chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.15
Sex: F
Vaccine: DTAPHEPBIP, RV5, DTAPHEPBIP, HIBV, PNC, RV5, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Diarrhoea, Escherichia infection, Gastroenteritis, Urinary tract infection, Vomiting
Clinical narrative: Information has been received from a registered nurse concerning a 10 week old female with a vibratory heart murmur who on 19-JAN-2007 was vaccinated with a first oral dose of Rotateq (Lot# 655866/1110F). Concomitant vaccines administered on the same day included a first intramuscular dose of Pediarix (Lot# A021B084BA),  a first intramuscular dose of PedvaxHib (Lot# "1015") and a first intramuscular dose of Prevnar (Lot# B08672E). It was noted that the patient had a cough at the time of vaccination. The patient developed vomiting and diarrhea, diagnosed as gastroenteritis, on 04-FEB-2007, 16 days after the immunizations. The patient was found to have a urinary tract infection and mild hydronephrosis, described as an underlying renal abnormality. The patient was hospitalized twice for the experiences from 05-FEB-2007 to 07-FEB-2007 and from 09-FEB-2007 to 12-FEB-2007. It was noted that during hospitalization the patient received a first dose of Recombivax HB (manufacturer unknown). The patient's stool was negative for Rotateq. Subsequently, the patient recovered. Additional information has been requested.
Age: 0.15
Sex: F
Vaccine: DTAPHEPBIP, RV5, DTAPHEPBIP, HIBV, PNC, RV5, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Diarrhoea, Gastroenteritis, Hydronephrosis, Renal disorder, Rotavirus test negative
Clinical narrative: Information has been received from a registered nurse concerning a 10 week old female with a vibratory heart murmur who on 19-JAN-2007 was vaccinated with a first oral dose of Rotateq (Lot# 655866/1110F). Concomitant vaccines administered on the same day included a first intramuscular dose of Pediarix (Lot# A021B084BA),  a first intramuscular dose of PedvaxHib (Lot# "1015") and a first intramuscular dose of Prevnar (Lot# B08672E). It was noted that the patient had a cough at the time of vaccination. The patient developed vomiting and diarrhea, diagnosed as gastroenteritis, on 04-FEB-2007, 16 days after the immunizations. The patient was found to have a urinary tract infection and mild hydronephrosis, described as an underlying renal abnormality. The patient was hospitalized twice for the experiences from 05-FEB-2007 to 07-FEB-2007 and from 09-FEB-2007 to 12-FEB-2007. It was noted that during hospitalization the patient received a first dose of Recombivax HB (manufacturer unknown). The patient's stool was negative for Rotateq. Subsequently, the patient recovered. Additional information has been requested.
Age: 0.15
Sex: F
Vaccine: DTAPHEPBIP, RV5, DTAPHEPBIP, HIBV, PNC, RV5, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Urinary tract infection, Vomiting
Clinical narrative: Information has been received from a registered nurse concerning a 10 week old female with a vibratory heart murmur who on 19-JAN-2007 was vaccinated with a first oral dose of Rotateq (Lot# 655866/1110F). Concomitant vaccines administered on the same day included a first intramuscular dose of Pediarix (Lot# A021B084BA),  a first intramuscular dose of PedvaxHib (Lot# "1015") and a first intramuscular dose of Prevnar (Lot# B08672E). It was noted that the patient had a cough at the time of vaccination. The patient developed vomiting and diarrhea, diagnosed as gastroenteritis, on 04-FEB-2007, 16 days after the immunizations. The patient was found to have a urinary tract infection and mild hydronephrosis, described as an underlying renal abnormality. The patient was hospitalized twice for the experiences from 05-FEB-2007 to 07-FEB-2007 and from 09-FEB-2007 to 12-FEB-2007. It was noted that during hospitalization the patient received a first dose of Recombivax HB (manufacturer unknown). The patient's stool was negative for Rotateq. Subsequently, the patient recovered. Additional information has been requested.
Age: 31.0
Sex: M
Vaccine: SMALL
Symptoms: Joint stiffness, Musculoskeletal pain
Clinical narrative: SHOULDER PAIN AND STIFFNESS SINCE VACCINATION, 2 MONTHS.
Age: 23.0
Sex: F
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Red all around shot, itchy   55mm in size
Age: 43.0
Sex: M
Vaccine: ANTH
Symptoms: Chest discomfort, Pericarditis, Pharyngeal erythema
Clinical narrative: Throat red, tightness in chestdiagnosis perio carditis
Age: 22.0
Sex: M
Vaccine: ANTH
Symptoms: Herpes zoster
Clinical narrative: 2ND SHOT OF ANTHRAX VACCINE CAUSED SHINGLES OUTBREAK.  oCCURED SAME DAY AND PROGESSIVELY GOT WORSE.
Age: 16.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Apnoea, Blood electrolytes normal, Computerised tomogram normal, Condition aggravated, Convulsion
Clinical narrative: Pt has a hx of seizures but has been seizure free for 10 years. Not on any seizure meds currently. Next day after vaccine administration developed 3-5 minute seizure, followed by incontinence, apnea, obtundation 04/11/2007-records received from facility. Seen in ER. Had single isolated seizure lasted 3-5 minutes, lost consciousness and incontinent and apneic. Generalzied motor activity observed. Post ictally has been obtunded and confused. No focal motor acitivity. Last seizure 5 years ago. PMH: MR, cerebral palsy, nonverbal. PE:WNL.
