It is interesting to look at the pattern of symptoms in all of VAERS. It is even more interesting to look at the pattern of symptoms associated with a specific vaccine. In the figure below, the left side shows the SOC symptoms found in all VAERS reports, and the right side shows the SOC symptoms found in those VAERS reports associated with a Flu vaccine.

Interestingly, the two graphs are similar, which tells us that Flu vaccine reactions are typical of all vaccine reactions.

But what about the HPV vaccine? Are the symptoms in VAERS reports associated with this vaccine typical of all vaccine reactions? No!

The HPV vaccine has noticeable spikes in Cardiac, Nervous, Pregnancy, and Vascular disorders. There is also a spike in “Investigations,” but this only indicates that the reports frequently warrant further examination.

An obvious follow-up question is to ask for more detail about the Cardiac, Nervous, Pregnancy, and Vascular symptoms. To find out, click Show Symptom Tree (again, an Expert Mode option). The symptom tree shows the entire five-level tree and shows the number of times that something appeared in that tree. Keep in mind that a typical VAERS report has many symptoms listed, so the total number of symptoms that appears in the tree is much larger than the number of VAERS reports. Here is the second level of the tree, showing details for the symptoms in question:

Some of these symptoms are pretty serious, and it is hard to ignore the basic fact that 138 people have died following an HPV vaccination. If you are prone to any of these problems, or if you have any concerns about the HPV vaccine, you should discuss these issues with your doctor and make an informed decision.

The graph shows a continuing trend for the past two years: there are fewer VAERS reports being filed. Last year showed a nearly 20% drop and this year continues that trend.

What changed? Let’s look at individual vaccines. Make a Graph of Year of Appearance and Vaccine Type (the Vaccine Type is the disease that the vaccine prevents).

The graph shows that there were fewer reports for nearly all of the vaccine types. There are a number of possible explanations for this:

• Fewer people are getting vaccinated. There are reports suggesting an increase in undervaccination (some reports suggest that this is significant among children enrolled in an HMO). However, if this were a widespread trend, the CDC would be raising alarms and reporting declining vaccine uptake rates. This has not happened.
• There are fewer people to vaccinate. If birth rates decline, then there will be fewer children to vaccinate and fewer adverse reactions to report. Birth rates have declined, but there is no data to suggest that this trend is of a significant size to explain the decline we are seeing in VAERS reports.
• Vaccines are safer. If this were the case, then it would mean that manufacturers have changed their production methods to improve safety, and then there would be reports of these changes (which there are not). Also, if this were true, as production methods improved, only selected vaccines would result in declining VAERS reports. But since the decline in VAERS reports is across the board, it is unlikely to be due to changes in vaccine manufacturing for specific vaccines.
• Underreporting has increased. Could it be that even fewer vaccine reactions are being reported than in previous years? Are doctors, manufacturers, and the public increasingly unwilling to admit that an adverse reaction could be related to a vaccine, and take the time and effort to report the reaction to VAERS? Or could it be that fewer people are aware of VAERS, and the fact that there is a law requiring them to report vaccine reactions?

As a side note, there is one vaccine that has not followed this declining trend: the Shingles vaccine (code name VARZOS, introduced in 2006). Let’s look at this vaccine more carefully. The graph below plots the Year of Appearance and Age.

Shingles affects older people, and can be quite painful. The graph shows that all of the older age groups experienced a higher-than-usual incidence of Shingles-related VAERS reports last year.

Is the vaccine dangerous, or are people just now starting to get the vaccine, causing a higher than usual number of reactions? It is impossible to tell at this point, because dosage data is unavailable for 2011 and 2012. But some people should not get the vaccine, as even the CDC acknowledges. So if you are considering getting the Shingles vaccine, check out the warnings before insisting on the shot.

The vaccines that have dosage patterns fall into three distinct categories:

• Short-lived vaccines were given for a few years and then discontinued. They were typicially removed because of adverse effects, and the VAERS data often shows this.
• Phased-out vaccines were given for many years, but discontinued in favor of other vaccines (for example, Measles has been phased out as MMR has become established).
• Current vaccines are still being given.

