chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.5
Sex: U
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Laparotomy, Mucous stools, Surgery, Tenderness, Ultrasound abdomen abnormal
Clinical narrative: Information has been received concerning a 6-month-old patient who on 27-DEC-2006 was vaccinated with a second dose of Rotateq (Lot # 655082/0779F). On 03-FEB-2007 the patient experienced intussusception and had surgery. Follow up information received concerning a previously health infant who on 27-DEC-2006 was vaccinated with a second dose of Rotateq (Lot # 655082/0779F). Concomitant vaccinations that day included a third dose of PEDIARIX (Lot # AC21B069AA), a third dose of ACTHIB (Lot # UF021AB), and a third dose of PREVNAR (Lot # B08678K). The patient was vaccinated with the first dose of Rotateq (Lot # 655050/0778F) within 4 weeks of 27-DEC-2006. Subsequently, the patient developed emesis and bloody mucoid stools. Upon physician exam, all was within normal limits except for a large palpable mass in the mid left abdomen which was mobile, firm, and somewhat tender to palpation. A barium enema/laborotomy showed intussusception to rectosigmoid only reducible to hepatic flexure. Abdominal ultrasound confirmed intussusception. On 03-FEB-2007, 38 days post vaccination, the patient was hospitalized for intussusception. On 4-FEB-2007, an exploratory laparotomy was done with right hemicolectomy and partial ilectomy. Diagnosis intussusception status post right hemicolectomy. The patient was discharged on 10-FEB-2007. The patient recovered. A standard lot check investigation was performed for Lot # 655050/0778F. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the agency and was released. A standard lot check investigation was performed for Lot # 655082/0779F. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the agency and was released. Additional information has been requested.
Age: 0.5
Sex: U
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Vomiting
Clinical narrative: Information has been received concerning a 6-month-old patient who on 27-DEC-2006 was vaccinated with a second dose of Rotateq (Lot # 655082/0779F). On 03-FEB-2007 the patient experienced intussusception and had surgery. Follow up information received concerning a previously health infant who on 27-DEC-2006 was vaccinated with a second dose of Rotateq (Lot # 655082/0779F). Concomitant vaccinations that day included a third dose of PEDIARIX (Lot # AC21B069AA), a third dose of ACTHIB (Lot # UF021AB), and a third dose of PREVNAR (Lot # B08678K). The patient was vaccinated with the first dose of Rotateq (Lot # 655050/0778F) within 4 weeks of 27-DEC-2006. Subsequently, the patient developed emesis and bloody mucoid stools. Upon physician exam, all was within normal limits except for a large palpable mass in the mid left abdomen which was mobile, firm, and somewhat tender to palpation. A barium enema/laborotomy showed intussusception to rectosigmoid only reducible to hepatic flexure. Abdominal ultrasound confirmed intussusception. On 03-FEB-2007, 38 days post vaccination, the patient was hospitalized for intussusception. On 4-FEB-2007, an exploratory laparotomy was done with right hemicolectomy and partial ilectomy. Diagnosis intussusception status post right hemicolectomy. The patient was discharged on 10-FEB-2007. The patient recovered. A standard lot check investigation was performed for Lot # 655050/0778F. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the agency and was released. A standard lot check investigation was performed for Lot # 655082/0779F. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the agency and was released. Additional information has been requested.
Age: 0.5
Sex: U
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Laparotomy, Surgery, Tenderness, Vomiting
Clinical narrative: Information has been received concerning a 6-month-old patient who on 27-DEC-2006 was vaccinated with a second dose of Rotateq (Lot # 655082/0779F). On 03-FEB-2007 the patient experienced intussusception and had surgery. Follow up information received concerning a previously health infant who on 27-DEC-2006 was vaccinated with a second dose of Rotateq (Lot # 655082/0779F). Concomitant vaccinations that day included a third dose of PEDIARIX (Lot # AC21B069AA), a third dose of ACTHIB (Lot # UF021AB), and a third dose of PREVNAR (Lot # B08678K). The patient was vaccinated with the first dose of Rotateq (Lot # 655050/0778F) within 4 weeks of 27-DEC-2006. Subsequently, the patient developed emesis and bloody mucoid stools. Upon physician exam, all was within normal limits except for a large palpable mass in the mid left abdomen which was mobile, firm, and somewhat tender to palpation. A barium enema/laborotomy showed intussusception to rectosigmoid only reducible to hepatic flexure. Abdominal ultrasound confirmed intussusception. On 03-FEB-2007, 38 days post vaccination, the patient was hospitalized for intussusception. On 4-FEB-2007, an exploratory laparotomy was done with right hemicolectomy and partial ilectomy. Diagnosis intussusception status post right hemicolectomy. The patient was discharged on 10-FEB-2007. The patient recovered. A standard lot check investigation was performed for Lot # 655050/0778F. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the agency and was released. A standard lot check investigation was performed for Lot # 655082/0779F. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the agency and was released. Additional information has been requested.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Abdominal X-ray, Barium enema, Haematochezia, Intussusception, Vomiting