Age: 16.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Depressed level of consciousness, Electrocardiogram normal, Full blood count normal, Incontinence
Clinical narrative: Pt has a hx of seizures but has been seizure free for 10 years. Not on any seizure meds currently. Next day after vaccine administration developed 3-5 minute seizure, followed by incontinence, apnea, obtundation 04/11/2007-records received from facility. Seen in ER. Had single isolated seizure lasted 3-5 minutes, lost consciousness and incontinent and apneic. Generalzied motor activity observed. Post ictally has been obtunded and confused. No focal motor acitivity. Last seizure 5 years ago. PMH: MR, cerebral palsy, nonverbal. PE:WNL.
Sex: M
Vaccine: DTAP, IPV
Symptoms: Lethargy, Malaise, Pyrexia, Urticaria, Wheezing
Clinical narrative: PT after injection at home mother states child fever 100, 10 cm x 8 cm welt and child had wheezing, lethargy and malaise per mother.
Age: 36.0
Sex: F
Vaccine: TYP, YF
Symptoms: Asthenia, Dizziness, Erythema, Feeling cold, Skin warm
Clinical narrative: Redness/hotness of neck, chest, cold, weak, dizzy no itching, no sob.
Age: 0.16
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, RV5, UNK
Symptoms: Diarrhoea, Gastroenteritis rotavirus, Pyrexia, Rotavirus test positive, Vomiting
Clinical narrative: Information has been received from a licensed practical nurse concerning an 8 week old female with a protein allergy (MPSI") and gastrooesophageal reflux on 09-MAR-2007 was vaccinated PO with the first dose of Rotateq (LOT # 656189/1239F). Additional vaccines administered on the same day included the first dose of Pediarix (Lot# AC21B066AA) IM in right thigh, first dose of hibconjugate, (654677/1124 F) IM in left thigh and first dose of Prevnar (B08681D) IM in the left thigh. There was no illness present at the time of vaccination. On 09-MAR-2007, in the evening the patient developed diarrhea and started vomiting. Prevacid was restarted. On 14-MAR-2007 the patient tested positive for rota stool. The patient was treated with lactinex and recovered on 15-MAR-2007. There was no product quality complaint reported. The licensed practical nurse considered rotavirus to be other important medical event. Additional information has been requested. A copy of the medical record is attached to further document the patient's experience. This is in follow-up to report(s) previously submitted on 4/15/2007. Information has been received from a registered nurse (RN) concerning a 2-month-old female who on 09-MAR-2007 was vaccinated PO with the first dose of ROTATEQ (lot number not provided). Concomitant vaccination administered on that same day included "all the required shots for a 2-month-old." The patient was noted to be asymptomatic on the day of vaccination. The RN reported that, within 24 hours after vaccination, on approximately 10-MAR-2007, the patient developed a fever and diarrhea. On 12-MAR-2007, the patient presented to the office where she tested positive for rotavirus. The RN noted that the patient had been in daycare where Influenza A had been "going around." No further information is available.
Age: 0.16
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, RV5, UNK
Symptoms: Diarrhoea, Exposure to communicable disease, Gastroenteritis rotavirus, Pyrexia, Rotavirus test positive
Clinical narrative: Information has been received from a licensed practical nurse concerning an 8 week old female with a protein allergy (MPSI") and gastrooesophageal reflux on 09-MAR-2007 was vaccinated PO with the first dose of Rotateq (LOT # 656189/1239F). Additional vaccines administered on the same day included the first dose of Pediarix (Lot# AC21B066AA) IM in right thigh, first dose of hibconjugate, (654677/1124 F) IM in left thigh and first dose of Prevnar (B08681D) IM in the left thigh. There was no illness present at the time of vaccination. On 09-MAR-2007, in the evening the patient developed diarrhea and started vomiting. Prevacid was restarted. On 14-MAR-2007 the patient tested positive for rota stool. The patient was treated with lactinex and recovered on 15-MAR-2007. There was no product quality complaint reported. The licensed practical nurse considered rotavirus to be other important medical event. Additional information has been requested. A copy of the medical record is attached to further document the patient's experience. This is in follow-up to report(s) previously submitted on 4/15/2007. Information has been received from a registered nurse (RN) concerning a 2-month-old female who on 09-MAR-2007 was vaccinated PO with the first dose of ROTATEQ (lot number not provided). Concomitant vaccination administered on that same day included "all the required shots for a 2-month-old." The patient was noted to be asymptomatic on the day of vaccination. The RN reported that, within 24 hours after vaccination, on approximately 10-MAR-2007, the patient developed a fever and diarrhea. On 12-MAR-2007, the patient presented to the office where she tested positive for rotavirus. The RN noted that the patient had been in daycare where Influenza A had been "going around." No further information is available.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Diarrhoea, Eyelid ptosis, Gastroenteritis, Haematochezia, Intussusception
Clinical narrative: Information has been received from a nurse practitioner and a physician concerning a 24-week-old female with no allergies and with a history of fevers (on and off) who on 01-NOV-2006 and 09-JAN-2007 was vaccinated PO with the first and second doses of Rotateq (Lot #'s 654352/0410F and /1082F, respectively). There was no concomitant medication. On 15-DEC-2006 the patient experienced fever. This fever was not related to therapy with Rotateq. On 26-DEC-2006 the patient experienced left eye ptosis. On 12-JAN-2007 the patient experienced diarrhea and vomiting and was hospitalized. The initial diagnosis was acute gastroenteritis. The patient's symptoms worsened, and the third day of hospitalization, the patient had blood in her stool and was diagnosed with bowel intussusception. The patient underwent surgical repair on 14-FEB-2007. The patient was discharged from the hospital within 24 hours of surgery, and was noted to be recovered. The patient was seeing another practice at the time of the report. No additional information is expected. There was no product quality complaint. The physician indicated that the intussusception was not related to vaccination with Rotateq. Additional information has been requested.  