Let’s look at two important measures of the safety of a vaccine: (1) the VAERS events considered “serious” (hospitalization, permanent-disability, life-threatening, or death) and (2) the VAERS events where the patient died.

A number of short-lived vaccines feature prominently in these graph, including ANTH (Anthrax, which may not actually have been phased-out, but dosage data is no longer available), LYME, MU (Mumps) and RV (Rotavirus). The graphs bear-out the government and/or industry’s decision to withdraw the vaccines.

Some phased-out vaccines also feature prominently, notably MEA (Measles) and DTP (being switched-over to DTAP and other combination vaccines). We can be thankful that these are gone and hope that their replacements are safer.

One current vaccine bears notice: RAB (Rabies). It is associated with many serious VAERS events and a very high rate of deaths.

These conclusions are tabulated below:

If you are considering a Rabies vaccination, it would be reasonable to discuss it with your doctor and be sure that you really need it.

One way to explore this is to look at the ages of people who report vaccination reactions to VAERS. It should be expected that the age groups with the most number of vaccine reactions will coincide with the ages that the CDC recommends for scheduled vaccinations. The graph should show spikes at the ages when most vaccines are given.

And in fact, that is what we see. The graph below is a custom age graph with finer age groupings in the early years (this requires Expert Mode to produce). What we see is an expected graph, with spikes in vaccine reactions in the second year of life as well as in the teenage years.

But now let’s change the graph so that it shows only those VAERS reports where the patient died. If you believe that death is merely an extreme reaction, and that some people react that way, then you would think that the graph of people who died would look the same, except with smaller numbers. But interestingly, the graph has a completely different shape:

This is frightening. Infants in their first three months of life are dying at a far greater rate than any other age group, and infants in the first six months of life seem to be at the greatest risk of dying after a vaccination. This is completely out-of-line with the rate of other vaccine reactions.

Are we vaccinating our children too early? Many people think so (see here or here). Might it be reasonable to delay some of these vaccines until we are a bit older and better able to cope with them?

But a government VAERS release is actually much more.

Each month’s release is a complete dump of the entire VAERS database, going all the way back to the start of the program in 1990. This is because the government never closes a VAERS report, and may make changes to any report at any time. They can even remove a VAERS report.

So who is watching this data, making sure that the changes are sensible or correct? In the past, it was the NVIC – now you can do it too!

This blog entry introduces a new feature in MedAlerts: the VAERS Wayback Machine, a collection of old VAERS releases that can be analyzed to help understand the changes being made each month. The NVIC has been using the Wayback Machine internally for a few years, and now it is part of the MedAlerts website.

First, some background. When you search the VAERS data at MedAlerts (or even at CDC Wonder) you are looking at the latest release of the government data. The date of that release is shown at the top of the search form:

When the month is over, that data will no longer be searchable, because the next month’s release will be available. But the data isn’t really gone, because MedAlerts has been saving the data since 2003.

The Wayback Machine lets you do three different things with the data.

1. Search an old release of the data.
2. Compare two releases of the data to see what is changed.
3. Track all changes to a single VAERS report.

Search an old release of the data

The Wayback Machine lets you choose an older version of the data, and then do a standard MedAlerts search on it. When searching old data, both the search form and the search results inform you that you are working with old data, so that there is no confusion. Here is what you see when you search the oldest release of the VAERS data available in MedAlerts:

Compare two releases of the data

The Wayback Machine lets you choose two different releases of the VAERS data and compare them. You can do an Added/Deleted comparison or a Changed comparison. Note that these searches, which compare two entire VAERS releases, can take a long time to complete, so be patient when asking for them.

