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Overview

Vaccines and Immunizations : Introduction , Side Effects , State Law

Instructions for Using VISs


Required Use


Provide a Vaccine Information Statement (VIS) when a vaccination is given.


As required under the National Childhood Vaccine Injury Act, all health care providers within 
us who administer, to any child or adult, any of the subsequent vaccines – diphtheria, tetanus, pertussis, measles, mumps, rubella, polio, hepatitis A, hepatitis B, Haemophilus influenzae type b (Hib), influenza, pneumococcal conjugate, meningococcal, rotavirus, human papillomavirus (HPV), or varicella (chickenpox) – shall, prior to administration of each dose of the vaccine, provide a copy to keep of the relevant current edition vaccine information materials that have been produced by the Centers for Disease Control and Prevention (CDC): the parent or legal representative of any child to whom the provider intends to administer such vaccine, or to any adult to whom the provider intends to administer such vaccine.


[1] “Legal representative” is defined as a parent or other individual who is qualified under state law to consent to the immunization of a minor child or incompetent adult.


[2] In the case of an incompetent adult, relevant VISs shall be provided to the individual’s legal representative. If the incompetent adult is living in a long-term care facility, all relevant VISs may be provided at the time of admission, or at the time of consent if later than admission, instead of 
before each vaccination.If there's not one VIS for a mixture vaccine, use the VISs for all component vaccines.VISs should be supplemented with visual presentations or oral explanations as appropriate.


2. Record information for each VIS provided.


Healthcare providers shall make a notation in each patient’s permanent medical history 
at the time vaccine information materials are provided, indicating:

 

Ø  The edition date of the VIS distributed, and

Ø  The date the VIS was provided.


This record keeping requirement supplements the need 
of all healthcare providers administering these vaccines must record in the patient’s permanent medical record (or in a permanent office log):

 

Ø  The name, address and title of the individual who administers the vaccine,

Ø  The date of administration, and

Ø  The vaccine manufacturer and lot number of the vaccine used.


Applicability of State Law


Healthcare providers should consult their legal counsel to work out 
additional State requirements concerning immunization. The Federal requirement to supply the vaccine information materials supplements any applicable State laws.



Possible Side effects from Vaccines


Any vaccine can cause side effects. For the foremost 
part these are minor (for example, a sore arm or low-grade fever) and get away within a couple of days. Vaccines are continually monitored for safety, and like all medication, vaccines can cause side effects. However, a choice to not immunize a toddler also involves risk and will put the kid et al. who inherits contact with him or her in danger of contracting a potentially deadly disease.



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