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Found 753 cases where Vaccine is RV5 and Symptom is Intussusception and Appearance Date on/before '2012-04-30'

Case Details

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VAERS ID: 319717 (history)  
Form: Version 1.0  
Age: 0.5  
Gender: Male  
Location: Kentucky  
Vaccinated:2008-07-02
Onset:2008-07-10
   Days after vaccination:8
Submitted: 2008-07-19
   Days after onset:9
Entered: 2008-07-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C2934BA / 3 LL / -
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UF373AB / 3 LL / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH C457211L / 3 RL / -
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 0211X / 3 MO / PO

Administered by: Unknown       Purchased by: Unknown
Symptoms: Barium double contrast, Intussusception
SMQs:, Gastrointestinal obstruction (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: PMH: eczema. NKDA
Allergies:
Diagnostic Lab Data: air enema diagnosed and treated the condition. Labs and Diagnostics: Abd X-ray (+) dilated bowel loops, Abd US (+) for IS in mid transverse colon. Air contrast enema (+) for IS. CBC WNL.
CDC Split Type:

Write-up: intussusception. 08/26/2008 MR received for DOS 7/10-11/2008 with D/C DX: Intussusception. Pt presented with 1 day hx of blood in stool and abdominal pain, fever, fussiness, nausea and vomiting. PE (+) for abdominal tenderness and guarding. Sent for air enema reduction following US (+) for IS. Reduction successful. D/C next day.


VAERS ID: 319862 (history)  
Form: Version 1.0  
Age: 0.34  
Gender: Male  
Location: California  
Vaccinated:2008-04-07
Onset:2008-05-22
   Days after vaccination:45
Submitted: 0000-00-00
Entered: 2008-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS AC14B060AB / 2 LL / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR A0127 / 2 RL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH C57539 / 2 RL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 1598U / 2 MO / PO

Administered by: Private       Purchased by: Public
Symptoms: Intussusception, Laparoscopy
SMQs:, Gastrointestinal obstruction (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: None
Current Illness: No
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Labs and Diagnostics: CT scan (+) for IS. Contrast enema (+) for IS. Abd X-ray suspicious for IS. CBC and Chem unremarkable.
CDC Split Type:

Write-up: Patient had intussusception on or before 5/24/08. Over a month after his second dose of rotavirus vaccine, he had failed reduction in a local facility, hence sent to hospital for laparoscopic reduction. 07/28/2008 MR received for DOS 5/23-24/2008 with D/C DX: Intussusception. Infant presented following transfer from another hospital with diarrhea, vomiting blood, blood in stool and decreased activity. PE (+) for a mass in the abdomen and rash. Contrast enema x 2 unable to fully reduce IS and pt taken to OR for Laparoscopic reduction of IS with appendectomy. F/U visit 6/9/08-doing well post-op. Labs and Diagnostics: CT scan (+) for IS. Contrast enema (+) for IS. Abd X-ray suspicious for IS. CBC and Chem unremarkable. 07/28/2008 MR received for DOS 5/23-24/2008 with D/C DX: Intussusception. Infant presented following transfer from another hospital with diarrhea, vomiting blood, blood in stool and decreased activity. PE (+) for a mass in the abdomen and rash. Contrast enema x 2 unable to fully reduce IS and pt taken to OR for Laparoscopic reduction of IS with appendectomy. F/U visit 6/9/08-doing well post-op.


VAERS ID: 320341 (history)  
Form: Version 1.0  
Age: 0.6  
Gender: Male  
Location: Unknown  
Vaccinated:2008-07-10
Onset:2008-07-15
   Days after vaccination:5
Submitted: 2008-07-23
   Days after onset:8
Entered: 2008-07-24
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS ACZ21B142 / 3 LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH C68310 / 3 RL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 02151X / 3 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Intussusception
SMQs:, Gastrointestinal obstruction (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 6 days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown 8/4/08-records received- Ultrasound suggested intussusception. Barium enema confirmed but unsuccessful reduction. Surgical reduction of ileocecal intussusception with necrotic ileoileal part resected. Stool positive for rotovirus. Labs WNL.
CDC Split Type: WAES0807USA03381

Write-up: Information has been received from a consumer concerning her son, a 6 month old male who on 10-JUL-2008 was vaccinated with his third dose of ROTATEQ (Lot # not reported). The consumer reported that her son had received his third dose of ROTATEQ on 10-JUL-2008. Approximately 24 hours after receiving dose, the patient experienced intussusception. The patient was rushed to the emergency room and needed surgery. He was hospitalized from 11-JUL-2008 to 16-JUL-2008. ROTATEQ was not reintroduced. The patient was considered to be not recovered. The reported considered intussusception as an other important medical event. There was no product quality complaint. Additional information has been requested.8/4/08-records received for DOS 7/16-7/22/08-DC DX: Intussusception. Laparotomy, small bowel resection, incidental appendectomy. Presented with C/O oen day history of fever, abdominal pain with intermittent crying, vomiting and blood in stool. Fussiness and abdominal distension.


