Tag: National Vaccine Errors Reporting Program

Avoiding the Most Common Vaccine Errors

Although it would be great if mistakes never ever happened, the best we can do is to understand that mistakes do sometimes happen and take steps to avoid them.

How can we avoid mistakes and errors about vaccines?

Avoiding Vaccine Errors

It can help to:

  • understand the 7 Rights of vaccine administration, including that you give the Right vaccine to the Right patient at the Right time by the Right route at the Right injection site and then follow it with the Right documentation
  • use a screening checklist to help avoid giving vaccines that are contraindicated
  • double check vaccines that look alike or have names that sound like, such as DTaP and Tdap
  • double check expiration dates
  • make sure you aren’t giving live vaccines within 28 days of each other, unless they are given at the same time
  • make sure you aren’t giving the wrong dosage amount for the patient’s age, as some vaccines have different formulations depending on the age of the patient, including flu shots, hepatitis A, and hepatitis B vaccines
  • be careful so that you don’t give a combination vaccine, such as Pediarix, Pentacel, Kinrix, Quadracel, or ProQuad, inappropriately

That we are have a 4-day grace period does help avoid the need to revaccinate some kids when vaccines are given a little too early.

“With the exception of rabies vaccine, ACIP allows a grace period of 4 days (i.e., vaccine doses administered up to 4 days before the recommended minimum interval or age can be counted as valid). However, if a dose was administered 5 or more days earlier than the recommended minimum interval between doses, it is not valid and must be repeated. The repeat dose should be spaced after the invalid dose by the recommended minimum interval.”

Ask the Experts About Scheduling Vaccines

In many cases, as long as vaccine doses were administered less than or equal to 4 days before the minimum interval or age, then they can still be counted and are considered valid.

Common Vaccine Errors

It’s easier than you think to prevent vaccine errors.

Especially if there are more than one child in the room getting vaccines, either the tray itself or the vaccines should be labeled with each child's name so that they don't get the wrong vaccines.
Especially if there is more than one child in the room getting vaccines, either the tray itself or the vaccines should be labeled with each child’s name so that they don’t get the wrong vaccines. Photo by Vincent Iannelli, MD

When are you most likely to make a vaccine error?

When you are doing something that isn’t routine, which most commonly happens when folks delay or skip some vaccines and are now playing catch-up.

In addition to the tips above, remember that:

  • the first dose of the rotavirus vaccines must be given by 15 weeks
  • the rotavirus vaccine series must be completed by 8 months (32 weeks)
  • ProQuad, the MMR and chicken pox combination vaccine, is not licensed for kids who are older than 12 years, although if a teen or adult did get ProQuad, it could be considered an off-label dose and could still count.
  • Kinrix and Quadracel, the DTaP and polio combination vaccines are only licensed for the 5th dose of DTaP and 4th dose of polio in children who are 4 to 6 years old, so wouldn’t be appropriate for an 18-month-old, even if he needs both (DTaP and polio) vaccines. Earlier doses can sometimes count as off-label doses though.
  • the combination vaccines Pediarix and Pentacel are only licensed up through age six years, but don’t necessarily need to be repeated if given to older kids.
  • children and adolescent’s get a pediatric dose (0.5ml) of the hepatitis A vaccine, while older teens, who are at least 19-years-old, get an adult (1.0ml) dose. Since most kids get vaccinated when they are younger, many pediatricians may not have the adult version of the hepatitis A or even realize that there is a different version.
  • children and adolescent’s get a pediatric dose (0.5ml) of the hepatitis B vaccine, while older teens, who are at least 20-years-old, get an adult (1.0ml) dose. Since most kids get vaccinated when they are younger, many pediatricians may not have the adult version of the hepatitis B vaccine or even realize that there is a different version.

Most importantly, even when giving vaccines on schedule, be sure to triple check everything. This is especially important if multiple kids in the same room are getting immunizations.

Also remember that vaccine errors should be reported to the ISMP National Vaccine Errors Reporting Program (VERP) or VAERS, with the correct dose repeated if necessary.

What to Know About Common Vaccine Errors

Although none of these vaccine errors are very common (hundreds of millions of doses of vaccines are given in the United States each year), understanding which ones occur the most often can help to make sure that they don’t happen in your office.

More on Common Vaccine Errors

Why Can’t My 9-Month-Old Get the Rotavirus Vaccine?

The rotavirus vaccines are typically given when infants are two to six months old.

The first dose can be given as early as 6 weeks or as late as 15 weeks though.

The rotavirus vaccines are given between 6 weeks to 32 weeks.

And the final dose can be given as late 8 months (32 weeks).

Why Can’t My 9-Month-Old Get the Rotavirus Vaccine?

What happens if your child didn’t get their rotavirus vaccine on time?

While these vaccines are usually given on either a two and four month (Rotarix) or two, four, and six month (RotaTeq) schedule, as you can see above, there is some flexibility in that timing.

Still, the first dose of the rotavirus vaccine can’t be given any later than 15 weeks and the final dose can’t be given any later than 8 months though, so there is no way that a nine-month-old would be able to get vaccinated.

What would happen if your child did?

“Vaccination should not be initiated for infants aged 15 weeks and 0 days or older because of insufficient data on safety of dose 1 of rotavirus vaccine in older infants. The minimum interval between doses of rotavirus vaccine is 4 weeks; no maximum interval is set. All doses should be administered by age 8 months and 0 days.”