Clinical narrative: Information has been received concerning a 6 month old patient who on 15-JAN-2007 was vaccinated with the third dose of Rotateq. On 25-JAN-2007 the patient developed intussusception which required a barium enema. Upon internal review, intussusception which required an enema was considered an other important medical event. Further information has been received concerning this 6 month old patient with no medical history and no known allergies who was vaccinated wit the third dose of Rotateq (Lot # 655866/1110F). Other vaccines administered on the same date included PEDIARIX AC 21B084CA third dose, ACTHIB UF0588AA third dose and, PREVNAR 2B08670B third dose. There were no other concomitant medications. The patient was hospitalized for a two night stay due to a history of vomiting for several days followed by bloody stools. Over the course of admission the infant developed bloody stools x 2 as well as bilious vomiting. Review of systems on admission were positive for vomiting and lethargy. Physician examination was within normal limits except it was noted that patient was mildly difficult to arouse. Laboratory date reported included abdominal x rays and barium enema. Labs and diagnostic: KUB reveals an abnormal gas pattern which may have reflected a mild paralytic ileus and small bowel obstruction. Contrast barium enema revealed an intussusception distal to the hepatic field. The intussusception was reduced with air enema. It was reported that the onset of the patients experienced was 25-JAN-2007 and that the patient recovered on 09-MAR-2007. The records of testing prior to release of the lot in question has been rechecked and found to be satisfactory. The lot met the requirements of the agency and was released.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Abdominal X-ray, Barium double contrast, Barium enema, Depressed level of consciousness, Haematochezia
Clinical narrative: Information has been received concerning a 6 month old patient who on 15-JAN-2007 was vaccinated with the third dose of Rotateq. On 25-JAN-2007 the patient developed intussusception which required a barium enema. Upon internal review, intussusception which required an enema was considered an other important medical event. Further information has been received concerning this 6 month old patient with no medical history and no known allergies who was vaccinated wit the third dose of Rotateq (Lot # 655866/1110F). Other vaccines administered on the same date included PEDIARIX AC 21B084CA third dose, ACTHIB UF0588AA third dose and, PREVNAR 2B08670B third dose. There were no other concomitant medications. The patient was hospitalized for a two night stay due to a history of vomiting for several days followed by bloody stools. Over the course of admission the infant developed bloody stools x 2 as well as bilious vomiting. Review of systems on admission were positive for vomiting and lethargy. Physician examination was within normal limits except it was noted that patient was mildly difficult to arouse. Laboratory date reported included abdominal x rays and barium enema. Labs and diagnostic: KUB reveals an abnormal gas pattern which may have reflected a mild paralytic ileus and small bowel obstruction. Contrast barium enema revealed an intussusception distal to the hepatic field. The intussusception was reduced with air enema. It was reported that the onset of the patients experienced was 25-JAN-2007 and that the patient recovered on 09-MAR-2007. The records of testing prior to release of the lot in question has been rechecked and found to be satisfactory. The lot met the requirements of the agency and was released.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Ileus paralytic, Intussusception, Lethargy, Small intestinal obstruction, Urinary system X-ray
Clinical narrative: Information has been received concerning a 6 month old patient who on 15-JAN-2007 was vaccinated with the third dose of Rotateq. On 25-JAN-2007 the patient developed intussusception which required a barium enema. Upon internal review, intussusception which required an enema was considered an other important medical event. Further information has been received concerning this 6 month old patient with no medical history and no known allergies who was vaccinated wit the third dose of Rotateq (Lot # 655866/1110F). Other vaccines administered on the same date included PEDIARIX AC 21B084CA third dose, ACTHIB UF0588AA third dose and, PREVNAR 2B08670B third dose. There were no other concomitant medications. The patient was hospitalized for a two night stay due to a history of vomiting for several days followed by bloody stools. Over the course of admission the infant developed bloody stools x 2 as well as bilious vomiting. Review of systems on admission were positive for vomiting and lethargy. Physician examination was within normal limits except it was noted that patient was mildly difficult to arouse. Laboratory date reported included abdominal x rays and barium enema. Labs and diagnostic: KUB reveals an abnormal gas pattern which may have reflected a mild paralytic ileus and small bowel obstruction. Contrast barium enema revealed an intussusception distal to the hepatic field. The intussusception was reduced with air enema. It was reported that the onset of the patients experienced was 25-JAN-2007 and that the patient recovered on 09-MAR-2007. The records of testing prior to release of the lot in question has been rechecked and found to be satisfactory. The lot met the requirements of the agency and was released.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Vomiting
Clinical narrative: Information has been received concerning a 6 month old patient who on 15-JAN-2007 was vaccinated with the third dose of Rotateq. On 25-JAN-2007 the patient developed intussusception which required a barium enema. Upon internal review, intussusception which required an enema was considered an other important medical event. Further information has been received concerning this 6 month old patient with no medical history and no known allergies who was vaccinated wit the third dose of Rotateq (Lot # 655866/1110F). Other vaccines administered on the same date included PEDIARIX AC 21B084CA third dose, ACTHIB UF0588AA third dose and, PREVNAR 2B08670B third dose. There were no other concomitant medications. The patient was hospitalized for a two night stay due to a history of vomiting for several days followed by bloody stools. Over the course of admission the infant developed bloody stools x 2 as well as bilious vomiting. Review of systems on admission were positive for vomiting and lethargy. Physician examination was within normal limits except it was noted that patient was mildly difficult to arouse. Laboratory date reported included abdominal x rays and barium enema. Labs and diagnostic: KUB reveals an abnormal gas pattern which may have reflected a mild paralytic ileus and small bowel obstruction. Contrast barium enema revealed an intussusception distal to the hepatic field. The intussusception was reduced with air enema. It was reported that the onset of the patients experienced was 25-JAN-2007 and that the patient recovered on 09-MAR-2007. The records of testing prior to release of the lot in question has been rechecked and found to be satisfactory. The lot met the requirements of the agency and was released.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Abdominal X-ray, Barium double contrast, Depressed level of consciousness, Haematochezia, Ileus paralytic
