 01-MAR-2008, the patient was hospitalized for severe abdominal pain and vomiting, and also complained of nausea and diarrhea. At discharge, on 07-MAR-2008, she was diagnosed with increased blood pressure, and was started on therapy with propanolol (not specified). An ultrasound indicated that both kidneys were enlarged. Although the CBC was normal, IV ROCEPHIN was started as a precautionary measure, and the patient was discharged on SUPRAX. On 10-MAR-2008 the patient was seen by the reporting physician and normal blood pressure, tender right and left flanks, and "on and off" flushing of the face. On 12-MAR-2008, she was seen again and flushing of the face was present, with blood pressure of 140/90 mmHg; a urine culture was negative. The patient was also seen by a nephrologist (date not specified), and "everything was normal, including blood pressure of 125/82." On 28-MAR-2008 the patient was lightheaded with a fever, and the wound from the laparoscopy was found to be infected; AUGMENTIN was initiated. On 02-APR-2008, the patient was pale and was admitted to the hospital with severe abdominal pain of the left flank with persistent vomiting. Intravenous (IV) fluids were started, and morphine injections for pain. A CBC, urinalysis, blood pressure and chest x-ray results were normal. There was tenderness at the left mid-abdominal area, but no enlargement of the kidneys. The pelvic ultrasound was normal. Although the peak and flow were normal, the physician felt that the patient had mild bronchospasms. On 07-APR-2008, the patient was ordered TYLENOL-CODEINE for abdominal pain, and nebulizer treatments for the mild bronchospasms. These symptoms were improving, and the patient was no longer vomiting. No further information was available. The physician considered the events to be significantly disabling. Additional information has been requested. 4/28/08-records received for DOS 4/3-4/4/08-DC DX: Abdominal pain of unknown etilogy. Presented to ED with servere abdominal pain which has been on and off since 4/1/08.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Culture urine negative, Diarrhoea, Dizziness, Fatigue, Flank pain
Clinical narrative: Information has been received from a physician, concerning a 14 year old female with no pertinent medical history, who on 22-NOV-2007 was vaccinated IM with the first dose, 0.5 ml, of GARDASIL (lot # 659435/1265U). Concomitant therapy included a dose of influenza virus vaccine (manufacturer unspecified). On 11-JAN-2008, the patient had a physical, and had no symptoms. On 15-FEB-2008, she was seen in the office by another physician, with complaints of 2 weeks (onset 01-FEB-2008) of vomiting, diarrhea, low grade fevers and abdominal pain; the reporting physician also noted the patient had tiredness, and fainting spells. On 19-FEB-2008, an ultrasound of the abdomen and upper right quadrant to rule out gallstones, was negative. A computed axial tomography (CAT) scan to rule out a cyst.  A complete blood count (CBC), and a urinalysis were normal. A laparoscopy of the pelvis was also normal. On 01-MAR-2008, the patient was hospitalized for severe abdominal pain and vomiting, and also complained of nausea and diarrhea. At discharge, on 07-MAR-2008, she was diagnosed with increased blood pressure, and was started on therapy with propanolol (not specified). An ultrasound indicated that both kidneys were enlarged. Although the CBC was normal, IV ROCEPHIN was started as a precautionary measure, and the patient was discharged on SUPRAX. On 10-MAR-2008 the patient was seen by the reporting physician and normal blood pressure, tender right and left flanks, and "on and off" flushing of the face. On 12-MAR-2008, she was seen again and flushing of the face was present, with blood pressure of 140/90 mmHg; a urine culture was negative. The patient was also seen by a nephrologist (date not specified), and "everything was normal, including blood pressure of 125/82." On 28-MAR-2008 the patient was lightheaded with a fever, and the wound from the laparoscopy was found to be infected; AUGMENTIN was initiated. On 02-APR-2008, the patient was pale and was admitted to the hospital with severe abdominal pain of the left flank with persistent vomiting. Intravenous (IV) fluids were started, and morphine injections for pain. A CBC, urinalysis, blood pressure and chest x-ray results were normal. There was tenderness at the left mid-abdominal area, but no enlargement of the kidneys. The pelvic ultrasound was normal. Although the peak and flow were normal, the physician felt that the patient had mild bronchospasms. On 07-APR-2008, the patient was ordered TYLENOL-CODEINE for abdominal pain, and nebulizer treatments for the mild bronchospasms. These symptoms were improving, and the patient was no longer vomiting. No further information was available. The physician considered the events to be significantly disabling. Additional information has been requested. 4/28/08-records received for DOS 4/3-4/4/08-DC DX: Abdominal pain of unknown etilogy. Presented to ED with servere abdominal pain which has been on and off since 4/1/08.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Flushing, Full blood count normal, Inflammation of wound, Laparoscopy, Nausea
