This is VAERS ID 296422

History of Changes from the VAERS Wayback Machine

First Appeared on 12/31/2007

Vaccin­ation / Manu­facturer	Lot / Dose	Site / Route
DTAPHE: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS	AC21B113AA / 1	LL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC.	1435T / 1	LL / IM
PNC: PNEUMO (PREVNAR) / WYETH PHARMACEUTICALS, INC	B08689K / 1	RL / IM
ROTHB5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC.	0241U / 1	- / PO

Administered by: Other      Purchased by: Unknown
Symptoms: Abdominal mass, Abdominal tenderness, Asthenia, Blood bicarbonate decreased, Blood culture negative

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? Yes
ER or ED Visit (V2.0)? No
Hospitalized? Yes, days: 4     Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: KUB X-ray 06/11/07 - decreased air in colon, diagnostic laboratory 06/10/07 - decreased bowel sounds, doughy abdomen; laboratory test 06/10/07 - bloodwork, stool culture 06/11/07 - negative
CDC 'Split Type':

Write-up: Information has been received from a physician concerning a 17 week old female who in April 2007 and June 2007, was vaccinated PO with her first and second (lot# 656705/0241U) doses of Rotateq. Vaccinations at two months of age included /"other 2 month re"commended vaccines./" On 05-JUL-2007 the patient was diagnosed with intussusception, was hospitalized and underwent emergency surgery. Subsequently, the patient recovered. It was noted that the patient did not have any adverse experience after the first d

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Changed on 12/8/2009

Vaccin­ation / Manu­facturer	Lot / Dose	Site / Route
DTAPHE: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS	AC21B113AA / 1	LL / IM
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS	AC21B113AA / 1	LL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC.	1435T / 1	LL / IM
PNC: PNEUMO (PREVNAR) / WYETH PHARMACEUTICALS, INC	B08689K / 1	RL / IM
ROTHB5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC.	0241U / 1	- / PO

Administered by: Other      Purchased by: Unknown Other
Symptoms: Abdominal mass, Abdominal tenderness, Asthenia, Blood bicarbonate decreased, Blood culture negative, Body temperature increased, Colonic polyp, Culture stool, Culture stool negative, Culture urine negative, Dehydration, Diarrhoea, Full blood count, Gastroenteritis, Haematochezia, Hepatomegaly, Intussusception, Laboratory test abnormal, Lethargy, Mucous stools, Pyrexia, Somnolence, Surgery, Urinary system X-ray, Vomiting, White blood cell count, Enema administration, Blood test normal, Explorative laparotomy, Intestinal anastomosis, Urine output decreased, Ischaemia, Histology abnormal, Metabolic function test, Gastrointestinal sounds abnormal

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? Yes
ER or ED Visit (V2.0)? No
Hospitalized? Yes, days: 4     Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown Unknown. PMH: none. NKDA.
Allergies:
Diagnostic Lab Data: KUB X-ray 06/11/07 - decreased air in colon, diagnostic laboratory 06/10/07 - decreased bowel sounds, doughy abdomen; laboratory test 06/10/07 - bloodwork, stool culture 06/11/07 - negative negative. Labs and Diagnostics: Abd X-ray with non-specifi
CDC 'Split Type': (blank) WAES0711USA00221

Write-up: Information has been received from a physician concerning a 17 week old female who in April 2007 and June 2007, was vaccinated PO with her first and second (lot# 656705/0241U) doses of Rotateq. Vaccinations at two months of age included /"other "other 2 month re"commended vaccines./" recommended vaccines." On 05-JUL-2007 the patient was diagnosed with intussusception, was hospitalized and underwent emergency surgery. Subsequently, the patient recovered. It was noted that the patient did not have any adverse experience after the first d dose two months earlier. There was no product quality complaint. The event was also considered to be an other important medical event (surgery) by the reporter. Follow-up information has been received from a physician indicating that the patient was vaccinated on 03-APR-2007 and 05-JUN-2007 with the first (lot# 655483/1116F) and second dose of Rotateq. Concomitant vaccinations administered on 05-JUN-2007 included a dose of PedvaxHIB, a dose of Pediarix and a dose of Prevnar. On 08-JUN-2007 the course of events were as follows: the patient had a two day history of diarrhea, non-bloody vomiting, decreased urinary output, was lethargic and sleepy, and had a low grade temperature. The patient presented to the emergency room on 10-JUN-2007 and was given fluids, blood work was done (results and specific tests not provided). On exam the patient had decreased bowel sounds and a doughy abdomen. A KUB was performed and showed decreased air in the colon. The passed a bloody mucous jelly stool in the ER. The patient was then transferred from the ER to another hospital for evaluation of intussusception. The patient was admitted to the hospital on 11-JUN-2007 and underwent surgery. Stool cultures performed while the patient was hospitalized were negative. The physician stated that the patient is "fine." On approximately 01-JUL-2007 (in the beginning of July), the patient seen by the surgeon who reported that the intussusception was "completely resolved." It was also noted that the surgeon "did not anticipate further problems." Ad

