|
VAERS ID: |
273694 (history) |
Form: |
Version 1.0 |
Age: |
0.48 |
Sex: |
Female |
Location: |
California |
Vaccinated: | 2006-12-27 |
Onset: | 2007-02-03 |
Days after vaccination: | 38 |
Submitted: |
2007-03-08 |
Days after onset: | 33 |
Entered: |
2007-03-08 |
Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS |
AC21B069AA / 3 |
LA / IM |
HIBV: HIB (ACTHIB) / SANOFI PASTEUR |
UF021AB / 3 |
LA / IM |
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH |
BO8678K / 3 |
RA / IM |
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. |
0779F / 2 |
- / - |
Administered by: Unknown Purchased by: Unknown Symptoms: Barium enema,
Explorative laparotomy,
Intussusception,
Laparotomy SMQs:, Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (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, 7 days
Extended hospital stay? No
Previous Vaccinations: Other Medications: Current Illness: Preexisting Conditions: Allergies: Diagnostic Lab Data: Barium Enema/laparotomy Lab/diagnostics received 3/15/07-BE:intussusception to rectosigmoid only reducible to hepatic flexure. US abdomen confirmed intussusception. CDC Split Type:
Write-up: Intussusception with exploratory laparotomy with right hemicolectomy and partial ileectomy. 03/15/07-records received from facility for DOS 2/3-2/10/07 DC DX: Intussusception status post right hemicolectomy. Previously healthy infant developed emesis and bloody mucoid stools PE:WNL except for abdomen large palpable mass in mid left which was mobile, somewhat tender to palpation and firm. Right hemicolectomy 2/4/07- |
|
VAERS ID: |
273703 (history) |
Form: |
Version 1.0 |
Age: |
0.52 |
Sex: |
Female |
Location: |
Alabama |
Vaccinated: | 2006-11-14 |
Onset: | 2007-02-21 |
Days after vaccination: | 99 |
Submitted: |
2007-03-08 |
Days after onset: | 15 |
Entered: |
2007-03-09 |
Days after submission: | 1 |
Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. |
0577F / 3 |
MO / PO |
Administered by: Other Purchased by: Other 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: Unknown Current Illness: Preexisting Conditions: Unknown Allergies: Diagnostic Lab Data: Unknown CDC Split Type: WAES0703USA00661
Write-up: Information has been received from a physician concerning a 9 month old white female patient who was vaccinated with a first, second and third oral dose of Rotateq on 01-JUL-2006 (Lot # 653754/0139F), 11-SEP-2006 (Lot # 654248/0577F), and 14-NOV-2006 (Lot# 654248/0577F). Medical history and drug allergies were reported as unknown. Concomitant therapy was unknown. On 21-FEB-2007 the patient was diagnosed with intussusception. Patient was admitted to hospital on 21-FEB-2007. The patient underwent 2 air enemas and the intussusception reversed. On 22-FEB-2007, the patient was discharged from the hospital. Outcome reported as recovered. there was no product quality complaint involved. Additional information has been requested. |
|
VAERS ID: |
273704 (history) |
Form: |
Version 1.0 |
Age: |
0.61 |
Sex: |
Female |
Location: |
Alabama |
Vaccinated: | 2006-10-25 |
Onset: | 2006-11-17 |
Days after vaccination: | 23 |
Submitted: |
2007-03-08 |
Days after onset: | 111 |
Entered: |
2007-03-09 |
Days after submission: | 1 |
Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. |
1017F / 3 |
MO / PO |
Administered by: Other Purchased by: Other Symptoms: Inappropriate schedule of drug administration,
Intussusception,
Surgery 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, 6 days
Extended hospital stay? No
Previous Vaccinations: Other Medications: NONE Current Illness: Preexisting Conditions: NONE Allergies: Diagnostic Lab Data: Unknown LABS: WBC 19,27. Blood c/s neg. Barium enema & air contrast enema were unsuccessful. CDC Split Type: WAES0703USA00508
