Vaccine Injury Compensation Program (VICP) completes review of ten petitions


PublishTime:2010-02-23

On February 11, 2010, VICP called a conference to review ten petitions. At the conference, VICP reviewed the cases’ clinical charts, laboratory data, medical treatment, disease development, past medical history, related vaccine characteristics, relevant literature and clinical experiences to determine the cause of each case and the association between the H1N1 vaccine and the case.According to the report released by VICP, all ten cases were deemed not associated with the pandemic influenza A (H1N1) vaccine: four of the cases were reimbursed NT$10,000~NT$20,000 for medical charges and examination fees imposed to determine the link between the case and the H1N1 vaccine according to the new regulation, one of the cases was reimbursed NT$50,000 for clinical laboratory fees and one case was reimbursed NT$300,000 for funeral expenses.

Case # 1 is a 12-year-old boy who experienced dizziness, headache and nausea immediately after he received the H1N1 vaccine.Since his symptoms persisted, he sought medical attention at a hospital.All the results of his medical examination, including hearing test, EEG (Brain Wave Test, Electroencephalogram) and brain CT scan showed no abnormalities. Therefore, it was determined that his symptoms were heart-caused, but not associated with the vaccination.

Case #2 is a 16-year-old girl who experienced increased heartbeat, shortness of breath, numbness in her limbs and dizziness 15 minutes after receiving the H1N1 vaccine. 19 days later, she was rushed to the emergency department and hospitalized for medical assistance because she experienced palpitation, general weakness and shortness of breath.At the hospital, she was found to have hypokalemia and mitral valve prolapse syndrome. The case was diagnosed with hyperventilation syndrome and congenital heart disease. Therefore, it was determined that her symptoms were not associated with the vaccination.The cases was reimbursed NT$10,000 for medical charges and examination fees imposed to determine the link between the case and the H1N1 vaccine according to the new regulation.

Case #3 is an 11-year-old boy who experienced dizziness and headache and nausea 10 minutes after he received the H1N1 vaccine.His symptoms improved after resting.However, his symptoms subsequently persisted, he was rushed to the emergency department at a hospital several times.All the results of his medical examination, including blood test, neurological examination and brain CT scan showed no abnormalities. Therefore, it was determined that his symptoms were a result of needle shock, but not associated with the vaccination.

Case #4 is a 43-year-old man who experienced discomfort, headache, dizziness and fever at the night of his vaccination.He was then hospitalized for treatment.His symptoms included fever, rash on the entire body, sore throat, muscle aches, fatigue, stiffness in the neck and headache. His rash is dark red macular rash, which is an atypical presentation. His skin biopsy showed infiltration of lymphoid cells around the area of blood vessels in the dermis.His physical examination showed acute pharyngitis and tonsillitis. In addition, his laboratory examination showed liver function abnormality.His condition stabilized after treatment and he was discharged from the hospital. It was determined that his symptoms were a result of viral infection, but not associated with the vaccination. The cases was reimbursed NT$10,000 for medical charges and examination fees imposed to determine the link between the case and the H1N1 vaccine according to the new regulation.

Case #5 is a 36-year-old pregnant woman who is 11 weeks into her pregnancy.After vaccination, she experienced general discomfort and vomiting.In addition, she had troubles getting out of bed.However, she did not seek any medical assistance.5 days after her vaccination, she sought medical attention at a hospital because she experienced severe abdominal pain.At the hospital, the ultrasound showed no fetal heartbeat.She was then diagnosed with early miscarriage.It was determined that her symptoms were not associated with the vaccination because she did not develop apparent allergy response or adverse reaction within five days of her vaccination. The cases was reimbursed NT$50,000 for embryo examination according to the new regulation.

