Tag: vaccine errors

A Toddler Has Died After Being Vaccinated in Cuba

No one expects to hear stories of kids dying after being vaccinated. Fortunately, these types of tragedies are very, very rare.

Still, even one is too many when it might have been prevented. After all, that’s why we vaccinate our kids in the first place. To protect them from life-threatening vaccine preventable diseases.

A Toddler Has Died After Being Vaccinated in Cuba

The Ministry of Health in Cuba released a statement a few days after her death:

“Between October 7 and 8 of this year, three one-year-old children were diagnosed with an adverse event associated with vaccination with PRS, which protects against Mumps, Rubella and Measles, this is applied according to official scheme to children one and six years old.

All had been vaccinated on October 7 at the “Betancourt Neninger” Polyclinic in the municipality of Habana del Este, province of Havana, and immediately after symptoms appeared, they were admitted and received medical attention by professionals of high scientific level in the Pediatric Hospitals ” Borrás Marfán ”and Centro Habana.

Through the active research carried out on all children vaccinated in that Health Area, two more children were detected with symptoms, which motivated their admission.

Painfully on October 9 at night, the one-year-old girl Paloma Domínguez Caballero dies, admitted to the “Borrás Marfán” Hospital as a result of complications. The remaining four children remain admitted: one with intensive attention, which is stable and the others evolve favorably.

The system of active surveillance of the events associated with vaccination carried out in the country has not identified any other children with symptoms.

The PRS vaccine has been used for years in Cuba, imported from India, is endorsed by the World Health Organization and certified by the Center for State Control of Medicines, Equipment and Medical Devices (CECMED).

A Commission of the Ministry of Public Health investigates the causes that caused this unfortunate event.”

Official Note from the Ministry of Public Health on adverse event associated with vaccination with PRS (computer translation)

So what happened?

Tragically, either because of errors or contamination, vaccines can rarely cause people to get sick, either if:

  • a reconstituted vaccine was used much after six hours – live vaccines can quickly become contaminated if they are kept and used for too long a time
  • vaccine diluents were mixed up – some vaccines need to be mixed before use and vaccination tragedies can occur when a dangerous medication is used instead of a vaccine’s standard diluent
  • vaccines were improperly handled – breaking the cold chain – or allowed to expire
  • a vaccine is given to someone with a true medical contraindication

In Samoa, the recent tragedy in which two toddlers died, we know that the vaccine diluent was mixed up with a powerful anesthetic.

It doesn’t sound like a diluent mixup happened in Cuba though.

“The mother told the news portal CiberCuba that the daughter’s arm began to swell the same day she was vaccinated. Then the vomits arrived. Less than 24 hours later I was already in intensive care, from where I did not come out alive again.”

Vacuna en mal estado suministrada en Cuba podría haber dejado 25 niños en estado de gravedad

With reports that the vaccines were possibly expired and the child getting sick later in the day, with swelling in her arm, it is more likely that there was some contamination, maybe in a vaccine vial itself.

A 10 dose vial of MMR from the Serum Institute of India Pvt. Ltd.
A 10 dose vial of MMR from the Serum Institute of India Pvt. Ltd.

Which vaccine?

The report says that it was the PRS vaccine – Parotiditis, Rubéola, and Sarampion – or MMR, which is usually available in 5 or 10 multi-dose vials when one dose vials aren’t available.

It was imported from India, which makes many of the vaccines that are used throughout the world, but any contamination likely would have occurred well after it was manufactured and shipped to Cuba.

In all of these cases, there is typically nothing inherently wrong with the vaccine itself.

“Cuba, a relatively poor and small country (population 11.2 million), has managed to bring about remarkable achievements in health in the past 30 years despite difficult fiscal restraints and limited resources.”

MacDonald et al on Infectious Disease Management: Lessons from Cuba

Interestingly, Cuba actually makes most of their other immunizations.

So why would they be using expired vaccines?

Was it a mistake?

Did someone use a leftover vial that had become contaminated with bacteria? Were the vaccines not refrigerated properly? Is it an isolated issue or part of a bigger breakdown in their healthcare system?

With four other sick kids, the use of a contaminated leftover vial that was part of an original 10 dose vial becomes one possible scenario.

