VAERS
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First of all do not confuse VAERS with the VICP. VAERS is the Vaccine Adverse Events Reporting System which was set up to be a centralized reporting system for all vaccine reactions, injuries or deaths. It receives reports from anyone including parents but has nothing to do with deciding who gets compensated.

VICP is the Vaccine Injury Compensation Program and was set up under PL-99-660 along with VAERS. When the CDC recommends a vaccine for universal use it is then added to the compensation program. There is a table of compensable events and if your injury fits into this table (includes time) then it is presumed to be a vaccine injury. If the injury falls outside the table of injuries and time then it is called an "off the table" case and you have to prove your case much like you would in a court battle. The big difference of course is that you are fighting the United States Government, defended  by the Department of Justice, instead of a drug company. In a lawsuit against a drug company there is a process called "discovery". This is the fact finding part of the trial and an injured person can ask for all the documents from the drug company that could be related to the product. Again, this does not happen in the compensation program.

Vaccines are licensed on a fast track now a days and there is very little study done on the front end. There are very few reports published in medical journals discussing adverse events because the government and the drug companies conduct the studies.

Vaccines now come into the program without events attached to them and it forces people into an "off the table" situation. These cases are very difficult to win.

YIKES--seems as though there is much confusion about  VAERS, NVICP, and NVIC.  VAERS does not compensate anyone; it is nothing more the a place to report an adverse reaction to a vaccination.  The database VAERS has compiled is very large and available for our sides docs to review and use!!!! 

 Here is a link to the VAERS website -- http://www.fda.gov/cber/vaers/vaers.htm.

    The NVICP, simply known as "Vaccine Court", is set up within the US Court of Federal Court of Claims.  In 1986, Congress passed the NVICP in an attempt to provide a no-fault, non-adversarial, fair and equitable system for compensating victims who suffered an adverse reaction to a mandatory vaccination.  Claimants are entitled to file Petitions for Compensation in the United States Court of Federal Claims in Washington, D.C.   The respondent for these claims is the Secretary of Department of Health and Human Services, and the claims are defended by the Department of Justice. The cases are initially heard by Special Masters, and their decisions are typically upheld on appeal.   If claimants can show that a vaccine caused their injuries, then they are entitled to compensation pursuant to the statute.  As is has evolved, the NVICP has become an adversarial roadblock, and the Secretary has made it extremely difficult to prove causation in many cases.  There are many legal pitfalls that may be encountered along the way, and, because of the limitations on attorneys fees and expenses, which are paid by the program, (only after the case is over), it is difficult to find lawyers who have extensive experience with the program and are willing or able to represent claimants.  It's not the best system, but it is the one we must operate under, until it is changed!!!!   The NVICP has become a perfect example of why, in my opinion, tort "deform" simply does not work.  See my website for details (link below my signature line).     The average awards under the NVICP are nearly $1,000,000.00 per successful claim, but successful claims are few and far between.  ONLY past economic damages are capped at $250,000.00, NOT FUTURE DAMAGES!!!!!  We have the highest award under the NVICP--$9.1 million.  You can get the average award details at -- http://www.hrsa.gov/osp/vicp/monthly.htm .  This site is updated monthly.     The NVIC -- http://www.909shot.com/ -- is a non-profit group that provides information.  It was started years ago by Barbara Loe Fisher.     Hope this helps clear up all the confusion.
    My best.Peacefully,
Jeff Sell
Hitt * Patterson * Sell
4309 Yoakum Boulevard
2nd Floor
Houston, Texas 77006
713.654.7776
713.654.7789 (fax)
www.HittPattersonSell.com 
JZSell@HittPattersonSell.com
832-731-3145 (cell/v-mail)
~~~~~~~~~~~~~~~~~~~~~
 

http://www.medalerts.org/vaersdb/

 

In addition to Wyeth Lederle discontinuing production of its tetanus and diphtheria toxoids and acellular pertussis vaccine (DTaP; ACEL-IMUNE®), Baxter Hyland Immuno Vaccines (formerly North American Vaccine, Inc.) (Baltimore, Maryland) is not producing its DTaP vaccine (Certiva™). Aventis Pasteur and Glaxo SmithKline (Philadelphia, Pennsylvania), producers of Tripedia® and Infanrix™, respectively, are the remaining suppliers of DTaP. On March 7, 2001, the Food and Drug Administration approved a newly formulated version of Tripedia® in one-dose vials without preservative and with only a trace amount of thimerosal. Approval of this vaccine should improve the supply of DTaP.
