Flu Vaccine

MAJOR REPORT: FLU VACCINE PROVEN TO
BE IN FACT AN ANTI FERTILITY VACCINE

Two subsequent years of receiving the flu vaccine boosts miscarriage rates from a
baseline of 14 percent to 77%
Everyone knows miscarriage rates are much higher than 14 percent "as a normal matter
of course." But as a side issue here, I figured out that the "as high as 40 percent"
rate is a sham by the abortion industry to make abortion not look so bad, and that
the normal miscarriage rate, after a woman comes up hot on a fertility test, is in fact
14 percent. Obviously this does not count failures to conceive after fertilization, because
in those cases a woman never shows up as pregnant on any test.
MAJOR DOCUMENTED STUDY PROVES THE FLU VACCINE IS AN ANTI FERTILITY

VACCINE
More than just the abstract was hidden behind a paywall, but the abstract had all the key
info!
The abstract proves that every time you get the flu shot after the first shot, it is only a
booster shot to make the anti fertility component work even better. This study only shows
what happens after two subsequent years of getting the shot. The numbers are not
obvious to the lay person, but by cross checking different data sources to make sure I
understood what they were saying, I was able to extract the real miscarriage rate from a
sea of planned parenthood inspired B.S. and then put the numbers this abstract states
into terms anyone can understand.
FINAL OUTCOME: Normal miscarriage rates are 14 percent after pregnancy is

confirmed (when you are not calling induced abortions miscarriages.) After ONE flu
shot, a woman's chance of miscarriage increases to 37 percent. If the next year she
gets another flu shot (which is obviously an anti fertility vaccine booster shot), her
chances of miscarriage increase to 77 percent. The study did not go to the third
year of getting the flu shot.
The abstract is so damning that the numbers look impossible! If you use planned
parenthood's numbers which are greatly overstated and plug them into the
numbers in this abstract, the miscarriage rate would have to be over 200 percent
(which we all know is not possible). My corrected numbers make sense when
plugged into this abstract and match pre abortion era medical stats.
HERE IT IS:
Association of spontaneous abortion with receipt of inactivated influenza vaccine
containing H1N1pdm09 in 2010-11 and 2011-12
James G. Donahuea, , , Burney A. Kiekea, , Jennifer P. Kinga, , Frank DeStefanob, ,
Maria A. Mascolac, , Stephanie A. Irvingd, , T. Craig Cheethame, , Jason M. Glanzf, ,
https://doi.org/10.1016/j.vaccine.2017.06.069
Abstract introductions Inactivated influenza vaccine is recommended in any stage of