The Added/Deleted comparison lists the VAERS ID numbers for reports that were added or deleted. These reports are characterized according to whether they are Minor, Serious, or Death-related (See an earlier blog for more on “serious”). It also analyzes the death-related reports and lists the vaccines found there. Note that all of the VAERS ID numbers are links which show the full details (even for deleted reports). Here is a sample comparison between the June 13, 2012 and the July 13, 2012 releases (abbreviated to save space):

The Changed comparison looks at those reports that were in both releases, and shows changes that were made to them. Changes are color-coded so you can tell what is different. Anything printed in Red is something that was in the older release, but not in the newer one (so red means something that was removed). Anything printed in Green is something that is in the newer release, but was not in the older one (so green means something that was added). Because this can be a large amount of data, this Changed comparison stops after 400 changed reports.

Here is an example of a ficticious change report in which the date of vaccination and onset has changed, the manufacturer of the Flu vaccine has changed, the number of days in the hospital was entered (was previously blank), four symptoms have been removed, and the write-up and preexisting conditions were edited:

Track all changes to a VAERS report

If you know the VAERS ID of a particular report, you can give it to the Wayback Machine and see the complete history of that report, going all the way back, and including all changes made since 2003. Once again, reports are color-coded so you can tell what has changed.

Note also, that when MedAlerts gives you an Event Detail report, there is a little button that offers this historical tracking:

What has been learned from the Wayback Machine?

Here are just a few of the things that have been discovered by the VAERS Wayback Machine:

• The government switched to the MedDRA symptom classification system in 2009, so all reports made prior to that date will have their symptoms changed in the December 8, 2009 release.
• There was a massive removal of symptoms in the May 13, 2011 VAERS data release. You can see nearly 9000 changed reports between 4/13/2011 and 5/13/2011. Many of these symptoms were restored in subsequent months, but not all.
• There has been a significant update of all military reports in recent months. Many of these reports used to state that the vaccine was administered by an “unknown” source, and have been changed to say “military.”

But there is probably much more to be found, so if you are a hard-core VAERS data follower, the Wayback Machine is the website for you!

Is the vaccine safe?

According to the CDC, “There is no evidence that anthrax vaccine causes long-term health problems.”

Let’s see what the VAERS database has to say about this.

In order to detect a “long-term health problem”, it makes sense to search for VAERS reports in which the patient did not recover. So let’s search for VAERS events where “Recovered?” is No (in Section 4 of the search form) and see which vaccines have the highest rate of non-recovery.

Also, let’s use the distributed-dosage information to get the VAERS rates. This feature of MedAlerts, described in an earlier blog entry, divides the number of VAERS reports by the number of doses distributed in order to determine the relative rate of adverse events. To get rates, we check Expert mode in the upper-right, and then make a Graph of Vaccines (dose adjusted). This plots the rate of VAERS events per dose of vaccine. The graph looks like this:

And what is the vaccine that is associated with the HIGHEST rate of non-recovery? Anthrax! It is followed by the vaccine for Lyme disease, which was pulled from the market in 2002. The Anthrax vaccine is known to have a high rate of VAERS reports, as you can see on page 15 of this CDC document.

How bad are the Anthrax numbers? This graph indicates that 1 out of every 1259 people given the vaccine report a VAERS event describing a reaction from which they did not recover. What could account for this amazingly high rate of reactions? Could it be that the people who get an Anthrax vaccine are overanxious in the first place, and this anxiety leads them to report reactions more frequently? Not likely: most of the people who get the vaccine are in the military. In fact, of the 7500 VAERS events associated with the Anthrax vaccine, 6638 of them (89%) were from vaccines administered by military doctors.

Could this high rate of Anthrax vaccine reactions be caused by underreporting of distributed doses? Definitely. The MedAlerts website has Anthrax vaccine dosage data only for the years 1998-2001, and after that, no further information is available.