Clinical narrative: Information has been received concerning a 6 month old patient who on 15-JAN-2007 was vaccinated with the third dose of Rotateq. On 25-JAN-2007 the patient developed intussusception which required a barium enema. Upon internal review, intussusception which required an enema was considered an other important medical event. Further information has been received concerning this 6 month old patient with no medical history and no known allergies who was vaccinated wit the third dose of Rotateq (Lot # 655866/1110F). Other vaccines administered on the same date included PEDIARIX AC 21B084CA third dose, ACTHIB UF0588AA third dose and, PREVNAR 2B08670B third dose. There were no other concomitant medications. The patient was hospitalized for a two night stay due to a history of vomiting for several days followed by bloody stools. Over the course of admission the infant developed bloody stools x 2 as well as bilious vomiting. Review of systems on admission were positive for vomiting and lethargy. Physician examination was within normal limits except it was noted that patient was mildly difficult to arouse. Laboratory date reported included abdominal x rays and barium enema. Labs and diagnostic: KUB reveals an abnormal gas pattern which may have reflected a mild paralytic ileus and small bowel obstruction. Contrast barium enema revealed an intussusception distal to the hepatic field. The intussusception was reduced with air enema. It was reported that the onset of the patients experienced was 25-JAN-2007 and that the patient recovered on 09-MAR-2007. The records of testing prior to release of the lot in question has been rechecked and found to be satisfactory. The lot met the requirements of the agency and was released.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Intussusception, Lethargy, Urinary system X-ray, Vomiting
Clinical narrative: Information has been received concerning a 6 month old patient who on 15-JAN-2007 was vaccinated with the third dose of Rotateq. On 25-JAN-2007 the patient developed intussusception which required a barium enema. Upon internal review, intussusception which required an enema was considered an other important medical event. Further information has been received concerning this 6 month old patient with no medical history and no known allergies who was vaccinated wit the third dose of Rotateq (Lot # 655866/1110F). Other vaccines administered on the same date included PEDIARIX AC 21B084CA third dose, ACTHIB UF0588AA third dose and, PREVNAR 2B08670B third dose. There were no other concomitant medications. The patient was hospitalized for a two night stay due to a history of vomiting for several days followed by bloody stools. Over the course of admission the infant developed bloody stools x 2 as well as bilious vomiting. Review of systems on admission were positive for vomiting and lethargy. Physician examination was within normal limits except it was noted that patient was mildly difficult to arouse. Laboratory date reported included abdominal x rays and barium enema. Labs and diagnostic: KUB reveals an abnormal gas pattern which may have reflected a mild paralytic ileus and small bowel obstruction. Contrast barium enema revealed an intussusception distal to the hepatic field. The intussusception was reduced with air enema. It was reported that the onset of the patients experienced was 25-JAN-2007 and that the patient recovered on 09-MAR-2007. The records of testing prior to release of the lot in question has been rechecked and found to be satisfactory. The lot met the requirements of the agency and was released.
Age: 0.2
Sex: U
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Intussusception, Surgery, Ultrasound abdomen
Clinical narrative: Information has been received concerning a 13-week-old patient who on 14-FEB-2007 was vaccinated with a first dose of Rotateq (Lot # 655485/1033F). On 08-MAR-2007 the patient experienced intussusception and had a surgical reduction. Follow up information received concerning a 2-month-old patient with no past medical history and no allergies, who on 14-FEB-2007 was vaccinated PO with a first dose of Rotateq (Lot # 655485/1033F). Concomitant vaccinations that day included a first dose of PEDIARIX (Lot # AC21B028AA), a first dose of HIBERIX (Lot # 1015), and a first dose of PREVNAR (Lot # B36258C). There were no other concomitant medications. On 08-MAR-2007, 28 days (also reported as 22 days) after the administration of Rotateq, the patient developed intussusception requiring surgical reduction and was hospitalized. The child was transferred from the local hospital for a several day history of intermittent vomiting and pain as shown by crying and curling up of his legs. Upon admission, he was somnolent and lethargic. He had episodes of bilious emesis and currant jelly stools. The patient was also dehydrated. Physical examination revealed a soft, mildly distend abdomen with tenderness to palpation in the right mid and lower abdomen. Hypoactive bowel sounds were noted. No masses were noted. The exam was otherwise within normal limits. Xray of the abdomen revealed multiple dilated loops of the small bowel. No gas in the right colon. The child was taken to surgery for a laparoscopic reduction of intussusception. Post operative diagnosis was intussusception. The relation to Rotateq was questioned. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the agency and was released. Intussusception was considered life threatening. Additional information has been requested.