04/20/2007 Records received from PCP which include vax record and D/C summary from 1st hospitalization and D/C order form and Final Report  from transfer facility. Infant presented to PCP on 02/12/2007 with a 2 day hx. of diarrhea, vomiting, lethargy and not eating well.  2 lb weight loss. Assessment:  Acute gastroenteritis and dehydration.  Admitted to hospital for IV hydration and further management. Transfered to another facility on 2/13/07 for eval. by a pediatric surgeon for possible intestinal obstruction vs. intussusception. Barium enema was obtained on 2/14/07 which was (+) for intussusception which could only be partially reduced.  Pt went for laparoscopic reduction of the intussusception on 2/14/07. Discharged the next day. D/C DX:  Incarcerated Intussusception.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Pyrexia, Surgery, Vomiting
Clinical narrative: Information has been received from a nurse practitioner and a physician concerning a 24-week-old female with no allergies and with a history of fevers (on and off) who on 01-NOV-2006 and 09-JAN-2007 was vaccinated PO with the first and second doses of Rotateq (Lot #'s 654352/0410F and /1082F, respectively). There was no concomitant medication. On 15-DEC-2006 the patient experienced fever. This fever was not related to therapy with Rotateq. On 26-DEC-2006 the patient experienced left eye ptosis. On 12-JAN-2007 the patient experienced diarrhea and vomiting and was hospitalized. The initial diagnosis was acute gastroenteritis. The patient's symptoms worsened, and the third day of hospitalization, the patient had blood in her stool and was diagnosed with bowel intussusception. The patient underwent surgical repair on 14-FEB-2007. The patient was discharged from the hospital within 24 hours of surgery, and was noted to be recovered. The patient was seeing another practice at the time of the report. No additional information is expected. There was no product quality complaint. The physician indicated that the intussusception was not related to vaccination with Rotateq. Additional information has been requested.  04/20/2007 Records received from PCP which include vax record and D/C summary from 1st hospitalization and D/C order form and Final Report  from transfer facility. Infant presented to PCP on 02/12/2007 with a 2 day hx. of diarrhea, vomiting, lethargy and not eating well.  2 lb weight loss. Assessment:  Acute gastroenteritis and dehydration.  Admitted to hospital for IV hydration and further management. Transfered to another facility on 2/13/07 for eval. by a pediatric surgeon for possible intestinal obstruction vs. intussusception. Barium enema was obtained on 2/14/07 which was (+) for intussusception which could only be partially reduced.  Pt went for laparoscopic reduction of the intussusception on 2/14/07. Discharged the next day. D/C DX:  Incarcerated Intussusception.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Abdominal X-ray, Barium enema, Blood alkaline phosphatase normal, Blood bicarbonate normal, Blood chloride increased
Clinical narrative: Information has been received from a nurse practitioner and a physician concerning a 24-week-old female with no allergies and with a history of fevers (on and off) who on 01-NOV-2006 and 09-JAN-2007 was vaccinated PO with the first and second doses of Rotateq (Lot #'s 654352/0410F and /1082F, respectively). There was no concomitant medication. On 15-DEC-2006 the patient experienced fever. This fever was not related to therapy with Rotateq. On 26-DEC-2006 the patient experienced left eye ptosis. On 12-JAN-2007 the patient experienced diarrhea and vomiting and was hospitalized. The initial diagnosis was acute gastroenteritis. The patient's symptoms worsened, and the third day of hospitalization, the patient had blood in her stool and was diagnosed with bowel intussusception. The patient underwent surgical repair on 14-FEB-2007. The patient was discharged from the hospital within 24 hours of surgery, and was noted to be recovered. The patient was seeing another practice at the time of the report. No additional information is expected. There was no product quality complaint. The physician indicated that the intussusception was not related to vaccination with Rotateq. Additional information has been requested.  04/20/2007 Records received from PCP which include vax record and D/C summary from 1st hospitalization and D/C order form and Final Report  from transfer facility. Infant presented to PCP on 02/12/2007 with a 2 day hx. of diarrhea, vomiting, lethargy and not eating well.  2 lb weight loss. Assessment:  Acute gastroenteritis and dehydration.  Admitted to hospital for IV hydration and further management. Transfered to another facility on 2/13/07 for eval. by a pediatric surgeon for possible intestinal obstruction vs. intussusception. Barium enema was obtained on 2/14/07 which was (+) for intussusception which could only be partially reduced.  Pt went for laparoscopic reduction of the intussusception on 2/14/07. Discharged the next day. D/C DX:  Incarcerated Intussusception.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Blood glucose increased, Blood sodium increased, Blood urine present, C-reactive protein increased, Clostridium difficile toxin test positive
Clinical narrative: Information has been received from a nurse practitioner and a physician concerning a 24-week-old female with no allergies and with a history of fevers (on and off) who on 01-NOV-2006 and 09-JAN-2007 was vaccinated PO with the first and second doses of Rotateq (Lot #'s 654352/0410F and /1082F, respectively). There was no concomitant medication. On 15-DEC-2006 the patient experienced fever. This fever was not related to therapy with Rotateq. On 26-DEC-2006 the patient experienced left eye ptosis. On 12-JAN-2007 the patient experienced diarrhea and vomiting and was hospitalized. The initial diagnosis was acute gastroenteritis. The patient's symptoms worsened, and the third day of hospitalization, the patient had blood in her stool and was diagnosed with bowel intussusception. The patient underwent surgical repair on 14-FEB-2007. The patient was discharged from the hospital within 24 hours of surgery, and was noted to be recovered. The patient was seeing another practice at the time of the report. No additional information is expected. There was no product quality complaint. The physician indicated that the intussusception was not related to vaccination with Rotateq. Additional information has been requested.  