|
VAERS ID: |
355049 (history) |
Form: |
Version 1.0 |
Age: |
0.5 |
Gender: |
Male |
Location: |
Tennessee |
Vaccinated: | 2009-07-17 |
Onset: | 2009-08-18 |
Days after vaccination: | 32 |
Submitted: |
2009-08-24 |
Days after onset: | 6 |
Entered: |
2009-08-24 |
Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR |
C3237AA / 3 |
UN / UN |
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS |
AHBVB610AA / 3 |
LA / UN |
HIBV: HIB (ACTHIB) / SANOFI PASTEUR |
C3307AA / UNK |
UN / UN |
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH |
D37015 / 3 |
UN / UN |
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS |
A41FA860A / 2 |
MO / PO |
Administered by: Private Purchased by: Public Symptoms: Abdominal mass,
Barium enema,
Incorrect dose administered,
Intussusception,
Lethargy,
Pain,
Pyrexia SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal obstruction (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
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? No
Previous Vaccinations: Other Medications: No concurrent medication Current Illness: Unknown Preexisting Conditions: The subject has no relevant medical history and no history of adverse events following previous vaccinations. PMH: none noted Allergies: Diagnostic Lab Data: UNK Labs and diagnostics: Abd US (+) mass, ? IS. Contrast enema (+) for ileocolic IS. Repeat US (-) CDC Split Type: A0803583A
Write-up: This case was reported by a healthcare professional and described the occurrence of intussusception in a 6-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). Previous vaccination included 1st dose of ROTARIX (GlaxoSmithKline) given on 25 March 2009 and ROTATEQ (manufacturer unspecified) given on 15 May 2009. Concurrent vaccination included PENTACEL (manufacturer unspecified), ACTHIB (manufacturer unspecified), ENGERIX B (GlaxoSmithKline) and PREVNAR (Wyeth Labs) all given on 17 July 2009. There were no concurrent medications. On 17 July 2009 at 11:09 the subject received 2nd dose of ROTARIX (oral). This was actually the 3rd dose of rotavirus vaccine as ROTATEQ was given to the subject inbetween doses of ROTARIX. An extra dose was administered. It was noted that the lot number for the ROTARIX diluent given with dose 2 was A41DA860A with an expiration date of 25 September 2011. On 18 August 2009, in the evening, 1 month after vaccination with ROTARIX, the subject experienced intussusception with pain, fever, abdominal mass and lethargy. The healthcare professional considered the events were clinically significant (or requiring intervention). The subject was seen by his physician and administered a barium enema as treatment which seemed to straighten everything out. At the time of reporting, the subject was at home resting and was reportedly improved. The subject''s physician did not think the events were caused by ROTARIX. 9/23/09 PCP records received dated 8/18/09-9/17/09 with DX: Intussusception. Pt presented 8/18/09 with vomiting, watery stool and excessive drooling. T''=99.2''F. Abd mass palpated in LLQ. Sent for outpt US which was (+) for IS. Barium Enema done with reduction of the IS. Observed in pcp office and d/c home doing well. Returned 9/13 09 after episode of vomiting. Abd exam WNL. (+) R OM. |
|
VAERS ID: |
355481 (history) |
Form: |
Version 1.0 |
Age: |
0.21 |
Gender: |
Female |
Location: |
Tennessee |
Vaccinated: | 2009-08-20 |
Onset: | 2009-08-24 |
Days after vaccination: | 4 |
Submitted: |
2009-08-26 |
Days after onset: | 2 |
Entered: |
2009-08-26 |
Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR |
C3295AA / 1 |
LL / IM |
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS |
AHBVB707AA / 2 |
LL / IM |
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH |
D48928 / 1 |
RL / IM |
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS |
A41DA802A / 2 |
MO / PO |