It makes sense to repeat the search, but only for the years 1998-2001. This is done by making a Graph of Vaccines (dose-adjusted) and Year of Vaccination (dose-adjusted) and restristing the Vaccination Date (in Section 6) to run from 1998 to 2001. As you can see below, the worst offender is the Lyme vaccine, but Anthrax runs a close second and towers above all others:

The high rate of long-term health problems associated with the Anthrax vaccine suggests that the vaccine may be highly-reactive. But there are many issues with this vaccine, some that make these numbers better, and some that make them worse. For a more thorough examination of the Anthrax Vaccine, see Meryl Nass’s Blog.

Military personnel have no choice about getting the Anthrax vaccine, but if your doctor recommends this vaccine and you are not in the military, or have any say in the matter, you may want to do more research and then discuss the risks with one or more doctors you trust before getting an Anthrax vaccine.

Are the conclusions reached in these VAERS blog reports valid?

Let’s start off by reviewing the two different ways that vaccine reactions can be monitored: active and passive.

An active monitoring system tracks a patient’s entire history, starting before the vaccine is administered, and continuing even after a vaccine reaction. Follow-up interviews may be made after vaccination to increase thoroughness. Such systems are typically managed by a health-care provider and usually include the complete medical record of the patient.

A passive monitoring system (such as VAERS) is one in which reports of vaccine reactions are volunatarily submitted by patients, doctors, and pharmaceutical companies. No reports are filed for healthy people, very little past history is recorded, and few post-reaction follow-ups are available

Passive monitoring systems are less useful than active systems for a number of reasons:

• Underreporting. Because the reports are submitted voluntarily, many patients and doctors do not report vaccine reactions. Different estimates exist for the amount of underreporting and range from a factor of 10 to as much as a factor of 100 (meaning that the true number of vaccine reactions is between 10 and 100 times higher than what is reported to VAERS).
• Subject to bias. There are many issues that can bias a passive monitoring system. There might be more reports from new vaccines because people are worried about them. News articles might excite the public to submit more VAERS reports. It is possible that the kind of people who report reactions may be different than those who don’t recognize a reaction or ignore it, causing more bias. And of course, serious reactions might be reported more frequently (even though they account for only 14% of VAERS data).
• Inaccuracy. Although most reports are submitted by medical professionals (83%, according to the government) there are still VAERS reports that are filed by people who are unfamiliar with vaccine reaction reporting, and therefore have incorrect or insufficient information. Some have suggested that the system is “gamed” by people intentionally filing false reports, but this is unlikely because the CDC and FDA staff screens the data and does follow-ups. For example, all VAERS reports are examined by trained medical coders in order to ensure correct symptom terminology. The May 2011 blog entry has more to say about errors in VAERS data.
• Missing context. Although the VAERS reporting form asks for previous medications and other history, it is not as complete as a full medical record. Also, because the report ends at the vaccine reaction, it misses any future medical issues that may arise. This is a problem because it is important to correlate “similar” patients when evaluating vaccine safety. For example, if one patient gets a vaccine and has a reaction, while another patient does not get a vaccine or reaction, you do not have enough information to say that the vaccine caused the reaction. What you need to do, in order to say anything with confidence, is to “stratify” the data, organizing patients into groups that have similar histories so that you can eliminate every difference except for the vaccination. Then, those who did not get the vaccine form a useful “control group” and can be compared with those who did get the vaccine. This is possible in an active monitoring system, but nearly impossible in a passive system.
• Missing rates. It is important to know the rate of vaccine reactions, so that you can say what percentage of vaccinated people react. Although the MedAlerts VAERS search engine does have biometric data showing the number of vaccine doses that were distributed, this is subject to many inaccuracies and is not as good as the data from an active monitoring system (see the July 2011 blog entry).

So what good is a passive monitoring system such as VAERS? Most people agree that VAERS is useful as an early-warning indicator of possible vaccine problems. Trends that show-up in VAERS may indicate a problem, which can be further investigated using other data.

Do these blog entries make appropriate use of the VAERS data? Some of the entries do exactly what VAERS is good at: they look through the data and identify possible trends. But other blog entries try to verify a trend by looking at VAERS data, and when this happens, the blog is careful in its wording, saying things like “VAERS data seems to confirm this trend” or “you might want to talk to your doctor about this.” Some of the early blog entries (for example December 2009), do discuss issues that can affect the blog’s conclusion.

