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Vaccine Adverse Event Case Information

This website provides the detailed information about a specific vaccine adverse event (VAE) case reported to the USA CDC/FDA VAE Reporting System (VAERS).

The input data of this program is a specific VAERS case ID.

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VAE Case Detail:

Patient Profile

VAERS identification number:204308
State:MI
Age in years:1.3
Calculated age in years:1
Calculated age in months:0
Sex:F

Outcomes

Emergency room or doctor visit:Y
Hospitalized:Y
Number of days hospitalized:1
Prolonged hospitalization:N/A
Life-threatening illness:N/A
Disability:N/A
Recovered:Y
Died:N/A
Date of death:N/A

Event Timeline

Vaccination date:2002-05-24
Adverse event onset date:2002-06-10
Days from vaccination to onset:17
Date form completed:2003-05-30
Date report received:2003-06-04

Administration Details

Vaccines purchased with funds:PVT
Vaccines Administered at:PVT
Manufacturer number:WAES0206USA02234

Symptoms & Medical Context

Reported symptom text:Information has been received from a woman in a physician's office and a consumer concerning her 16 month old white daughter, with no past medical history or known allergies, who on 5/24/02 was vaccinated SC with the first dose of MMR (second generation) (lot # 642181/0183M), administered in the left arm. There was no concomitant medication or illness at the time of vaccination. ON 6/10/02 the patient developed fever, cough and was very tired. On 6/13/02 the patient experienced a seizure and was hospitalized. She was diagnosed with a febrile seizure. She remained hospitalized for the next two days. It was reported that as soon as her fever broke, she broke out in a rash all over her body. The woman in the physician's office reported that the seizure was not associated with the vaccination because the patient's sister who was not vaccinated with MMR (second generation) also had similar symptoms of a fever and a rash. Follow up information was received, from the physician, on 9/24/02. Twenty-one days post vaccination, on 6/14/02 (also reported as 6/10/02 and 6/13/02), the child developed a fever. That same day (previously reported as 6/13/02), she developed seizures times 3, for which she was hospitalized, for a duration of one day (previously reported as two days). Admission and discharge diagnoses were febrile seizure and fever, rule out sepsis. According to the hospital discharge summary, the child's parents noted that she was having increased temperature the day prior to admission, measured at 101 degrees F. Her parents administered acetaminophen which helped the fever. They denied any recent upper respiratory tract infection symptoms, earache, nausea, vomiting, diarrhea, or rashes. They stated that the child's appetite and fluid intake had been good on the day prior to admission. The parents described the event as a seizure at approximately 5:00 AM the day of admission which involved her eyes rolling back into her head. The child was described as stiff and had been making shaking movements and strange vocaliza
Diagnostic laboratory data:Diagnostic lab: bacterial antigen detection negative; Pulse oximetry 98% on room air; Blood culture negative; Hemoglobin 12.7; Platelet count 403; Body temp: 101, 105; Serum Bicarbonate 21; Vital sign 48 respiratory rate, 153 pulse rate; Ur
Other medications:NONE
Current illnesses:N/A
History:NONE
Prior vaccination event information:N/A

Vaccine Information:

Vaccine Name Type Manufacturer Lot Dose Route Site Mapped VIOLIN Vaccine
MEASLES + MUMPS + RUBELLA (MMR II)MMRMERCK & CO. INC.0183M0SCM-M-R II
VO ID: VO_0000069

Symptom Information:

AE MedDRA Symptom Term MedDRA Dictionary Version MedDRA ID Ontology ID
Convulsion8.110010904OAE_0000306
Cough8.110011224OAE_0000398
Cyanosis8.110011703OAE_0000549
Eye movement disorder8.110061129OAE_0006047
Fatigue8.110016256OAE_0000034
Laboratory test abnormal8.110061253OAE_0000628
Musculoskeletal stiffness8.110052904OAE_0000334
Pyrexia8.110005911OAE_0000361
Rash8.110037844OAE_0000362
Vomiting8.110047700OAE_0000601

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DISCLAIMER: Before using this website, please ensure that you have read, understand, and agree on the VAERS disclaimer shown at: https://vaers.hhs.gov/data.html. As described in the indicated CDC/FDA VAERS Disclaimer, the VAERS data largely came from voluntary reporting. It has the advantage of nation-wide reporting and can provide some early warning of potential safety issue(s) with a vaccine. However, the VAERS "Reports may include incomplete, inaccurate, coincidental and unverified information". In addition, the VAERS data alone cannot be used to determine the causality of the identified VAE. Instead of being causal, it only shows statistical association.

VAERS Data Use Guide: https://vaers.hhs.gov/docs/VAERSDataUseGuide_June2017.pdf.