Write-up: Information has been received from a physician concerning an 8 month old white female patient who was vaccinated with a first, second and third oral dose of Rotateq on 28-JUL-2006 (Lot # 654504/0695F), 28-AUG-2006 (Lot # 654504/0695F), and 25-OCT-2006 (654665/1017F). the patient had no medical history, no known drug allergies and was not on any concomitant medication. On 17-NOV-2006 the patient was seen in the doctors office and was diagnosed with intussusception. The patient was admitted to hospital that same day, where she underwent emergency surgery. On 22-NOV-2006, the patient was discharged from the hospital. on 07-DEC-2007, the patient was seen in the doctors office for a well-visit and was considered recovered from the intussusception. There was no product quality complaint involved. Additional information has been requested. 3/22/07 Received medical records from hospital which reveal patient experienced intermittent abdominal pain associated w/vomiting approx 24 hours prior to admit on 11/17/06-11/22/06. Seen by PCP who noted bloody stool & tender abdomen. Barium enema performed at outlying facility but failed to reduce IS noted in mid transverse colon near splenic flexure. Then transferred to higher level of care where air reduction enema was also unsuccessful. Peds Surg consult obtained. Taken to OR where ileocolic resection w/primary anastomosis was performed. Progressed slowly but steadily, oral diet tolerated by d/c to home w/o further complication except for oral thrush which was treated. FINAL DX: Ileocecal intussusception w/necrotic bowel, surgically reduced w/bowel resection. |
|
VAERS ID: |
273714 (history) |
Form: |
Version 1.0 |
Age: |
0.52 |
Sex: |
Male |
Location: |
Michigan |
Vaccinated: | 2007-01-15 |
Onset: | 2007-01-25 |
Days after vaccination: | 10 |
Submitted: |
2007-03-02 |
Days after onset: | 36 |
Entered: |
2007-03-09 |
Days after submission: | 7 |
Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS |
AC21B084CA / 3 |
LL / - |
HIBV: HIB (ACTHIB) / SANOFI PASTEUR |
UF058AA / 3 |
LL / - |
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH |
B08670B / 3 |
LL / - |
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. |
1110F / 3 |
MO / PO |
Administered by: Private Purchased by: Private Symptoms: Abdominal X-ray,
Barium enema,
Haematochezia,
Intussusception,
Vomiting 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? Yes Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 4 days
Extended hospital stay? No
Previous Vaccinations: Other Medications: NONE. Meds: none. Current Illness: NONE Preexisting Conditions: NONE. PMH: none. Allergies: NKDA. Allergies: Diagnostic Lab Data: Abdominal x-rays and barium enema. Labs and Diagnostics: KUB reveals an abnormal gas pattern which may reflect a mild paralytic ileus or small bowel obstruction. Contrast Barium Enema revealed an intussusception distal to the hepatic flexure which was sucessfully reduced. BMP unremarkable. CDC Split Type:
Write-up: Intussusception diagnosed. History of vomiting for several days then had bloody stools. 03/20/2007 MR received for a 2 night hospital stay for several day history of vomiting. Over the course of the admission the infant developed bloody stools x2 as well as bilious vomiting. Review of systems on admission (+) for vomiting and lethargy. PE: WNL except mildly difficult to arouse. Intussusception reduced with air enema. The infant was dicharged the following day. Discharge DX: Intussusception. |
|
VAERS ID: |
273760 (history) |
Form: |
Version 1.0 |
Age: |
0.2 |
Sex: |
Male |
Location: |
Tennessee |
Vaccinated: | 2007-02-14 |
Onset: | 2007-03-08 |
Days after vaccination: | 22 |
Submitted: |
2007-03-09 |
Days after onset: | 1 |
Entered: |
2007-03-09 |
Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS |
AC21B028AA / 1 |
LL / IM |
HIBV: HIB (HIBERIX) / GLAXOSMITHKLINE BIOLOGICALS |
1015 / 1 |
RL / IM |
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH |
B36258C / 1 |
LL / IM |
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. |
1033F / 1 |
MO / PO |
Administered by: Private Purchased by: Private Symptoms: Intussusception,
Surgery,
Ultrasound abdomen SMQs:, Gastrointestinal obstruction (narrow)
Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
Extended hospital stay? No