pregnancy, but evidence of safety in early pregnancy is limited, including for vaccines
containing A/H1N1pdm2009 (pH1N1) antigen. We sought to determine if receipt of
vaccine containing pH1N1 was associated with spontaneous abortion (SAB).
Methods.
My comment - the bolded text means that this was a study to see if the flu vaccine really
was an anti fertility vaccine, hence the phrase "spontaneous abortion methods". This
proves they had a reason to be suspicious, because they only did this study to see
if the flu vaccine was an anti fertility vaccine, which causes spontaeous abortions.
We conducted a case-control study over two influenza seasons (2010-11, 2011-12) in the
Vaccine Safety Datalink. Cases had spontaneous abortion and controls had live births or
stillbirths and were matched on site, date of last menstrual period, and age. Of 919
potential cases identified using diagnosis codes, 485 were eligible and confirmed by
medical record review. Exposure was defined as vaccination with inactivated influenza
vaccine before the SAB date; the primary exposure window was the 1-28 days before the
SAB.
My comment - This paragraph establishes the legitimacy of the test, by stating the test
conditions.
Results
The overall adjusted odds ratio (aOR) was 2.0 (95% CI, 1.1-3.6) for vaccine receipt in the
28-day exposure window; there was no association in other exposure windows. In season-
specific analyses, the aOR in the 1-28 days was 3.7 (95% CI 1.4-9.4) in 2010-11 and 1.4
(95% CI 0.6-3.3) in 2011-12. The association was modified by influenza vaccination in the
prior season (post hoc analysis). Among women who received pH1N1-containing vaccine
in the previous influenza season, the aOR in the 1-28 days was 7.7 (95% CI 2.2-27.3); the
aOR was 1.3 (95% CI 0.7-2.7) among women not vaccinated in the previous season. This
effect modification was observed in each season.
My comment: The above states the ratios of what happened between unvaccinated
women and vaccinated women, with the maximum possible error swings also stated. The
error swings are reported in a way that is way out of whack to leave near mentally
deranged margins of error. In this case the margin allowed was 2.0, when the normal rate
of miscarriage was 1.4, which represents a margin of error that allows a result more than
double normal miscarriage rates to simply be called "error" to help conceal how bad the
damage from the vaccines was. This fails because the damage was too much to bury
even with that huge error swing allowed.
The first numbers outside of quotes - 3.7 followed by 1.4, shows 3.7 as the rate of
miscarriage after vaccination in the first year (before their "error margins" were
applied, and 1.4 as the baseline miscarriage rate in unvaccinated women for the
same year. For the second subsequent year of women getting the flu shot, the rate
of miscarriage in vaccinated women was 7.7, and the rate of miscarriage in
unvaccinated women was 1.3
Conclusion
Spontaneous abortion was associated with influenza vaccination in the preceding 28 days.
The association was significant only among women vaccinated in the previous influenza
season with pH1N1-containing vaccine. This study does not and cannot establish a causal
relationship between repeated influenza vaccination and spontaneous abortion, but further
research is warranted
My comment: It is clear they tried to lie here by leaving margin of errors so high that
they buried the first year stats, but in the second year the damage was so much
they could not hide it, no matter how they fudged the data. After showing an
increase in miscarriage from 14 percent to 77 percent, they then say it is no big deal
and can be ignored until further research proves the vaccine is actually a veiled anti
fertility vaccine. But the numbers more than obviously speak for themselves.
This abstract was discovered by GreenMedInfo.com. Their report is very different from
mine, because I saw what they were talking about, and then re-did all the
confirmation my own way, in much easier to understand terms.
The problem with their report, (even though they stated the same thing in a different way)
is that if anyone tries to confirm what they said, and then gets mired in a pool of Planned
parenthood fact rigging bullshit which dominates the infosphere, they won't make any
sense of the abstract because inserting planned parenthood's numbers into it would put
the miscarriage rate after two years of flu vaccination at over 200 percent, and almost
every source out there is using planned parenthood's numbers.
But Greenmedinfo found this buried abstract to begin with and should be commended for
that, and may have made the mistake of not clearing up the issue of planned parenthood
fact rigging because they know planned parenthood has obscured the real miscarriage
stats badly and as a result never got ensnared by them and then had to filter fact from
bullshit. You can read their report HERE
http://www.greenmedinfo.com/blog/devastating-flu-vaccine-miscarriage-study-sparks-
ridiculous-spin
http://www.sciencedirect.com/science/article/pii/S0264410X17308666
Their report is well worth reading also, because it goes into the politics of the issue, and
my report was a basic fact check.
SO MY FINAL NUMBERS: The flu vaccine, after two subsequent years, boosts the
miscarriage rate to 77 percent, which is a 592 percent increase over normal. Green
Med Info came up with a final answer of a 640 percent increase. The difference is
negligible. Two decent sites looked at the same abstract and reached the same
conclusion. OBVIOUS ANSWER: There is no way the flu vaccine is anything but an
anti fertility vaccine, and I'd bet the kids who do get through pregnancy after their
mom takes the jab have a hugely higher autism stat.
http://82.221.129.208/baaaasepaageh5.html
Devastating Flu Vaccine-Miscarriage

Study Sparks Ridiculous Spin
Posted on:
Thursday, September 14th 2017 at 2:00 pm
Written By:
J.B. Handley, Jr.
This article is copyrighted by GreenMedInfo LLC, 2017

Visit our Re-post guidelines
The mainstream media is doing their best to minimize a