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Changed on 3/2/2010

Vaccin­ation / Manu­facturer	Lot / Dose	Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS	AC21B113AA / 1	LL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC.	1435T / 1	LL / IM
PNC: PNEUMO (PREVNAR) PNEUMO (PREVNAR7) / WYETH PHARMACEUTICALS, INC	B08689K / 1	RL / IM
ROTHB5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC.	0241U / 1	- / PO

Administered by: Other      Purchased by: Other
Symptoms: Abdominal mass, Abdominal tenderness, Asthenia, Blood bicarbonate decreased, Blood culture negative, Body temperature increased, Colonic polyp, Culture stool, Culture stool negative, Culture urine negative, Dehydration, Diarrhoea, Full blood count, Gastroenteritis, Haematochezia, Hepatomegaly, Intussusception, Laboratory test abnormal, Lethargy, Mucous stools, Pyrexia, Somnolence, Surgery, Urinary system X-ray, Vomiting, White blood cell count, Enema administration, Blood test normal, Explorative laparotomy, Intestinal anastomosis, Urine output decreased, Ischaemia, Histology abnormal, Metabolic function test, Gastrointestinal sounds abnormal

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? Yes
ER or ED Visit (V2.0)? No
Hospitalized? Yes, days: 4     Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown. PMH: none. NKDA.
Allergies:
Diagnostic Lab Data: KUB X-ray 06/11/07 - decreased air in colon, diagnostic laboratory 06/10/07 - decreased bowel sounds, doughy abdomen; laboratory test 06/10/07 - bloodwork, stool culture 06/11/07 - negative. Labs and Diagnostics: Abd X-ray with non-specifi
CDC 'Split Type': WAES0711USA00221

Write-up: Information has been received from a physician concerning a 17 week old female who in April 2007 and June 2007, was vaccinated PO with her first and second (lot# 656705/0241U) doses of Rotateq. Vaccinations at two months of age included "other 2 month recommended vaccines." On 05-JUL-2007 the patient was diagnosed with intussusception, was hospitalized and underwent emergency surgery. Subsequently, the patient recovered. It was noted that the patient did not have any adverse experience after the first dose two months earlier. There was no product quality complaint. The event was also considered to be an other important medical event (surgery) by the reporter. Follow-up information has been received from a physician indicating that the patient was vaccinated on 03-APR-2007 and 05-JUN-2007 with the first (lot# 655483/1116F) and second dose of Rotateq. Concomitant vaccinations administered on 05-JUN-2007 included a dose of PedvaxHIB, a dose of Pediarix and a dose of Prevnar. On 08-JUN-2007 the course of events were as follows: the patient had a two day history of diarrhea, non-bloody vomiting, decreased urinary output, was lethargic and sleepy, and had a low grade temperature. The patient presented to the emergency room on 10-JUN-2007 and was given fluids, blood work was done (results and specific tests not provided). On exam the patient had decreased bowel sounds and a doughy abdomen. A KUB was performed and showed decreased air in the colon. The passed a bloody mucous jelly stool in the ER. The patient was then transferred from the ER to another hospital for evaluation of intussusception. The patient was admitted to the hospital on 11-JUN-2007 and underwent surgery. Stool cultures performed while the patient was hospitalized were negative. The physician stated that the patient is "fine." On approximately 01-JUL-2007 (in the beginning of July), the patient seen by the surgeon who reported that the intussusception was "completely resolved." It was also noted that the surgeon "did not anticipate further problems." Ad

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Changed on 4/7/2010

Vaccin­ation / Manu­facturer	Lot / Dose	Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS	AC21B113AA / 1	LL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC.	1435T / 1	LL / IM
PNC: PNEUMO (PREVNAR7) PNEUMO (PREVNAR) / WYETH PHARMACEUTICALS, INC	B08689K / 1	RL / IM
ROTHB5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC.	0241U / 1	- / PO