04/20/2007 Records received from PCP which include vax record and D/C summary from 1st hospitalization and D/C order form and Final Report  from transfer facility. Infant presented to PCP on 02/12/2007 with a 2 day hx. of diarrhea, vomiting, lethargy and not eating well.  2 lb weight loss. Assessment:  Acute gastroenteritis and dehydration.  Admitted to hospital for IV hydration and further management. Transfered to another facility on 2/13/07 for eval. by a pediatric surgeon for possible intestinal obstruction vs. intussusception. Barium enema was obtained on 2/14/07 which was (+) for intussusception which could only be partially reduced.  Pt went for laparoscopic reduction of the intussusception on 2/14/07. Discharged the next day. D/C DX:  Incarcerated Intussusception.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Dehydration, Diarrhoea, Eyelid ptosis, Gastroenteritis, Haematochezia
Clinical narrative: Information has been received from a nurse practitioner and a physician concerning a 24-week-old female with no allergies and with a history of fevers (on and off) who on 01-NOV-2006 and 09-JAN-2007 was vaccinated PO with the first and second doses of Rotateq (Lot #'s 654352/0410F and /1082F, respectively). There was no concomitant medication. On 15-DEC-2006 the patient experienced fever. This fever was not related to therapy with Rotateq. On 26-DEC-2006 the patient experienced left eye ptosis. On 12-JAN-2007 the patient experienced diarrhea and vomiting and was hospitalized. The initial diagnosis was acute gastroenteritis. The patient's symptoms worsened, and the third day of hospitalization, the patient had blood in her stool and was diagnosed with bowel intussusception. The patient underwent surgical repair on 14-FEB-2007. The patient was discharged from the hospital within 24 hours of surgery, and was noted to be recovered. The patient was seeing another practice at the time of the report. No additional information is expected. There was no product quality complaint. The physician indicated that the intussusception was not related to vaccination with Rotateq. Additional information has been requested.  04/20/2007 Records received from PCP which include vax record and D/C summary from 1st hospitalization and D/C order form and Final Report  from transfer facility. Infant presented to PCP on 02/12/2007 with a 2 day hx. of diarrhea, vomiting, lethargy and not eating well.  2 lb weight loss. Assessment:  Acute gastroenteritis and dehydration.  Admitted to hospital for IV hydration and further management. Transfered to another facility on 2/13/07 for eval. by a pediatric surgeon for possible intestinal obstruction vs. intussusception. Barium enema was obtained on 2/14/07 which was (+) for intussusception which could only be partially reduced.  Pt went for laparoscopic reduction of the intussusception on 2/14/07. Discharged the next day. D/C DX:  Incarcerated Intussusception.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Intussusception, Laparoscopy, Lymphocyte count decreased, Monocyte count decreased, Nausea
Clinical narrative: Information has been received from a nurse practitioner and a physician concerning a 24-week-old female with no allergies and with a history of fevers (on and off) who on 01-NOV-2006 and 09-JAN-2007 was vaccinated PO with the first and second doses of Rotateq (Lot #'s 654352/0410F and /1082F, respectively). There was no concomitant medication. On 15-DEC-2006 the patient experienced fever. This fever was not related to therapy with Rotateq. On 26-DEC-2006 the patient experienced left eye ptosis. On 12-JAN-2007 the patient experienced diarrhea and vomiting and was hospitalized. The initial diagnosis was acute gastroenteritis. The patient's symptoms worsened, and the third day of hospitalization, the patient had blood in her stool and was diagnosed with bowel intussusception. The patient underwent surgical repair on 14-FEB-2007. The patient was discharged from the hospital within 24 hours of surgery, and was noted to be recovered. The patient was seeing another practice at the time of the report. No additional information is expected. There was no product quality complaint. The physician indicated that the intussusception was not related to vaccination with Rotateq. Additional information has been requested.  04/20/2007 Records received from PCP which include vax record and D/C summary from 1st hospitalization and D/C order form and Final Report  from transfer facility. Infant presented to PCP on 02/12/2007 with a 2 day hx. of diarrhea, vomiting, lethargy and not eating well.  2 lb weight loss. Assessment:  Acute gastroenteritis and dehydration.  Admitted to hospital for IV hydration and further management. Transfered to another facility on 2/13/07 for eval. by a pediatric surgeon for possible intestinal obstruction vs. intussusception. Barium enema was obtained on 2/14/07 which was (+) for intussusception which could only be partially reduced.  Pt went for laparoscopic reduction of the intussusception on 2/14/07. Discharged the next day. D/C DX:  Incarcerated Intussusception.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Neutrophil count increased, Occult blood positive, Pyrexia, Rotavirus test negative, Small intestinal obstruction