We might get some answers if the vaccine vials had not been thrown away after they were used, and are still available for testing.

In Chapias, Mexico, after two infants died in 2015 after getting multiple vaccines, a vial was found to be contaminated with the Staphylococcus hominis bacteria.

A few years later, in 2017, 15 children died in South Sudan when unrefrigerated vaccine was mixed with a syringe that was reused over and over for four days and given to kids by untrained workers.

Again, these are very rare and isolated cases. Remember that billions of doses of vaccines are given each year without problems, saving millions of lives.

Hopefully we will soon learn what really happened to these children in Cuba, especially as that will hopefully help to make sure it doesn’t happen again.

Most importantly, don’t let these very rare tragedies scare you away from vaccinating and protecting your kids.

“The Cuban government has confirmed that five children suffered severe reactions and one of them — a 1-year-old girl — died after receiving a vaccine. The serum came from the same company in India that produced vaccines linked to the deaths of three other children following inoculations administered in Cuba in 2002.”

Child dies in Cuba after receiving vaccine made in India. It’s not the first time

We should remember what happened following the tragedy in Samoa. All vaccinations were unnecessarily suspended in the country for a time and MMR vaccinations were suspended for nine months!

What came next?

A measles epidemic that has already seen the death of one toddler!

The death of the girl in Cuba is a terrible tragedy, but folks shouldn’t make it any worse. There is almost certainly nothing wrong with the vaccines from India or any other vaccines in Cuba or anywhere else.

Vaccines are safe, with few risks.

Hopefully we can continue to work to eliminate even the rare risk of these kinds of awful tragedies too.

And no, this is not the MMR vaccine that is used in the United States in case anyone is wondering.

More on Vaccination Tragedies

The Tragedy in Samoa Was Not Caused by the MMR Vaccine

Remember the two young children who died in Samoa in early July 2018, shortly after getting an MMR vaccine?

In addition to the tragic deaths of those two children, it led to the suspension of all vaccinations in the country.

The Tragedy in Samoa Was Not Caused by the MMR Vaccine

Fortunately, that suspension was eventually reversed, but they did continue to hold MMR vaccinations.

How long did they suspend MMR vaccinations?

They didn’t restart until April 15.

And while the trial for the two nurses involved in the tragedy is delayed until June, the Director General of Health, Leausa Take Naseri, has said that their deaths were a mistake caused by human error.

“On 4 June 2019, both nurses pleaded guilty to negligence causing manslaughter. On 2 August, both nurses were sentenced to five years in prison. During the sentencing hearing, it was confirmed that one of the nurses mixed the MMR vaccine powder with expired muscle relaxant anaesthetic instead of water for injection supplied in a vial with the vaccine.”

Infant deaths in Samoa a tragic outcome from error preparing MMR vaccine

With measles outbreaks in many nearby countries, health experts and parents are eager to get vaccinations restarted and to get kids caught up.

Local officials say that Taylor Winterstein, the face of the VAXXED tour in Australia, is taking advantage of what happened at the Safotu District Hospital

Hopefully, they get vaccinated before anti-vaccine folks head to Samoa to try and scare folks away from getting vaccinated.

More on The Vaccine Tragedy in Samoa

Vaccine 2D Barcoding and Barcode Scanners

Since at least 2004, most vaccine vials and syringes have had barcodes on them.

A lot of information is stored in that little 2D barcode on our vaccines.
A lot of information is stored in that little 2D barcode on our vaccines.

At first they were linear barcodes (like a UPC code), but since 2016, vaccine products began using 2D barcoding.

Vaccine 2D Barcoding

Although you may have never heard about it, vaccine barcoding has a lot of benefits, including:

  • improved patient safety by reducing vaccine errors, including flagging when the wrong vaccine or an expired vaccine is scanned
  • improved documentation
  • improved efficiency, as using a vaccine barcode scanner is faster than manually entering vaccine lot numbers

And vaccine barcoding makes it easier for clinics to manage their vaccine inventory.

Vaccine Barcode Scanners

Which vaccine barcode scanner should you get?