Administered by: Other      Purchased by: Other
Symptoms: Abdominal mass, Abdominal tenderness, Asthenia, Blood bicarbonate decreased, Blood culture negative, Body temperature increased, Colonic polyp, Culture stool, Culture stool negative, Culture urine negative, Dehydration, Diarrhoea, Full blood count, Gastroenteritis, Haematochezia, Hepatomegaly, Intussusception, Laboratory test abnormal, Lethargy, Mucous stools, Pyrexia, Somnolence, Surgery, Urinary system X-ray, Vomiting, White blood cell count, Enema administration, Blood test normal, Explorative laparotomy, Intestinal anastomosis, Urine output decreased, Ischaemia, Histology abnormal, Metabolic function test, Gastrointestinal sounds abnormal

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? Yes
ER or ED Visit (V2.0)? No
Hospitalized? Yes, days: 4     Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown. PMH: none. NKDA.
Allergies:
Diagnostic Lab Data: KUB X-ray 06/11/07 - decreased air in colon, diagnostic laboratory 06/10/07 - decreased bowel sounds, doughy abdomen; laboratory test 06/10/07 - bloodwork, stool culture 06/11/07 - negative. Labs and Diagnostics: Abd X-ray with non-specifi
CDC 'Split Type': WAES0711USA00221

Write-up: Information has been received from a physician concerning a 17 week old female who in April 2007 and June 2007, was vaccinated PO with her first and second (lot# 656705/0241U) doses of Rotateq. Vaccinations at two months of age included "other 2 month recommended vaccines." On 05-JUL-2007 the patient was diagnosed with intussusception, was hospitalized and underwent emergency surgery. Subsequently, the patient recovered. It was noted that the patient did not have any adverse experience after the first dose two months earlier. There was no product quality complaint. The event was also considered to be an other important medical event (surgery) by the reporter. Follow-up information has been received from a physician indicating that the patient was vaccinated on 03-APR-2007 and 05-JUN-2007 with the first (lot# 655483/1116F) and second dose of Rotateq. Concomitant vaccinations administered on 05-JUN-2007 included a dose of PedvaxHIB, a dose of Pediarix and a dose of Prevnar. On 08-JUN-2007 the course of events were as follows: the patient had a two day history of diarrhea, non-bloody vomiting, decreased urinary output, was lethargic and sleepy, and had a low grade temperature. The patient presented to the emergency room on 10-JUN-2007 and was given fluids, blood work was done (results and specific tests not provided). On exam the patient had decreased bowel sounds and a doughy abdomen. A KUB was performed and showed decreased air in the colon. The passed a bloody mucous jelly stool in the ER. The patient was then transferred from the ER to another hospital for evaluation of intussusception. The patient was admitted to the hospital on 11-JUN-2007 and underwent surgery. Stool cultures performed while the patient was hospitalized were negative. The physician stated that the patient is "fine." On approximately 01-JUL-2007 (in the beginning of July), the patient seen by the surgeon who reported that the intussusception was "completely resolved." It was also noted that the surgeon "did not anticipate further problems." Ad

---

Changed on 8/31/2010

Vaccin­ation / Manu­facturer	Lot / Dose	Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS	AC21B113AA / 1	LL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC.	1435T / 1	LL / IM
PNC: PNEUMO (PREVNAR) / WYETH PHARMACEUTICALS, INC PFIZER/WYETH	B08689K / 1	RL / IM
ROTHB5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC.	0241U / 1	- / PO

Administered by: Other      Purchased by: Other
Symptoms: Abdominal mass, Abdominal tenderness, Asthenia, Blood bicarbonate decreased, Blood culture negative, Body temperature increased, Colonic polyp, Culture stool, Culture stool negative, Culture urine negative, Dehydration, Diarrhoea, Full blood count, Gastroenteritis, Haematochezia, Hepatomegaly, Intussusception, Laboratory test abnormal, Lethargy, Mucous stools, Pyrexia, Somnolence, Surgery, Urinary system X-ray, Vomiting, White blood cell count, Enema administration, Blood test normal, Explorative laparotomy, Intestinal anastomosis, Urine output decreased, Ischaemia, Histology abnormal, Metabolic function test, Gastrointestinal sounds abnormal

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? Yes
ER or ED Visit (V2.0)? No
Hospitalized? Yes, days: 4     Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown. PMH: none. NKDA.
Allergies:
Diagnostic Lab Data: KUB X-ray 06/11/07 - decreased air in colon, diagnostic laboratory 06/10/07 - decreased bowel sounds, doughy abdomen; laboratory test 06/10/07 - bloodwork, stool culture 06/11/07 - negative. Labs and Diagnostics: Abd X-ray with non-specifi
CDC 'Split Type': WAES0711USA00221