Age: 0.2
Sex: U
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Abdominal distension, Abdominal tenderness, Bowel sounds abnormal, Crying, Dehydration
Clinical narrative: Information has been received concerning a 13-week-old patient who on 14-FEB-2007 was vaccinated with a first dose of Rotateq (Lot # 655485/1033F). On 08-MAR-2007 the patient experienced intussusception and had a surgical reduction. Follow up information received concerning a 2-month-old patient with no past medical history and no allergies, who on 14-FEB-2007 was vaccinated PO with a first dose of Rotateq (Lot # 655485/1033F). Concomitant vaccinations that day included a first dose of PEDIARIX (Lot # AC21B028AA), a first dose of HIBERIX (Lot # 1015), and a first dose of PREVNAR (Lot # B36258C). There were no other concomitant medications. On 08-MAR-2007, 28 days (also reported as 22 days) after the administration of Rotateq, the patient developed intussusception requiring surgical reduction and was hospitalized. The child was transferred from the local hospital for a several day history of intermittent vomiting and pain as shown by crying and curling up of his legs. Upon admission, he was somnolent and lethargic. He had episodes of bilious emesis and currant jelly stools. The patient was also dehydrated. Physical examination revealed a soft, mildly distend abdomen with tenderness to palpation in the right mid and lower abdomen. Hypoactive bowel sounds were noted. No masses were noted. The exam was otherwise within normal limits. Xray of the abdomen revealed multiple dilated loops of the small bowel. No gas in the right colon. The child was taken to surgery for a laparoscopic reduction of intussusception. Post operative diagnosis was intussusception. The relation to Rotateq was questioned. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the agency and was released. Intussusception was considered life threatening. Additional information has been requested.
Age: 0.2
Sex: U
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Flatulence, Intussusception, Lethargy, Mucous stools, Pain
Clinical narrative: Information has been received concerning a 13-week-old patient who on 14-FEB-2007 was vaccinated with a first dose of Rotateq (Lot # 655485/1033F). On 08-MAR-2007 the patient experienced intussusception and had a surgical reduction. Follow up information received concerning a 2-month-old patient with no past medical history and no allergies, who on 14-FEB-2007 was vaccinated PO with a first dose of Rotateq (Lot # 655485/1033F). Concomitant vaccinations that day included a first dose of PEDIARIX (Lot # AC21B028AA), a first dose of HIBERIX (Lot # 1015), and a first dose of PREVNAR (Lot # B36258C). There were no other concomitant medications. On 08-MAR-2007, 28 days (also reported as 22 days) after the administration of Rotateq, the patient developed intussusception requiring surgical reduction and was hospitalized. The child was transferred from the local hospital for a several day history of intermittent vomiting and pain as shown by crying and curling up of his legs. Upon admission, he was somnolent and lethargic. He had episodes of bilious emesis and currant jelly stools. The patient was also dehydrated. Physical examination revealed a soft, mildly distend abdomen with tenderness to palpation in the right mid and lower abdomen. Hypoactive bowel sounds were noted. No masses were noted. The exam was otherwise within normal limits. Xray of the abdomen revealed multiple dilated loops of the small bowel. No gas in the right colon. The child was taken to surgery for a laparoscopic reduction of intussusception. Post operative diagnosis was intussusception. The relation to Rotateq was questioned. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the agency and was released. Intussusception was considered life threatening. Additional information has been requested.
Age: 0.2
Sex: U
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Small intestinal obstruction, Somnolence, Surgery, Urinary system X-ray, Vomiting
Clinical narrative: Information has been received concerning a 13-week-old patient who on 14-FEB-2007 was vaccinated with a first dose of Rotateq (Lot # 655485/1033F). On 08-MAR-2007 the patient experienced intussusception and had a surgical reduction. Follow up information received concerning a 2-month-old patient with no past medical history and no allergies, who on 14-FEB-2007 was vaccinated PO with a first dose of Rotateq (Lot # 655485/1033F). Concomitant vaccinations that day included a first dose of PEDIARIX (Lot # AC21B028AA), a first dose of HIBERIX (Lot # 1015), and a first dose of PREVNAR (Lot # B36258C). There were no other concomitant medications. On 08-MAR-2007, 28 days (also reported as 22 days) after the administration of Rotateq, the patient developed intussusception requiring surgical reduction and was hospitalized. The child was transferred from the local hospital for a several day history of intermittent vomiting and pain as shown by crying and curling up of his legs. Upon admission, he was somnolent and lethargic. He had episodes of bilious emesis and currant jelly stools. The patient was also dehydrated. Physical examination revealed a soft, mildly distend abdomen with tenderness to palpation in the right mid and lower abdomen. Hypoactive bowel sounds were noted. No masses were noted. The exam was otherwise within normal limits. Xray of the abdomen revealed multiple dilated loops of the small bowel. No gas in the right colon. The child was taken to surgery for a laparoscopic reduction of intussusception. Post operative diagnosis was intussusception. The relation to Rotateq was questioned. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the agency and was released. Intussusception was considered life threatening. Additional information has been requested.