Clinical narrative: Information has been received from a physician, concerning a 14 year old female with no pertinent medical history, who on 22-NOV-2007 was vaccinated IM with the first dose, 0.5 ml, of GARDASIL (lot # 659435/1265U). Concomitant therapy included a dose of influenza virus vaccine (manufacturer unspecified). On 11-JAN-2008, the patient had a physical, and had no symptoms. On 15-FEB-2008, she was seen in the office by another physician, with complaints of 2 weeks (onset 01-FEB-2008) of vomiting, diarrhea, low grade fevers and abdominal pain; the reporting physician also noted the patient had tiredness, and fainting spells. On 19-FEB-2008, an ultrasound of the abdomen and upper right quadrant to rule out gallstones, was negative. A computed axial tomography (CAT) scan to rule out a cyst.  A complete blood count (CBC), and a urinalysis were normal. A laparoscopy of the pelvis was also normal. On 01-MAR-2008, the patient was hospitalized for severe abdominal pain and vomiting, and also complained of nausea and diarrhea. At discharge, on 07-MAR-2008, she was diagnosed with increased blood pressure, and was started on therapy with propanolol (not specified). An ultrasound indicated that both kidneys were enlarged. Although the CBC was normal, IV ROCEPHIN was started as a precautionary measure, and the patient was discharged on SUPRAX. On 10-MAR-2008 the patient was seen by the reporting physician and normal blood pressure, tender right and left flanks, and "on and off" flushing of the face. On 12-MAR-2008, she was seen again and flushing of the face was present, with blood pressure of 140/90 mmHg; a urine culture was negative. The patient was also seen by a nephrologist (date not specified), and "everything was normal, including blood pressure of 125/82." On 28-MAR-2008 the patient was lightheaded with a fever, and the wound from the laparoscopy was found to be infected; AUGMENTIN was initiated. On 02-APR-2008, the patient was pale and was admitted to the hospital with severe abdominal pain of the left flank with persistent vomiting. Intravenous (IV) fluids were started, and morphine injections for pain. A CBC, urinalysis, blood pressure and chest x-ray results were normal. There was tenderness at the left mid-abdominal area, but no enlargement of the kidneys. The pelvic ultrasound was normal. Although the peak and flow were normal, the physician felt that the patient had mild bronchospasms. On 07-APR-2008, the patient was ordered TYLENOL-CODEINE for abdominal pain, and nebulizer treatments for the mild bronchospasms. These symptoms were improving, and the patient was no longer vomiting. No further information was available. The physician considered the events to be significantly disabling. Additional information has been requested. 4/28/08-records received for DOS 4/3-4/4/08-DC DX: Abdominal pain of unknown etilogy. Presented to ED with servere abdominal pain which has been on and off since 4/1/08.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Pallor, Pyrexia, Renal disorder, Syncope, Ultrasound abdomen normal
Clinical narrative: Information has been received from a physician, concerning a 14 year old female with no pertinent medical history, who on 22-NOV-2007 was vaccinated IM with the first dose, 0.5 ml, of GARDASIL (lot # 659435/1265U). Concomitant therapy included a dose of influenza virus vaccine (manufacturer unspecified). On 11-JAN-2008, the patient had a physical, and had no symptoms. On 15-FEB-2008, she was seen in the office by another physician, with complaints of 2 weeks (onset 01-FEB-2008) of vomiting, diarrhea, low grade fevers and abdominal pain; the reporting physician also noted the patient had tiredness, and fainting spells. On 19-FEB-2008, an ultrasound of the abdomen and upper right quadrant to rule out gallstones, was negative. A computed axial tomography (CAT) scan to rule out a cyst.  