Write-up: Information has been received from a physician concerning a 17 week old female who in April 2007 and June 2007, was vaccinated PO with her first and second (lot# 656705/0241U) doses of Rotateq. Vaccinations at two months of age included "other 2 month recommended vaccines." On 05-JUL-2007 the patient was diagnosed with intussusception, was hospitalized and underwent emergency surgery. Subsequently, the patient recovered. It was noted that the patient did not have any adverse experience after the first dose two months earlier. There was no product quality complaint. The event was also considered to be an other important medical event (surgery) by the reporter. Follow-up information has been received from a physician indicating that the patient was vaccinated on 03-APR-2007 and 05-JUN-2007 with the first (lot# 655483/1116F) and second dose of Rotateq. Concomitant vaccinations administered on 05-JUN-2007 included a dose of PedvaxHIB, a dose of Pediarix and a dose of Prevnar. On 08-JUN-2007 the course of events were as follows: the patient had a two day history of diarrhea, non-bloody vomiting, decreased urinary output, was lethargic and sleepy, and had a low grade temperature. The patient presented to the emergency room on 10-JUN-2007 and was given fluids, blood work was done (results and specific tests not provided). On exam the patient had decreased bowel sounds and a doughy abdomen. A KUB was performed and showed decreased air in the colon. The passed a bloody mucous jelly stool in the ER. The patient was then transferred from the ER to another hospital for evaluation of intussusception. The patient was admitted to the hospital on 11-JUN-2007 and underwent surgery. Stool cultures performed while the patient was hospitalized were negative. The physician stated that the patient is "fine." On approximately 01-JUL-2007 (in the beginning of July), the patient seen by the surgeon who reported that the intussusception was "completely resolved." It was also noted that the surgeon "did not anticipate further problems." Ad

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Changed on 5/13/2013

Vaccin­ation / Manu­facturer	Lot / Dose	Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS	AC21B113AA / 1	LL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC.	1435T / 1	LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH	B08689K / 1	RL / IM
ROTHB5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC.	0241U / 1	- / PO
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC.	0241U / 1	- / PO

Administered by: Other      Purchased by: Other
Symptoms: Abdominal mass, Abdominal tenderness, Asthenia, Blood bicarbonate decreased, Blood culture negative, Body temperature increased, Colonic polyp, Culture stool, Culture stool negative, Culture urine negative, Dehydration, Diarrhoea, Full blood count, Gastroenteritis, Haematochezia, Hepatomegaly, Intussusception, Laboratory test abnormal, Lethargy, Mucous stools, Pyrexia, Somnolence, Surgery, Urinary system X-ray, Vomiting, White blood cell count, Enema administration, Blood test normal, Explorative laparotomy, Intestinal anastomosis, Urine output decreased, Ischaemia, Histology abnormal, Metabolic function test, Gastrointestinal sounds abnormal

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? Yes
ER or ED Visit (V2.0)? No
Hospitalized? Yes, days: 4     Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown. PMH: none. NKDA.
Allergies:
Diagnostic Lab Data: KUB X-ray 06/11/07 - decreased air in colon, diagnostic laboratory 06/10/07 - decreased bowel sounds, doughy abdomen; laboratory test 06/10/07 - bloodwork, stool culture 06/11/07 - negative. Labs and Diagnostics: Abd X-ray with non-specifi
CDC 'Split Type': WAES0711USA00221

Write-up: Information has been received from a physician concerning a 17 week old female who in April 2007 and June 2007, was vaccinated PO with her first and second (lot# 656705/0241U) doses of Rotateq. Vaccinations at two months of age included "other 2 month recommended vaccines." On 05-JUL-2007 the patient was diagnosed with intussusception, was hospitalized and underwent emergency surgery. Subsequently, the patient recovered. It was noted that the patient did not have any adverse experience after the first dose two months earlier. There was no product quality complaint. The event was also considered to be an other important medical event (surgery) by the reporter. Follow-up information has been received from a physician indicating that the patient was vaccinated on 03-APR-2007 and 05-JUN-2007 with the first (lot# 655483/1116F) and second dose of Rotateq. Concomitant vaccinations administered on 05-JUN-2007 included a dose of PedvaxHIB, a dose of Pediarix and a dose of Prevnar. On 08-JUN-2007 the course of events were as follows: the patient had a two day history of diarrhea, non-bloody vomiting, decreased urinary output, was lethargic and sleepy, and had a low grade temperature. The patient presented to the emergency room on 10-JUN-2007 and was given fluids, blood work was done (results and specific tests not provided). On exam the patient had decreased bowel sounds and a doughy abdomen. A KUB was performed and showed decreased air in the colon. The passed a bloody mucous jelly stool in the ER. The patient was then transferred from the ER to another hospital for evaluation of intussusception. The patient was admitted to the hospital on 11-JUN-2007 and underwent surgery. Stool cultures performed while the patient was hospitalized were negative. The physician stated that the patient is "fine." On approximately 01-JUL-2007 (in the beginning of July), the patient seen by the surgeon who reported that the intussusception was "completely resolved." It was also noted that the surgeon "did not anticipate further problems." Ad