Previous Vaccinations: Other Medications: Meds: none. Current Illness: NONE Preexisting Conditions: NONE. PMH: none. Allergies: none. Allergies: Diagnostic Lab Data: abdominal u/s. Labs and Diagnsotics: X-ray of the abdomen revealed multiple dilated loops of small bowel. No free air noted. Findings suggestive of a small bowel obstruction. KUB showed a paucity of gas in the right colon. Ultrasound confirmed intussusception. A contrast enema was done and partially reduced the intussusception, but not completely. CDC Split Type:
Write-up: 28 days after administration of Rotateq vaccine, patient developed intussusception requiring surgical reduction. Questioned relation to Rotateq? 03/12/2007 MR received from treating hospital. Child was transfered from local hospital for a several day history of intermittant vomiting and pain as shown by crying and curling up of his legs. Upon admission he was somnolent and lethargic. He has had episodes of bilious emesis and currant jelly stools. Also dehydrated. PE: revealed a soft, mildly distended abdomen with tenderness to palpation in the right mid and lower abdomen. Hypoactive bowel sounds. No masses noted. Otherwise WNL. The child was taken to sugery for a laparoscopic reduction of intussusception. Post -operative DX: Intussusception. |
|
VAERS ID: |
273884 (history) |
Form: |
Version 1.0 |
Age: |
0.19 |
Sex: |
Female |
Location: |
Missouri |
Vaccinated: | 2007-01-25 |
Onset: | 2007-03-10 |
Days after vaccination: | 44 |
Submitted: |
2007-03-13 |
Days after onset: | 2 |
Entered: |
2007-03-13 |
Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR |
C2521AA / 1 |
LL / IM |
HBHEPB: HIB + HEP B (COMVAX) / MERCK & CO. INC. |
1158F / 1 |
LL / IM |
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR |
Z0324 / 1 |
RL / IM |
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH |
B08670F / 1 |
RL / IM |
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. |
1166F / 1 |
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? No
Previous Vaccinations: Other Medications: Polytrim ophthalmic Current Illness: None known Preexisting Conditions: Dacryostenosis Allergies: Diagnostic Lab Data: Air contrast enema - (+) for intususception records received 4/24/07-Colon air contrast enema revealed ileocolic intussusception. US positive for ileocolic intussusception. Labs WNL rotavirus antigen negative CDC Split Type:
Write-up: Intususception diagnosed by hospital. 04/24/07-records received from facility for DOS 03/13-03/16/07. DC DX: Intussusception. C/O fussy for 2 days large emesis, bloody stools. Multiple mucousy bloody stools. Abdomen fullness palpated in right lower quadrant. Unsuccessful attempt at reduction via enema. Laparotomy including appendectomy. |
|
VAERS ID: |
273890 (history) |
Form: |
Version 1.0 |
Age: |
0.16 |
Sex: |
Male |
Location: |
Washington |
Vaccinated: | 2007-01-23 |
Onset: | 2007-03-10 |
Days after vaccination: | 46 |
Submitted: |
2007-03-13 |
Days after onset: | 2 |
Entered: |
2007-03-13 |
Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS |
AC21BO89AA / UNK |
LL / IM |
HIBV: HIB (ACTHIB) / SANOFI PASTEUR |
UFO52AA / UNK |
LL / IM |
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH |
BO8666A / UNK |
RL / IM |
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. |
1115F / UNK |
MO / PO |
Administered by: Unknown Purchased by: Unknown Symptoms: Enema administration,
Intussusception,
Laboratory test,
Ultrasound scan 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: Current Illness: no Preexisting Conditions: Allergies: Diagnostic Lab Data: US labs records received 3/20/07-X-Ray-Ileocolonic intussusception with successful reduction by air enema. Labs WNL Cultures negative CDC Split Type:
Write-up: Intussusception dxd by US treated with enema resolved and d/cd from hospital 03/20/07-records received from facility for DOS: 3/10/07-DX:Bloody diarrhea, dehydration, abdominal pain, vomiting. HX:bloody stools for 2 days. PE:WNL, abdomen soft nondistened and nontender. |
|
VAERS ID: |
273982 (history) |
Form: |
Version 1.0 |
Age: |
0.17 |
Sex: |
Female |
Location: |