Age: 0.2
Sex: U
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: X-ray abnormal
Clinical narrative: Information has been received concerning a 13-week-old patient who on 14-FEB-2007 was vaccinated with a first dose of Rotateq (Lot # 655485/1033F). On 08-MAR-2007 the patient experienced intussusception and had a surgical reduction. Follow up information received concerning a 2-month-old patient with no past medical history and no allergies, who on 14-FEB-2007 was vaccinated PO with a first dose of Rotateq (Lot # 655485/1033F). Concomitant vaccinations that day included a first dose of PEDIARIX (Lot # AC21B028AA), a first dose of HIBERIX (Lot # 1015), and a first dose of PREVNAR (Lot # B36258C). There were no other concomitant medications. On 08-MAR-2007, 28 days (also reported as 22 days) after the administration of Rotateq, the patient developed intussusception requiring surgical reduction and was hospitalized. The child was transferred from the local hospital for a several day history of intermittent vomiting and pain as shown by crying and curling up of his legs. Upon admission, he was somnolent and lethargic. He had episodes of bilious emesis and currant jelly stools. The patient was also dehydrated. Physical examination revealed a soft, mildly distend abdomen with tenderness to palpation in the right mid and lower abdomen. Hypoactive bowel sounds were noted. No masses were noted. The exam was otherwise within normal limits. Xray of the abdomen revealed multiple dilated loops of the small bowel. No gas in the right colon. The child was taken to surgery for a laparoscopic reduction of intussusception. Post operative diagnosis was intussusception. The relation to Rotateq was questioned. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the agency and was released. Intussusception was considered life threatening. Additional information has been requested.
Age: 0.2
Sex: U
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Enema administration, Intussusception, Laboratory test, Ultrasound scan
Clinical narrative: Information has been received concerning a 14-week-old patient who on 23-JAN-2007 was vaccinated with a first dose of Rotateq (Lot # 655407/1115P). On 10-MAR-2007 the patient experienced intussusception. A barium enema was done. Information has been received from one agency through another. On 23-JAN-2007, the patient was vaccinated with a first dose of Rotateq (Lot # 655407/1115F). Concomitant vaccinations that day included PEDIARIX (Lot # AC21B089AA), ACTHIB (Lot # UF052AA), and PREVNAR (Lot # B08666A). On 10-MAR-2007, 46 days post vaccination, the patient developed intussusception and was hospitalized. The patient was noted to have a 2 day history of bloody stools. Physician exam was within normal limits, abdomen soft, nondistended, and nontender. Admission diagnosis included bloody diarrhea, dehydration, abdominal pain, and vomiting. Intussusception was diagnosed by ultrasound. The patient was treated with enema, and was noted to have an ileocolonic intussusception with successful reduction by air enema. Labs were within normal limits. Cultures were negative. The patient recovered on 13-MAR-2007 and was discharged from the hospital on 20-MAR-2007. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the agency and was released. Additional information has been requested.
Age: 0.2
Sex: U
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Abdominal pain, Barium enema, Blood culture negative, Dehydration, Diarrhoea haemorrhagic
Clinical narrative: Information has been received concerning a 14-week-old patient who on 23-JAN-2007 was vaccinated with a first dose of Rotateq (Lot # 655407/1115P). On 10-MAR-2007 the patient experienced intussusception. A barium enema was done. Information has been received from one agency through another. On 23-JAN-2007, the patient was vaccinated with a first dose of Rotateq (Lot # 655407/1115F). Concomitant vaccinations that day included PEDIARIX (Lot # AC21B089AA), ACTHIB (Lot # UF052AA), and PREVNAR (Lot # B08666A). On 10-MAR-2007, 46 days post vaccination, the patient developed intussusception and was hospitalized. The patient was noted to have a 2 day history of bloody stools. Physician exam was within normal limits, abdomen soft, nondistended, and nontender. Admission diagnosis included bloody diarrhea, dehydration, abdominal pain, and vomiting. Intussusception was diagnosed by ultrasound. The patient was treated with enema, and was noted to have an ileocolonic intussusception with successful reduction by air enema. Labs were within normal limits. Cultures were negative. The patient recovered on 13-MAR-2007 and was discharged from the hospital on 20-MAR-2007. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the agency and was released. Additional information has been requested.