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Changed on 2/14/2017

Vaccin­ation / Manu­facturer	Lot / Dose	Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS	AC21B113AA / 1	LL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC.	1435T / 1	LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH	B08689K / 1	RL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC.	0241U / 1	- / PO

Administered by: Other      Purchased by: Other
Symptoms: Abdominal mass, Abdominal tenderness, Asthenia, Blood bicarbonate decreased, Blood culture negative, Body temperature increased, Colonic polyp, Culture stool, Culture stool negative, Culture urine negative, Dehydration, Diarrhoea, Full blood count, Gastroenteritis, Haematochezia, Hepatomegaly, Intussusception, Laboratory test abnormal, Lethargy, Mucous stools, Pyrexia, Somnolence, Surgery, Urinary system X-ray, Vomiting, White blood cell count, Enema administration, Blood test normal, Explorative laparotomy, Intestinal anastomosis, Urine output decreased, Ischaemia, Histology abnormal, Metabolic function test, Gastrointestinal sounds abnormal

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? Yes
ER or ED Visit (V2.0)? No
Hospitalized? Yes, days: 4     Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown. PMH: none. NKDA.
Allergies:
Diagnostic Lab Data: KUB X-ray 06/11/07 - decreased air in colon, diagnostic laboratory 06/10/07 - decreased bowel sounds, doughy abdomen; laboratory test 06/10/07 - bloodwork, stool culture 06/11/07 - negative. Labs and Diagnostics: Abd X-ray with non-specifi non-specific gas pattern. ? hepatomegaly. Stool cx (-) with occ WBCs. UC (-). Blood cx (-). CBC with WBCs 9.3. BMP with bicarb 18. Labs and Diagnostics: Contrast enema (+) for IS, partially reduced. Surgical path report noted Cecum with mucosal hemorrhage and necrosis, c/w ischemic injury.
CDC 'Split Type': WAES0711USA00221

Write-up: Information has been received from a physician concerning a 17 week old female who in April 2007 and June 2007, was vaccinated PO with her first and second (lot# 656705/0241U) doses of Rotateq. Vaccinations at two months of age included "other 2 month recommended vaccines." On 05-JUL-2007 the patient was diagnosed with intussusception, was hospitalized and underwent emergency surgery. Subsequently, the patient recovered. It was noted that the patient did not have any adverse experience after the first dose two months earlier. There was no product quality complaint. The event was also considered to be an other important medical event (surgery) by the reporter. Follow-up information has been received from a physician indicating that the patient was vaccinated on 03-APR-2007 and 05-JUN-2007 with the first (lot# 655483/1116F) and second dose of Rotateq. Concomitant vaccinations administered on 05-JUN-2007 included a dose of PedvaxHIB, a dose of Pediarix and a dose of Prevnar. On 08-JUN-2007 the course of events were as follows: the patient had a two day history of diarrhea, non-bloody vomiting, decreased urinary output, was lethargic and sleepy, and had a low grade temperature. The patient presented to the emergency room on 10-JUN-2007 and was given fluids, blood work was done (results and specific tests not provided). On exam the patient had decreased bowel sounds and a doughy abdomen. A KUB was performed and showed decreased air in the colon. The passed a bloody mucous jelly stool in the ER. The patient was then transferred from the ER to another hospital for evaluation of intussusception. The patient was admitted to the hospital on 11-JUN-2007 and underwent surgery. Stool cultures performed while the patient was hospitalized were negative. The physician stated that the patient is "fine." On approximately 01-JUL-2007 (in the beginning of July), the patient seen by the surgeon who reported that the intussusception was "completely resolved." It was also noted that the surgeon "did not anticipate further problems." Ad Additional information has been requested. 11/15/2007 Vax record received from PCP and info updated in VAERS database. 12/21/2007 MR received for DOS 6/11/2007 with DX: Acute Gastroenteritis. Dehydration. Somewhat lethargic. Child presented to ER with 2 day hx of diarrhea, vomiting, low grade fever, and decreased UO and energy level. PE (+) for sleepiness, doughy abdomen with decreased BS, and a tubular mass in the LUQ. Bloody stool noted during admission, but pt D/C same day. No D/C Summ written. Child transfered to higher level of care. 12/31/07 MR received from transfer facility for DOS 6/11-14/2007 with primary DX: Cecal polyp from ischemia. Presented as above. IS noted on contrast enema, partially reduced. Taken to OR for exploratory lap for Intussusception. IS was reduced. Polyp noted in ileocecal valve which appeared to be acting as lead point. A limited ileoceccectomy was also performed. D/C on post-op day 3 in stable cond.

