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Administered by: Private Purchased by: Public
Life Threatening? No Write-up: Rotateq vaccine given 8-13-07. Infant diagnosed and treated for intussusception 9/16/07.12/10/07-records received for DOS 9/16/07-DC DX: Intussusception. Barium enema reduction of colo-colonic intussusception with reflux of contrast into the terminal ileum. C/O vomiting and blood stools. Fussy. | ||||||||||||||||||||||||||||||||
Administered by: Unknown Purchased by: Unknown
Life Threatening? No Write-up: After first dose of Rotateq developed intussusception approx. 5 weeks later. After second dose of Rotateq developed intussusception one week later. Both episdoses treated at Hospital. 10/29/2007 MR received for hospital DOS 7/28-29/2007 fo Dx: Intussusception. Infant initially presented with inconsolable crying and blood in stool. Vomiting developed which was green initially then orange. Rectal exam at another facility (+) for rectal bleeding and pt transfered to current facility. In ER had Currant Jelly stool, Guiac (+). Decreased po intake. Infant had a successful reduction of Intussusception via Barium enema. 10/31/2007 Vax record received and submitted for scanning. Lot number same as VAERS report. 01/25/2008 MR received for ER visit 9/08/2007 with DX: Intussusception-reduced spontaneously. Child presented to ER with blood in stool which "looked like jelly", vomiting and abdominal pain. Rust colored sputum noted in tracea on PE. | ||||||||||||||||||||||||||||||||
Administered by: Other Purchased by: Other
Life Threatening? No Write-up: Information has been received from a physician concerning an 8 week old male who received his first dose of oral Rotateq. On an unspecified date, he was seen in the physician''s office after he had developed sudden bouts of crying and appeared to be in pain. At the time of this report, the physician was awaiting the results of unspecified test but he suspects a diagnosis of intussusception. It is reported that the patient has not recovered. A product quality complaint was not reported. No further information was available. Upon internal review it was determined that intussusception was an other important medical event. Additional information has been requested. 10/23/07 Patient demographics provided by CDC./ss 10/23/2007 Reviewed hospital medical records which reveal patient experienced emesis x 2, diarrhea, irritability, decreased oral intake x 1 week. Seen by pcp & KUB obtained c/w IS. Confirmed by BE as outpatient & sent to outlying hospital but they were unable to do the BE for reduction. Transferred to higher level of care. Repeat KUB revealed distended bowel but no IS. Admitted 9/7-9/8/07 for observation s/p reduction. Had recurrent IS s/s. US of abdomen confirmed IS within transverse colon recurred & air contrast enema successfully reduced. Surgical consult done. FINAL DX: Intussusception, enema reduced. Records faxed to CDC. 11/30/07 Reviewed hospital ER records which reveal patient seen 9/6/07 with intermittent emesis, watery stools & poor appetite x 4 days. BE revealed IS & patient transferred to higher level of care. Records faxed to CDC. | ||||||||||||||||||||||||||||||||
Administered by: Other Purchased by: Other
Life Threatening? No Write-up: Information has been received from health professionals concerning a 7 month old male who received his first dose on 17-APR-2007, second dose 20-JUN-2007, and a third dose, 2 ml oral 21-AUG-2007, of Rotateq (lot #655866/1110F; 56385/0030U; 656381/0875U respectively). Concomitant vaccines included Hib conj vaccine (lot#''s53523/0063U and 654679/1126F respectively), PREVNAR (lot #''s B08691F; B08690H; and B58845F respectively), and PEDIARIX (lot #''s AC21B096A; AC21B114CA; and AC21B124AA respectively). On 11-SEP-2007, the patient''s mother phoned the office reporting that the patient had developed a fever, loose stools, was gassy, and was screaming every 1 1/2 hours at night. He was seen in the office and stool samples on 12-SEP-2007 were negative for Rota virus. The reporter stated that he continued to experience symptoms "on and off over the next couple of weeks." He was seen in the office again on 04-OCT-2007, after developing loose stools with mucous and low grade fever "on and off". On 05-OCT-2007, he was hospitalized and underwent an x-ray with barium enema "which cleared the intussusception". He was seen in the office in follow up to his hospitalization and reportedly was "doing fine". The reporter stated "the admission to the hospital and enema administration was intervention to prevent serious criteria". No product quality complaint was reported. The patients experiences were considered to be other important medical events by the reporter. This is one of two reports from the same source. Additional information has been requested. 10/23/07 Patient demographics provided by CDC. 10/23/07 Recieved contrast enema report from CDC which reveals patient had ileocolic IS at hepatic flexure & was successfully reduced. 10/23/07 Received vax record from pcp & VAERS database updated w/same. 12/4/07 Received ER medical records which reveal patient experienced irritability, fever & distended abdomen. BE reduced IS but transferred to higher level of care for continued observation. FINAL ER DX: Intussusception. Records faxed to CDC. 12/7/07 Reviewed hospital medical records which reveal patient experienced abdominal discomfort for approx 1 month starting w/ulcerations in mouth & throat & progressed to nightly abdominal pain, large amounts of gas, low grade fever intermittently. PCP tested for rotavirus which was neg. Initially had increased WBC. GI consult done as outpatient 1 week prior to admit who dx GERD, tx w/antacid & antibiotic. Transferred from outlying ER s/p BE revealed IS. Admitted 10/6 & d/c same day. To f/u w/PCP & have GI small bowel series done as outpatient. FINAL DX: abdominal pain, possible formula intolerance, unlikely intussusception. Records faxed to CDC. | ||||||||||||||||||||||||||||||||