Clinical narrative: Information has been received from a nurse practitioner and a physician concerning a 24-week-old female with no allergies and with a history of fevers (on and off) who on 01-NOV-2006 and 09-JAN-2007 was vaccinated PO with the first and second doses of Rotateq (Lot #'s 654352/0410F and /1082F, respectively). There was no concomitant medication. On 15-DEC-2006 the patient experienced fever. This fever was not related to therapy with Rotateq. On 26-DEC-2006 the patient experienced left eye ptosis. On 12-JAN-2007 the patient experienced diarrhea and vomiting and was hospitalized. The initial diagnosis was acute gastroenteritis. The patient's symptoms worsened, and the third day of hospitalization, the patient had blood in her stool and was diagnosed with bowel intussusception. The patient underwent surgical repair on 14-FEB-2007. The patient was discharged from the hospital within 24 hours of surgery, and was noted to be recovered. The patient was seeing another practice at the time of the report. No additional information is expected. There was no product quality complaint. The physician indicated that the intussusception was not related to vaccination with Rotateq. Additional information has been requested.  04/20/2007 Records received from PCP which include vax record and D/C summary from 1st hospitalization and D/C order form and Final Report  from transfer facility. Infant presented to PCP on 02/12/2007 with a 2 day hx. of diarrhea, vomiting, lethargy and not eating well.  2 lb weight loss. Assessment:  Acute gastroenteritis and dehydration.  Admitted to hospital for IV hydration and further management. Transfered to another facility on 2/13/07 for eval. by a pediatric surgeon for possible intestinal obstruction vs. intussusception. Barium enema was obtained on 2/14/07 which was (+) for intussusception which could only be partially reduced.  Pt went for laparoscopic reduction of the intussusception on 2/14/07. Discharged the next day. D/C DX:  Incarcerated Intussusception.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Specific gravity urine normal, Surgery, Urine analysis normal, Urine ketone body present, Vomiting
Clinical narrative: Information has been received from a nurse practitioner and a physician concerning a 24-week-old female with no allergies and with a history of fevers (on and off) who on 01-NOV-2006 and 09-JAN-2007 was vaccinated PO with the first and second doses of Rotateq (Lot #'s 654352/0410F and /1082F, respectively). There was no concomitant medication. On 15-DEC-2006 the patient experienced fever. This fever was not related to therapy with Rotateq. On 26-DEC-2006 the patient experienced left eye ptosis. On 12-JAN-2007 the patient experienced diarrhea and vomiting and was hospitalized. The initial diagnosis was acute gastroenteritis. The patient's symptoms worsened, and the third day of hospitalization, the patient had blood in her stool and was diagnosed with bowel intussusception. The patient underwent surgical repair on 14-FEB-2007. The patient was discharged from the hospital within 24 hours of surgery, and was noted to be recovered. The patient was seeing another practice at the time of the report. No additional information is expected. There was no product quality complaint. The physician indicated that the intussusception was not related to vaccination with Rotateq. Additional information has been requested.  04/20/2007 Records received from PCP which include vax record and D/C summary from 1st hospitalization and D/C order form and Final Report  from transfer facility. Infant presented to PCP on 02/12/2007 with a 2 day hx. of diarrhea, vomiting, lethargy and not eating well.  2 lb weight loss. Assessment:  Acute gastroenteritis and dehydration.  Admitted to hospital for IV hydration and further management. Transfered to another facility on 2/13/07 for eval. by a pediatric surgeon for possible intestinal obstruction vs. intussusception. Barium enema was obtained on 2/14/07 which was (+) for intussusception which could only be partially reduced.  Pt went for laparoscopic reduction of the intussusception on 2/14/07. Discharged the next day. D/C DX:  Incarcerated Intussusception.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Weight decreased, White blood cell count increased, White blood cells urine positive, X-ray abnormal
Clinical narrative: Information has been received from a nurse practitioner and a physician concerning a 24-week-old female with no allergies and with a history of fevers (on and off) who on 01-NOV-2006 and 09-JAN-2007 was vaccinated PO with the first and second doses of Rotateq (Lot #'s 654352/0410F and /1082F, respectively). There was no concomitant medication. On 15-DEC-2006 the patient experienced fever. This fever was not related to therapy with Rotateq. On 26-DEC-2006 the patient experienced left eye ptosis. On 12-JAN-2007 the patient experienced diarrhea and vomiting and was hospitalized. The initial diagnosis was acute gastroenteritis. The patient's symptoms worsened, and the third day of hospitalization, the patient had blood in her stool and was diagnosed with bowel intussusception. The patient underwent surgical repair on 14-FEB-2007. The patient was discharged from the hospital within 24 hours of surgery, and was noted to be recovered. The patient was seeing another practice at the time of the report. No additional information is expected. There was no product quality complaint. The physician indicated that the intussusception was not related to vaccination with Rotateq. Additional information has been requested.  04/20/2007 Records received from PCP which include vax record and D/C summary from 1st hospitalization and D/C order form and Final Report  from transfer facility. Infant presented to PCP on 02/12/2007 with a 2 day hx. of diarrhea, vomiting, lethargy and not eating well.  2 lb weight loss. Assessment:  Acute gastroenteritis and dehydration.  Admitted to hospital for IV hydration and further management. Transfered to another facility on 2/13/07 for eval. by a pediatric surgeon for possible intestinal obstruction vs. intussusception. Barium enema was obtained on 2/14/07 which was (+) for intussusception which could only be partially reduced.  Pt went for laparoscopic reduction of the intussusception on 2/14/07. Discharged the next day. D/C DX:  Incarcerated Intussusception.
Age: 30.0
Sex: F
Vaccine: VARCEL
Symptoms: Demyelination, Hypoaesthesia, Multiple sclerosis, Neurological examination abnormal, Nuclear magnetic resonance imaging abnormal
Clinical narrative: Information has been received from a physician concerning a 30 year old female with no allergies who was vaccinated with a first and second dose of Varivax on 02-FEB-2007 and 06-MAR-2007. Three days after vaccination with the second dose, on 09-MAR-2007 the patient began to experience tingling and numbness. The patient was referred to a neurologist. An MRI of her brain was done which showed "demylenating plaques on the brain". The neurologist stated that patient "may have multiple sclerosis". The patient was asymptomatic of multiple sclerosis prior to vaccination with Varivax. There was no product quality complaint involved. Additional information has been requested.