 

VAERS ID 152825 Vaccination Date: 2000-03-29
Age 5.0 Date filed: 2000-07-10
Sex M Where Administered: PUB
State WV Purchased by: PUB
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness: NONE
Diagnostic Lab Data: NONE
Previous Vaccinations:
Other Medications: NONE
Preexisting Conditions: NONE

Vaccinations Manufacturer Lot Dose Route Site
1 DTAP NORTH AMERICAN V D009 1 IM RA
2 OPV LEDERLE 0800D 1 PO

Onset Date: 2000-03-30 Number of Days: 1
Symptoms: ALLERG REACT URTICARIA
Mother states that one day post vax, the child broke out in whelps the size of quarters and in certain areas these were raw. She took him to see an MD and he suspected an allergic reaction to immunizations.


VAERS ID 152443 Vaccination Date: 1999-04-28
Age 2.0 Date filed: 2000-06-13
Sex F Where Administered: PUB
State TX Purchased by: OTH
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness: NONE
Diagnostic Lab Data:
Previous Vaccinations:
Other Medications: NONE
Preexisting Conditions: jaundice

Vaccinations Manufacturer Lot Dose Route Site
1 DTAP NORTH AMERICAN V C001 2 RL

Onset Date: 1999-05-05 Number of Days: 7
Symptoms: FEVER TREMOR
Mom states she took the child to the ER on 5/5/99 with a fever of 104, shaking as though she was falling. Mom states child received reducer and antibiotics by mouth and also seizure medication. Child has recovered and mom states no more seizures since this time.


VAERS ID 150901 Vaccination Date: 2000-02-25
Age 0.3 Date filed: 2000-04-12
Sex F Where Administered: OTH
State TX Purchased by: PUB
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? Yes (days in hospital: 1)
Prolonged Hospitalization? No
Current Illness: Bronchitis
Diagnostic Lab Data: CBC, UA, Electrolytes, CT of head, EKG, EEG - all wnl.
Previous Vaccinations:
Other Medications: Albuterol Elixir, Naldecon Infant drops
Preexisting Conditions: NONE

Vaccinations Manufacturer Lot Dose Route Site
1 DTAP NORTH AMERICAN V D004R 1 IM LL
2 HEP MSD 1804J 1 IM RL
3 HIBV LEDERLE(PRAXIS) 56753A 1 IM RL
4 IPV MERIEUX INST P0568 1 SC LL

Onset Date: 2000-02-27 Number of Days: 2
Symptoms: ASTHMA CONVULS EYES GAZE UPWARD OTITIS MED TREMOR
Post vax, child was admitted to hospital after history of 3 episodes of eyes rolling back, followed by arm then leg shaking. Observed by parents. NO episodes during admission. Dismissed 02/28/2000. Final dx was possible seizure, bilateral otitis media, possible asthma. MD recommended no pertussis vax in the future.



VAERS ID 150874 Vaccination Date: 2000-04-06
Age 0.3 Date filed: 2000-04-10
Sex M Where Administered: PVT
State TX Purchased by: PUB
Life Threatening Illness? No
Died? Yes (date died: 2000-04-07)
Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Current Illness: Cold
Diagnostic Lab Data: Autopsy at examiner's office
Previous Vaccinations:
Other Medications: Amoxil completed on 4/3/2000 and Panmist
Preexisting Conditions: NONE

Vaccinations Manufacturer Lot Dose Route Site
1 DTAP NORTH AMERICAN V 1004R 1 IM RL
2 HIBV LEDERLE(PRAXIS) 512453A 1 IM RL
3 IPV MERIEUX INST P0474 1 IM LL

Onset Date: 2000-04-06 Number of Days: 0
Symptoms: APNEA BRONCHIOLITIS BRONCHITIS CHILLS EDEMA LUNG HEART ARREST HYPOTONIA LUNG DIS RHINITIS SIDS
Child presented to ER, lifeless and not breathing. Baby cool with rigor mortis. Mom had fed infant at 13:30 and he was fine. At 17:00, noted to be pale and lifeless. CPR began and brought to ER. Autopsy shows pulmonary vascular congestion, pulmonary edema, tracheobronchitis with bronchiolotis and peri-bronchiolar pulmonary inflammation, generalized visceral congestion, sudden infant death


VAERS ID 150467 Vaccination Date: 2000-03-09
Age 1.0 Date filed: 2000-03-30
Sex M Where Administered: PUB
State TX Purchased by: PUB
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes (days in hospital: )
Prolonged Hospitalization? No
Current Illness: NONE
Diagnostic Lab Data:
Previous Vaccinations:
Other Medications: PPD, Lot 251411, ID in forearm, 1st test.