The bottom line is this: We use VAERS because it’s all we have. The only active vaccine monitoring system that exists in the U.S. is the Vaccine Safety Datalink, but it is government-private data that is available only to “qualified investigators”. Even CDC medical researchers (who do have access to the Vaccine Safety Datalink) often use VAERS data instead. If these blog entries are faulty, then so are those government VAERS analyses that “prove” vaccine safety.

So I will continue to make VAERS blog entries each month and look at all aspects of the data. I hope that I do not mislead, but my goal is to raise awareness of potential vaccine safety issues. I am not a medical researcher (as I state quite clearly). In the end, some will disregard these blog entries because of the problems with VAERS, but hopefully others will find the issues raised here to be useful.

Let’s search the VAERS database to see if the data agrees with this report.

Rather than asking for the results of any particular vaccine, let’s look at those VAERS events that list seizures as a symptom, and then examine the age groups and vaccines that were given. This avoids pre-judging any particular vaccine, and may turn up fresh results.

To identify VAERS events that have seizure symptoms, we use the MedDRA symptom classification (a 5-level organization of all known symptoms). The top-level of the MedDRA does not mention anything about seizures, but the next level down (High-Level Group Terms, or HLGT) has a symptom category called “Seizures (incl subtypes)”.

So search the data, check Expert Mode in the upper-right (to access different MedDRA levels), and make a Graph of Vaccine Type and Age. Also, open up Section 2 (Symptoms), check the MedDRA level HLGT and select “Seizures (incl subtypes)”. This will organize all of the seizure-related VAERS events according to the diseases that the vaccine prevents (the Vaccine Type) and the patient’s age.

The result is shown here:

The result seems to confirm the JAMA report. The five biggest spikes are for Diphtheria, Haemophilus, Pertussis, Polio, and Tetanus in children under 3 years of age. No other age group gets seizures with as high a frequency.

Of course, this raises another question: is the DTP-Polio-Hib combination-shot the problem, or are the individual vaccines also culpable? For example, is it safer to get a DTP and then separate shots for Polio and Hib? The spikes for the five separate serums suggest that each one is reactive, and when combined could create a vaccine that is more reactive than most other routinely recommended childhood vaccines.

The only way to know whether a given combination vaccine is more reactive than its individual components is to divide the number of VAERS events associated with a vaccine by the number of doses actually given. This gives us the rate of VAERS events. Unfortunately, dosage data for Pentacel isn’t available. However, dosage data is available for another combination vaccine: DTAPHEPBIP (known as Pediarix, a 5-in-1 shot with DTP, Polio, and Hepatitis B). Although this is not directly comparable to the JAMA article’s study data, it does allow us to examine the reactivity difference between combination vaccines and their component parts.

So let’s make a dose-adjusted graph, and look at the Vaccines, not the Vaccine Types. Once again, we look at seizure-related VAERS events, and this time we’ll limit it to children under age 1. This gives us the rate at which a particular vaccine is associated with childhood seizures. Keep in mind that dosage numbers are always an approximation (see my July 2011 blog). Also, Pediarix dosage data began in 2004, so let’s only look at data since then. Here is the relevant part of the graph (showing all of the DTP vaccines):

The results confirm that the Pediarix combination shot runs a noticeably-higher rate of VAERS events per dose than any of the other DTP vaccines (DTAP has a rate of 1 VAERS report per 155,000 doses given, but Pediarix has a rate of 1 per 93,000).

This data suggests that, when combined, vaccines are more reactive than when they are administered separately. My April 2010 blog showed that multiple vaccinations, given on the same day, cause more problems. It appears that multiple serums given in the same shot are also troublesome.