Age: 30.0
Sex: F
Vaccine: VARCEL
Symptoms: Paraesthesia
Clinical narrative: Information has been received from a physician concerning a 30 year old female with no allergies who was vaccinated with a first and second dose of Varivax on 02-FEB-2007 and 06-MAR-2007. Three days after vaccination with the second dose, on 09-MAR-2007 the patient began to experience tingling and numbness. The patient was referred to a neurologist. An MRI of her brain was done which showed "demylenating plaques on the brain". The neurologist stated that patient "may have multiple sclerosis". The patient was asymptomatic of multiple sclerosis prior to vaccination with Varivax. There was no product quality complaint involved. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Feeding disorder, Movement disorder, Tic
Clinical narrative: Information has been received from a physician concerning a 15 year old female patient with Opitz syndrome (hypertelorism-hypospadias), Turner's syndrome and migraines who was on 12-MAR-2007 vaccinated with a first dose of Gardasil, lot #654389/0961F (dose not reported). Concomitant therapy included TOPAMAX, fentanyl and other "unknown medications". On 19-MAR-2007 the patient developed a movement disorder characterized by "verbal and bodily" tics. On 20-MAR-2007 patient was hospitalized and treated with IV fluids. Unspecified laboratory tests were normal. She was seen by a neurologist who felt her tics were volitional because she could stop them when asked. Another neurologist felt the tics were not volitional because they occurred in her sleep. At the time of this report, the patient had not recovered. The physician considered the events to be disabling since she was unable to feed herself. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: TDAP
Symptoms: Caesarean section, Drug exposure during pregnancy, Stillbirth
Clinical narrative: Emergency C-Section - Stillbirth - 37 weeks. Pt has Tdap earlier in day.   05/01/2007 MR progress note received detailing the resusscitation attempt on infant delivered by emergency C/S for severe fetal bradycardia.  Upon arrival of the MD, no cardiac activity was visualized via ultrasound.  Upon delivery the infant was noted to have no muscle tone, no response, no reflex irritability and was blue/pale.  Resussitation was attempted x 30 minutes without success. 5/07/2007 Narritive Summary rec'd from hospital.  Pre and post operative DX was Placental Abruption.
Age: 0.63
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Apparent life threatening event, Cyanosis
Clinical narrative: pt with ATLE with cyanosis approximately 2 hrs after receiving immunization Hospitalized with observation for 2 hr- 05/23/07-records received from facility-Episode apparent breath holding or vasovagal event occurred about an hour and half after immunization.  Assessment:reflux possible account for symptoms since patient has had reflux documented previously. Breath holding spells are also a possible explanation.
Age: 1.9
Sex: M
Vaccine: DTAPHEPBIP, MMR, VARCEL, DTPHIB, MMR, VARCEL
Symptoms: Aggression, Cough, Epistaxis, Head banging, Injection site erythema
Clinical narrative: Child did not sleep for 3 days, ran fever, injection sites were red and inflamed. Site of Varicella had pass coming out for over a week. Child had aggressive behavior and beat his head on the floor and with his fists. His speech has been delayed. Child is now almost 3 and shows slow learning and verbal formation.  04/24/2007 Brief MR received from Ped for an ear re-check for OM on 04/14/2006.  Vax received. MD reports speech delays at this visit.   Assessment:  Otitis media.  Speech delay.  05/14/2007 MR from PCP received beginning 4/12/06 through 4/06/07. Exam 4/12/06 WNL except bulging erythematous TMs. DX:  Otitis Media. Next visit 5/08/06 with c/o agressive behavior following visit with dad. Behavioral rxn noted after 1st set of vax.  (+) head banging. Vocab is "coming along with good receptive skills". Assessment:  Well child 2 years. Visit 6/30/06 with mom's concern re: speech, with request for audiology consult.  MD notes speech is normal for a boy that age. Multiple visits for cold sx, OM, reported epistaxis,and cough.  04/17/2008 F/U report received with various attached medical records wit DX: ? regressive encephalopathy of toxic nature, functional diarrhea, delayed development, delayed speech, Adverse reaction to vaccines, yeast enteritis, and possible autism form eval of 10/29/07. Eval 1/22/08 with Assessment:Autistic Disorder.  Likely sensory dysfunction.  Sensory issues significant. Neuro eval 11/5/2007 with Assessment:  High functioning Autism. Night terrors. Autism/PDD see attached medical records faxed Faxing 15 additional pages lab report confirmation - mailed 4-17-08
Age: 1.9
Sex: M
Vaccine: DTAPHEPBIP, MMR, VARCEL, DTPHIB, MMR, VARCEL
Symptoms: Injection site inflammation, Injection site reaction, Insomnia, Laboratory test, Learning disability
Clinical narrative: Child did not sleep for 3 days, ran fever, injection sites were red and inflamed. Site of Varicella had pass coming out for over a week. Child had aggressive behavior and beat his head on the floor and with his fists. His speech has been delayed. Child is now almost 3 and shows slow learning and verbal formation.  04/24/2007 Brief MR received from Ped for an ear re-check for OM on 04/14/2006.  Vax received. MD reports speech delays at this visit.   Assessment:  Otitis media.  Speech delay.  05/14/2007 MR from PCP received beginning 4/12/06 through 4/06/07. Exam 4/12/06 WNL except bulging erythematous TMs. DX:  Otitis Media. Next visit 5/08/06 with c/o agressive behavior following visit with dad. Behavioral rxn noted after 1st set of vax.  (+) head banging. Vocab is "coming along with good receptive skills". Assessment:  Well child 2 years. Visit 6/30/06 with mom's concern re: speech, with request for audiology consult.  MD notes speech is normal for a boy that age. Multiple visits for cold sx, OM, reported epistaxis,and cough.  04/17/2008 F/U report received with various attached medical records wit DX: ? regressive encephalopathy of toxic nature, functional diarrhea, delayed development, delayed speech, Adverse reaction to vaccines, yeast enteritis, and possible autism form eval of 10/29/07. Eval 1/22/08 with Assessment:Autistic Disorder.  Likely sensory dysfunction.  Sensory issues significant. Neuro eval 11/5/2007 with Assessment:  High functioning Autism. Night terrors. Autism/PDD see attached medical records faxed Faxing 15 additional pages lab report confirmation - mailed 4-17-08