A complete blood count (CBC), and a urinalysis were normal. A laparoscopy of the pelvis was also normal. On 01-MAR-2008, the patient was hospitalized for severe abdominal pain and vomiting, and also complained of nausea and diarrhea. At discharge, on 07-MAR-2008, she was diagnosed with increased blood pressure, and was started on therapy with propanolol (not specified). An ultrasound indicated that both kidneys were enlarged. Although the CBC was normal, IV ROCEPHIN was started as a precautionary measure, and the patient was discharged on SUPRAX. On 10-MAR-2008 the patient was seen by the reporting physician and normal blood pressure, tender right and left flanks, and "on and off" flushing of the face. On 12-MAR-2008, she was seen again and flushing of the face was present, with blood pressure of 140/90 mmHg; a urine culture was negative. The patient was also seen by a nephrologist (date not specified), and "everything was normal, including blood pressure of 125/82." On 28-MAR-2008 the patient was lightheaded with a fever, and the wound from the laparoscopy was found to be infected; AUGMENTIN was initiated. On 02-APR-2008, the patient was pale and was admitted to the hospital with severe abdominal pain of the left flank with persistent vomiting. Intravenous (IV) fluids were started, and morphine injections for pain. A CBC, urinalysis, blood pressure and chest x-ray results were normal. There was tenderness at the left mid-abdominal area, but no enlargement of the kidneys. The pelvic ultrasound was normal. Although the peak and flow were normal, the physician felt that the patient had mild bronchospasms. On 07-APR-2008, the patient was ordered TYLENOL-CODEINE for abdominal pain, and nebulizer treatments for the mild bronchospasms. These symptoms were improving, and the patient was no longer vomiting. No further information was available. The physician considered the events to be significantly disabling. Additional information has been requested. 4/28/08-records received for DOS 4/3-4/4/08-DC DX: Abdominal pain of unknown etilogy. Presented to ED with servere abdominal pain which has been on and off since 4/1/08.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Ultrasound kidney abnormal, Urine analysis normal, Vomiting
Clinical narrative: Information has been received from a physician, concerning a 14 year old female with no pertinent medical history, who on 22-NOV-2007 was vaccinated IM with the first dose, 0.5 ml, of GARDASIL (lot # 659435/1265U). Concomitant therapy included a dose of influenza virus vaccine (manufacturer unspecified). On 11-JAN-2008, the patient had a physical, and had no symptoms. On 15-FEB-2008, she was seen in the office by another physician, with complaints of 2 weeks (onset 01-FEB-2008) of vomiting, diarrhea, low grade fevers and abdominal pain; the reporting physician also noted the patient had tiredness, and fainting spells. On 19-FEB-2008, an ultrasound of the abdomen and upper right quadrant to rule out gallstones, was negative. A computed axial tomography (CAT) scan to rule out a cyst.  A complete blood count (CBC), and a urinalysis were normal. A laparoscopy of the pelvis was also normal. On 01-MAR-2008, the patient was hospitalized for severe abdominal pain and vomiting, and also complained of nausea and diarrhea. At discharge, on 07-MAR-2008, she was diagnosed with increased blood pressure, and was started on therapy with propanolol (not specified). An ultrasound indicated that both kidneys were enlarged. Although the CBC was normal, IV ROCEPHIN was started as a precautionary measure, and the patient was discharged on SUPRAX. On 10-MAR-2008 the patient was seen by the reporting physician and normal blood pressure, tender right and left flanks, and "on and off" flushing of the face. On 12-MAR-2008, she was seen again and flushing of the face was present, with blood pressure of 140/90 mmHg; a urine culture was negative. The patient was also seen by a nephrologist (date not specified), and "everything was normal, including blood pressure of 125/82." On 28-MAR-2008 the patient was lightheaded with a fever, and the wound from the laparoscopy was found to be infected; AUGMENTIN was initiated. On 02-APR-2008, the patient was pale and was admitted to the hospital with severe abdominal pain of the left flank with persistent vomiting. Intravenous (IV) fluids were started, and morphine injections for pain. A CBC, urinalysis, blood pressure and chest x-ray results were normal. There was tenderness at the left mid-abdominal area, but no enlargement of the kidneys. The pelvic ultrasound was normal. Although the peak and flow were normal, the physician felt that the patient had mild bronchospasms. On 07-APR-2008, the patient was ordered TYLENOL-CODEINE for abdominal pain, and nebulizer treatments for the mild bronchospasms. These symptoms were improving, and the patient was no longer vomiting. No further information was available. The physician considered the events to be significantly disabling. Additional information has been requested. 4/28/08-records received for DOS 4/3-4/4/08-DC DX: Abdominal pain of unknown etilogy. Presented to ED with servere abdominal pain which has been on and off since 4/1/08.