Age: 0.2
Sex: U
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Haematochezia, Intussusception, Ultrasound abdomen abnormal, Vomiting, X-ray abnormal
Clinical narrative: Information has been received concerning a 14-week-old patient who on 23-JAN-2007 was vaccinated with a first dose of Rotateq (Lot # 655407/1115P). On 10-MAR-2007 the patient experienced intussusception. A barium enema was done. Information has been received from one agency through another. On 23-JAN-2007, the patient was vaccinated with a first dose of Rotateq (Lot # 655407/1115F). Concomitant vaccinations that day included PEDIARIX (Lot # AC21B089AA), ACTHIB (Lot # UF052AA), and PREVNAR (Lot # B08666A). On 10-MAR-2007, 46 days post vaccination, the patient developed intussusception and was hospitalized. The patient was noted to have a 2 day history of bloody stools. Physician exam was within normal limits, abdomen soft, nondistended, and nontender. Admission diagnosis included bloody diarrhea, dehydration, abdominal pain, and vomiting. Intussusception was diagnosed by ultrasound. The patient was treated with enema, and was noted to have an ileocolonic intussusception with successful reduction by air enema. Labs were within normal limits. Cultures were negative. The patient recovered on 13-MAR-2007 and was discharged from the hospital on 20-MAR-2007. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the agency and was released. Additional information has been requested.
Age: 0.2
Sex: U
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Abdominal pain, Barium double contrast, Blood culture negative, Dehydration, Diarrhoea haemorrhagic
Clinical narrative: Information has been received concerning a 14-week-old patient who on 23-JAN-2007 was vaccinated with a first dose of Rotateq (Lot # 655407/1115P). On 10-MAR-2007 the patient experienced intussusception. A barium enema was done. Information has been received from one agency through another. On 23-JAN-2007, the patient was vaccinated with a first dose of Rotateq (Lot # 655407/1115F). Concomitant vaccinations that day included PEDIARIX (Lot # AC21B089AA), ACTHIB (Lot # UF052AA), and PREVNAR (Lot # B08666A). On 10-MAR-2007, 46 days post vaccination, the patient developed intussusception and was hospitalized. The patient was noted to have a 2 day history of bloody stools. Physician exam was within normal limits, abdomen soft, nondistended, and nontender. Admission diagnosis included bloody diarrhea, dehydration, abdominal pain, and vomiting. Intussusception was diagnosed by ultrasound. The patient was treated with enema, and was noted to have an ileocolonic intussusception with successful reduction by air enema. Labs were within normal limits. Cultures were negative. The patient recovered on 13-MAR-2007 and was discharged from the hospital on 20-MAR-2007. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the agency and was released. Additional information has been requested.
Age: 0.2
Sex: U
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Enema administration, Haematochezia, Intussusception, Laboratory test, Ultrasound scan abnormal
Clinical narrative: Information has been received concerning a 14-week-old patient who on 23-JAN-2007 was vaccinated with a first dose of Rotateq (Lot # 655407/1115P). On 10-MAR-2007 the patient experienced intussusception. A barium enema was done. Information has been received from one agency through another. On 23-JAN-2007, the patient was vaccinated with a first dose of Rotateq (Lot # 655407/1115F). Concomitant vaccinations that day included PEDIARIX (Lot # AC21B089AA), ACTHIB (Lot # UF052AA), and PREVNAR (Lot # B08666A). On 10-MAR-2007, 46 days post vaccination, the patient developed intussusception and was hospitalized. The patient was noted to have a 2 day history of bloody stools. Physician exam was within normal limits, abdomen soft, nondistended, and nontender. Admission diagnosis included bloody diarrhea, dehydration, abdominal pain, and vomiting. Intussusception was diagnosed by ultrasound. The patient was treated with enema, and was noted to have an ileocolonic intussusception with successful reduction by air enema. Labs were within normal limits. Cultures were negative. The patient recovered on 13-MAR-2007 and was discharged from the hospital on 20-MAR-2007. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the agency and was released. Additional information has been requested.
Age: 0.2
Sex: U
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Vomiting, X-ray abnormal
Clinical narrative: Information has been received concerning a 14-week-old patient who on 23-JAN-2007 was vaccinated with a first dose of Rotateq (Lot # 655407/1115P). On 10-MAR-2007 the patient experienced intussusception. A barium enema was done. Information has been received from one agency through another. On 23-JAN-2007, the patient was vaccinated with a first dose of Rotateq (Lot # 655407/1115F). Concomitant vaccinations that day included PEDIARIX (Lot # AC21B089AA), ACTHIB (Lot # UF052AA), and PREVNAR (Lot # B08666A). On 10-MAR-2007, 46 days post vaccination, the patient developed intussusception and was hospitalized. The patient was noted to have a 2 day history of bloody stools. Physician exam was within normal limits, abdomen soft, nondistended, and nontender. Admission diagnosis included bloody diarrhea, dehydration, abdominal pain, and vomiting. Intussusception was diagnosed by ultrasound. The patient was treated with enema, and was noted to have an ileocolonic intussusception with successful reduction by air enema. Labs were within normal limits. Cultures were negative. The patient recovered on 13-MAR-2007 and was discharged from the hospital on 20-MAR-2007. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the agency and was released. Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Autopsy, Diarrhoea, Respiratory arrest, Unresponsive to stimuli
Clinical narrative: Pt found in parents bed, face down, not breathing, unresponsive on 5/6/07 at 9am. Mom called office 5/4/07 pt had been having 1 episode diarrhea daily since 4/31/07. No vomiting, no fever, no other signs of illness.  5/15/07 Received vax records from provider which corrected Lot number of RO & & confirmed dose as number 1.  VAERS database updated.  6/25/07 SIDS per Proof of Death letter from ME (reported cosleeping w/parents in adult bed, found face down in pillow).  Manner of death undetermined.