Age: 1.9
Sex: M
Vaccine: DTAPHEPBIP, MMR, VARCEL, DTPHIB, MMR, VARCEL
Symptoms: Otitis media, Pyrexia
Clinical narrative: Child did not sleep for 3 days, ran fever, injection sites were red and inflamed. Site of Varicella had pass coming out for over a week. Child had aggressive behavior and beat his head on the floor and with his fists. His speech has been delayed. Child is now almost 3 and shows slow learning and verbal formation.  04/24/2007 Brief MR received from Ped for an ear re-check for OM on 04/14/2006.  Vax received. MD reports speech delays at this visit.   Assessment:  Otitis media.  Speech delay.  05/14/2007 MR from PCP received beginning 4/12/06 through 4/06/07. Exam 4/12/06 WNL except bulging erythematous TMs. DX:  Otitis Media. Next visit 5/08/06 with c/o agressive behavior following visit with dad. Behavioral rxn noted after 1st set of vax.  (+) head banging. Vocab is "coming along with good receptive skills". Assessment:  Well child 2 years. Visit 6/30/06 with mom's concern re: speech, with request for audiology consult.  MD notes speech is normal for a boy that age. Multiple visits for cold sx, OM, reported epistaxis,and cough.  04/17/2008 F/U report received with various attached medical records wit DX: ? regressive encephalopathy of toxic nature, functional diarrhea, delayed development, delayed speech, Adverse reaction to vaccines, yeast enteritis, and possible autism form eval of 10/29/07. Eval 1/22/08 with Assessment:Autistic Disorder.  Likely sensory dysfunction.  Sensory issues significant. Neuro eval 11/5/2007 with Assessment:  High functioning Autism. Night terrors. Autism/PDD see attached medical records faxed Faxing 15 additional pages lab report confirmation - mailed 4-17-08
Age: 1.9
Sex: M
Vaccine: DTAPHEPBIP, MMR, VARCEL, DTPHIB, MMR, VARCEL
Symptoms: Aggression, Anger, Head banging, Injection site discharge, Injection site erythema
Clinical narrative: Child did not sleep for 3 days, ran fever, injection sites were red and inflamed. Site of Varicella had pass coming out for over a week. Child had aggressive behavior and beat his head on the floor and with his fists. His speech has been delayed. Child is now almost 3 and shows slow learning and verbal formation.  04/24/2007 Brief MR received from Ped for an ear re-check for OM on 04/14/2006.  Vax received. MD reports speech delays at this visit.   Assessment:  Otitis media.  Speech delay.  05/14/2007 MR from PCP received beginning 4/12/06 through 4/06/07. Exam 4/12/06 WNL except bulging erythematous TMs. DX:  Otitis Media. Next visit 5/08/06 with c/o agressive behavior following visit with dad. Behavioral rxn noted after 1st set of vax.  (+) head banging. Vocab is "coming along with good receptive skills". Assessment:  Well child 2 years. Visit 6/30/06 with mom's concern re: speech, with request for audiology consult.  MD notes speech is normal for a boy that age. Multiple visits for cold sx, OM, reported epistaxis,and cough.  04/17/2008 F/U report received with various attached medical records wit DX: ? regressive encephalopathy of toxic nature, functional diarrhea, delayed development, delayed speech, Adverse reaction to vaccines, yeast enteritis, and possible autism form eval of 10/29/07. Eval 1/22/08 with Assessment:Autistic Disorder.  Likely sensory dysfunction.  Sensory issues significant. Neuro eval 11/5/2007 with Assessment:  High functioning Autism. Night terrors. Autism/PDD see attached medical records faxed Faxing 15 additional pages lab report confirmation - mailed 4-17-08
Age: 1.9
Sex: M
Vaccine: DTAPHEPBIP, MMR, VARCEL, DTPHIB, MMR, VARCEL
Symptoms: Injection site inflammation, Injection site pain, Injection site swelling, Insomnia, Speech disorder
Clinical narrative: Child did not sleep for 3 days, ran fever, injection sites were red and inflamed. Site of Varicella had pass coming out for over a week. Child had aggressive behavior and beat his head on the floor and with his fists. His speech has been delayed. Child is now almost 3 and shows slow learning and verbal formation.  04/24/2007 Brief MR received from Ped for an ear re-check for OM on 04/14/2006.  Vax received. MD reports speech delays at this visit.   Assessment:  Otitis media.  Speech delay.  05/14/2007 MR from PCP received beginning 4/12/06 through 4/06/07. Exam 4/12/06 WNL except bulging erythematous TMs. DX:  Otitis Media. Next visit 5/08/06 with c/o agressive behavior following visit with dad. Behavioral rxn noted after 1st set of vax.  (+) head banging. Vocab is "coming along with good receptive skills". Assessment:  Well child 2 years. Visit 6/30/06 with mom's concern re: speech, with request for audiology consult.  MD notes speech is normal for a boy that age. Multiple visits for cold sx, OM, reported epistaxis,and cough.  04/17/2008 F/U report received with various attached medical records wit DX: ? regressive encephalopathy of toxic nature, functional diarrhea, delayed development, delayed speech, Adverse reaction to vaccines, yeast enteritis, and possible autism form eval of 10/29/07. Eval 1/22/08 with Assessment:Autistic Disorder.  Likely sensory dysfunction.  Sensory issues significant. Neuro eval 11/5/2007 with Assessment:  High functioning Autism. Night terrors. Autism/PDD see attached medical records faxed Faxing 15 additional pages lab report confirmation - mailed 4-17-08
Age: 27.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Axillary mass, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: 10 days after varicella vaccine pt had redness, swelling, itching, and axillary nodes at injection site.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: 4-3-07 mom reported by phone, localized redness of L deltoid area, warm to touch. 4-4-07 mom called stated redness and warmth from deltoid to elbow. Recommend child to be seen. Child was going out of town - mom refused appt.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Contusion, Idiopathic thrombocytopenic purpura, Petechiae, Platelet count decreased
Clinical narrative: MMR-V given 3/9/07. On 3/29/07, patient developed bruising/petechiae. Her platelet count was 6,000. She was admitted with diagnosis of ITP.