Sex: F
Vaccine: HPV4
Symptoms: Convulsion
Clinical narrative: Information has been received from a medical assistant concerning a female (age not reported) who on an unspecified date was vaccinated with a dose of Gardasil, 0.5 mL, once, IM.  Concomitant medication was not reported.  Subsequently on an unspecified date, the patient experienced seizure.  Unspecified medical attention was sought.  The reporting medical assistant was not sure if this was the patient's first or second dose of Gardasil, but the patient definitely has not had the third dose yet.  Subsequently on an unspecified date, the patient recovered from seizure.  No product quality complaint was involved.  Seizure was considered to be disabling.  Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: DTAP, HPV4, MEN, VARCEL, HPV4, TDAP
Symptoms: Electroencephalogram normal, Inappropriate schedule of drug administration, Injection site erythema, Injection site irritation, Injection site pain
Clinical narrative: Information has been received from a consumer concerning her 11 year old daughter with allergic reaction to most antibiotics (products not reported) and a history of "deflux surgery for her kidneys" who in November 2007, was vaccinated with the first dose of GARDASIL, injection, single dose and concomitantly with meningococcal vaccine (unspecified). In January 2008, the patient was vaccinated with the second dose of GARDASIL, injection, single dose, left arm and concomitantly with varicella virus vaccine live (MSD). On 31-MAR-2008, the patient was vaccinated with the third dose of GARDASIL, injection, single dose, right arm and concomitantly with diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid, injection, left arm. In November 2007 following the first dose GARDASIL, the patient experienced a burning sensation while GARDASIL was being administered and had a little tenderness around the injection site. In January 2008 following the second dose GARDASIL, the patient experienced burning sensation while GARDASIL was administered and had a little tenderness around the injection site. Approximatley two weeks after receiving the second dose of GARDASIL, the same arm where she was given GARDASIL (left arm), the patient began shaking uncontrollably and she had severe pain in this arm. The patient was taken to the hospital where she was admitted and stayed for 24 hours. X-rays, EEG, and blood tests were performed which determined that she had not had any seizures. On 31-MAR-2008 following the third dose of GARDASIL, the patient's right arm turned bright red and was also hot to the touch. On 01-APR-2008 one day later, the patient developed a huge welt on her right arm which persisted for 72 hours. Subsequently on unspecified dates, the patient recovered from the events. No product quality complaint was involved. Additional information has been requested.  5/1/08-office notes received-2/22/08-seen in ER previous night for C/O hyperventilation. After ER slept without incident. 3/31/08-Tdap and Gardasil #3 given. 4/2/08-C/O pain at injection site of both vaccines. Redness and swelling size of 50cent piece. C/O doesn't feel well, stomach ache. Subsequent call to patient later same day feeling better with some discomfort of arms and at base of neck. No headache or fever. 4/3/08-phone call-half dollar size welt from tetanus a little bigger today. No other symptoms. 4/4/08-4 days after vaccines increased edema to both size. Induration upper arm, tender and swelling decreased over past 24 hours but erythema and C/O severe pain. Skin warm, no streaking. Assessment-allergic reaction to vaccine .
Age: 11.0
Sex: F
Vaccine: DTAP, HPV4, MEN, VARCEL, HPV4, TDAP
Symptoms: Injection site streaking, Injection site warmth, Laboratory test, Pain in extremity, Tremor
Clinical narrative: Information has been received from a consumer concerning her 11 year old daughter with allergic reaction to most antibiotics (products not reported) and a history of "deflux surgery for her kidneys" who in November 2007, was vaccinated with the first dose of GARDASIL, injection, single dose and concomitantly with meningococcal vaccine (unspecified). In January 2008, the patient was vaccinated with the second dose of GARDASIL, injection, single dose, left arm and concomitantly with varicella virus vaccine live (MSD). On 31-MAR-2008, the patient was vaccinated with the third dose of GARDASIL, injection, single dose, right arm and concomitantly with diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid, injection, left arm. In November 2007 following the first dose GARDASIL, the patient experienced a burning sensation while GARDASIL was being administered and had a little tenderness around the injection site. In January 2008 following the second dose GARDASIL, the patient experienced burning sensation while GARDASIL was administered and had a little tenderness around the injection site. Approximatley two weeks after receiving the second dose of GARDASIL, the same arm where she was given GARDASIL (left arm), the patient began shaking uncontrollably and she had severe pain in this arm. The patient was taken to the hospital where she was admitted and stayed for 24 hours. X-rays, EEG, and blood tests were performed which determined that she had not had any seizures. On 31-MAR-2008 following the third dose of GARDASIL, the patient's right arm turned bright red and was also hot to the touch. On 01-APR-2008 one day later, the patient developed a huge welt on her right arm which persisted for 72 hours. Subsequently on unspecified dates, the patient recovered from the events. No product quality complaint was involved. Additional information has been requested.  5/1/08-office notes received-2/22/08-seen in ER previous night for C/O hyperventilation. After ER slept without incident. 3/31/08-Tdap and Gardasil #3 given. 4/2/08-C/O pain at injection site of both vaccines. Redness and swelling size of 50cent piece. C/O doesn't feel well, stomach ache. Subsequent call to patient later same day feeling better with some discomfort of arms and at base of neck. No headache or fever. 4/3/08-phone call-half dollar size welt from tetanus a little bigger today. No other symptoms. 4/4/08-4 days after vaccines increased edema to both size. Induration upper arm, tender and swelling decreased over past 24 hours but erythema and C/O severe pain. Skin warm, no streaking. Assessment-allergic reaction to vaccine .