Preexisting Conditions: Asthma

Vaccinations Manufacturer Lot Dose Route Site
1 DTAP NORTH AMERICAN V D004R 3 IM RL
2 HIBV LEDERLE(PRAXIS) 530453A 3 IM LL
3 IPV MERIEUX INST PO4742 2 SC RL
4 MMR MSD 0915J 0 SC RA
5 VARCEL MSD 1456J 0 SC LL

Onset Date: 2000-03-10 Number of Days: 1
Symptoms: ASTHMA CONVULS FEVER
3/10 One day post vax, patient experienced fever and convulsion. Was admitted to hospital and released 3/11. Child remained well until 3/14 when he experienced fever and convulsion. Was hospitalized again. Evening of 3/14, he experienced convulsion in hospital and remains hospitalized to date. Mother states that child had diarrhea and illness for about one month when her physician stated on 3/8 that he was well and could receive vax. Follow up information received 7/18/00 stating that during childs hospital


VAERS ID 134672 Vaccination Date: 2000-01-12
Age 0.4 Date filed: 2000-03-09
Sex M Where Administered: PUB
State TX Purchased by: PUB
Life Threatening Illness? No
Died? Yes (date died: 2000-01-17)
Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Current Illness: NONE
Diagnostic Lab Data:
Previous Vaccinations:
Other Medications: NONE
Preexisting Conditions: NONE

Vaccinations Manufacturer Lot Dose Route Site
1 DTAP NORTH AMERICAN V D006R 0 IM LL
2 HEP SMITHKLINE 3201A2 0 IM RL
3 HIBV LEDERLE(PRAXIS) 520453 0 IM LL
4 IPV MERIEUX INST PO168 0 SC RL

Onset Date: 2000-01-17 Number of Days: 5
Symptoms: SIDS
No signs, no symptoms, found dead at 3 AM 1/17/00. Autopsy findings (per grandmother) stated that infant died of SIDS. Grandmother interviewed by phone.



VAERS ID 129954 Vaccination Date: 1999-06-23
Age 0.2 Date filed: 1999-11-10
Sex F Where Administered: PUB
State UT Purchased by: PUB
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Current Illness: NONE
Diagnostic Lab Data:
Previous Vaccinations:
Other Medications: NONE
Preexisting Conditions: NONE

Vaccinations Manufacturer Lot Dose Route Site
1 DTAP NORTH AMERICAN V C007 0 IM LL
2 HBHEPB MSD 1797H 0 IM RL
3 IPV CONNAUGHT LTD N0426 0 SC LA

Onset Date: 1999-06-23 Number of Days: 0
Symptoms: AGITATION DYSPNEA
approx 5hr later had uncontrollable crying for @ least 2hr-last hr seemed to have a hard time breathing;father did artificial resp & then finally quit crying & breathing back to nl;



VAERS ID 127879 Vaccination Date: 1999-07-26
Age 0.5 Date filed: 1999-09-08
Sex F Where Administered: UNK
State CA Purchased by: UNK
Life Threatening Illness? Yes
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? Yes (days in hospital: 1)
Prolonged Hospitalization? No
Current Illness: NONE
Diagnostic Lab Data: Barium Enema confirmed Intussusception of rt colon, could not be reduced during enema;
Previous Vaccinations: none
Other Medications: recv HEP #2, DTaP#2, HIBV #2 and RV- Wyeth- 4998175 -po-1st dose on 5/27
Preexisting Conditions: NONE

Vaccinations Manufacturer Lot Dose Route Site
1 DTAP NORTH AMERICAN V C010 2 IM LL
2 HEP SMITHKLINE 2958 2 IM RL
3 HIBV LEDERLE(PRAXIS) 441003A 2 IM LL

Onset Date: 1999-08-07 Number of Days: 12
Symptoms: ANOREXIA DEHYDRAT INTUSS PAIN ABDO VOMIT
p/vax pt devel abd pain, vomiting;tx for dehydration;taken to surgery for intussusception, confirmed during surgery;



VAERS ID 127063 Vaccination Date: 1999-07-26
Age 0.5 Date filed: 1999-08-12
Sex F Where Administered: PUB
State UT Purchased by: PUB