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Changed on 9/14/2017

Vaccin­ation / Manu­facturer	Lot / Dose	Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS	AC21B113AA / 1 2	LL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC.	1435T / 1 2	LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH	B08689K / 1 2	RL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC.	0241U / 1 2	- MO / PO

Administered by: Other      Purchased by: Other
Symptoms: Abdominal tenderness, Body temperature increased, Culture stool negative, Diarrhoea, Haematochezia, Intussusception, Laboratory test abnormal, Lethargy, Mucous stools, Somnolence, Surgery, Urinary system X-ray, Vomiting, Blood test normal, Urine output decreased, Gastrointestinal sounds abnormal

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? Yes
ER or ED Visit (V2.0)? No
Hospitalized? Yes, days: 4     Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown. PMH: none. NKDA.
Allergies:
Diagnostic Lab Data: KUB X-ray 06/11/07 - decreased air in colon, diagnostic laboratory 06/10/07 - decreased bowel sounds, doughy abdomen; laboratory test 06/10/07 - bloodwork, stool culture 06/11/07 - negative. Labs and Diagnostics: Abd X-ray with non-specific gas pattern. ? hepatomegaly. Stool cx (-) with occ WBCs. UC (-). Blood cx (-). CBC with WBCs 9.3. BMP with bicarb 18. Labs and Diagnostics: Contrast enema (+) for IS, partially reduced. Surgical path report noted Cecum with mucosal hemorrhage and necrosis, c/w ischemic injury.
CDC 'Split Type': WAES0711USA00221

Write-up: Information has been received from a physician concerning a 17 week old female who in April 2007 and June 2007, was vaccinated PO with her first and second (lot# 656705/0241U) doses of Rotateq. Vaccinations at two months of age included "other 2 month recommended vaccines." On 05-JUL-2007 the patient was diagnosed with intussusception, was hospitalized and underwent emergency surgery. Subsequently, the patient recovered. It was noted that the patient did not have any adverse experience after the first dose two months earlier. There was no product quality complaint. The event was also considered to be an other important medical event (surgery) by the reporter. Follow-up information has been received from a physician indicating that the patient was vaccinated on 03-APR-2007 and 05-JUN-2007 with the first (lot# 655483/1116F) and second dose of Rotateq. Concomitant vaccinations administered on 05-JUN-2007 included a dose of PedvaxHIB, a dose of Pediarix and a dose of Prevnar. On 08-JUN-2007 the course of events were as follows: the patient had a two day history of diarrhea, non-bloody vomiting, decreased urinary output, was lethargic and sleepy, and had a low grade temperature. The patient presented to the emergency room on 10-JUN-2007 and was given fluids, blood work was done (results and specific tests not provided). On exam the patient had decreased bowel sounds and a doughy abdomen. A KUB was performed and showed decreased air in the colon. The passed a bloody mucous jelly stool in the ER. The patient was then transferred from the ER to another hospital for evaluation of intussusception. The patient was admitted to the hospital on 11-JUN-2007 and underwent surgery. Stool cultures performed while the patient was hospitalized were negative. The physician stated that the patient is "fine." On approximately 01-JUL-2007 (in the beginning of July), the patient seen by the surgeon who reported that the intussusception was "completely resolved." It was also noted that the surgeon "did not anticipate further problems." Additional information has been requested. 11/15/2007 Vax record received from PCP and info updated in VAERS database. 12/21/2007 MR received for DOS 6/11/2007 with DX: Acute Gastroenteritis. Dehydration. Somewhat lethargic. Child presented to ER with 2 day hx of diarrhea, vomiting, low grade fever, and decreased UO and energy level. PE (+) for sleepiness, doughy abdomen with decreased BS, and a tubular mass in the LUQ. Bloody stool noted during admission, but pt D/C same day. No D/C Summ written. Child transfered to higher level of care. 12/31/07 MR received from transfer facility for DOS 6/11-14/2007 with primary DX: Cecal polyp from ischemia. Presented as above. IS noted on contrast enema, partially reduced. Taken to OR for exploratory lap for Intussusception. IS was reduced. Polyp noted in ileocecal valve which appeared to be acting as lead point. A limited ileoceccectomy was also performed. D/C on post-op day 3 in stable cond.