Age: 11.0
Sex: F
Vaccine: DTAP, HPV4, MEN, VARCEL, HPV4, TDAP
Symptoms: Vaccine positive rechallenge, X-ray, X-ray normal
Clinical narrative: Information has been received from a consumer concerning her 11 year old daughter with allergic reaction to most antibiotics (products not reported) and a history of "deflux surgery for her kidneys" who in November 2007, was vaccinated with the first dose of GARDASIL, injection, single dose and concomitantly with meningococcal vaccine (unspecified). In January 2008, the patient was vaccinated with the second dose of GARDASIL, injection, single dose, left arm and concomitantly with varicella virus vaccine live (MSD). On 31-MAR-2008, the patient was vaccinated with the third dose of GARDASIL, injection, single dose, right arm and concomitantly with diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid, injection, left arm. In November 2007 following the first dose GARDASIL, the patient experienced a burning sensation while GARDASIL was being administered and had a little tenderness around the injection site. In January 2008 following the second dose GARDASIL, the patient experienced burning sensation while GARDASIL was administered and had a little tenderness around the injection site. Approximatley two weeks after receiving the second dose of GARDASIL, the same arm where she was given GARDASIL (left arm), the patient began shaking uncontrollably and she had severe pain in this arm. The patient was taken to the hospital where she was admitted and stayed for 24 hours. X-rays, EEG, and blood tests were performed which determined that she had not had any seizures. On 31-MAR-2008 following the third dose of GARDASIL, the patient's right arm turned bright red and was also hot to the touch. On 01-APR-2008 one day later, the patient developed a huge welt on her right arm which persisted for 72 hours. Subsequently on unspecified dates, the patient recovered from the events. No product quality complaint was involved. Additional information has been requested.  5/1/08-office notes received-2/22/08-seen in ER previous night for C/O hyperventilation. After ER slept without incident. 3/31/08-Tdap and Gardasil #3 given. 4/2/08-C/O pain at injection site of both vaccines. Redness and swelling size of 50cent piece. C/O doesn't feel well, stomach ache. Subsequent call to patient later same day feeling better with some discomfort of arms and at base of neck. No headache or fever. 4/3/08-phone call-half dollar size welt from tetanus a little bigger today. No other symptoms. 4/4/08-4 days after vaccines increased edema to both size. Induration upper arm, tender and swelling decreased over past 24 hours but erythema and C/O severe pain. Skin warm, no streaking. Assessment-allergic reaction to vaccine .
Age: 11.0
Sex: F
Vaccine: DTAP, HPV4, MEN, VARCEL, HPV4, TDAP
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Local reaction
Clinical narrative: Information has been received from a consumer concerning her 11 year old daughter with allergic reaction to most antibiotics (products not reported) and a history of "deflux surgery for her kidneys" who in November 2007, was vaccinated with the first dose of GARDASIL, injection, single dose and concomitantly with meningococcal vaccine (unspecified). In January 2008, the patient was vaccinated with the second dose of GARDASIL, injection, single dose, left arm and concomitantly with varicella virus vaccine live (MSD). On 31-MAR-2008, the patient was vaccinated with the third dose of GARDASIL, injection, single dose, right arm and concomitantly with diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid, injection, left arm. In November 2007 following the first dose GARDASIL, the patient experienced a burning sensation while GARDASIL was being administered and had a little tenderness around the injection site. In January 2008 following the second dose GARDASIL, the patient experienced burning sensation while GARDASIL was administered and had a little tenderness around the injection site. Approximatley two weeks after receiving the second dose of GARDASIL, the same arm where she was given GARDASIL (left arm), the patient began shaking uncontrollably and she had severe pain in this arm. The patient was taken to the hospital where she was admitted and stayed for 24 hours. X-rays, EEG, and blood tests were performed which determined that she had not had any seizures. On 31-MAR-2008 following the third dose of GARDASIL, the patient's right arm turned bright red and was also hot to the touch. On 01-APR-2008 one day later, the patient developed a huge welt on her right arm which persisted for 72 hours. Subsequently on unspecified dates, the patient recovered from the events. No product quality complaint was involved. Additional information has been requested.  5/1/08-office notes received-2/22/08-seen in ER previous night for C/O hyperventilation. After ER slept without incident. 3/31/08-Tdap and Gardasil #3 given. 4/2/08-C/O pain at injection site of both vaccines. Redness and swelling size of 50cent piece. C/O doesn't feel well, stomach ache. Subsequent call to patient later same day feeling better with some discomfort of arms and at base of neck. No headache or fever. 4/3/08-phone call-half dollar size welt from tetanus a little bigger today. No other symptoms. 4/4/08-4 days after vaccines increased edema to both size. Induration upper arm, tender and swelling decreased over past 24 hours but erythema and C/O severe pain. Skin warm, no streaking. Assessment-allergic reaction to vaccine .
