|
VAERS ID: |
304665 (history) |
Form: |
Version 1.0 |
Age: |
0.33 |
Sex: |
Male |
Location: |
Kansas |
Vaccinated: | 2008-01-01 |
Onset: | 2008-01-01 |
Days after vaccination: | 0 |
Submitted: |
2008-02-08 |
Days after onset: | 38 |
Entered: |
2008-02-11 |
Days after submission: | 3 |
Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. |
- / 2 |
MO / PO |
Administered by: Other Purchased by: Other Symptoms: Intussusception,
Surgery SMQs:, Gastrointestinal obstruction (narrow)
Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
Extended hospital stay? No
Previous Vaccinations: Other Medications: None Current Illness: Preexisting Conditions: Unknown Allergies: Diagnostic Lab Data: Unknown CDC Split Type: WAES0802USA00328
Write-up: Information has been received from a physician concerning an approximately 4 month old male who in January 2008, was vaccinated PO with his second dose of Rotateq. There was no concomitant medication. In January 2008, a few days after the second dose, the patient experienced intussusception and was subsequently hospitalized. In January 2008, the patient underwent surgery. The outcome was unknown at the time of this report. There was no product quality complaint. Intussusception was considered to be an other important medical event (surgery) by the physician. Additional information has been requested. |
|
VAERS ID: |
304871 (history) |
Form: |
Version 1.0 |
Age: |
0.42 |
Sex: |
Female |
Location: |
Kentucky |
Vaccinated: | 2008-01-01 |
Onset: | 2008-01-24 |
Days after vaccination: | 23 |
Submitted: |
2008-02-12 |
Days after onset: | 19 |
Entered: |
2008-02-14 |
Days after submission: | 2 |
Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS |
- / UNK |
UN / UN |
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. |
- / UNK |
UN / UN |
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH |
- / UNK |
UN / UN |
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. |
- / 2 |
MO / PO |
Administered by: Other Purchased by: Other Symptoms: Barium enema,
Intussusception,
Surgery 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, 0 days
Extended hospital stay? No
Previous Vaccinations: Other Medications: Current Illness: Preexisting Conditions: Unknown Allergies: Diagnostic Lab Data: Unknown CDC Split Type: WAES0802USA01323
Write-up: Information has been received from a physician concerning a 5 month old female who on 16-NOV-2007 and in approximately January 2008, was vaccinated PO with her first and second 2.0 ml doses of ROTATEQ. Concomitant vaccinations administered in approximately January 2008, with the second dose included a dose of PEDIARIX, a dose of PEDVAXHIB and a dose of PREVNAR. On 24-JAN-2008 the patient experienced intussusception and was hospitalized. A barium enema was administered as an intervention and subsequently the patient underwent a "surgical correction." After the event on that same day, the physician decided to discontinue therapy with ROTATEQ. The outcome was unknown at the time of this report. It was noted that the patient had no adverse event with the first dose of ROTATEQ. There was no product quality complaint. Intussusception was also considered to be an other important medical event (surgery) by the physician. Additional information has been requested. |
|
VAERS ID: |
305052 (history) |
Form: |
Version 1.0 |
Age: |
0.36 |
Sex: |
Male |
Location: |
Colorado |
Vaccinated: | 2008-01-29 |
Onset: | 2008-02-01 |
Days after vaccination: | 3 |
Submitted: |
2008-02-15 |
Days after onset: | 14 |
Entered: |
2008-02-15 |
Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS |
AC21B137AA / 2 |
RL / - |
HIBV: HIB (ACTHIB) / SANOFI PASTEUR |
UF229AA / 2 |
RL / - |
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH |
C35171 / 2 |
LL / - |
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. |
11934 / 2 |
MO / PO |
Administered by: Unknown Purchased by: Unknown Symptoms: Intussusception,
Surgery SMQs:, Gastrointestinal obstruction (narrow)
Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 5 days
Extended hospital stay? No
Previous Vaccinations: intusussception~ ()~~0.00~Patient Other Medications: none Current Illness: none Preexisting Conditions: none. PMH: respiratory problem at 9 days of age. Eczema. Allergies: Diagnostic Lab Data: Barium Enema, Confirmation by Surgery Labs and Diagnostics: Air contrast enema (+) for IS.. Abdominal X-ray (+) for SBO c/w IS. Abdominal US confirmed. CBC with WNL on admit, WBC 11.0, RBC 3.61, Hgb 9.1, Hct 28.0 post op. CDC Split Type:
Write-up: Intusussception, Surgery required 02-01-08, associated with administration of ROTATEQ 01-29-08. 03/03/2008 MR received from PCP including vax record and hospital surgical report and F/U. DOS 2/1-2/2008 with DX: Intussusception. Child had first OV WCC on 1/29/08 with normal exam except eczema. Seen again 2/1/08 with c/o crying and decreased appetite. Had bloody, mucusy stool in office. Transferred to hospital for eval and tx. Air contrast enema (+) for Intussusception but unable to fully reduce. Pt had an Exploratory Laparotomy, confirmation of intussusception, reduction and appendectomy. D/C next day. F/U OV with PCP doing well except for facial eczema. Surgical F/U 2/25/08 doing well. |
|
VAERS ID: |
305057 (history) |
Form: |
Version 1.0 |
Age: |
0.2 |
Sex: |
Female |
Location: |
New York |
Vaccinated: | 2008-02-11 |
Onset: | 2008-02-15 |
Days after vaccination: | 4 |
Submitted: |
2008-02-15 |
Days after onset: | 0 |
Entered: |
2008-02-15 |
Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER |
C2607AB / 1 |
LL / - |
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. |
0012F / 1 |
RL / - |
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR |
A0474PK / 1 |
LL / - |
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH |
C49271 / 1 |
RL / - |
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. |
1392U / 1 |
MO / PO |
Administered by: Unknown Purchased by: Unknown Symptoms: Barium enema,
Colectomy,
Intestinal anastomosis,
Intussusception,
Surgery SMQs:, Malignancy related therapeutic and diagnostic procedures (narrow), Gastrointestinal obstruction (narrow)
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, 5 days
Extended hospital stay? No
Previous Vaccinations: Intussuception~Rotavirus (no brand name)~1~0.00~In Patient Other Medications: none Current Illness: Intussuception Preexisting Conditions: none Allergies: Diagnostic Lab Data: Barium Enema without reduction of intusseption. Surgical right hemicolectomy with ileocolonic anastomosis. LABS: Abdominal x-ray abnormal. BE failed at reducing IS. ER LABS: abdominal US (+) for IS. CBC, chemistry WNL. Blood c/s done. CDC Split Type:
Write-up: Rotatec given at 2month visit at PMD 4/1/08 Reviewed hospital medical records of 2/14-2/19/2008. FINAL DX: gangrenous ileocolic, colocolic compound intussusception; laparotomy; right hemicolectomy w/ileocolic anastomosis. Records reveal patient experienced diet refusal, crying, abdominal pain, vomiting, decreased urine output & rectal bleeding x 1 day. Seen at outlying ER where US of abdomen confirmed IS. Transferred to higher level of care. Hydrostatic reduction was unsuccessful & taken to OR. Surgical findings included compound ileocolic, colocolic IS involving entire large bowel to level of sigmoid colon. Unable to manually reduce & terminal ileum & ascending colon were resected. Patient admitted to PICU post operatively. Progressed well & d/c to home w/surgery clinic f/u. 5/23/08 Reviewed ER medical records of 2/14/2008. FINAL DX: Intussusception Records reveal patient experienced rectal bleeding, vomiting, lethargy & abdominal mass. Transferred to higher level of care. |
|
VAERS ID: |
305116 (history) |
Form: |
Version 1.0 |
Age: |
0.33 |
Sex: |
Male |
Location: |
Texas |
Vaccinated: | 2008-02-15 |
Onset: | 2008-02-17 |
Days after vaccination: | 2 |
Submitted: |
2008-02-19 |
Days after onset: | 2 |
Entered: |
2008-02-19 |
Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR |
C2800AA / 2 |
LL / IM |
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. |
0874U / 2 |
RL / IM |
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. |
0258U / 2 |
RL / IM |
IPV: POLIO VIRUS, INACT. (POLIOVAX) / SANOFI PASTEUR |
A0298 / 2 |
LL / SC |
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH |
B70145K / 2 |
RL / IM |
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. |
1388U / 1 |
MO / PO |
Administered by: Unknown Purchased by: Unknown Symptoms: Haematochezia,
Intussusception,
Vomiting projectile SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Ischaemic colitis (broad)
Life Threatening? Yes