Administered by: Unknown Purchased by: Unknown Symptoms: Culture stool,
Intussusception,
Stool analysis,
Urinary system X-ray,
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? No Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
Extended hospital stay? No
Previous Vaccinations: Other Medications: Nystatin oral susp Current Illness: Thrush Preexisting Conditions: None Allergies: Diagnostic Lab Data: CBC, stool for blood and culture, KUB and abdominal ultrasound 9/3/09 Received medical records w/LABS: Abdominal x-ray & US & KUB abnormal. CBC & CMP WNL. BE w/air contrast unable to reduce. Stool guiaic (+). CDC Split Type:
Write-up: Patient received Rotarix oral vaccine on 08/20/09. Taken to ER on 08/24/09 with vomiting. Diagnosed with intussusception. 9/3/09 Received hospital records of 8/24-8/26/2009. FINAL DX: cecal intussusception, surgically reduced Records reveal patient experienced vomiting & fever x 1 day. Had bloody stool in ER w/abdominal distention & hypoactive bowel sounds. Tx w/IV antibiotics. Surg consult done when BE unable to reduce IS. Progressed well post op & d/c to home. ICD9 codes: 560.0 |
|
VAERS ID: |
360569 (history) |
Form: |
Version 1.0 |
Age: |
0.17 |
Gender: |
Female |
Location: |
Michigan |
Vaccinated: | 2009-09-28 |
Onset: | 2009-10-06 |
Days after vaccination: | 8 |
Submitted: |
2009-10-17 |
Days after onset: | 11 |
Entered: |
2009-10-13 |
Days after submission: | 4 |
Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR |
C3427AA / 1 |
UN / IM |
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS |
AHBVB708A / 1 |
UN / IM |
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH |
D57302 / 1 |
UN / IM |
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS |
A41FA860A / 1 |
MO / PO |
Administered by: Private Purchased by: Public Symptoms: Intussusception,
Vomiting,
X-ray abnormal SMQs:, Acute pancreatitis (broad), Gastrointestinal obstruction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (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: None Preexisting Conditions: None Allergies: Diagnostic Lab Data: Xray study consistent with diagnosis above. 10/20/09 PCP medical records received service dates 9/28/09 to 10/6/09.LABS and DIAGNOSTICS: Abdominal X-ray - Abnormal, suspicious for bowel obstruction. 10/26/09 ED report received service date 10/6/09. LABS and DIAGNOSTICS: CBC - Neutrophils 52% (H) Lymphocytes 31% (L) ABS Monocytes 1.72 K/uL (H) HGB 12.8 g/dL (L) MCV 82 fL (L) MCH 28.6 pg (L) Platelets 533 K/uL (H). CHEM - Potassium 3.9 mEq/L (L). Abdominal X-ray - Abnormal, suspicious for obstruction, possible intussusception vs volvulus. Urinalysis - cloudy. CDC Split Type:
Write-up: Presented with vomiting. Dx: Intussusception per radiology report. Reduced and sent home. 10/20/09 PCP medical records received service dates 9/28/09 to 10/6/09. Assessment: Suspicious for bowel obstruction. Patient presents with abdominal pain and vomiting. 10/26/09 ED report received service date 10/6/09. Assessment: Vomiting (Possible small bowel obstruction). Patient presents with vomiting that started last night and is still present. Nausea and decreased oral intake. Black stools. Difficulty with urination, decreased activity, lethargic. Poor muscle tone. Sleepier that usual. Nasal discharge. Appears "sick''. Bilious vomiting. NGT placed. Transfer to higher level facility. |
|
VAERS ID: |
368114 (history) |
Form: |
Version 1.0 |
Age: |
0.55 |
Gender: |
Male |
Location: |
Iowa |
Vaccinated: | 2009-10-26 |
Onset: | 2009-10-31 |
Days after vaccination: | 5 |
Submitted: |
2009-11-09 |
Days after onset: | 9 |
Entered: |
2009-11-17 |
Days after submission: | 8 |
Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS |
AC21B213AA / 2 |
LL / IM |
HIBV: HIB (ACTHIB) / SANOFI PASTEUR |
UF729AA / 2 |
LL / IM |
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH |
D90888 / 2 |
LL / IM |
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS |
A41CA943A / 2 |
MO / PO |
Administered by: Private Purchased by: Private 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, 1 days
Extended hospital stay? No
Previous Vaccinations: Other Medications: Current Illness: None Preexisting Conditions: None. ED record and vaccination records received for date of service 10/31/09. PMH: None. Allergies: Diagnostic Lab Data: ED record and vaccination records received for date of service 10/31/09. Labs and diagnostics: UA. Labs: CBC, CMP Dx studies: air contrast barium enema CDC Split Type:
Write-up: Intussusception resolved with Barium Enema after special Enema on 11/1/09. 11/18 & 11/19/09: ED record and vaccination records received for date of service 10/31/09. Dx: Intussusception Assessment: Presents with intussusception, admitted. 12/10/2009 ED record, Admission and consult notes for 10/31-11/1/2009, patient with c/o''s persistent vomiting x 2 days. Tx: IVF, NPO, barium enema + for intussusception |
|
VAERS ID: |
378219 (history) |
Form: |
Version 1.0 |
Age: |
0.33 |
Gender: |
Female |
Location: |
Alabama |
Vaccinated: | 2009-10-15 |
Onset: | 2010-01-01 |
Days after vaccination: | 78 |
Submitted: |
2010-01-19 |
Days after onset: | 18 |
Entered: |
2010-01-26 |
Days after submission: | 7 |
Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR |
C3157AA / 2 |
RL / UN |
HIBV: HIB (ACTHIB) / SANOFI PASTEUR |
UF727AA / 2 |
RL / UN |
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR |
D0041 / 2 |
LL / UN |
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH |
D87185 / 2 |
LL / UN |
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS |
A41FA895A / 2 |
MO / PO |
Administered by: Private Purchased by: Private Symptoms: Enema administration,
Intestinal resection,
Intussusception,
Laparoscopic surgery,
Lethargy,
Vomiting,
X-ray SMQs:, Acute pancreatitis (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal obstruction (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypoglycaemia (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, 10 days
Extended hospital stay? No
Previous Vaccinations: Other Medications: Finishing AMOXICILLIN Current Illness: Resolving OM & bronchiolitis Preexisting Conditions: Allergies: Diagnostic Lab Data: X-ray, 2 air enemas CDC Split Type:
Write-up: Pt started "violently vomiting after breakfast" on 01/01/10, acting lethargic. Went to ED - x-ray showed intussusception, tried air enema x 2 tried laparoscopic surgery, had to cut open and do bowel resection - took out 8 inches of bowel. |
|
VAERS ID: |
378753 (history) |
Form: |
Version 1.0 |
Age: |
0.45 |
Gender: |
Male |
Location: |
Connecticut |
Vaccinated: | 2010-01-20 |
Onset: | 2010-01-23 |
Days after vaccination: | 3 |
Submitted: |
2010-01-27 |
Days after onset: | 4 |
Entered: |
2010-01-29 |
Days after submission: | 2 |
Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS |
AHBVB762CA / 2 |
RL / UN |
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS |
A41FA963A / 2 |
MO / PO |
Administered by: Private Purchased by: Private Symptoms: Abdominal pain upper,
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? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
Extended hospital stay? No
Previous Vaccinations: Vomiting, abd pain~Rotavirus (Rotarix)~1~0.00~Patient Other Medications: Current Illness: None Preexisting Conditions: Murmur. Allergies: Diagnostic Lab Data: CDC Split Type:
Write-up: 12/16/09 ROTARIX #1-developed belly pain and vomiting. 1/20/10 ROTARIX #2-on 1/23/10 intussusception. |
|
VAERS ID: |
380180 (history) |
Form: |
Version 1.0 |
Age: |
0.44 |
Gender: |
Male |
Location: |
Arkansas |
Vaccinated: | 2009-08-19 |
Onset: | 2009-09-18 |
Days after vaccination: | 30 |
Submitted: |
0000-00-00 |
Entered: |
2010-02-12 |
Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS |
AC21B213 / 2 |
LL / IM |
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. |
UF596AA / 2 |
RL / IM |
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH |
D74257 / 2 |
RL / IM |
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS |
A41FA859 / 2 |
MO / PO |
Administered by: Private Purchased by: Private Symptoms: Abdominal X-ray,
Barium enema,
Dehydration,
Intussusception,
Vomiting SMQs:, Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Gastrointestinal obstruction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Dehydration (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: Preexisting Conditions: Allergies: Diagnostic Lab Data: Flat plate Abd; Barium enema ultrasound, had exploratory surgery for intussusception 09/19/09 CDC Split Type:
Write-up: Vomiting-$gdehydration-$gintussusception. |
|
VAERS ID: |
383135 (history) |
Form: |
Version 1.0 |
Age: |
0.52 |
Gender: |
Male |
Location: |
New York |
Vaccinated: | 2010-03-15 |
Onset: | 2010-03-19 |
Days after vaccination: | 4 |
Submitted: |
2010-03-22 |
Days after onset: | 3 |
Entered: |
2010-03-22 |
Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR |
C3555AA / 2 |
LL / IM |
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. |
AHBVB818BA / 4 |
LL / IM |
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH |
D94434 / 2 |
RL / IM |
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS |
A41FB036A / 2 |
MO / PO |
Administered by: Private Purchased by: Public Symptoms: Intussusception 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, 2 days
Extended hospital stay? No
Previous Vaccinations: Other Medications: Current Illness: No Preexisting Conditions: No Allergies: Diagnostic Lab Data: CDC Split Type:
Write-up: intussusception |
|
VAERS ID: |
383903 (history) |
Form: |
Version 1.0 |
Age: |
0.33 |
Gender: |
Female |
Location: |
North Carolina |
Vaccinated: | 2010-03-18 |
Onset: | 2010-03-25 |
Days after vaccination: | 7 |
Submitted: |
2010-03-29 |
Days after onset: | 4 |
Entered: |
2010-03-31 |
Days after submission: | 2 |
Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR |
C3542AA / 2 |
LL / IM |
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH |
D888183 / 2 |
RL / IM |
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS |
A41FB057A / 2 |
MO / PO |
Administered by: Private Purchased by: Public Symptoms: Abdominal operation,
Enema administration,
Intestinal mass,
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, 5 days
Extended hospital stay? No
Previous Vaccinations: Other Medications: None Current Illness: None Preexisting Conditions: Allergies: Diagnostic Lab Data: CDC Split Type:
Write-up: Intussusception - failed enema reduction X3. Abd surgery to reduce, also found mass (duplication of cecum). Final Dx intussusception duplicate cecum. |
|
VAERS ID: |
385949 (history) |
Form: |
Version 1.0 |
Age: |
0.17 |
Gender: |
Male |
Location: |
Nebraska |
Vaccinated: | 2010-03-01 |
Onset: | 2010-04-24 |
Days after vaccination: | 54 |
Submitted: |
2010-04-26 |
Days after onset: | 2 |
Entered: |
2010-04-26 |
Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR |
C3606AA / 1 |
UN / IM |
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS |
AHBVB772CA / 2 |
UN / IM |
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH |
E20366 / 1 |
UN / IM |
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS |
A41DB036A / 1 |
MO / PO |
Administered by: Private Purchased by: Private Symptoms: Intussusception 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: intussusception~Rotavirus (Rotarix)~1~0.00~Patient Other Medications: PRILOSEC 1 ml BID (2mg/ml) Current Illness: Preexisting Conditions: Allergies: Diagnostic Lab Data: Fluoro Barium Enema and ultra sound CDC Split Type:
Write-up: Infant was admitted to hospital with intussusception on 4/24/10. |
|