Administered by: Private Purchased by: Public
Life Threatening? No Write-up: Intussusception. 11/02/07 Reviewed medical records from 2nd ER of 10/19/07 which reveal patient experienced pulling up of legs, vomiting & apparent abdominal pain. Seen in outlying ER & admitted overnight. Tx w/IVF & serial abdominal exams. D/c to home & had continued gagging, reduced oral intake, irritability, decreased sleep & uncomfortable abdomen. BE reduced IS & admitted overnight for observation s/p reduction. FINAL DX: Intussusception, enema reduced. Records faxed to CDC. 11/13/07 Reviewed hospital medical records which reveal patient experienced vomiting, fever & abdominal pain. Admitted 10/18-10/19/2007. Abdomen was diffusely tender. Tx w/IVF, antipyretic & antinausea meds. Improved & d/c to home. ER Diagnosis: dehydration, vomiting & abdominal pain. Seen at outlying hospital for persistent vomiting where IS was dx & reduced by BE. Admitted overnight for observation & d/c to home. Continued to run fever & had diarrhea & returned to ER. Temp 103 in ER. Tx w/antipyretic & d/c to home. Final ER dx: fever secondary to vaccines. Records faxed to CDC. 11/16/07 Received vax record from pcp which confirms RO dose & lot as reported. Record faxed to CDC. | ||||||||||||||||||||||||||||||||
Administered by: Other Purchased by: Other
Life Threatening? No Write-up: Information has been received from a physician concerning an 8 month old male with reflux and history of "MSPI type" diet with no other medical history or drug allergies who on 22-MAR-2007, 24-MAY-2007 and 25-JUL-2007 was vaccinated PO with his first, second and third doses (lot# 656381/0875U) of Rotateq. Concomitant vaccinations administered on 25-JUL-2007 included a dose of DTaP, a dose of poliovirus vaccine inactivated (unspecified) and a dose of (Prevnar). Other concomitant drug therapy included nizatidine (AXID) drops for reflux. On 04-OCT-2007 the patient experienced intussusception and was hospitalized. Medical attention was sought through the physician. Labs and abdominal x-rays were performed. A barium enema was also performed to reduce the intussusception. Subsequently, the patient recovered. There was no product quality complaint. Additional information has been requested. 10/26/07 Patient demographics provided by CDC. 10/30/07 Reviewed vax records which confirms RO dose & lot as reported & provides other vax info. VAERS database updated w/same. 11/2/07 Received hospital medical records which reveal patient experienced bilious vomiting x 2 days & 1 episode of bloody stool. Seen by pcp, sent to ER when vomiting persisted. Admitted 10/4-10/5/2007. Noted to have exanthem, lethargy, reduced oral intake & urine output. Progressed well s/p enema reduction & d/c to home. FINAL DX: Intussusception, enema reduced. Records faxed to CDC. | ||||||||||||||||||||||||||||||||
Administered by: Private Purchased by: Private
Life Threatening? No Write-up: Infant hospitalized for intussusception on 10/21/07-Rotateq given on 7/11/07 and 9/12/07. 10/26/07 Received vax record from reporter which provides RO dose #2 & lot #. VAERS database updated w/same. Record faxed to CDC. 11/13/07 Linked w/296061. 12/4/07 Reviewed hospital medical records which reveal patient experienced vomiting & bloody stools. Admitted 10/21-10/23/2007. BE/air enema diagnosed IS but unable to completely reduce. Did well post operatively & d/c to home. FINAL DX: Intussusception, surgically reduced & appendectomy. Records faxed to CDC. | ||||||||||||||||||||||||||||||||
Administered by: Other Purchased by: Other
Life Threatening? No Write-up: Information has been received from a physician concerning an 8 month old patient who was vaccinated with a complete series of Rotateq. Subsequently, a complete series of the patient experienced intussusception, sought unspecified medical attention and recovered. No product quality complaint was reported. No further information was available. Upon internal review intussuception was considered an other important medical event. Additional information has been requested. | ||||||||||||||||||||||||||||||||
Administered by: Other Purchased by: Public
Life Threatening? No Write-up: Hospitalized with intussusception on 10/24/07. 12/4/07 Reviewed vax record which confirms dose & lot numbers as reported. Records faxed to CDC. 12/7/07 Reviewed hospital medical records which reveal patient experienced vomiting & bloody stool. Had been seen at outlying ER & transferred to higher level of care. Admitted 10/24/2007 & d/c to home same day. FINAL DX: Intussusception, enema reduced. Records faxed to CDC. | ||||||||||||||||||||||||||||||||
Administered by: Other Purchased by: Other
Life Threatening? Yes Write-up: Information has been received from a physician concerning a 4 month old male who on 06-OCT-2007 was vaccinated p.o. with a dose ("1 tube") of Rotateq. On 07-OCT-2007 the patient experienced bloody stools and was hospitalized due to intussusception on the same day. The patient''s diagnosis was considered to be immediately life threatening. The intussusception was corrected with surgery. No other information was available. Unspecified medical attention was sought. The outcome was reported as recovered. There was no product quality complaint. The event was considered to be an other important medical event by the reporter. Additional information has been requested. 9/27/07- Seen on 10/5/07-visit after hospitalization for gastroenteritis. 1/29/08-records received for DOS 10/7-10/9/07-DC DX: Intussusception status post reduction with exploratory laparotomy, manual reduction and incidental appendectomy. C/O nausea, vomiting and bloody stools times 1 day. | ||||||||||||||||||||||||||||||||
Link To This Search Result:
http://www.medalerts.org/vaersdb/findfield.php?EVENTS=ON&PAGENO=20&SYMPTOMS[]=Intussusception_%2810022863%29&VAX[]=RV5&REPORT_YEAR_HIGH=2012&REPORT_MONTH_HIGH=04
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