VAERS ID: 320442 (history)  
Form: Version 1.0  
Age: 0.4  
Gender: Female  
Location: Kansas  
Vaccinated:2008-03-05
Onset:2008-03-05
   Days after vaccination:0
Submitted: 2008-07-24
   Days after onset:140
Entered: 2008-07-25
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C2797AA / 2 - / -
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UF20849B / 2 - / -
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR A0273 / 2 - / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH B540140 / 2 - / -
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 1664U / 2 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Inappropriate schedule of drug administration, Intussusception
SMQs:, Gastrointestinal obstruction (narrow), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown. PMH: none. NKDA.
Allergies:
Diagnostic Lab Data: Labs and Diagnostics: BE (+) for IS. Upper GI (+) for dilated bowel loops c/w obstruction. Abdominal CT obscured by barium. BMP with bicarb 15 and anion gap of 18. Stool and gastric occult blood (+).
CDC Split Type: WAES0807USA03859

Write-up: Information has been received from a physician concerning a 7 month old female patient who on 05-MAR-2008 was vaccinated orally with a second 2ml dose of ROTATEQ (lot # 659775/1664U). The first dose of ROTATEQ (lot # 657518/1192U) was administered on 18-NOV-2007. Subsequently, on 27-APR-2008 the patient had intussusception and was hospitalized until 29-APR-2008. It was unspecified if lab studies were performed. A surgical correction was done and the patient recovered on an unspecified date. There was no product quality complaint involved. Additional information has been requested. 8/11/2008 MR received for DOS 4/28-29/2008 with D/C DX: Intussusception. Infant presented with 24 hr hx of frequent emesis, intermittantly green with blood. Fussy for several days prior to admit. Later had bloody stool in hospital. Surgical consult noted fullness to abdomen with mass effect on R. BE done which identified and reduced an ileocecal IS. PO advanced post-procedure, tolerated well.


VAERS ID: 320443 (history)  
Form: Version 1.0  
Age: 0.5  
Gender: Male  
Location: Texas  
Vaccinated:2008-05-29
Onset:2008-07-15
   Days after vaccination:47
Submitted: 2008-07-24
   Days after onset:9
Entered: 2008-07-25
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B153AA / 3 RL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UF253AD / 3 LL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 0017X / 3 MO / PO
TTOX: TETANUS TOXOID (TEVAX) / GLAXOSMITHKLINE BIOLOGICALS C54269 / 1 LL / IM

Administered by: Other       Purchased by: Other
Symptoms: Intussusception
SMQs:, Gastrointestinal obstruction (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown 9/10/08-records received-Stool guaiac positive. Ultrasound abdomen demonstrated ileocolic intussusception right lower quadrant into right upper and left upper quadrants. Successful barium air enema reduction.
CDC Split Type: WAES0807USA03587

Write-up: Information has been received from a physician concerning a male who on 29-MAY-2008 was vaccinated po with the third dose of ROTATEQ. On 16-JUL-2008 the patient experienced intussusception. Patient sought medical attention from physician. The physician reported that the patient is "fine now". The patient recovered from intussusception (date unspecified). Upon internal review intussusception was determined to be an other important medical event. Additional information has been requested. 9/10/08-records received for DOS 7/16 and 7/17/08-DX:Intussusception. Presented to ED with 1 1/2 days of vomiting, wretching and bloody mucus stool. Abdominal pain and decreased oral intake. Returned later in day to ED with C/O small speck of blood in stool and fussy. Referred for follow up to PCP.