Sex: U
Vaccine: PER
Symptoms: Cerebral palsy
Clinical narrative: Initial report received on 04 April 2008 from another manufacturer, reference number not provided. The initial reporter to this manufacturer had been a health care professional. An adult patient received an injection of an unspecified pertussis vaccine, manufacturer not reported, lot number not reported, on an unspecified date as a child. At an unspecified time post-vaccination, the patient developed cerebral palsy. "No other information is available at this time." Additional medically relevant information was not provided.
Age: 6.0
Sex: F
Vaccine: FLUN3, FLUN3
Symptoms: Asthenia, Ataxia, Congenital anomaly, Dyspnoea, Expired drug administered
Clinical narrative: Received FluMist on 1/11/08. Approx 7-10 days later became weak with multiple episodes of falling to ground, difficulty walking, ataxia. Weakness progressive leading to breathing problems. Neurology and genetics diagnosed congenital disease - Leigh's disease which may have been 1st manifested after this vaccine.Swallowing problems, 5/15/08-death certificate received-final cause of death Leigh's syndrome. 5/1/08-records received for DOS 3/15-4/5/08-DX: Leigh's encephalopathy syndrome. Respiratory failure. Sepsis. Presented to ED and subsequently transferred. About 2 months ago received FluMist and since then became weak and wobbly. Weak prior to vaccination but more so after vaccination and was receiving physical and occupational therapy. Starring episodes usually at night. Became more limp. Appears sleepy acts as if drunk. Ataxia. With thes episodes has become unresponsive and starring with them. No clonic seizure acitivity. after surgery remained intubated with mechanical ventilation and required CPAP. Neurologic status became more obtunded and unresponsive. Fever. Fevers secondary to brain inflammation due to Leigh syndrome. Withdrawn from life support and expired.
Age: 6.0
Sex: F
Vaccine: FLUN3, FLUN3
Symptoms: Fall, Gait disturbance, Gene mutation identification test, Mitochondrial encephalomyopathy, Nuclear magnetic resonance imaging abnormal
Clinical narrative: Received FluMist on 1/11/08. Approx 7-10 days later became weak with multiple episodes of falling to ground, difficulty walking, ataxia. Weakness progressive leading to breathing problems. Neurology and genetics diagnosed congenital disease - Leigh's disease which may have been 1st manifested after this vaccine.Swallowing problems, 5/15/08-death certificate received-final cause of death Leigh's syndrome. 5/1/08-records received for DOS 3/15-4/5/08-DX: Leigh's encephalopathy syndrome. Respiratory failure. Sepsis. Presented to ED and subsequently transferred. About 2 months ago received FluMist and since then became weak and wobbly. Weak prior to vaccination but more so after vaccination and was receiving physical and occupational therapy. Starring episodes usually at night. Became more limp. Appears sleepy acts as if drunk. Ataxia. With thes episodes has become unresponsive and starring with them. No clonic seizure acitivity. after surgery remained intubated with mechanical ventilation and required CPAP. Neurologic status became more obtunded and unresponsive. Fever. Fevers secondary to brain inflammation due to Leigh syndrome. Withdrawn from life support and expired.
