|
VAERS ID: |
277111 (history) |
Form: |
Version 1.0 |
Age: |
0.5 |
Sex: |
Male |
Location: |
California |
Vaccinated: | 2007-03-01 |
Onset: | 2007-03-19 |
Days after vaccination: | 18 |
Submitted: |
2007-04-19 |
Days after onset: | 31 |
Entered: |
2007-04-20 |
Days after submission: | 1 |
Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER |
U1751BA / 3 |
RL / - |
HBHEPB: HIB + HEP B (COMVAX) / MERCK & CO. INC. |
1243F / 3 |
LL / - |
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. |
B47742A / 3 |
RL / - |
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. |
1234F / 3 |
MO / PO |
Administered by: Other Purchased by: Other Symptoms: Intussusception,
Wrong drug administered 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, ? days
Extended hospital stay? No
Previous Vaccinations: Other Medications: Current Illness: Preexisting Conditions: Unknown PMH: eczema Allergies: Diagnostic Lab Data: Unknown LABS: US of abdomen revealed +intussussception. Air enema successfully reduced. CDC Split Type: WAES0704USA02415
Write-up: Information has been received from a physician concerning a 6 month old male who on 01-MAR-2007 was vaccinated with a 2 mL PO third dose of Rotateq. Concomitant vaccination included a dose of pneumococcal, polyval (MSD), a dose of HIB and a dose of DTaP. On 19-MAR-2007 the patient developed intussusception and was hospitalized. Surgery was not required. Subsequently, the patient recovered from intussusception on 3/21/07. There was no product quality complaint involved. Additional information has been requested. 5/4/07 Received medical records from hospital which reveal patient seen in ER on 3/20-3/21/07 for vomiting, abdominal pain, inconsolable fussiness, lethargy & dark heme + diarrhea stools. Kept overnight for observation. Did well, tolerated oral feedings & was d/c to home w/o complication. FINAL DX: Intussusception, reduced by air enema. 5/29/07 Received vax record which confirmed RO as reported. VAERS database updated w/other vax info. |
|
VAERS ID: |
277125 (history) |
Form: |
Version 1.0 |
Age: |
0.3 |
Sex: |
Male |
Location: |
Pennsylvania |
Vaccinated: | 2007-02-13 |
Onset: | 2007-04-14 |
Days after vaccination: | 60 |
Submitted: |
2007-04-20 |
Days after onset: | 6 |
Entered: |
2007-04-20 |
Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR |
C2553AA / 2 |
LL / - |
HIBV: HIB (ACTHIB) / SANOFI PASTEUR |
UF064AA / 2 |
- / - |
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR |
Z0326 / 2 |
LL / - |
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH |
B36258B / 2 |
- / - |
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. |
1166F / 2 |
MO / PO |
Administered by: Private Purchased by: Unknown Symptoms: Adenovirus infection,
Appendicectomy,
Barium enema,
Haematemesis,
Haematochezia,
Intussusception,
Polymerase chain reaction,
Surgery,
Virus serology test,
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), Infective pneumonia (broad), Opportunistic infections (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, 4 days
Extended hospital stay? Yes
Previous Vaccinations: Other Medications: None Current Illness: None Preexisting Conditions: None Allergies: Diagnostic Lab Data: (+) adenovirus PCR LABS: nasopharyngeal c/s +adenovirus. Rotavirus antigen neg. Abdominal x-ray revealed possible IS. US of abdomen revealed +IS. Barium enema attempt to reduce IS was unsuccessful. CDC Split Type:
Write-up: 4/14/07 - Presented with "coffee ground emesis" and bloody stools. Mom took him to ER, dx''d with adenovirus and intussusception. Unable to reduce with barium enema reduced with surgery. S/P Appendectomy. 6/1/07 Received vax record from PCP which indicates RO Lot # is as reported & was 2nd dose. VAERS database updated w/same. 6/5/07 Received hospital medical records which reveal patient experienced diarrhea x 7 days, bloody mucous x 1 day & abdominal pain. Also w/rhinorrhea, cough & sneeze. Admitted 4/14-4/17/07 for bacterial gastroenteritis. On initial hospital day had coffee ground emesis. Taken to OR for laproscopic reduction of IS & appendectomy. Stable post op FINAL DX: Ileocolic intussusception, surgically reduced; adenovirus. |
|
VAERS ID: |
277165 (history) |
Form: |
Version 1.0 |
Age: |
|
Sex: |
Unknown |
Location: |
California |