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes (days in hospital: 1)
Prolonged Hospitalization? No
Current Illness: runny nose
Diagnostic Lab Data: NONE
Previous Vaccinations: NONE
Other Medications: NONE
Preexisting Conditions: eczema; hayfever per MD

Vaccinations Manufacturer Lot Dose Route Site
1 DTAP NORTH AMERICAN V C007 2 RL
2 HIBV CONNAUGHT LABS 0996880 2 LL

Onset Date: 1999-07-26 Number of Days: 0
Symptoms: APNEA CONVULS HYPERKINESIA TWITCH
no fever;mom said seizures for next 24hr-approx 30x; describes sudden sitting up, waking w/a jerk;stops breathing; in hosp x 24hr; no tests done;



VAERS ID 125498 Vaccination Date: 1999-06-30
Age 1.7 Date filed: 1999-07-19
Sex M Where Administered: PUB
State UT Purchased by: PUB
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness:
Diagnostic Lab Data:
Previous Vaccinations: NONE
Other Medications: NONE
Preexisting Conditions:

Vaccinations Manufacturer Lot Dose Route Site
1 DTAP NORTH AMERICAN V C0105100 3
2 HEP SMITHKLINE ENG796A2 0

Onset Date: 1999-06-30 Number of Days: 0
Symptoms: CONVULS REACT AGGRAV
had 2" seizure w/in 3hr of vax;



VAERS ID 150475 Vaccination Date: 2000-03-15
Age 0.5 Date filed: 2000-03-29
Sex M Where Administered: PVT
State IL Purchased by: OTH
Life Threatening Illness? No
Died? Yes (date died: 2000-03-18)
Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Current Illness: NONE
Diagnostic Lab Data: Autopsy being performed
Previous Vaccinations:
Other Medications: NONE
Preexisting Conditions: NONE

Vaccinations Manufacturer Lot Dose Route Site
1 DTAP UNCLASSIFIED

Onset Date: 2000-03-17 Number of Days: 2
Symptoms: HEART ARREST SIDS
Pt received vaccination 2 days prior to arrival at ER in full cardiac arrest. Autopsy shows cause of death as sudden infant death syndrome


VAERS ID 152445 Vaccination Date: 2000-03-07
Age 4.0 Date filed: 2000-06-13
Sex F Where Administered: PUB
State TX Purchased by: PUB
Life Threatening Illness? No
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Current Illness: coughing
Diagnostic Lab Data: BP - 140, pulse - 72, physical - nml
Previous Vaccinations:
Other Medications: NONE
Preexisting Conditions: NONE

Vaccinations Manufacturer Lot Dose Route Site
1 DTAP NORTH AMERICAN V C009 1 IM RA
2 IPV CONNAUGHT LTD N0826 0 SC LA
3 MMR MSD 1754H 1 SC LA

Onset Date: 2000-03-07 Number of Days: 0
Symptoms: EYES GAZE UPWARD HYPERTENS OPISTHOTONOS PALLOR SWEAT TREMOR
Post vax, the child was in mother's arms and arched back and mother felt trembling an saw eyes roll back. The child became pale an diaphoretic, still breathing. Has laid down then became alert.

VAERS ID 155787 Vaccination Date: 2000-05-05
Age 5.7 Date filed: 2000-07-05
Sex M Where Administered: OTH
State TX Purchased by: PUB
Life Threatening Illness? No
Died? No
Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes (days in hospital: 0)
Prolonged Hospitalization? No
Current Illness: NONE
Diagnostic Lab Data:
Previous Vaccinations:
Other Medications: NONE
Preexisting Conditions: NONE

Vaccinations Manufacturer Lot Dose Route Site
1 DTAP NORTH AMERICAN V D0048 4 IM
2 IPV MERIEUX INST P04742 3 SC
3 MMR MSD 1456J SC

Onset Date: 2000-05-05 Number of Days: 0
Symptoms: AMBLYOPIA CATARACT NOS COORDINAT ABNORM GAIT ABNORM VISION ABNORM
Pt experienced problems with seeing, walking into things, tripping over things, sits close to television, blurred vision, cataracts. Had a lensectomy on 6/27/00.