Age: 6.0
Sex: F
Vaccine: FLUN3, FLUN3
Symptoms: Asthenia, Ataxia, Blood lactic acid increased, Continuous positive airway pressure, Death
Clinical narrative: Received FluMist on 1/11/08. Approx 7-10 days later became weak with multiple episodes of falling to ground, difficulty walking, ataxia. Weakness progressive leading to breathing problems. Neurology and genetics diagnosed congenital disease - Leigh's disease which may have been 1st manifested after this vaccine.Swallowing problems, 5/15/08-death certificate received-final cause of death Leigh's syndrome. 5/1/08-records received for DOS 3/15-4/5/08-DX: Leigh's encephalopathy syndrome. Respiratory failure. Sepsis. Presented to ED and subsequently transferred. About 2 months ago received FluMist and since then became weak and wobbly. Weak prior to vaccination but more so after vaccination and was receiving physical and occupational therapy. Starring episodes usually at night. Became more limp. Appears sleepy acts as if drunk. Ataxia. With thes episodes has become unresponsive and starring with them. No clonic seizure acitivity. after surgery remained intubated with mechanical ventilation and required CPAP. Neurologic status became more obtunded and unresponsive. Fever. Fevers secondary to brain inflammation due to Leigh syndrome. Withdrawn from life support and expired.
Age: 6.0
Sex: F
Vaccine: FLUN3, FLUN3
Symptoms: Depressed level of consciousness, Disorientation, Dysphagia, Dyspnoea, Electroencephalogram normal
Clinical narrative: Received FluMist on 1/11/08. Approx 7-10 days later became weak with multiple episodes of falling to ground, difficulty walking, ataxia. Weakness progressive leading to breathing problems. Neurology and genetics diagnosed congenital disease - Leigh's disease which may have been 1st manifested after this vaccine.Swallowing problems, 5/15/08-death certificate received-final cause of death Leigh's syndrome. 5/1/08-records received for DOS 3/15-4/5/08-DX: Leigh's encephalopathy syndrome. Respiratory failure. Sepsis. Presented to ED and subsequently transferred. About 2 months ago received FluMist and since then became weak and wobbly. Weak prior to vaccination but more so after vaccination and was receiving physical and occupational therapy. Starring episodes usually at night. Became more limp. Appears sleepy acts as if drunk. Ataxia. With thes episodes has become unresponsive and starring with them. No clonic seizure acitivity. after surgery remained intubated with mechanical ventilation and required CPAP. Neurologic status became more obtunded and unresponsive. Fever. Fevers secondary to brain inflammation due to Leigh syndrome. Withdrawn from life support and expired.
Age: 6.0
Sex: F
Vaccine: FLUN3, FLUN3
Symptoms: Encephalitis, Expired drug administered, Fall, Fatigue, Gait disturbance
Clinical narrative: Received FluMist on 1/11/08. Approx 7-10 days later became weak with multiple episodes of falling to ground, difficulty walking, ataxia. Weakness progressive leading to breathing problems. Neurology and genetics diagnosed congenital disease - Leigh's disease which may have been 1st manifested after this vaccine.Swallowing problems, 5/15/08-death certificate received-final cause of death Leigh's syndrome. 5/1/08-records received for DOS 3/15-4/5/08-DX: Leigh's encephalopathy syndrome. Respiratory failure. Sepsis. Presented to ED and subsequently transferred. About 2 months ago received FluMist and since then became weak and wobbly. Weak prior to vaccination but more so after vaccination and was receiving physical and occupational therapy. Starring episodes usually at night. Became more limp. Appears sleepy acts as if drunk. Ataxia. With thes episodes has become unresponsive and starring with them. No clonic seizure acitivity. after surgery remained intubated with mechanical ventilation and required CPAP. Neurologic status became more obtunded and unresponsive. Fever. Fevers secondary to brain inflammation due to Leigh syndrome. Withdrawn from life support and expired.
Age: 6.0
Sex: F
Vaccine: FLUN3, FLUN3
Symptoms: Gastrointestinal tube insertion, Hyperreflexia, Hyperventilation, Inflammation, Mechanical ventilation
Clinical narrative: Received FluMist on 1/11/08. Approx 7-10 days later became weak with multiple episodes of falling to ground, difficulty walking, ataxia. Weakness progressive leading to breathing problems. Neurology and genetics diagnosed congenital disease - Leigh's disease which may have been 1st manifested after this vaccine.Swallowing problems, 5/15/08-death certificate received-final cause of death Leigh's syndrome. 5/1/08-records received for DOS 3/15-4/5/08-DX: Leigh's encephalopathy syndrome. Respiratory failure. Sepsis. Presented to ED and subsequently transferred. About 2 months ago received FluMist and since then became weak and wobbly. Weak prior to vaccination but more so after vaccination and was receiving physical and occupational therapy. Starring episodes usually at night. Became more limp. Appears sleepy acts as if drunk. Ataxia. With thes episodes has become unresponsive and starring with them. No clonic seizure acitivity. after surgery remained intubated with mechanical ventilation and required CPAP. Neurologic status became more obtunded and unresponsive. Fever. Fevers secondary to brain inflammation due to Leigh syndrome. Withdrawn from life support and expired.