Vaccinated: | 0000-00-00 |
Onset: | 0000-00-00 |
Submitted: |
2007-04-20 |
Entered: |
2007-04-23 |
Days after submission: | 3 |
Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. |
- / UNK |
MO / PO |
Administered by: Unknown Purchased by: Unknown 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? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
Extended hospital stay? Yes
Previous Vaccinations: Other Medications: Unknown Current Illness: Preexisting Conditions: Unknown Allergies: Diagnostic Lab Data: Unknown CDC Split Type: WAES0704USA02490
Write-up: Information has been received from a physician concerning three patients who were vaccinated with Rotateq 2.5 ml PO to prevent Rotateq. The physician reported that all three patients experienced intussusception and were hospitalized. The length of hospitalization was unknown. The three patients requires surgery to correct the intussusception but the outcome of the surgery and the type of surgery is unknown. Intussusception which required surgery was reported to be an other important medical event. Additional ifnormation has been requested. |
|
VAERS ID: |
277567 (history) |
Form: |
Version 1.0 |
Age: |
0.6 |
Sex: |
Male |
Location: |
North Carolina |
Vaccinated: | 2007-03-28 |
Onset: | 2007-04-15 |
Days after vaccination: | 18 |
Submitted: |
2007-04-27 |
Days after onset: | 12 |
Entered: |
2007-04-30 |
Days after submission: | 3 |
Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. |
1238F / 3 |
MO / PO |
Administered by: Other Purchased by: Other Symptoms: Intussusception,
Surgery SMQs:, Gastrointestinal obstruction (narrow)
Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? Yes
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 medical records received 5/2/07-PMH RSV. Pneumonia. Allergies: Diagnostic Lab Data: Unknown records received 5/2/07-Barium enema CDC Split Type: WAES0704USA04328
Write-up: Information has been received from a registered nurse concerning a female who was vaccinated PO with a third dose of Rotateq. Subsequently, about a month after vaccination, the patient experienced intussusception. It was noted that the patient had surgery, but no additional information was available. There was no product quality complaint. Intussusception was considered to be immediately life-threatening and disabling and an other important medical event. Additional information has been requested. 05/02/07-records received for DOS 04/15-04/17/07-DC DX:Intussusception. Presented with sudden onset of emesis and bloody stool. Barium enema and attempt to reduce radiologiclly was unsuccessful. Surgery laprascopic reduction and appendectomy. |
|
VAERS ID: |
277569 (history) |
Form: |
Version 1.0 |
Age: |
|
Sex: |
Unknown |
Location: |
Unknown |
Vaccinated: | 0000-00-00 |
Onset: | 2007-04-24 |
Submitted: |
2007-04-27 |
Days after onset: | 3 |
Entered: |
2007-04-30 |
Days after submission: | 3 |
Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. |
- / UNK |
MO / PO |
Administered by: Other Purchased by: Other Symptoms: Intussusception,
Surgery SMQs:, Gastrointestinal obstruction (narrow)
Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
Extended hospital stay? Yes
Previous Vaccinations: Other Medications: Unknown Current Illness: Preexisting Conditions: Unknown Allergies: Diagnostic Lab Data: Unknown CDC Split Type: WAES0704USA05547
Write-up: Information has been received from a physician concerning a patient (age and sex not reported) who on an unspecified date was vaccinated with Rotateq (unknown how many doses of the vaccine the patient received). On 24-APR-2007, the patient experienced intussusception and was admitted to the hospital. The patient had surgery to remedy the situation. The reporter felt that intussusception was not related to therapy with Rotateq. Intussusception was considered to be immediately life-threatening and other important medical event. No further information was available from physician. |
|
VAERS ID: |
277757 (history) |
Form: |
Version 1.0 |
Age: |
0.2 |
Sex: |
Male |
Location: |
Connecticut |
Vaccinated: | 2007-02-06 |
Onset: | 2007-03-12 |
Days after vaccination: | 34 |
Submitted: |
2007-03-22 |
Days after onset: | 10 |
Entered: |
2007-05-02 |
Days after submission: | 41 |
Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. |
