# 3843
It would be the height of irresponsibility for me, or anyone else for that matter, to insist that vaccines are absolutely 100% safe. While they have an excellent safety record, there is no such thing as a totally benign drug.
Over the next few weeks and months, I fully expect that we will hear about adverse reactions . . . perhaps even deaths, that are potentially linked to flu vaccines.
Many of these will probably be coincidental occurrences, but some may in fact be caused by the vaccine.
Unlike most years, this fall we will be heavily focused on finding these types of events – because there is an expectation, a fear, really - that we may see a repeat of the 1976 swine flu vaccine fiasco.
That vaccine was linked (albeit, inconclusively) to as many as 25 deaths, and several hundred cases of GBS (Guillain Barre Syndrome).
Of course, this year is vastly different from 1976 (see Deja Flu, All Over Again) in that we have a pandemic virus that has already killed thousands of people.
In this past month of September, we saw nearly as many pediatric flu deaths in the US as we saw in all of the 2005-06 flu season (n=46).
The number of injuries and deaths caused by the 1976 swine flu vaccine would have been considered `acceptable losses’ had the pandemic arrived as expected that fall. It didn’t, and so there turned out to be no `up side’ to giving the vaccine.
If we assume that all 25 deaths and roughly 500 cases of GBS were caused by the 1976 vaccine, we can come up with a reasonable `worst-case’ incidence of severe reactions to that vaccine.
With 40 millions shots given, that works out to 1 death in every 1.6 million shots, and 1 case of GBS for about every 80,000 vaccinations.
Grim numbers, and obviously personal tragedies. One of the people I gave the 1976 flu shot to developed GBS, the mother of one of our EMS dispatchers. So I am well aware of the impact it had.
But they pale in comparison to the deaths and severe hospitalizations we’ve already seen from the H1N1 virus. And we aren’t even properly into `flu season’ yet.
Every day, in the United States, 15 people (on average) are diagnosed with GBS. About 5,500 a year or about 1 to 2 out of every 100,000 people. What causes it, isn’t well understood. Here is what the CDC has to say about it:
About two-thirds of people who develop GBS symptoms do so several days or weeks after they have been sick with a diarrheal or respiratory illness. Infection with the bacterium Campylobacter jejuni is one of the most common risk factors for GBS.
People can also develop GBS after having the flu or other infections (such as cytomegalovirus and Epstein Barr virus). On very rare occasions, they may develop GBS in the days or weeks following receiving a vaccination.
The hope is to get the `target population’ of the US vaccinated against the H1N1 virus over the next 60-90 days. About 160 million people. More than 100 million seasonal vaccinations are expected to be given as well.
If we assume that 160 million people get one (or both) vaccines, then based on this background rate, we could expect more than 600 cases of GBS to occur within 90 days of the recipients getting their shot.
And that assumes the vaccine does nothing to contribute to the rate of cases.
Will the vaccine cause an increase in GBS cases?
We don’t know. The risk is slight, but it is certainly possible.
And if (hypothetically) today’s vaccine is as `bad’ as the one we had in 1976, we might expect to see an increase of a couple of thousand GBS cases (most would recover), and perhaps 100 additional deaths from the vaccine.
Not something anyone wants to see, of course. And hopefully it won’t happen. But if it did, it would still represent just a fraction of the human costs that this H1N1 virus has exacted so far.
Over the coming weeks and months we are likely to see a lot of news reports about suspected adverse effects.
Already, I’ve seen reports of two suspected cases, both linked to seasonal flu shots.
The first is a young Virginia woman who was stricken by dystonia, a rare neurological condition, a couple of weeks after getting the seasonal flu shot.
Woman Disabled by Flu Shot Reaction
Updated: Thursday, 15 Oct 2009, 6:54 PM EDT
WASHINGTON, D.C. - An Ashburn, Virginia woman is in the fight of her life after suffering a very rare side effect to the seasonal flu shot.
The vast majority of doctors say flu shots are safe. In this case, the FDA says they found nothing wrong with this particular batch, but sometimes there are complications.
Was her condition brought about by the vaccine? Well, that’s not proven, but it is possible.
The CDC however, reportedly says that there have only been 5 cases of possible vaccine-related dystonia reported since 1991 – out of more than 1 billion vaccinations – and that they have been unable to establish a link between those cases and the vaccine.
And from New York State, a report of a nurse who came down with GBS two weeks after getting the seasonal vaccination. Again, no causal link has been established.
City Nurse Stricken With Rare Syndrome After Flu Shot
By Alice McQuillan
NBCNewYork.com
updated 11:16 a.m. ET, Fri., Oct . 16, 2009
A nurse was stricken with a rare nerve disorder that can cause paralysis two weeks after receiving a seasonal flu shot, the New York State Health Department confirmed Wednesday.
The unidentified female nurse has been diagnosed with Guillain-Barre Syndrome and has been hospitalized at North Shore University Hospital on Long Island since September 14th, the department said.
Michelle Pinto, a spokeswoman for the North Shore-LIJ Heath System, said "we do have a patient at North Shore University Hospital with Guillain Barre syndrome. The cause of the Guillain Barre is inconclusive."
My thanks to Indigo Girl on Allnurses pandemic forum for compiling these reports from the media and various flu forums.
The bottom line is that all drugs are double-edged swords, a caveat that applies to vaccines as well.
And while I consider myself `pro-vaccine’, I don’t intend to ignore reports of possible side effects. They are a legitimate part of the pandemic story.
It is important, however,for us to keep these news reports in perspective. To view the bigger picture, including the normally occurring background rate of these events.
As tragic as these stories are, there may be absolutely no causal link to the vaccine. And if, in rare instances, the vaccine does cause harm . . . that has to be balanced against the overall good that it does.