Prevention of Rotavirus Gastroenteritis Among Infants and Children Recommendations of the Advisory Committee on Immunization Practices

The rotavirus vaccines are only licensed at these specific ages, so were not studied in older infants and toddlers. If your 9-month-old did receive a rotavirus vaccine, it would be considered a vaccination error and should be reported.

So why not study them in older kids?

Since severe rotavirus infections mostly occur in younger children between the ages of 4 and 23 months, it doesn’t make any sense to wait until they are older to get them vaccinated.

“To minimize potential risk of intussusception, the World Health Organization (WHO) recommends that rotavirus immunization should be initiated by age 15 weeks and completed before age 32 weeks.”

Age restrictions for rotavirus vaccination: evidence-based analysis of rotavirus mortality reduction versus risk of fatal intussusception by mortality stratum

Also, although the risk is low, a small risk of intussusception after getting the rotavirus vaccine is thought to increase with increasing age of the first dose.

What does all of this mean?

It means that you should follow the immunization schedule and get your kids vaccinated and protected on time.

What to Know About Rotavirus Vaccine Timing

Don’t delay getting your child’s rotavirus vaccine or you may not be able to get it at all, as unlike most other vaccines, these vaccines have strict upper limits for when they can be given.

More on Rotavirus Vaccine Timing

When a Vaccine Doesn’t Count and Needs to Be Repeated

Of course, anti-vaccine folks are wrong when they say that vaccines don’t work.

Vaccines work and they work well to protect us from many different vaccine preventable diseases.

At least they do when you get the right vaccine at the right time and it is given properly. If an error is made, sometimes a vaccine dose needs to be repeated.

When a Vaccine Doesn’t Count and Needs to Be Repeated

While it would be unfortunate to have to repeat a vaccine dose, in most cases, if you didn’t, it would leave the child without full protection.

Why might a vaccine dose not count?

The Menomune vaccine has been discontinued, but this label is a good example of things to check before giving a vaccine.
The Menomune vaccine has been discontinued, but this label is a good example of things to check before giving a vaccine.

Although it doesn’t happen often, it is possible that:

  • the wrong vaccine was given
  • the vaccine was given too early, either before the next dose was due or when the child was too young. Although there is some leeway for when most vaccines can be given, there are still some specific rules to follow, especially the minimum time between doses, the earliest age you can get a dose, and the age requirement for booster doses. (sticking to the standard immunization schedule can help avoid these types of errors)
  • the vaccine was mixed improperly (many vaccines are now premixed, making this error less likely to occur)
  • part of the vaccine leaked out when it was being injected, which can happen when kids move, if they aren’t being held well as the shot is being given (rotavirus doses aren’t repeated if a child spits up though)
  • the vaccine had expired or had not been stored properly
  • two live vaccines (except for the typhoid vaccine) were given on separate days, but less than 28 days apart (again, sticking to the standard immunization schedule can help avoid this types of error)
  • the vaccine was given by the wrong route, although depending on the vaccine, this dose might still be valid (most vaccines, except hepatitis B and rabies)

Still, instead of a vaccine dose not counting, the much more common reason for a vaccine dose to be repeated is for folks to lose their vaccine records.

Do You Really Have to Repeat That Vaccine Dose?

Are you worried now that your kids might get a vaccine dose that has to be repeated?

Don’t be. It doesn’t happen very often.

It helps that we don’t actually have a one-size-fits-all immunization schedule and

  • there is a range of recommended ages for most vaccines
  • there is a range of recommended ages for catch-up immunization, which is basically an accelerated immunization schedule, which is why infants can typically start getting their vaccines as early as age 6 weeks and get the first few sets as early as 4 weeks apart

Also, you typically have a grace period, during which early vaccine doses will still count.

“…administering a dose a few days earlier than the minimum interval or age is unlikely to have a substantially negative effect on the immune response to that dose. Known as the “grace period”, vaccine doses administered ≤4 days before the minimum interval or age are considered valid…”

AICP on Timing and Spacing of Immunobiologics

The grace period doesn’t count for the rabies vaccine and while it is an ACIP guideline, it might be superseded by local or state mandates. The grace period also can’t be used to shorten the interval between two live vaccines, which must be at least 28 days.

One last way to get away without repeating an invalid dose would be checking your child’s titers.

When Do You Repeat the Invalid Vaccine Dose?

The next question that comes up after you realize that you have to repeat a dose of a vaccine is when should you repeat it?

It depends.

  • give the correct vaccine as soon as possible if the problem was that the wrong vaccine was given
  • repeat the dose as soon as possible if the problem was an expired, improperly stored, or a dose that had leaked out
  • if the dose was given too early, then you need to wait for the appropriate interval or when your child is old enough to get the dose. Keep in mind that when you repeat the dose, you would generally restart counting your interval from the invalid dose, not from the previous dose. That’s because the invalid dose might interfere with mounting a good immune response.

And in all cases, report the error to the ISMP National Vaccine Errors Reporting Program (VERP) or VAERS.

What to Know About Vaccine Errors

Although they aren’t common, vaccine errors sometimes lead to the need to repeat your child’s vaccines.

More on Vaccine Errors