Tag: Chiapas

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

Vaccination Tragedies are Rare

Vaccines work to prevent at least 2 to 3 million deaths each year worldwide.

Tragically, either because of errors or contamination, vaccines can sometimes actually cause people to get sick.

This can happen when health workers:

  • use a reconstituted vaccine after six hours – live vaccines can quickly become contaminated if they are kept and used for too long a time
  • mixup diluents – in addition to using the wrong diluent vaccination tragedies can occur when a dangerous medication is used instead of a vaccine’s standard diluent
  • improperly handle vaccines – breaking the cold chain
  • a vaccine is given to someone with a true medical contraindication

Fortunately, these situations are rare.

History of Vaccination Tragedies

With billions of doses of vaccines being given each year, it is likely not surprising that we see some problems. But when many of those vaccines are being given to kids, even one mishap, especially if it leads to life-threatening complications, is too many.

That’s why many safe guards have been put in place in the manufacturer and distribution of modern vaccines, so that we don’t see these types of vaccine tragedies:

  • the Cutter Incident, when, in 1955, at least 56 people developed polio and 5 children died after being vaccinated with inactivated polio vaccine that was poorly manufactured by Cutter Laboratories and still contained live polio virus
  • hepatitis-contaminated yellow fever vaccines – some lots of yellow fever vaccines used in the military in 1942 were unintentionally contaminated with the hepatitis B virus
  • the Lubeck Disaster – 75 children died and others got tuberculosis in 1929 Germany after there was a mixup between the BCG vaccine and the strain of Mycobacterium tuberculosis that causes tuberculosis. The BCG vaccine was supposed to be made with a weakened strain of Mycobacterium bovis bacteria instead.
  • the Bundaberg incident – 12 children died in Australia in 1928 after being given contaminated diphtheria vaccine from a multidose vial without preservative
  • tetanus contaminated smallpox vaccine in the 1890s and early 20th century

Although vaccines are much safer now, some rare incidents still occur.

Fifteen infants died and 75 children got sick in Syria in 2014 after they received a neuromuscular blocking agent, atracurium, instead of the measles vaccine they were supposed to get. How? The measles vaccine that was being used is mixed with a diluent, but instead of using the proper diluent, the health worker unintentionally used a bottle of atracurium instead.

In 2015, at least two kids died and 29 got sick in Chiapas, Mexico, among 52 children who were vaccinated. The children were reportedly given a BCG vaccine, the rotavirus vaccine, and/or a hepatitis B vaccine that day. However, the only vaccine that all of the sick children received in common was the hepatitis B vaccine. Since 130,000 doses from the same batch of vaccines had been given in the area, it was not thought to be a manufacturing problem or widespread issue. It was instead bacterial contamination of hepatitis B vaccine vials at that one clinic.

Fifteen children died in 2017 in a village in South Sudan after a poorly trained team that wasn’t adhering to WHO immunization safety standards used the same syringe to reconstitute measles vaccines over a four day period. They also didn’t keep the vaccine vials refrigerated.

“A single reconstitution syringe was used for multiple vaccine vials for the entire four days of the campaign instead of being discarded after single use. The reuse of the reconstitution syringe causes it to become contaminated which in turn contaminates the measles vaccine vials and infects the vaccinated children.”

Statement regarding findings of joint investigation of 15 deaths of children in Nachodokopele village, Kapoeta East County in South Sudan

As you can imagine, the conditions that led to these tragedies aren’t present when most kids get vaccinated.

Even in developing countries, most children get vaccinated by people adhering to WHO immunization safety standards. Why did they happened then? Both Syria and South Sudan have been rocked by war for years, leading to a breakdown in the ability to provide routine health care, even as basic as getting kids vaccinated. And Comunidad La Pimienta, Simojovel, Chiapas is a very poor part of southern Mexico.

These kinds of tragedies aren’t going to happen at your pediatrician’s office, as they don’t even have drugs like atracurium.

What Happened in Samoa?

In Samoa, four years after the deaths of the children in Syria, two children died within minutes of being vaccinated on the same day in the same hospital on the island of Savai’i.

Two toddlers died after being vaccinated at Safotu Hospital in Samoa.
Two toddlers died after being vaccinated at Safotu Hospital in Samoa.

Not surprisingly, as health officials investigate the cause, use of the MMR vaccine was suspended in Samoa.

So what happened?

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. Eight Samoan speaking New Zealand nurses visited Samoa in June to provide training for vaccinating nurses at district hospitals.

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

As suspected, since it happened so quickly, it ended up being a mix-up with the diluent, as happened in Syria. A five dose vial of MMR is used in Samoa, which means that unlike premixed vaccines, it does have to be mixed with a diluent.

Unfortunately, we are now hearing of a case 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)

What happened?

Unlike the case in Samoa and Syria, this one sounds like contamination.

It is known that vaccine vials can be contaminated with Staphylococcus bacteria if they are mishandled. Although Staphylococcus bacteria can directly cause infections, they can also release a toxin that can cause toxic shock syndrome (TSS).

There have been reports of TSS following vaccination in the past, usually with vaccines that don’t use preservatives, with symptoms developing over four to 24 hours.

Fortunately, these kinds of tragedies are very rar. Remember that billions of doses of vaccines are given each year without problems, saving millions of lives.

That some folks would use these rare tragedies to scare parents from vaccinating and protecting their kids is shameful. But that’s the modern anti-vaccine movement

What to Know About Vaccination Tragedies

Kids shouldn’t get sick or die after getting vaccinated. Fortunately, they rarely do, except in extreme circumstances that can make it more likely for errors to occur.

More on Vaccination Tragedies