VAERS ID 156861 Vaccination Date: 2000-06-06
Age 0.3 Date filed: 2000-07-18
Sex M Where Administered: PUB
State AL Purchased by: PUB
Life Threatening Illness? No
Died? Yes (date died: 2000-06-09)
Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Current Illness: NONE
Diagnostic Lab Data: Autopsy done-SIDS
Previous Vaccinations:
Other Medications: Mylicon drops
Preexisting Conditions: NONE

Vaccinations Manufacturer Lot Dose Route Site
1 DTAP NORTH AMERICAN V D009 0 IM LL
2 HEP MSD 0147K 1 IM RL
3 HIBV LEDERLE(PRAXIS) 581313A 0 IM RL
4 IPV MERIEUX INST P0739 0 SC LL

Onset Date: 2000-06-09 Number of Days: 3
Symptoms: SIDS
Infant was given routine 2 month IZ on 6/6/00 and on 6/9/00, the infant was found in his crib at 06:15 AM and was not breathing. Maternal grandmother found infant. She states infant was fine after receiving IZ but was fussy but no fever. She reported that she gave the infant o.4 ml of infant acetaminophen to ease soreness in infants legs. She denies any problems, no fever, etc. On 6/7/00 and 6/8/00, child took formula well. On 6/8/00, she fed baby a bottle of formula with cereal and rocked him to sleep. She


VAERS ID 159339 Vaccination Date: 2000-08-03
Age 0.2 Date filed: 2000-09-01
Sex F Where Administered: PVT
State MD Purchased by: PVT
Life Threatening Illness? Yes
Died? No
Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? Yes (days in hospital: 2)
Prolonged Hospitalization? No
Current Illness: NONE
Diagnostic Lab Data: EEG - abn
Previous Vaccinations:
Other Medications:
Preexisting Conditions: NONE

Vaccinations Manufacturer Lot Dose Route Site
1 DTAP NORTH AMERICAN V D010 0 IM LL
2 HIBV LEDERLE(PRAXIS) 520253A 0 IM RL
3 IPV CONNAUGHT LTD R1251 0 RL

Onset Date: 2000-08-06 Number of Days: 3
Symptoms: CONVULS EEG ABNORM
Developed multiple seizures approximately 2 days post vax. Required hospitalization and child was prescribed phenobarbital. Was afebrile.

 

CDC AIMS TO DENY OUTSIDE ACCESS TO VACCINE DATABASE. PARENTS OF VACCINE-
INJURED CRY, "COVER-UP!" AND ASK, "WHAT ARE THEY TRYING TO HIDE?"

WASHINGTON, Aug. 19 /PRNewswire/ -- The Centers for Disease Control (CDC) has paid for another Institute of Medicine (IOM) meeting on August 23rd to do its dirty work in hiding the vaccine-autism link. This time they want to deny access to the Vaccine Safety Datalink (VSD) containing data that could further confirm the link between thimerosal, the mercury-based preservative found in
vaccines and flu shots, to neurodevelopmental disorders such as autism and ADHD.

The VSD, housed at the CDC, is an epidemiological gold mine recording millions of doses of vaccines and has cost taxpayers $11 million a year for 14 years. In Oct. 2003, at the behest of Congress, two independent researchers were the first to gain access to the database. They found shocking evidence that the link between autism and thimerosal was real. Data prove that children are 27 times more likely to develop autism after exposure to three TCVs, than those who receive thimerosal-free versions. (Symptoms of autism and mercury poisoning are almost identical.) The relative risk of 27 is higher than that between lung cancer and smoking, which according to the American Cancer Society is only 22 for men and 11 for women.

Soon after, the CDC denied further access to these investigators. Congressman Dave Weldon (R-FL) and others got involved to help but with no success. Now, 10 months later, the CDC wants to close the VSD forever to those who seek the truth. CDC officials say it's to protect patient privacy.
But, according to government officials, the VSD was specifically created with patient privacy in mind to facilitate scientific research. There are no names or other identifying numbers. VSD information includes gender, age, vaccination dates and any subsequent diagnosis: asthma, speech/language delay, ADD, ADHD, autism, etc.