VAERS ID: 320464 (history)  
Form: Version 1.0  
Age: 0.34  
Gender: Male  
Location: Pennsylvania  
Vaccinated:2008-07-10
Onset:2008-07-14
   Days after vaccination:4
Submitted: 2008-07-21
   Days after onset:7
Entered: 2008-07-25
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (TRIPEDIA) / SANOFI PASTEUR C2953AA / 2 LL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UF446AA / 2 LL / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR A0836 / 2 RL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH C65931 / 2 RL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 1829U / 2 MO / PO

Administered by: Private       Purchased by: Private
Symptoms: Abdominal pain, Blood test, Intussusception, Vomiting
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal obstruction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: Atopic dermatitis/blocked tear duct L
Allergies:
Diagnostic Lab Data: Bloodwork; Xray 9/8/08-records received-Abdominal x-ray demonstrated dilated loops of small bowel with no air in colon consistent with small bowel obstruction. Air reduction barium enema for ileocolic intussusception successful.
CDC Split Type:

Write-up: Child received first dose ROTATEQ on 5-9-08. Child received 2nd dose ROTATEQ on 7-10-08. Child started with vomiting/colic on 7/14/08 - dx with intussusception which was reduced with an enema on 7/16/08 at hospital. 9/8/08-records received for DOS 7/16-7/17/08. DC DX: Intussusception. Dehydration. Received from another facility after day stay 7/14-7/16/08 presentation C/O vomiting and abdominal pain and bilious vomiting. Lethargic, feeding poorly, decreased abdominal sounds and tenderness to palpation in lower quadrants of abdomen. Post reduction experienced bout of excess gas in intestine with passage of gas per rectum. Bowel movement next day normal.


VAERS ID: 320829 (history)  
Form: Version 1.0  
Age: 0.42  
Gender: Male  
Location: Michigan  
Vaccinated:0000-00-00
Onset:2008-07-01
Submitted: 2008-07-29
   Days after onset:28
Entered: 2008-07-30
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. - / 3 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Abdominal distension, Haematochezia, Intussusception, Vomiting, X-ray abnormal
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: x-ray, Reduced airflow and suspected intussusception
CDC Split Type: WAES0807USA04599

Write-up: Information has been received from a physician concerning a 5 month old male patient who was vaccinated with a dose of ROTATEQ on an unknown date. The physician, who works in the emergency room, reported that she was aware of a patient who presented to the emergency room with possible intussusception in JUL-2008. The patient''s symptoms were vomiting, abdominal distention, and blood in the stool. The emergency room performed an x-ray and determined that the patient had reduced airflow and suspected intussusception. This adverse event occurred one week after a dose of ROTATEQ. It is unknown if the adverse event occurred after the first, second, or third vaccination. The patient was sent to another hospital that specializes in pediatrics but it is unknown if the child was admitted. No product quality complaint was involved. Upon internal review, intussusception was considered to be another important medical event. Additional information has been requested.


VAERS ID: 320886 (history)  
Form: Version 1.0  
Age: 0.2  
Gender: Female  
Location: California  
Vaccinated:2008-07-21
Onset:2008-07-25
   Days after vaccination:4
Submitted: 2008-07-30
   Days after onset:5
Entered: 2008-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 0413X / 1 MO / PO

Administered by: Private       Purchased by: Private
Symptoms: Abdominal X-ray, Carbon dioxide decreased, Intestinal obstruction, Intussusception, Leukocyturia, Surgery, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal obstruction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Chronic kidney disease (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Levsin drops PRN
Current Illness: None
Preexisting Conditions: Colic (intermittent); history of milia. PMH: none. NKDA
Allergies:
Diagnostic Lab Data: Low CO2, Leukocyturia, Abnormal Abdominal Films. Labs and Diagnostics: CBC with WBC 13, Hct 32. Electrolytes abnormal with Na+ 144, K+ 9, Cl- 114, bicarb 12. Barium enema (+) for ileocolic IS and bowel perf. Upper GI. US.
CDC Split Type:

Write-up: Patient had emesis x 5-7 episodes 4 days after ROTATEQ vaccination; diagnosed with obstruction due to INTUSSUSCEPTION; required surgery to relieve obstruction and removal of small segment of ascending colon. 08/27/2008 MR received for DOS 7/26-30/2008 with D/C DX: Intussusception. Pt presented with several day hx of vomiting with dehydration. Pt had bloody stool during eval. PE (+) for depressed fontanelle and abdominal distention. Enema attempted for reduction which resulted in a bowel perforation. Pt taken for emergent exploratory lap with small bowel resection of perforated segment with primary anastomosis. Pt developed mild ileus post-op which resolved spontaneously and diet then advanced.