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: none~ ()~~0.00~Patient|none~ ()~~0.00~Sibling|none~ ()~~0.00~Sibling Other Medications: none Current Illness: none Preexisting Conditions: none Allergies: Diagnostic Lab Data: Medical Center KUB showed small bowel obstruction with air fluid levels and paucity of bowel gas within right abdomen. Air enema reduction successful after 2 attempts. Blood culture no growth. Segs 55. CDC Split Type:
Write-up: Pt had severe projectile vomiting 48 hours after recieving vaccine, had bloody stools 72 hours after recieving vaccination and was diagnosed with Intussusception of the intestines 78 hours after receiving vaccination. 2/25/08-records received for DOS 2/18-2/19/08-DC DX: Intussusception. Presented to ED with projectile vomiting and inability to take PO and 2 episodes of bloody stools fever of 101.0 (R). |
|
VAERS ID: |
305329 (history) |
Form: |
Version 1.0 |
Age: |
0.29 |
Sex: |
Female |
Location: |
California |
Vaccinated: | 2007-08-22 |
Onset: | 2008-01-22 |
Days after vaccination: | 153 |
Submitted: |
2008-02-20 |
Days after onset: | 29 |
Entered: |
2008-02-21 |
Days after submission: | 1 |
Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS |
AC21B101AA / 1 |
UN / IM |
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER |
UE97AA / 1 |
UN / IM |
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH |
BO8666D / 1 |
UN / IM |
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. |
0026U / 1 |
MO / PO |
Administered by: Other Purchased by: Other Symptoms: Intussusception,
Surgery 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, 1 days
Extended hospital stay? No
Previous Vaccinations: Other Medications: Unknown Current Illness: Preexisting Conditions: Unknown Allergies: Diagnostic Lab Data: surgery 01/24/08 5/2/08-records received-Reduction barium enema unsuccessful. Incomplete hydrostatic reduction of inutssusception. Could be reduced from distal transverse colon to area of ileocecal valve but complete reduction could not be achieved. X-ray abdomen small bowel obstructive pattern. Stool culture negative. Segs increased 55. CDC Split Type: WAES0802USA02989
Write-up: Information has been received from a physician concerning an 8-month-old female who on 22-AUG-2007 was vaccinated orally, with the "first dose of series" of Rotateq (lot# 656196/0026U). On 22-JAN-2008 the patient developed intussusception. On 24-Jan-2008 the patient had surgery. The patient was hospitalized but the length of stay was unknown. On an unspecified date, the patient recovered. No product quality complaint was involved. The reporter considered intussusception to be an other important medical event (surgery). Additional information has been requested. 5/2/08-records received for DOS 1/24/08-presented to ED with C/O blood and mucous stool and bilious vomiting times 2 days since 01/23/08. 7/22/08-records received for DOS 1/24/08-exploratory laparoscopy, laparoscopic reduction of ileocecal intussusception. |
|
VAERS ID: |
305749 (history) |
Form: |
Version 1.0 |
Age: |
0.2 |
Sex: |
Male |
Location: |
California |
Vaccinated: | 2007-12-17 |
Onset: | 2008-02-13 |
Days after vaccination: | 58 |
Submitted: |
2008-02-26 |
Days after onset: | 13 |
Entered: |
2008-02-26 |
Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS |
AC21B096BA / 1 |
LL / IM |
HIBV: HIB (ACTHIB) / SANOFI PASTEUR |
UF101AB / 1 |
RL / IM |
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH |
C57539 / 1 |
RL / IM |
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. |
0669U / 1 |
MO / PO |
Administered by: Unknown Purchased by: Unknown Symptoms: Abdominal X-ray,
Intussusception,
Ultrasound abdomen abnormal SMQs:, Retroperitoneal fibrosis (broad), 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, 2 days
Extended hospital stay? No
Previous Vaccinations: None~ ()~~0.00~In Patient|None~ ()~~0.00~In Sibling Other Medications: Acetaminophen Current Illness: Colds x 1 week Preexisting Conditions: Pre-term birth 34 weeks gestation, second of twin 3/6/08-PMH: 34 week preemie born as a twin. Allergies: Diagnostic Lab Data: Abdominal Xray, Limited abdominal Ultrasound both diagnostic of Intussusception. 3/6/08-records received-US abdomen:intussusceptionright upper quadrant. Air enema uncomplicated reduction of intussusception. CDC Split Type:
Write-up: On February 13, 2008, patient developed intussusception which was reduced by air enema without complication at Hospital. 3/6/08-records received-DOS 2/13/08-Seen in ED with C/O 12-16 hours of episodic abdominal pain accompanied by crying and bending of his knees up to chest and flexing his body. Emesis. Blood in stool. Decreasing oral intake. |