Age: 0.3
Sex: M
Vaccine: DTAP, DTAPHEPBIP, HEP, HIBV, PNC
Symptoms: Abscess, Erythema, Infection, Local reaction, Mass
Clinical narrative: This case was reported by a nurse on behalf of an immunologist, and described the occurrence of double sterile abscesses in a 4 to 5-month-old male subject who was vaccinated with Pediarix, or Infanrix plus Engerix B for Prophylaxis. The nurse stated that it was uncertain whether the subject was vaccinated with Pediarix or alternatively with Infanrix Plus Engerix-B, but stated that the manufacturer was known. On 07 March 2007, the subject was also vaccinated with Hib vaccine (manufacturer unspecified) and Prevnar. On 7 March 2007 the subject received his "four month" vaccines including unspecified dose of Pediarix (unknown, unknown thigh), or unspecified dose of Infanrix (unknown, unknown thigh) plus unspecified dose of Engerix B (unknown, unknown thigh). In 2007, at an unspecified time after vaccination with Engerix B - Infanrix or Pediarix, the subject developed double sterile abscesses. Following vaccination on 07 March 2007, the subject developed a hard mass on both thighs and a "large local reaction". The subject subsequently developed infection, and the areas became "raised, red, and almost puffy". On 28 April 2007 the subject was evaluated by a pediatric surgeon, who reportedly felt the reaction was related to the vaccinations. The abscesses required surgical intervention, and were removed. The subject was hospitalized and the healthcare professional considered the events were clinically significant (or requiring intervention). At the time of reporting the events were resolved. The healthcare professional stated that the pediatric surgeon considered the events were related to vaccination with Pediarix, or Infanrix plus Engerix B. The healthcare professional also stated that the double sterile abscess were unrelated to vaccination with Pediarix, or Infanrix plus Engerix B.
Age: 0.3
Sex: M
Vaccine: DTAP, DTAPHEPBIP, HEP, HIBV, PNC
Symptoms: Surgery, Swelling, Vaccination complication
Clinical narrative: This case was reported by a nurse on behalf of an immunologist, and described the occurrence of double sterile abscesses in a 4 to 5-month-old male subject who was vaccinated with Pediarix, or Infanrix plus Engerix B for Prophylaxis. The nurse stated that it was uncertain whether the subject was vaccinated with Pediarix or alternatively with Infanrix Plus Engerix-B, but stated that the manufacturer was known. On 07 March 2007, the subject was also vaccinated with Hib vaccine (manufacturer unspecified) and Prevnar. On 7 March 2007 the subject received his "four month" vaccines including unspecified dose of Pediarix (unknown, unknown thigh), or unspecified dose of Infanrix (unknown, unknown thigh) plus unspecified dose of Engerix B (unknown, unknown thigh). In 2007, at an unspecified time after vaccination with Engerix B - Infanrix or Pediarix, the subject developed double sterile abscesses. Following vaccination on 07 March 2007, the subject developed a hard mass on both thighs and a "large local reaction". The subject subsequently developed infection, and the areas became "raised, red, and almost puffy". On 28 April 2007 the subject was evaluated by a pediatric surgeon, who reportedly felt the reaction was related to the vaccinations. The abscesses required surgical intervention, and were removed. The subject was hospitalized and the healthcare professional considered the events were clinically significant (or requiring intervention). At the time of reporting the events were resolved. The healthcare professional stated that the pediatric surgeon considered the events were related to vaccination with Pediarix, or Infanrix plus Engerix B. The healthcare professional also stated that the double sterile abscess were unrelated to vaccination with Pediarix, or Infanrix plus Engerix B.
Age: 0.67
Sex: M
Vaccine: RV5
Symptoms: Diarrhoea, Haematochezia, Inappropriate schedule of drug administration, Laboratory test abnormal
Clinical narrative: Information has been received from a physician concerning a n 8-month-old male with a history of gastrooesophageal reflux who was vaccinated PO with a second dose of Rotateq. Subsequently the patient experienced diarrhea with a lot of mucous. The patient tested positive for blood in Stool. The symptoms lasted for a month and the patient was still experiencing mucous. The physician did not give a third dose to the patient. The outcome is recovering. There was no product quality complaint. Upon internal review, blood in stool was considered to be an other important medical event. Additional information has been requested.