VAERS ID: 320912 (history)  
Form: Version 1.0  
Age: 0.2  
Gender: Female  
Location: Unknown  
Vaccinated:2008-03-17
Onset:2008-04-19
   Days after vaccination:33
Submitted: 2008-07-30
   Days after onset:102
Entered: 2008-07-31
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C2933AB / 1 UN / UN
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 1106F / 1 UN / UN
HIBV: HIB (ACTHIB) / SANOFI PASTEUR - / 1 UN / UN
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR A0301 / 1 UN / UN
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 1665U / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Barium enema, Diarrhoea, Endotracheal intubation, Hydronephrosis, Intussusception, Septic shock, Ultrasound scan abnormal, Urosepsis
SMQs:, Agranulocytosis (broad), Angioedema (broad), Retroperitoneal fibrosis (narrow), Toxic-septic shock conditions (narrow), Pseudomembranous colitis (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Gastrointestinal obstruction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Respiratory failure (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Renal ultrasound, 04/19?/08, hydronephrosis; Ultrasound, 06/30/08, positive for intussusception; Barium enema X-ray, 06/30/08, negative for intussusception. 8/13/08-records received-WBC 14.5. Abdominal x-ray concern for right lower quadrant intussusception. Barium enema demonstrated large amount of stool no evidence of for obstruction. Intussusception not identified. CT scan unremarkable.
CDC Split Type: WAES0807USA04635

Write-up: Information has been received from a nurse practitioner concerning a 16 week old female with no medical history who on 17-MAR-2008 and 07-MAY-2008 was vaccinated PO with 2.0 ml of the first and second doses of ROTATEQ (first dose lot # 659852/1665U and second dose lot # 659774/0140X). Concomitant vaccine therapy included on 17-MAR-2008 a dose of HEP B (lot #654436/1106F), IPOL, ACTHIB and PREVNAR. No concomitant drug therapy reported. On 19-APR-2008 the patient developed severe acute diarrhea and was hospitalized (19-APR-2008 - 25-APR-2008) for the treatment of urosepsis, septic shock. The patient required intubation for correction of the septic shock. The patient was diagnosed as having hydronephrosis by a renal ultrasound on approximately 19-APR-2008. The patient recovered (date unspecified) after receiving unspecified treatment. The NP felt that the diarrhea may have caused the urinary symptoms. On 15-JUN-2008 the patient experienced intussusception and was hospitalized. The patient recovered and was discharged on 17-JUN-2008. On 30-JUN-2008 the patient experienced intussusception, the barium enema was negative for intussusception but the ultrasound was positive and the patient was hospitalized until 02-JUL-2008. The NP reported that the third dose of ROTATEQ was held. The patient fully recovered on an unspecified date. The reporter considered the severe diarrhea, urosepsis, septic shock, hydronephrosis and both episodes of intussusception an other important medical event and immediately life-threatening. Additional information has been requested. 8/13/08-records received for DOS 6/30-7/2/08-DC DX: Vomiting. Intussusception. Presented with coughing, vomiting and nonbloody diarrhea. Positive upper respiratory infections. Previously seen on 6/15/08 for self reduced intussusception times 2 and was negative on barium enema and E. coli pyelonephritis on 4/08.


VAERS ID: 321006 (history)  
Form: Version 1.0  
Age: 0.7  
Gender: Female  
Location: Unknown  
Vaccinated:2008-06-23
Onset:2008-07-20
   Days after vaccination:27
Submitted: 2008-07-31
   Days after onset:11
Entered: 2008-08-01
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 0301X / 3 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Intussusception
SMQs:, Gastrointestinal obstruction (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown 12/2/09 Hospital records received for date 7/20/08 PMH: umbilical hernia
Allergies:
Diagnostic Lab Data: Unknown 12/24/08-records received-US demonstrated intussusception in right upper quadrant represents an ileocolic intussusception. KUB paucity of bowel gas, soft tissue density consistent with intussusception. Reduced air contrast barium enema under fluoroscopy.WBC 15.83. 12/2/09 Hospital records received for date 7/20/08 Diag/Labs: 7/20/08 barium enema air contrast w/ success reduction.
CDC Split Type: WAES0807USA05533

Write-up: Information has been received from a physician concerning an infant who was vaccinated with a second 2 mL oral dose of ROTATEQ on an unknown date and experienced intussusception (date not specified). The patient went to the emergency room for 24 hours for observation. The patient was not hospitalized. Subsequently, the patient recovered from intussusception (date not reported). No product quality complaint was involved. Upon internal review, intussusception was considered to be another important medical event. Additional information has been requested. 12/24/08-records received for DOS 7/20/08-DX Intussusception-presented with one day history of abdominal pain and decrease oral intake, lethargic. 9/22/09 ED records received DOS 7/20/08. Assessment: Intussusception. Mother states child was having abdominal pain with intermittent crying. 12/2/09 Hospital records received for date 7/20/08. DX: intussusception. Observation nurse records. ER visit 9/30/08 DX: fever. Presented w/ fever, exposure to sibling w/ URI.


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