Case #6 is a 34-year-old pregnant woman who is 21 weeks into her pregnancy. 7 days after vaccination, she sought medical attention at a gynecologist’s clinic because she experienced abdominal pain and her water broke.Immediately, she was rushed to the emergency department at a hospital and she was hospitalized for fetal sedative. She gave birth to a baby boy that subsequently died despite resuscitation.Her amniotic fluid culture found group B streptococcus.It was determined that her miscarriage was highly likely a result of her diabetes, obesity and group B streptococcus infection, but not associated with the vaccination.

Case #7 is a 43-year-old man who has a medical history of hepatitis B.He was found to have a liver tumor in August, 2009 and was diagnosed with liver cancer in September the same year.He experienced diarrhea after returning home from vaccination in December, 2009.Subsequently, his diarrhea persisted and he experienced vomiting.He was then hospitalized for medical treatment.The ultrasound showed tumor spread and an accumulation of excessive fluid within the peritoneal cavity.His abdominal CT scan showed several hematomas and excessive fluid.He then developed unconsciousness, a drop in his blood pressure and cardiac arrhythmia.After resuscitation, his conditions still got worsened and he died. The case had liver cancer at final stage.He died of malignant liver cancer and esophageal variceal rupture.It was determined that his symptoms were but not associated with the vaccination.The case was reimbursed NT$300,000 for funeral expenses.

Case #8 is a 31-year-old woman who did not experience any discomfort on the day of her vaccination. When she subsequently developed fever and sore throat, she sought medical attention at a clinic and a hospital.The results of her medical examination, including blood test, thyroid function test and chest X-ray, showed no abnormalities. Therefore, it was determined that the case’s symptoms were not associated with the vaccination. The case was reimbursed NT$10,000 for medical charges and examination fees imposed to determine the link between the case and the H1N1 vaccine according to the new regulation.

Case #9 is a 14-year-old boy who has experienced blood in the urine several times since he was 3 years old and had never sought medical attention concerning his bloody urine. About 10 days after his vaccination, he developed nausea and loss of appetite.He then sought medical attention at a clinic.Subsequently, he developed spasm in the neck and limbs.He was then rushed to the emergency department at a hospital and hospitalized for further treatment.The kidney ultrasound showed shrinkage of both kidneys.The case was diagnosed with severe uremia, anemia, hypocalcemia and high blood pressure.He was subsequently transferred to the children’s ICU.His conditions stabilized after peritoneal dialysis and he was then discharged.It was determined that the case’s symptoms were a result of acute exacerbation of his chronic renal failure, but not associated with the vaccination.

Case #10 is a 9-year-old girl who developed cough, runny nose, diarrhea and fever ten days after her vaccination. When she subsequently developed swollen feet, rash on her face, abdominal pain and increased heartbeat, she was rushed to the emergency department at a hospital because she was suspected to have myocarditis and was placed in the ICU on the same day.The echocardiogram showed left atrial and left ventricular dilation, moderate-to-severe tricuspid regurgitation and mitral regurgitation.The case was diagnosed with dilated myocarditis.It was determined that the case’s symptoms were a result of her heart disease, but not associated with the vaccination.The case was reimbursed NT$20,000 for medical charges and examination fees imposed to determine the link between the case and the H1N1 vaccine according to the new regulation.

As of February 12, 2010, the Vaccine Injury Compensation Program (VICP) has received a total of 358 claims requesting compensation for individuals thought to be injured by the pandemic influenza A (H1N1) vaccine. VICP has completed reviewing 58 petitions.Seven cases were ruled compensable (association is confirmed in one while association cannot be excluded in the other six) while the other fifty-one cases were ruled non-compensable.Twenty-three cases were reimbursed NT$10,000~ NT$50,000 for medical charges and examination fees imposed to determine the link between the case and the H1N1 vaccine according to the new regulation and five cases were reimbursed for performing autopsy.The total amount of reimbursement made so far is NT$ 1, 770, 000.A total of 37 suspected vaccine-related deaths were filed for compensation, and 9 have been reviewed and ruled non-compensable.