Age: 31.0
Sex: M
Vaccine: SMALL
Symptoms: Blood culture negative, Injection site induration, Injection site reaction, Polymerase chain reaction, Skin ulcer
Clinical narrative: Received vaccine Aug 06 site crusted over x 4 months then fell off to expose a 1cm ulcer that persisted ever since our first visit Mar 07. I changed the dressing for bandaid  with Teffa and over course of 2 weeks it worsened/ progressed to entire upper arm and small area over face.
Age: 63.0
Sex: M
Vaccine: VARCEL
Symptoms: Musculoskeletal pain, Musculoskeletal stiffness, Neck pain
Clinical narrative: Pain and stiffness in right scapula, shoulder and right side of neck for 96 hours post injection. Treated with Tylenol to reduce symptoms until end of recovery period.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness, Skin laceration
Clinical narrative: Student received Gardasil at 1500 on 4/2/07 - tolerated vaccine well - returned to dorm - subsequently passed out in dorm bathroom causing laceration to head.
Age: 1.5
Sex: M
Vaccine: DTAP, HEPA, MMRV
Symptoms: Urticaria
Clinical narrative: Urticaria starting on 3/27/07 immunizations on 3/23/07.
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Crying, Pallor, Skin discolouration
Clinical narrative: Woke from nap, about 4 hours after vaccinations and crying then pale, green lime looked like "in shock" but no LOC called the office and told to come in - fine in office and observed for 2 hours.
Age: 1.01
Sex: M
Vaccine: DTAP, HEPA, HIBV, MMRV, PNC
Symptoms: Pyrexia, Rash
Clinical narrative: Morning of 4-2-07 child developed fine rash on anterior and posterior trunk along with a low grade fever.
Age: 1.08
Sex: F
Vaccine: PNC, VARZOS
Symptoms: Inappropriate schedule of drug administration, Medication error, Wrong drug administered
Clinical narrative: N/A @ this time.
Age: 1.36
Sex: F
Vaccine: DTAPH, VARZOS
Symptoms: Inappropriate schedule of drug administration, Medication error
Clinical narrative: N/A @ this time.
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Arthralgia, Musculoskeletal pain, Pain in extremity
Clinical narrative: On 3-24 07 patient developed pain on her left shoulder /left elbow/left knee / left shin/and left ankle (no arthritis) (injection was left arm)
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Antinuclear antibody negative, Arthralgia, Full blood count normal, Red blood cell sedimentation rate normal
Clinical narrative: On 3-24 07 patient developed pain on her left shoulder /left elbow/left knee / left shin/and left ankle (no arthritis) (injection was left arm)
Age: 31.0
Sex: M
Vaccine: ANTH, FLUX, TYP
Symptoms: Erythema, Induration
Clinical narrative: Pt with 8x6cm of erythema, 5x5cm of induration.  NOT ALL INFORMATION IS AVAILABLE.
Age: 1.0
Sex: F
Vaccine: IPV, MMRV
Symptoms: Cough, Culture urine negative, Diarrhoea, Pyrexia, Urine analysis normal
Clinical narrative: RECEIVED VACCINES ON 3/27/07. PRESENTED ON 4/5/07 WITH A 2 DAY HISTORY OF HIGH GRADE FEVER (104.1).  ALSO REPORTED 1 LOOSE STOOL AND SOME COUGH. OTHERWISE WELL.
Age: 0.67
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Cough, Otitis media, Pyrexia
Clinical narrative: VACCINES ADMINISTERED ON 4/5/07. DEVELOPED HIGH GRADE FEVER (106) ON 4/6/07. WAS SEEN IN ER AT TMC ON 4/6-4/7/07. DIAGNOSED WITH LEFT OTITIS MEDIA RX WITH ROCEPHIN AND BREATHING TREATMENT.  WAS SEEN IN OFFICE ON 4/9/07. NO FURTHER FEVER BUT SOME COUGH AND PULLING AT EARS.  TM'S MOBILE WITH A DISPERSED LIGHT REFLEX BILATERALLY. TREATED WITH AUGMENTIN, AURALGEN, AND ALDEX D.
Age: 22.0
Sex: M
Vaccine: ANTH
Symptoms: Pruritus, Rash maculo-papular
Clinical narrative: itchy maculopapular rash over arms and trunk
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Abnormal behaviour
Clinical narrative: Behavior changes.  Started spitting and hitting Mom 6-8 hours after immunization was given.  Behavior was terrible, hitting, kicking, spitting still 24 hours after immunization was given.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Grand mal convulsion, Pyrexia
Clinical narrative: 45 second generalized tonic-clonic seizure with low grade fever (37.8) 1 day after vaccination.
Age: 1.17
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Rash papular
Clinical narrative: papular scattered rash on arms, legs, face, ear lobes and diaper area.  Onset of rash day 16 post vaccine.  Rx - Orapred 15mg/5ml give 1.6ml once a day x5days.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Blood bicarbonate decreased, Diarrhoea, Gastroenteritis rotavirus
Clinical narrative: Child developed severe diarrhea, rotavirus positive and 2 weeks after the Rotateq was admitted to hospital for IV hydration and a bicarbonate of 16, so it was not just a poor judgement of his hydration status. Records received 5/15/07-Discharge Summary received for DOS 4/7-4/9/07-DX: Rotavirus positive diarrhea. Dehydration. Temp 103(R). IV fluids for 48 hours.