|
VAERS ID: |
305758 (history) |
Form: |
Version 1.0 |
Age: |
0.5 |
Sex: |
Male |
Location: |
California |
Vaccinated: | 2007-11-19 |
Onset: | 2008-01-28 |
Days after vaccination: | 70 |
Submitted: |
2008-02-26 |
Days after onset: | 29 |
Entered: |
2008-02-26 |
Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR |
C2606AA / 3 |
LL / - |
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER |
LUT2474EA / 1 |
LL / - |
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH |
B08702H / 4 |
RL / - |
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. |
1127U / 3 |
MO / PO |
Administered by: Private Purchased by: Public Symptoms: Intussusception,
Obstruction 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: None Preexisting Conditions: Allergies: Diagnostic Lab Data: 3/7/08records received-KUB:dilated loop of bowel. Computerized tomography showed intussusception. Unable to reduce with hydrostatic enema. CDC Split Type:
Write-up: Intussusception, with obstruction. Required surgery at hospital 1/24/08. 3/7/08-records received for DOS 1/24-1/25/08-DC DX: Intussusception. C/O one day history of vomitng and cramping abdominal pain and listlessness. Surgery:laparoscopic reduction of intussusception and saline enema. |
|
VAERS ID: |
306368 (history) |
Form: |
Version 1.0 |
Age: |
0.5 |
Sex: |
Female |
Location: |
New York |
Vaccinated: | 2008-01-28 |
Onset: | 2008-02-18 |
Days after vaccination: | 21 |
Submitted: |
2008-02-28 |
Days after onset: | 10 |
Entered: |
2008-03-04 |
Days after submission: | 5 |
Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS |
AC21B133DA / 3 |
LL / IM |
HIBV: HIB (ACTHIB) / SANOFI PASTEUR |
UF216AA / 3 |
LL / IM |
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH |
C45891 / 3 |
LL / IM |
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. |
1598U / 3 |
MO / PO |
Administered by: Unknown Purchased by: Unknown Symptoms: Barium enema,
Intussusception,
Surgery SMQs:, Gastrointestinal obstruction (narrow)
Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
Extended hospital stay? No
Previous Vaccinations: Other Medications: Current Illness: Preexisting Conditions: Allergies: Diagnostic Lab Data: Barium enema; surgery . Labs and Diagnostics: Abd X-ray suspicious for IS, confirmed by Barium Enema CDC Split Type:
Write-up: Pt with intussusception on 2/18/08. For which she underwent surgery. 03/14/2008 MR received for DOS 2/17-20/2008 with D/C DX: Intussusception. Infant presented to ER with irritability and crying. Barium enema (+) for IS but unable to fully reduce. Pt had an Exploratory Lap with manual reduction of Intussusception and appendectomy. Pt taking po well and d/c on POD#3. |
|
VAERS ID: |
306369 (history) |
Form: |
Version 1.0 |
Age: |
0.2 |
Sex: |
Male |
Location: |
Nebraska |
Vaccinated: | 2008-01-16 |
Onset: | 2008-02-17 |
Days after vaccination: | 32 |
Submitted: |
2008-02-28 |
Days after onset: | 11 |
Entered: |
2008-03-04 |
Days after submission: | 5 |
Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR |
C2798AA / 1 |
UN / IM |
HBHEPB: HIB + HEP B (COMVAX) / MERCK & CO. INC. |
0538U / 1 |
UN / IM |
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR |
A0298 / 1 |
UN / IM |
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH |
C35169 / 1 |
UN / IM |
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. |
1734U / 1 |
MO / PO |
Administered by: Private Purchased by: Private Symptoms: Abdominal X-ray,
Enema administration,
Intussusception,
Ultrasound scan abnormal SMQs:, Malignancy related therapeutic and diagnostic procedures (narrow), 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: None Current Illness: None Preexisting Conditions: None Allergies: Diagnostic Lab Data: abdominal films & Abd U/S revealed intussusception on 2/17/08 LABS: Air contrast enema reduced IS. CDC Split Type:
Write-up: 2-17-08 Pt. presented to ER with intussusception. This was reduced by air contrast enema. He received a Rotateq vaccine on 1-16-08. 3/14/08 FINAL DX: Intussusception, enema reduced. Reviewed hospital medical records which reveal patient experienced bloody stools, irritability & abdominal pain. Admitted 2/17-2/18/2008 for observation s/p enema administration for IS. |
|