"This blatant act of secrecy and manipulation of data for the benefit of the vaccine industry is corruption at its worst," said Jo Pike, President of NAA. "Follow the money. Many of these officials have financial ties to the pharmaceutical industry. They fear well-deserved public backlash for allowing catastrophic damage to children, want to protect their careers and drug companies from liability. To do so, they intend to deny Americans their rights to vital records about vaccination risks. If there is no evidence of mercury-poisoning in the VSD, why are they so determined not to let qualified, professional scientists look at the data?" NAA will hold a joint press conference with five other organizations representing the vaccine-injured at 9 a.m. in the main hall of the National Academies of Sciences in D.C. Jo Pike, Rita Shreffler, Scott Bono and Laura Bono, parents of mercury-poisoned children, will be available for interviews. http://www.nationalautismassociation.org

Contact:
Laura Bono, (919) 423-3749
Rita Shreffler, (417) 818-9030

 

From Edda West, VRAN, Canada

VRAN has been contacted by a paper in the UK today.

 Dear ..............
 
Following is information we sent to a colleague in Britain who runs a vaccine awareness email list - will send separately additional points re law suits & lack of vaccine injury compensation in Canada.

Edda West here from VRAN (Canada).  Good for the folks in the UK who are protesting the new 5 in 1 vaccine being foisted on them. Here in Canada, we didn't hear a peep in the media when Aventis Pasteur's 5 in 1 vaccine (Pentacel) was introduced across the board and injected into most Canadian babies starting in 1997.

Although we can be grateful that thimerosal is no longer in the vaccine (except perhaps for trace amounts used in the manufacturing process which apparently they don't have to disclose), it has been replaced with 2-phenoxyethanol, a main ingredient in anti-freeze. You'd need to check the ingredients list to determine whether this is also being used in the U.K.version of the 5 in 1 vaccine. We've not been able to find any data showing that it is safe to inject infants with 2-phenoxyethanol or anti-freeze for that matter.  Our understanding is that they were unable to continue using thimerosal, not because of safety concerns to babies, but because the inactivated polio viruses in Pentacel vaccine are altered by thimerosal, hence the need to switch to another preservative.  Some sources state that 2-phenoxyethanol is a 'protoplasmic poison'.  No matter how many vaccines your David Salisbury and Paul Offit in the U.S. think babies can handle, the bottom line is they are still being injected with toxic substances.

Canadian infants have been the main test market for this vaccine these past 7 years, and based on this large experiment, Aventis is aiming to have it licensed for use in the U.S. either in 2004 or 05. Undoubtedly licensing in other countries is pending as well.

Canada is the perfect test market for pharmaceutical companies testing new vaccines because:

a) There is no mandatory reporting of vaccine reactions in this country, with the result that only a small fraction (between 1-10%) of adverse reactions are reported.

b)Reporting of adverse reactions hinges solely on the individual doctor's 'opinion' as to whether a reaction is vaccine related. Most physicians  refuse to entertain the possibility of vaccine involvement when a child presents with any range of collapse, seizures, neurological injury post vaccination. Hence, the vast majority of vaccine reactions are discounted as 'coincidental' and reports are not filed.

c) to the best of our knowledge the original trials did not monitor reactions in children beyond 72 hours (see attached pdf medscape report), and prelicensure testing was only done in healthy children.

d)Testing on children with existing or evolving neurological or other health problems was not undertaken until after the vaccine was already in widespread use. (we have not seen the results of this additional post licensure evaluation) We suspect that parents whose children suffered existing health problems and who were vaccinated with Pentacel were not informed their children were included in a test group. (see Marina's story, attached)

e)Although reporting of adverse reactions in the first 72 hours are substantially less than with the old whole cell vaccine that contained thimerosal, the pattern we have observed from parents who have contacted us, is that serious reactions to this 5 in 1 vaccine are delayed often by 10 or 12 days, way beyond a time frame that any physician will consider the seizures or collapse to be vaccine related. See Kirk's story http://64.41.99.118/vran/news_art/stories/story_shunter.htm

f)No public access to government or pharmaceutical data bases for independent inquiries into reactions that are being reported. Without independent evaluation of reactions and in the absence of mandatory reporting of vaccine reactions,  sweeping statements claiming that the 5 in 1 vaccine has been proven safe after 7 years of injection into Canadian children are fraudulent.