1365F / 1 |
MO / PO |
Administered by: Other Purchased by: Public Symptoms: Barium swallow abnormal,
Gastrointestinal necrosis,
Intussusception,
Mass,
Surgery,
Urinary system X-ray SMQs:, Gastrointestinal obstruction (narrow), Ischaemic colitis (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, 14 days
Extended hospital stay? Yes
Previous Vaccinations: Other Medications: None Current Illness: Progressive abd distention/pain Preexisting Conditions: None Allergies: Diagnostic Lab Data: KUB - dilated bowel, BA swallow - obstructive mass, surgery for intussusception with removal necrosed bowel LABS: WBC 10.5, BUN 16, creatinine 0.7, Na 131, K 6.9. Abd x-ray was neg. Barium air contrast enema revealed IS which was not reducible. CDC Split Type:
Write-up: Intussusception. 5/15/07 Received medical records from hospital which reveal patient experienced 4 days of vomiting/obstipation. Exam revealed very distended abdomen w/umbilical hernia & rectal exam revealed no stool or blood. Admitted 3/13-3/25/07. Surgery for exp lap & noted to have ischemic terminal ileum w/ileocolic IS which was resected & anastomosis was performed along w/appendectomy & hernia repair. Continued to have significant abdominal distention, tachypnea & fever. Transferred to PICU & started on multiple antibiotics. Initial hospital course was rocky, requiring multiple fluid replacements & w/resp distress, was intubated & started on hyperalimentation via central line. Continued to have fever & was kept on antibiotics. Slowly fevers & dehydration resolved & he was extubated. Oozing from abdominal wound was noted along w/increased WBC. CT of abdomen showed no sign of obstruction or leak but did reveal inflammatory changes & fascial dehiscence. Taken back to OR & wound was reopened. Small amount of murky drainage was cultured & grew out pseudomonas & enterobacter, both sensitive to antibiotics he was already on. Retention sutures were placed & he was returned to PICU, extubated & slowly progressed to be afebrile w/oral feeds & normal bowel movements. Central line & TPN were d/c. D/C to home on oral feeds, topical wound management & off all antibiotics. FINAL DX:Ileocolic intussusception, & umbilical hernia, s/p bowel resection w/anastomosis, hernia repair & appendectomy. |
|
VAERS ID: |
277783 (history) |
Form: |
Version 1.0 |
Age: |
0.2 |
Sex: |
Male |
Location: |
Arizona |
Vaccinated: | 2007-03-08 |
Onset: | 2007-04-24 |
Days after vaccination: | 47 |
Submitted: |
2007-05-02 |
Days after onset: | 8 |
Entered: |
2007-05-02 |
Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS |
AC21B059CA / 1 |
LL / IM |
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. |
1272F / 1 |
RL / IM |
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH |
B08684D / 1 |
RL / IM |
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. |
1231F / 1 |
MO / PO |
Administered by: Unknown Purchased by: Unknown Symptoms: Intussusception 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, 2 days
Extended hospital stay? No
Previous Vaccinations: Other Medications: Current Illness: Preexisting Conditions: Allergies: Diagnostic Lab Data: CDC Split Type:
Write-up: April 24, 2007 patient was treated for intersusseption records received 5/15/07-intussusception. exploratory laparotomy. |
|
VAERS ID: |
277820 (history) |
Form: |
Version 1.0 |
Age: |
0.6 |
Sex: |
Female |
Location: |
Texas |
Vaccinated: | 2007-04-21 |
Onset: | 2007-04-29 |
Days after vaccination: | 8 |
Submitted: |
2007-05-02 |
Days after onset: | 3 |
Entered: |
2007-05-03 |
Days after submission: | 1 |
Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER |
C2552AA / 3 |
- / - |
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER |
UE981AA / 3 |
- / - |
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER |
20547 / 3 |
- / - |
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH |
B086820 / 3 |
- / - |
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. |
0389F / 3 |
MO / PO |
Administered by: Private Purchased by: Public Symptoms: Intussusception,
Screaming,
Sleep disorder,