Age: 1.1
Sex: M
Vaccine: MMRV, MMRV, PNC
Symptoms: Blister, Cellulitis, Incisional drainage, Rash, Staphylococcal infection
Clinical narrative: Information has been received from a physician concerning a 13-month-old male with no pertinent medical history who on 05-APR-2007 was vaccinated with a dose of ProQuad. There were no concomitant therapies. On 19-APR-2007 the patient experienced a generalized varicella rash. The rash was not localized around the injection site, but rather generalized at the trunk and leg. One vesicle developed into a methycillin-resistant staphylococcus aureus (MRSA) (onset-23-APR-2007). The patient was seen daily by the physician at the office from 20-APR-2007 to 23-APR-2007 for cellulitis at one of his legs. On 23-APR-2007, the patient was admitted to the hospital for cellulitis, and was treated with several courses of antibiotics. He had an incision and the doctors drained about 15cc of fluid from the thigh. The outcome was reported as not recovered. There was no product quality complaint. The event were considered to be other important medical events by the reporter. Additional information has been requested.
Age: 1.1
Sex: M
Vaccine: MMRV, MMRV, PNC
Symptoms: Varicella
Clinical narrative: Information has been received from a physician concerning a 13-month-old male with no pertinent medical history who on 05-APR-2007 was vaccinated with a dose of ProQuad. There were no concomitant therapies. On 19-APR-2007 the patient experienced a generalized varicella rash. The rash was not localized around the injection site, but rather generalized at the trunk and leg. One vesicle developed into a methycillin-resistant staphylococcus aureus (MRSA) (onset-23-APR-2007). The patient was seen daily by the physician at the office from 20-APR-2007 to 23-APR-2007 for cellulitis at one of his legs. On 23-APR-2007, the patient was admitted to the hospital for cellulitis, and was treated with several courses of antibiotics. He had an incision and the doctors drained about 15cc of fluid from the thigh. The outcome was reported as not recovered. There was no product quality complaint. The event were considered to be other important medical events by the reporter. Additional information has been requested.
Age: 1.1
Sex: M
Vaccine: MMRV, MMRV, PNC
Symptoms: Abscess, Abscess drainage, Antimicrobial susceptibility test resistant, Cellulitis, Injection site vesicles
Clinical narrative: Information has been received from a physician concerning a 13-month-old male with no pertinent medical history who on 05-APR-2007 was vaccinated with a dose of ProQuad. There were no concomitant therapies. On 19-APR-2007 the patient experienced a generalized varicella rash. The rash was not localized around the injection site, but rather generalized at the trunk and leg. One vesicle developed into a methycillin-resistant staphylococcus aureus (MRSA) (onset-23-APR-2007). The patient was seen daily by the physician at the office from 20-APR-2007 to 23-APR-2007 for cellulitis at one of his legs. On 23-APR-2007, the patient was admitted to the hospital for cellulitis, and was treated with several courses of antibiotics. He had an incision and the doctors drained about 15cc of fluid from the thigh. The outcome was reported as not recovered. There was no product quality complaint. The event were considered to be other important medical events by the reporter. Additional information has been requested.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Pain, Pyrexia
Clinical narrative: Woke up 4/11/07 with 102 fever, body aches and redness, induration at site right deltoid and shoulder. Resolved after approx. 12 hours.
Age: 52.0
Sex: M
Vaccine: TDAP
Symptoms: Abdominal pain, Blood pressure increased, Chills, Headache, Injection site pain
Clinical narrative: H/A, abd pain, fever, chills, increased BP, pain and swelling at injection site
Age: 52.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site swelling, Pyrexia
Clinical narrative: H/A, abd pain, fever, chills, increased BP, pain and swelling at injection site
Sex: F
Vaccine: SMALL
Symptoms: Secondary transmission
Clinical narrative: Apparently a woman he had sex with a few days after he received smallpox vaccination in his left upper arm subsequently developed vulvar vaccinia. See attached MMWR report of this incident.
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Redness, erythema and induration 3 x 6 cm at site of MMRV, just below DaPT
Age: 0.5
Sex: F
Vaccine: DTAP, PNC, RV5
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: Hives began 5/9/07 PM on Left thigh around injection site and spread to rest of body. Instructed to continue Benadryl and given Oraped 15/5, 1 tsp. PO QDAY X 3 days
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Nausea
Clinical narrative: c/o lightheaded, dizzy nausea (L) BP 110/60 (R) BR 104/60
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Autopsy
Clinical narrative: Reported to me by another PT on about 4/23/07 that patient had died and autopsy was consistent with SIDS. Parents have not returned our calls.  6/21/07 Received vax record from PCP which confirms RO lot & dose number as reported.  8/10/07 Received autopsy report which reveals COD as Undetermined & manner of death as undetermined.  Final dx: infant w/age appropriate weight & development found unresponsive while co-sleeping in adult bed in prone sleeping position.
Age: 4.0
Sex: F
Vaccine: DTAP, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling on RVL day after shot. Redness and swelling spread day 2 no treatment needed