Colorado |
Vaccinated: | 2007-02-16 |
Onset: | 2007-03-10 |
Days after vaccination: | 22 |
Submitted: |
2007-03-14 |
Days after onset: | 3 |
Entered: |
2007-03-14 |
Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS |
AC21B084BA / 1 |
UN / IM |
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. |
1271F / 1 |
UN / IM |
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH |
B36258C / 1 |
UN / IM |
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. |
1032F / 1 |
MO / PO |
Administered by: Unknown Purchased by: Unknown Symptoms: Barium double contrast,
Diverticulitis Meckel's,
Fatigue,
Gastrointestinal necrosis,
Haematochezia,
Intussusception,
Irritability,
Surgery SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Congenital, familial and genetic disorders (narrow), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Ischaemic colitis (narrow), Hypoglycaemia (broad)
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: Current Illness: None Preexisting Conditions: Allergies: Diagnostic Lab Data: Air enema an intussusception was found but not completely reduced. CDC Split Type:
Write-up: Patient came into office fussy. Alternating with tired, no source identified, patient was sent out with symptomatic care. Parents called the next day with bloody stools and sent to ED. Patient diagnosed with intussuception - Air Enema failed to reduce. Surgery showed 4cm of necrotic bowel. Primary anastomosed, Meckel''s found at time of surgery. As given by MD 04/11/07-DC Summary received for DOS 3/11-3/17/07-DX Intussusception. Presented with emesis and bright red blood per rectum. Laparotomy and ileal resection and subclavian placement. Recovered and discharged. |
|
VAERS ID: |
274077 (history) |
Form: |
Version 1.0 |
Age: |
|
Sex: |
Unknown |
Location: |
Alabama |
Vaccinated: | 0000-00-00 |
Onset: | 0000-00-00 |
Submitted: |
2007-03-15 |
Entered: |
2007-03-16 |
Days after submission: | 1 |
Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. |
- / 1 |
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? No
Previous Vaccinations: Other Medications: UNK Current Illness: Preexisting Conditions: UNK Allergies: Diagnostic Lab Data: UNK CDC Split Type: WAES0703USA00908
Write-up: Information has been requested from a physician concerning a patient who was vaccinated with a first oral 2 ml dose of Rotateq. Subsequently the patient developed intussusception. Medical attention was not sought. No product quality complaint was involved. No other information was provided. Upon internal review, the patient''s intussusception was considered to be an other important medical event. Additional information has been requested. |
|
VAERS ID: |
274158 (history) |
Form: |
Version 1.0 |
Age: |
0.18 |
Sex: |
Female |
Location: |
California |
Vaccinated: | 2007-02-28 |
Onset: | 2007-03-08 |
Days after vaccination: | 8 |
Submitted: |
2007-03-16 |
Days after onset: | 7 |
Entered: |
2007-03-16 |
Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. |
06E605 / 2 |
MO / PO |
Administered by: Unknown Purchased by: Unknown 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? Yes, 2 days
Extended hospital stay? No
Previous Vaccinations: Other Medications: NONE Current Illness: TAKING SYNAGIS FOR RSV PROPHYLAXIS Preexisting Conditions: 34 WEEK PREEMIE PMH: preemie at 34.5 wks, born by c-section. Allergies: Diagnostic Lab Data: LABS: abdominal x-ray revealed IS. Barium enema reduced IS. WBC 9.2, plt 582, lymphs 40, monos 55, bands 4 & polys 49. UA revealed 3 hyaline casts. Urine & blood c/s were neg. CDC Split Type:
Write-up: PATIENT WAS ADMITTED WITH INTUSSUSCEPTION NINE DAYS LATER, AND REDUCED SUCCESSFULLY, AT HOSPITAL 4/3/07 Received medical records from hospital which reveal patient experienced emesis for 3 daysw/decreased feeding beginning 3/5/07 & patient became increasingly lethargic. On exam, palpable mass was felt in abdomen. Kept over night for observation, did well & was d/c to home on 3/9/07. No D/c summary available. FINAL DX: ileocolic intussusception, reduced by barium enema. |
|