The graph shows a surprising result for 2011: it is the first year that had a noticeable decrease in the number of VAERS events. The slight decrease between 2009 and 2010 is nothing compared with the nearly 20% drop between 2010 and 2011 (from 36,806 events in 2010 to 29,908 events in 2011).

What changed? Let’s look at individual vaccines. Make a Graph of Year of Appearance and Vaccine Type (the Vaccine Type is the disease that the vaccine prevents).

Although there were fewer reports for nearly all of the vaccine types, one of them (Flu) went down significantly. In fact, the change in the number of Flu-related events (down from 16,742 in 2010 to 9,758 in 2011) more than accounts for the overall drop in VAERS events.

Of course, when looking at yearly Flu seasons it is important to note that they occur in the winter months, which span two different calendar years. So it is more useful to graph Month of Appearance instead of Year of Appearance. Doing that for the past few years confirms the decrease in Flu-related VAERS events during this current Flu season:

The trend is unmistakeable: Flu-related VAERS events are way down. In my September Blog Entry, I predicted a bad year for Flu-related VAERS events, but apparently I was wrong.

Of course, the number of Flu-related VAERS events rose significantly in the previous two years, no-doubt fueled by the H1N1 scare, so this may simply be the “normalizing” of an unusual spike. But Flu shots are still pushed hard during the winter months and many people still get the vaccination.

Is the decrease in the number of Flu-related VAERS reports caused by a safer Flu vaccine? Has the unusually late Flu season resulted in people avoiding the shot until 2012, leaving 2011 numbers low? Or are people intentionally avoiding getting the Flu vaccine?

This month I want to continue the investigation by asking what happens to the women in these pregnancy-and-HPV-related VAERS reports. Are the symptoms related to their pregnancy or are they simply general issues? And if they are pregnancy-related, are they serious? To find out, I will look at the symptoms in these reports and see what they indicate.

The best way to look at symptoms in the VAERS data is to consider the fact that they are organized using the 5-level MedDRA classification system. So for starts, let’s look at the top-level of the MedDRA, called the System Organ Class, or SOC. This breaks all symptoms into 26 different categories.

The two graphs below show the number of symptoms in the SOC categories. On the left is the entire VAERS database and on the right is just those VAERS events that mention an HPV vaccine and are pregnancy-related. Note that these graphs are made using Expert Mode (to access MedDRA) and then graphing Symptoms SOC (Highest).

The left graph shows the sort of things that would be expected in a typical VAERS report: a big spike in the broad SOC “General disorders” and other spikes involving injuries, investigations, and skin issues. It is perhaps interesting that “Nervous system disorders” also figure prominently.

The right graph focuses on the symptoms of pregnant women who got an HPV vaccine. It is not surprising that the biggest spike here is for Pregnancy conditions.

But although this graph indicates that the injuries to pregnant women are indeed pregnancy-related, it still doesn’t tell us what happens in any sort of detail. To do that, we need a new feature of MedAlerts that lets you see the MedDRA symptom hierarchy. So use Expert Mode and check Show Symptom Tree. You also have to narrow the search to pregnant women who got the HPV vaccine (as described in last month’s report). Here is a partial view of the symptom tree, showing the “Pregnancy” SOC as well as the next two levels of the hierarchy. There are two deeper levels in the tree that are not shown here.

Note that the numbers next to each symptom are not the number of VAERS reports that mention that symptom. Instead, they are the number of times that the particular point in the symptom tree appears in the pregnancy/HPV reports. Since each VAERS report has many symptoms, these points in the tree are visited many times. So the numbers are useful only for comparing relative frequency of a given point in the tree. See the MedAlerts Help page on MedDRA for more information about examining the MedDRA.

As you can see, the most common issue is “Foetal complications” followed by “Abortions and stillbirth” and “Maternal complications”. The graph continues deeper, showing more symptom detail. So it appears that, according to VAERS reports involving pregnant women who received the HPV vaccine, they indeed had substantial pregnancy-related difficulties and the pattern of symptoms appears to be different than what is generally reported to VAERS.