“Scanners, once configured for the specific EHR/PMS/IIS set-up, can decode the 2D barcode into a “string of numbers”. Once this string of numbers is available, the configuration from the scanner to the health record translates the informati​​​​on into the appropriate data needed to document GTIN, lot number, and expiration date.”

AAP on Getting the Scanner to Work

That’s probably going to depend on which EHR that you use, as you want to make sure that your scanner works with your EHR.

Scanning a vaccine into our EMR.
Scanning a vaccine into our EMR.

Once you know which model to get, you can also decide if you want one that is corded or that connects via WiFi or Bluetooth. While it might seem most convenient to go with a cordless device, that doesn’t necessarily mean that you can easily use the scanner on multiple computers. Each cordless device typically needs to be paired with a specific computer.

Are you using a vaccine barcode scanner yet?

More on Vaccine 2D Barcoding and Barcode Scanners

What Are the Recommended and Minimum Ages and Intervals Between Doses of Vaccines?

Most parents likely don’t think about the minimum age or minimum intervals between vaccines, as they just get their kids vaccinated according to the routine immunization schedule.

Things don’t always go according to schedule though…

Recommended and Minimum Ages for Vaccines

After their birth dose of the hepatitis B vaccine, your baby’s next vaccines are usually at two months.

Can you get them earlier?

When necessary, many vaccines can be given earlier and faster than the standard schedule.
When necessary, many vaccines can be given earlier and faster than the standard schedule.

Yes. The minimum age for the first dose of rotavirus, DTaP, IPV, Hib, Prevnar, is 6 weeks.

Some other vaccines can be given earlier than their recommended age too, including:

  • the first MMR vaccine, which can be given as early as age 6 months in certain high risk situations, like traveling out of the country or in an outbreak situation, although this dose will have to be repeated once the child is 12 months old
  • the 4th dose of DTaP, which can be given as early as age 12 to 15 months, as long as at least 4 to 6 months have passed since the third dose
  • the 2nd dose of Varivax, which may be given as early as 1 to 3 months after the first dose
  • the Tdap vaccine, which can be given as early as age 7 years, instead of the more typical 11 to 12 years
  • the HPV vaccine, which can be given as early as age 9 years, instead of the more typical 11 to 12 years

Why would you get a vaccine early?

What if you are going to be traveling just before you infant is going to be 2 months old? Or your 9 year old stepped on a rusty nail, and it had been just over 5 years since his last tetanus (DTaP) shot?

Recommended and Minimum Intervals for Vaccines

In addition to earlier ages, you can sometimes get vaccines more quickly, on an accelerated schedule.

For example:

  • the minimum interval between the 1st and 2nd dose of rotavirus, DTaP, IPV, Hib, Prevnar is 4 weeks, instead of the standard 2 months
  • the minimum interval between the 2nd and 3rd dose of rotavirus, DTaP, IPV, Hib, Prevnar is 4 weeks, instead of the standard 2 months
  • the minimum interval between the 1st and 2nd dose of HPV is either 4 weeks (3 dose schedule) or 5 months (2 dose schedule)
  • the minimum interval between the 2nd and 3rd dose of HPV is 12 weeks
  • the minimum interval between the 1st and 3rd dose of HPV is 5 months, instead of the standard 6 months

Why give these vaccines more quickly than usual?

The usual reason is that a child is a little behind and is working to get caught up.

Absolute Minimum Ages for Vaccines

It is important to remember that in some cases, there are some hard and fast rules about minimum ages. That means that if you get these vaccines any earlier, they won’t count and you will likely have to repeat them, including getting :

  • the 3rd dose of hepatitis B before 6 months (24 weeks) or sooner than 8 weeks after 2nd dose and  16 weeks after 1st dose
  • the first dose of MMR, Varivax or hepatitis A before 12 months
  • the 4th dose of Hib before 12 months
  • the 4th dose of Prevnar before 12 months
  • the 4th dose of DTaP before 12 months
  • the 5th dose of DTaP before 4 years
  • the 4th dose of IPV before 4 years

Sticking to the routine schedule helps to avoid vaccine errors, like giving a vaccine too early. In some situations, the 4 day grace period helps if a vaccine is given a little early.

More on Recommended and Minimum Ages and Intervals Between Doses of Vaccines