Vomiting SMQs:, Acute pancreatitis (broad), Gastrointestinal obstruction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (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: Other Medications: None Current Illness: None Preexisting Conditions: None Allergies: Diagnostic Lab Data: Reports to follow LABS: KUB, US of abdomen revealed IS at hepatic flexure & air contrast enema successfully reduced.. CDC Split Type:
Write-up: Intussusception, increased screaming, vomit, deep sleep. 5/4/07 Received vax records from PCP which reveal the following also received on 4/21/07: DTaP C2552AA 3rd dose Hib UE981AA 3rd dose IPV 20547 3rd dose PCV B086820 3rd dose Rotavirus 0389F 3rd dose 6/19/07 Received ER records. No D/C Summary available. Patient seen only in ER on 4/30/07 for vomiting & increased sleepiness. FINAL DX: Intussusception, reduced by air contrast enema. |
|
VAERS ID: |
277882 (history) |
Form: |
Version 1.0 |
Age: |
0.4 |
Sex: |
Female |
Location: |
Pennsylvania |
Vaccinated: | 2007-04-03 |
Onset: | 2007-04-26 |
Days after vaccination: | 23 |
Submitted: |
2007-05-03 |
Days after onset: | 7 |
Entered: |
2007-05-03 |
Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR |
C2569AA / 2 |
LL / - |
HIBV: HIB (ACTHIB) / SANOFI PASTEUR |
UF073AA / 2 |
RL / - |
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH |
B08672K / 2 |
- / - |
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. |
1238F / 2 |
MO / PO |
Administered by: Private Purchased by: Private Symptoms: Barium double contrast,
Intussusception,
Vomiting SMQs:, Acute pancreatitis (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? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
Extended hospital stay? No
Previous Vaccinations: Other Medications: Current Illness: None Preexisting Conditions: Pilonydal dimple Allergies: Diagnostic Lab Data: Patient admitted to hospital overnight 4/27-4/28. Diagnosed w/intussusception reduced w/air. LABS: heme (+) stool. US (+) for IS in transverse colon. Blood work WNL. Abd x-ray suspicious for IS. Air enema successfully reduced IS. CDC Split Type:
Write-up: Patient developed vomiting on 4/26/2007 on 4/27 parent report bilious vomiting episode 1 referred to hospital ED for evaluation. 5/4/07 Received vax records from PCP which confirm RO lot & dose as reported on VAERS form. 7/6/07 Received hospital medical records which reveal patient experienced bilious emesis & had blood in stool in ER. Surgery consult done. Admitted 4/27-4/28/07. FINAL DX: Ileocolic intussusception, successfully reduced by air enema. |
|
VAERS ID: |
277899 (history) |
Form: |
Version 1.0 |
Age: |
0.2 |
Sex: |
Female |
Location: |
Unknown |
Vaccinated: | 2007-03-29 |
Onset: | 2007-04-23 |
Days after vaccination: | 25 |
Submitted: |
2007-05-03 |
Days after onset: | 10 |
Entered: |
2007-05-04 |
Days after submission: | 1 |
Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR |
C21521AA / 1 |
LL / - |
HBHEPB: HIB + HEP B (COMVAX) / MERCK & CO. INC. |
0757F / 1 |
RL / - |
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR |
Z0306 / 1 |
RL / - |
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH |
B08681D / 1 |
LL / - |
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. |
1239F / 1 |
UN / - |
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: Current Illness: Preexisting Conditions: Unknown Allergies: Diagnostic Lab Data: Barium enema X-ray CDC Split Type: WAES0704USA05624
Write-up: Information has been received from a physician concerning a 11 week female who on 29-MAR-2007 was vaccinated with the first dose of Rotateq (Lot # 656189/1239F). Concomitant vaccinations included Dtap, PREVNAR, Comvax, poliovirus vaccine. On 23-APR-2007, the patient experienced intussusception and was hospitalized and given an air contrast enema. The patient recovered from intussusception on 25-APR-2007. Additional information has been requested. 5/15/07 Received vax record which confirmed RO Lot & dose as reported. VAERS database updated w/additional vax info from same date. 5/22/07 Received hospital medical records which reveal patient experienced irritability, bilious vomiting & bloody stool x 1 day. Seen in ER on 4/23 & dx w/IS by barium enema which also reduced successfully. Kept for overnight observation s/p reduction & progressed well. D/C home 4/24/07. Returned to ER on 4/27/07 for irritability/crying w/BM. Abdominal x-ray revealed nonspecific bowel gas pattern. US of abd was WNL & pt was d/c to home. |
|