CDC Difference of VIS and Package Inserts for MMR

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What are the risks listed in the Vaccine Information Statement

Vaccine Information Statement

A vaccine, like any medicine, is capable of causing serious problems, such as severe allergic reactions.

The risk of MMR vaccine causing serious harm, or death, is extremely small.

Getting MMR vaccine is much safer than getting measles, mumps or rubella.

Most people who get MMR vaccine do not have any serious problems with it.

Mild problems

  • Fever (up to 1 person out of 6)
  • Mild rash (about 1 person out of 20)
  • Swelling of glands in the cheeks or neck (about 1 person out of 75)

If these problems occur, it is usually within 6-14 days after the shot. They occur less often after the second dose.

Moderate problems

  • Seizure (jerking or staring) caused by fever (about 1 out of 3,000 doses)
  • Temporary pain and stiffness in the joints, mostly in teenage or adult women (up to 1 out of 4)
  • Temporary low platelet count, which can cause a bleeding disorder (about 1 out of 30,000 doses)

Severe problems (very rare)

  • Serious allergic reaction (less than 1 out of a million doses)
  • Several other severe problems have been reported after a child gets MMR vaccine, including:
    • Deafness
    • Long-term seizures, coma, or lowered consciousness
    • Permanent brain damage

These are so rare that it is hard to tell whether they are caused by the vaccine.

[It isn’t hard to tell for the parents of vaccine injured children. Serious adverse events in clinical trials most always are not due to the vaccine.]

What are the warnings for the MMR vaccine?

MMR II Package Insert

WARNINGS

Due caution should be employed in administration of M-M-R II to persons with a history of cerebral injury, individual or family histories of convulsions, or any other condition in which stress due to fever should be avoided. The physician should be alert to the temperature elevation which may occur following vaccination (see ADVERSE REACTIONS).

[Why isn’t the statement above in the Vaccine Information Statement? Why weren’t some parents given the Vaccine Information Statements?]

Hypersensitivity to Eggs Live measles vaccine and live mumps vaccine are produced in chick embryo cell culture. Persons with a history of anaphylactic, anaphylactoid, or other immediate reactions (e.g., hives, swelling of the mouth and throat, difficulty breathing, hypotension, or shock) subsequent to egg ingestion may be at an enhanced risk of immediate-type hypersensitivity reactions after receiving vaccines containing traces of chick embryo antigen. The potential risk to benefit ratio should be carefully evaluated before considering vaccination in such cases. Such individuals may be vaccinated with extreme caution, having adequate treatment on hand should a reaction occur (see PRECAUTIONS).{46}

However, the AAP has stated, “Most children with a history of anaphylactic reactions to eggs have no untoward reactions to measles or MMR vaccine. Persons are not at increased risk if they have egg allergies that are not anaphylactic, and they should be vaccinated in the usual manner. In addition, skin testing of egg-allergic children with vaccine has not been predictive of which children will have an immediate hypersensitivity reaction…Persons with allergies to chickens or chicken feathers are not at increased risk of reaction to the vaccine.”{47} Hypersensitivity to Neomycin

[Parents are expected to play Russian Roulette with their child’s allergy]

The AAP states, “Persons who have experienced anaphylactic reactions to topically or systemically administered neomycin should not receive measles vaccine. Most often, however, neomycin allergy manifests as a contact dermatitis, which is a delayed-type (cell-mediated) immune response rather than anaphylaxis. In such persons, an adverse reaction to neomycin in the vaccine would be an erythematous, pruritic nodule or papule, 48 to 96 hours after vaccination. A history of contact dermatitis to neomycin is not a contraindication to receiving measles vaccine.”

[Dermatitis is a part of anaphylaxis. Can the AAP state with complete accuracy that neomycin will not lead into severe anaphylaxis?]

Definition of anaphylaxis from the U.S. National Library of Medicine

{47} Thrombocytopenia Individuals with current thrombocytopenia may develop more severe thrombocytopenia following vaccination. In addition, individuals who experienced thrombocytopenia with the first dose of M-M-R II (or its component vaccines) may develop thrombocytopenia with repeat doses. Serologic status may be evaluated to determine whether or not additional doses of vaccine are needed. The potential risk to benefit ratio should be carefully evaluated before considering vaccination in such cases (see ADVERSE REACTIONS).

[Are serologic tests 100% accurate to determine thrombocytopenia will not occur?] 

Preventing and Managing Adverse Reactions

I’ve never received a Vaccine Information Statement for our children. The VIS for MMR II does not give a parent the information that is given in the package insert.  Vaccine Information Statement questions and answers.

“The National Childhood Vaccine Injury Act of 1986 (1) requires that vaccine information materials be developed for each vaccine covered by the Act (uscode.house.gov). These materials, known as vaccine information statements (VISs), must be provided by all public and private vaccination providers each time a vaccine is administered. Copies of VISs are available from state health authorities responsible for vaccination and from CDC.

Obviously in my family the Childhood Vaccine Injury Act of 1986 wasn’t enforced. How many parents have not received the Vaccine Information Statements?  The vaccine package inserts should be made available to everyone who receives a vaccine.

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