Age: 6.0
Sex: F
Vaccine: FLUN3, FLUN3
Symptoms: Mitochondrial cytopathy, Mitochondrial encephalomyopathy, Nuclear magnetic resonance imaging brain abnormal, Photophobia, Pyrexia
Clinical narrative: Received FluMist on 1/11/08. Approx 7-10 days later became weak with multiple episodes of falling to ground, difficulty walking, ataxia. Weakness progressive leading to breathing problems. Neurology and genetics diagnosed congenital disease - Leigh's disease which may have been 1st manifested after this vaccine.Swallowing problems, 5/15/08-death certificate received-final cause of death Leigh's syndrome. 5/1/08-records received for DOS 3/15-4/5/08-DX: Leigh's encephalopathy syndrome. Respiratory failure. Sepsis. Presented to ED and subsequently transferred. About 2 months ago received FluMist and since then became weak and wobbly. Weak prior to vaccination but more so after vaccination and was receiving physical and occupational therapy. Starring episodes usually at night. Became more limp. Appears sleepy acts as if drunk. Ataxia. With thes episodes has become unresponsive and starring with them. No clonic seizure acitivity. after surgery remained intubated with mechanical ventilation and required CPAP. Neurologic status became more obtunded and unresponsive. Fever. Fevers secondary to brain inflammation due to Leigh syndrome. Withdrawn from life support and expired.
Age: 6.0
Sex: F
Vaccine: FLUN3, FLUN3
Symptoms: Respiratory failure, Sepsis, Sleep apnoea syndrome, Sleep study abnormal, Somnolence
Clinical narrative: Received FluMist on 1/11/08. Approx 7-10 days later became weak with multiple episodes of falling to ground, difficulty walking, ataxia. Weakness progressive leading to breathing problems. Neurology and genetics diagnosed congenital disease - Leigh's disease which may have been 1st manifested after this vaccine.Swallowing problems, 5/15/08-death certificate received-final cause of death Leigh's syndrome. 5/1/08-records received for DOS 3/15-4/5/08-DX: Leigh's encephalopathy syndrome. Respiratory failure. Sepsis. Presented to ED and subsequently transferred. About 2 months ago received FluMist and since then became weak and wobbly. Weak prior to vaccination but more so after vaccination and was receiving physical and occupational therapy. Starring episodes usually at night. Became more limp. Appears sleepy acts as if drunk. Ataxia. With thes episodes has become unresponsive and starring with them. No clonic seizure acitivity. after surgery remained intubated with mechanical ventilation and required CPAP. Neurologic status became more obtunded and unresponsive. Fever. Fevers secondary to brain inflammation due to Leigh syndrome. Withdrawn from life support and expired.
Age: 6.0
Sex: F
Vaccine: FLUN3, FLUN3
Symptoms: Staring, Unresponsive to stimuli
Clinical narrative: Received FluMist on 1/11/08. Approx 7-10 days later became weak with multiple episodes of falling to ground, difficulty walking, ataxia. Weakness progressive leading to breathing problems. Neurology and genetics diagnosed congenital disease - Leigh's disease which may have been 1st manifested after this vaccine.Swallowing problems, 5/15/08-death certificate received-final cause of death Leigh's syndrome. 5/1/08-records received for DOS 3/15-4/5/08-DX: Leigh's encephalopathy syndrome. Respiratory failure. Sepsis. Presented to ED and subsequently transferred. About 2 months ago received FluMist and since then became weak and wobbly. Weak prior to vaccination but more so after vaccination and was receiving physical and occupational therapy. Starring episodes usually at night. Became more limp. Appears sleepy acts as if drunk. Ataxia. With thes episodes has become unresponsive and starring with them. No clonic seizure acitivity. after surgery remained intubated with mechanical ventilation and required CPAP. Neurologic status became more obtunded and unresponsive. Fever. Fevers secondary to brain inflammation due to Leigh syndrome. Withdrawn from life support and expired.
Age: 0.3
Sex: M
Vaccine: DTAP, HIBV, IPV
Symptoms: Pyrexia, Screaming
Clinical narrative: High pitched screaming for 3 days (more than 3 hours over the course of 3 days), low grade fever - developmentally delayed. 4/28/08-records received-evaluation 3/31/08 13 months of age- Reflux. Assessment: not eligible for early intervention services.  Per family patient screamed after 2, 4 and 6 month immunizations and experienced convulsions.