 
Following is backgrounder from Scott Hunter, (parent of vaccine injured child) who has been investigating Pentacel:
 
"I have not been able to unearth any clinical trials used to license the product in 1996 that used the products exact ingredients. To the contrary I’ve been able to find several references pointing in the opposite direction. The accellular component was added in 1997 post-licensure and the preservative Thimerosal was replaced with 2-phenoxyethanol seemingly without the product being retrialed. Most clinical trials references in the monograph utilize component trials not the DTaPP -ActHib all in one
combination with the one mention of Quadracel trials in Canada not dated. Any change in the product ingredients should have constituted a reason for retrial given the potential immunologic sensitivities to the new elements."
 
Additional writes Scott "VAESS (canadian reporting system)  requires that physicians and health professionals NOT make causal assessments prior to reporting. Kirk’s neurologist refused to entertain vaccine injury to such an extent, he informed us after 6 months of intensive testing which confirmed a diagnosis of idiopathic seizures, he would "never" reconsider vaccine as a possible trigger. This, I presume, contributed to the reason it took us over a year of constant parental shoving to get this "possible" injury recorded. As a matter of fact Kirk's only official documenting of the our suspicions was recorded at the MAYO Clinic in Rochester, despite repeated attempts with several health professionals here." (see attached letter to minister of health - saskatchewan)
 
The attached is a significant piece of the puzzle I've been trying to put together. The other pieces regarding my sons injury and the lack of reporting is apart from this. But suffice to say, even if they had performed these trials properly - the way in which they report/monitor injury is flawed. ie:

1. it's a completely volunteer system - health professionals are left to decide what constitutes injury even though the guidelines clearly state causal determinations are not to be made.
2. the manufacturer (Aventis) says Health Canada isn't legally bound to report injury claims to them therefore what piecemeal data do the trials represent.
3.  Aventis said they encourage reporting through their monograph - which no one in this province receives. Just the one pager Sask Health gives to parents which says the benefit outweighs risk.
4. It took almost two years for my sons possible injury (intractable seizures) to be reported when it should have taken 15 days.
5. By their own admission trial data is so small (as few as 250 kids) they rely on post-market data tracking to reveal anomalies and trends in injury
(See above)

Beginning with the attached, the following observations/questions come to mind.

1. Vaccine approved for use in Canada in 1996 (I need to reconfirm this)
2. Vaccine changed in 1997 (whole cell to accellular) (and at some point thimerosal changed to phenoxethanol2)
3. appears only data used to trial done on healthy children
4. data required on children with underlying heath issues
5. What were the parents told when their children with health problems were vaccinated/offered vaccination ie: was info given that related to healthy children's trial only?
6. There are additional questions on reporting - Is 0-72 hours really
sufficient? How is the data collected shared with the maker?

BTW - Aventis is seeking FDA approval this year for the product.
 
There has been a HUGE increase in anaphylaxis disorders following the widespread use of the 5 in 1 vaccine and its precursor Penta (4 in one plus Hib). Attached is a letter from a parent whose child developed anaphylaxis following injection with Penta, the precursor to Pentacel - it took her over a year to get a list of reactions to the lot numbers of vaccine her boy was injected with. Of course we have no idea how many lot numbers were issued in all, or how many children overall were vaccinated during the course of this experiment before they created its progeny, the 5 in 1 vaccine trademarked Pentacel in Canada.

.............I'm sending you a separate email on the legal perspective of vaccine injury cases in Canada - that's another huge topic.

Best wishes,

Edda West,
VRAN - Vaccination Risk Awareness Network Inc.
info@vran.org
www.vran.org

 

On July 1, the Department of Health and Human Services (DHHS) issued a press release announcing that influenza vaccine injuries had been added to the National Vaccine Injury
Compensation Program, effective July 1. Portions of the press release are reprinted below.

******************

People thought to be injured by influenza vaccines given annually will be eligible for compensation under [the] National Vaccine Injury Compensation Program (VICP), effective July 1, 2005.

The VICP, created by Congress in 1986 as an alternative to traditional civil litigation, provides financial compensation to eligible individuals thought to be injured by covered childhood vaccines. Administered by the U.S. Department of Health and Human Services' Health Resources and Services Administration, the program allows compensation for past and future medical expenses, pain and suffering, and lost wages. In addition, compensation may also be awarded for attorneys' fees and costs. . . .

To access the Federal Register notice announcing coverage of the influenza vaccine under the VICP, to learn how to file a claim, or to obtain more information on the program, visit
http://www.hrsa.gov/osp/vicp, or call (800) 338-2382.



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