---

Changed on 2/14/2018

Vaccin­ation / Manu­facturer	Lot / Dose	Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS	AC21B113AA / 2	LL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC.	1435T / 2	LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH	B08689K / 2	RL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC.	0241U / 2	MO / PO

Administered by: Other      Purchased by: Other
Symptoms: Abdominal tenderness, Body temperature increased, Culture stool negative, Diarrhoea, Haematochezia, Intussusception, Laboratory test abnormal, Lethargy, Mucous stools, Somnolence, Surgery, Urinary system X-ray, Vomiting, Blood test normal, Urine output decreased, Gastrointestinal sounds abnormal

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? Yes
ER or ED Visit (V2.0)? No
Hospitalized? Yes, days: 4     Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown. PMH: none. NKDA.
Allergies:
Diagnostic Lab Data: KUB X-ray 06/11/07 - decreased air in colon, diagnostic laboratory 06/10/07 - decreased bowel sounds, doughy abdomen; laboratory test 06/10/07 - bloodwork, stool culture 06/11/07 - negative. Labs and Diagnostics: Abd X-ray with non-specific gas pattern. ? hepatomegaly. Stool cx (-) with occ WBCs. UC (-). Blood cx (-). CBC with WBCs 9.3. BMP with bicarb 18. Labs and Diagnostics: Contrast enema (+) for IS, partially reduced. Surgical path report noted Cecum with mucosal hemorrhage and necrosis, c/w ischemic injury.
CDC 'Split Type': WAES0711USA00221

Write-up: Information has been received from a physician concerning a 17 week old female who in April 2007 and June 2007, was vaccinated PO with her first and second (lot# 656705/0241U) doses of Rotateq. Vaccinations at two months of age included "other 2 month recommended vaccines." On 05-JUL-2007 the patient was diagnosed with intussusception, was hospitalized and underwent emergency surgery. Subsequently, the patient recovered. It was noted that the patient did not have any adverse experience after the first dose two months earlier. There was no product quality complaint. The event was also considered to be an other important medical event (surgery) by the reporter. Follow-up information has been received from a physician indicating that the patient was vaccinated on 03-APR-2007 and 05-JUN-2007 with the first (lot# 655483/1116F) and second dose of Rotateq. Concomitant vaccinations administered on 05-JUN-2007 included a dose of PedvaxHIB, a dose of Pediarix and a dose of Prevnar. On 08-JUN-2007 the course of events were as follows: the patient had a two day history of diarrhea, non-bloody vomiting, decreased urinary output, was lethargic and sleepy, and had a low grade temperature. The patient presented to the emergency room on 10-JUN-2007 and was given fluids, blood work was done (results and specific tests not provided). On exam the patient had decreased bowel sounds and a doughy abdomen. A KUB was performed and showed decreased air in the colon. The passed a bloody mucous jelly stool in the ER. The patient was then transferred from the ER to another hospital for evaluation of intussusception. The patient was admitted to the hospital on 11-JUN-2007 and underwent surgery. Stool cultures performed while the patient was hospitalized were negative. The physician stated that the patient is "fine." On approximately 01-JUL-2007 (in the beginning of July), the patient seen by the surgeon who reported that the intussusception was "completely resolved." It was also noted that the surgeon "did not anticipate further problems." Additional information has been requested. 11/15/2007 Vax record received from PCP and info updated in VAERS database. 12/21/2007 MR received for DOS 6/11/2007 with DX: Acute Gastroenteritis. Dehydration. Somewhat lethargic. Child presented to ER with 2 day hx of diarrhea, vomiting, low grade fever, and decreased UO and energy level. PE (+) for sleepiness, doughy abdomen with decreased BS, and a tubular mass in the LUQ. Bloody stool noted during admission, but pt D/C same day. No D/C Summ written. Child transfered to higher level of care. 12/31/07 MR received from transfer facility for DOS 6/11-14/2007 with primary DX: Cecal polyp from ischemia. Presented as above. IS noted on contrast enema, partially reduced. Taken to OR for exploratory lap for Intussusception. IS was reduced. Polyp noted in ileocecal valve which appeared to be acting as lead point. A limited ileoceccectomy was also performed. D/C on post-op day 3 in stable cond.

---

Changed on 6/14/2018

Vaccin­ation / Manu­facturer	Lot / Dose	Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS	AC21B113AA / 2	LL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC.	1435T / 2	LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH	B08689K / 2	RL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC.	0241U / 2	MO / PO

Administered by: Other      Purchased by: Other
Symptoms: Abdominal tenderness, Body temperature increased, Culture stool negative, Diarrhoea, Haematochezia, Intussusception, Laboratory test abnormal, Lethargy, Mucous stools, Somnolence, Surgery, Urinary system X-ray, Vomiting, Blood test normal, Urine output decreased, Gastrointestinal sounds abnormal

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? Yes
ER or ED Visit (V2.0)? No
Hospitalized? Yes, days: 4     Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown. PMH: none. NKDA.
Allergies:
Diagnostic Lab Data: KUB X-ray 06/11/07 - decreased air in colon, diagnostic laboratory 06/10/07 - decreased bowel sounds, doughy abdomen; laboratory test 06/10/07 - bloodwork, stool culture 06/11/07 - negative. Labs and Diagnostics: Abd X-ray with non-specific gas pattern. ? hepatomegaly. Stool cx (-) with occ WBCs. UC (-). Blood cx (-). CBC with WBCs 9.3. BMP with bicarb 18. Labs and Diagnostics: Contrast enema (+) for IS, partially reduced. Surgical path report noted Cecum with mucosal hemorrhage and necrosis, c/w ischemic injury.
CDC 'Split Type': WAES0711USA00221

Write-up: Information has been received from a physician concerning a 17 week old female who in April 2007 and June 2007, was vaccinated PO with her first and second (lot# 656705/0241U) doses of Rotateq. Vaccinations at two months of age included "other 2 month recommended vaccines." On 05-JUL-2007 the patient was diagnosed with intussusception, was hospitalized and underwent emergency surgery. Subsequently, the patient recovered. It was noted that the patient did not have any adverse experience after the first dose two months earlier. There was no product quality complaint. The event was also considered to be an other important medical event (surgery) by the reporter. Follow-up information has been received from a physician indicating that the patient was vaccinated on 03-APR-2007 and 05-JUN-2007 with the first (lot# 655483/1116F) and second dose of Rotateq. Concomitant vaccinations administered on 05-JUN-2007 included a dose of PedvaxHIB, a dose of Pediarix and a dose of Prevnar. On 08-JUN-2007 the course of events were as follows: the patient had a two day history of diarrhea, non-bloody vomiting, decreased urinary output, was lethargic and sleepy, and had a low grade temperature. The patient presented to the emergency room on 10-JUN-2007 and was given fluids, blood work was done (results and specific tests not provided). On exam the patient had decreased bowel sounds and a doughy abdomen. A KUB was performed and showed decreased air in the colon. The passed a bloody mucous jelly stool in the ER. The patient was then transferred from the ER to another hospital for evaluation of intussusception. The patient was admitted to the hospital on 11-JUN-2007 and underwent surgery. Stool cultures performed while the patient was hospitalized were negative. The physician stated that the patient is "fine." On approximately 01-JUL-2007 (in the beginning of July), the patient seen by the surgeon who reported that the intussusception was "completely resolved." It was also noted that the surgeon "did not anticipate further problems." Additional information has been requested. 11/15/2007 Vax record received from PCP and info updated in VAERS database. 12/21/2007 MR received for DOS 6/11/2007 with DX: Acute Gastroenteritis. Dehydration. Somewhat lethargic. Child presented to ER with 2 day hx of diarrhea, vomiting, low grade fever, and decreased UO and energy level. PE (+) for sleepiness, doughy abdomen with decreased BS, and a tubular mass in the LUQ. Bloody stool noted during admission, but pt D/C same day. No D/C Summ written. Child transfered to higher level of care. 12/31/07 MR received from transfer facility for DOS 6/11-14/2007 with primary DX: Cecal polyp from ischemia. Presented as above. IS noted on contrast enema, partially reduced. Taken to OR for exploratory lap for Intussusception. IS was reduced. Polyp noted in ileocecal valve which appeared to be acting as lead point. A limited ileoceccectomy was also performed. D/C on post-op day 3 in stable cond.

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