devastating study showing a high correlation (7.7-fold)
between flu vaccines and miscarriages. A review of the
scientific literature shows a body of evidence that supports the
new studys conclusions. Why cant we all just deal with the
facts?
WASHINGTON, D.C.Lena Sun, reporter for the Washington Post, had an unenviable task: cover a
newly released study implicating the flu vaccine in spontaneous abortions (aka, miscarriages). The
study, released today in the highly respected and prestigious journal Vaccine, has a title that will
likely increase the stress level of pregnant women trying to figure out how to keep their baby safe:
Association of spontaneous abortion with receipt of inactivated influenza vaccine
containing H1N1 pdm09 in 201011 and 201112
Like all good journalists working in the mainstream media, Ms. Suns challenge was to report on a
potentially catastrophic new study that might hurt the primary source of advertising revenue for her
employer: the pharmaceutical industry. And while Ive seen a number of different ways for reporters
to try and minimize the implications of damaging studies, Ms. Suns headline may just take the cake:
For those of you not steeped in the jargon of statistics or epidemiology, youre going to have to take
my word for it that hint is not a statistical term nor does hint in any way provide a specific
assessment of risk. Hint is more like a word that you hope might keep people from reading your
article.
(Imagine saying McDonalds hamburgers provide a hint of spontaneous death or riding a
rollercoaster provides a hint of lifelong paralysis)
Despite Ms. Suns choice to minimize the significance of the study, the actual conclusions by the
study authors were deeply troubling. In a nutshell, what the authors found is that women who had
received an H1N1flu shot in the 201011 season and who then received a normal flu vaccine in the
201112 season were dramatically more likely to have a spontaneous abortion. How much more
likely? Heres what the study says:
Among women who received pH1N1-containing vaccine in the previous influenza

season, the aOR in the 128 days was 7.7 (95% CI 2.227.3); the aOR was 1.3
(95% CI 0.72.7) among women not vaccinated in the previous season.
(Authors note: soon after my article was published, the headline of Ms. Suns article was changed to
remove the word hint although she is still using the word to describe the 7-fold relationship
researchers found within the article itself.)
For those of you who need to brush up on your statistics (pretty much all of us), an odds ratio is a
measure of association between an exposure and an outcome. The OR represents the odds that an
outcome will occur given a particular exposure, compared to the odds of the outcome occurring in
the absence of that exposure. In plain English, an odds ratio greater than 1 would tend to imply that
two things are in fact linked (like tobacco use and lung cancer). What was the odds ratio for
spontaneous abortion for women who had received an H1N1 shot in 20102011 and then a flu
vaccine in 201112?
The study says 7.7, for those of you counting at home, thats not a hint, thats a giant
disturbing alarm (which is why the damage control is being rolled out en masse today).
Women who had received the two flu shots in successive seasons were almost 8x more
likely to have a spontaneous abortion than those who had nota nearly 700% increase.
Ms. Sun compounds her minimization of a very serious conclusion by then saying something thats
simply not true:
The findings suggest an association, not a causal link, and the research is too weak and preliminary,
experts said, to change the advice, which is based on a multitude of previous studies, that pregnant
women should get a flu vaccine to protect them from influenza, a deadly disease that may cause
serious birth defects and miscarriage.
Its always ridiculous when I read things from reporters that say multitude of previous studies
because I know that its pretty easy to verify whether or not thats true. You see, every vaccine is
required to have a package insert, and unlike a Washington Post reporter, the law requires package
insert writers to tell the truth, which Sanofi Pasteur (a flu vaccine maker) did when they wrote this
package insert for their flu vaccine one year ago, in 2016:
Multitude or zero?
Ms. Sun, in the case of Sanofis flu vaccine, routinely given to pregnant women, the sum
total of the multitude of safety studies done on the vaccines safety in pregnant women
is ZERO, at least according to the products package insert written by the vaccine maker
(and is true for every other flu vaccine).
Before I jump into the science on the flu vaccine, I need to mention that this whole issue of what
impact getting flu vaccines in successive years does to peoples immune systems (and to an unborn
fetus) is not new. In fact, it was actually a giant controversy in Canada just a few years ago. Heres
an article:
Not only was there a vaccine mismatch with that dominant strainH3N2 is
responsible for about 90 per cent of all flu deaths, especially among the elderly
but researchers found that people who had been inoculated in previous years
actually had a higher risk of coming down with the flu than those who typically
didnt get a shot.
Thats a controversial finding, obviously, said Skowronski, who led the study recently published in
the journal Clinical Infectious Diseases. But thats not a reason for us to shy away from addressing
it.
Scientists actually speak up, while CDC says pipe down
In the last week, two things happened that are starting to look less like a coincidence and more likely
related to this miscarriage-flu shot study:
1. A group of prestigious scientists wrote a withering critique of the opposition they
experience when publishing studies that show negative outcomes for vaccines (its
published in the same journal where the new flu shot study is published, Vaccine):
The authors write:
Recently, the authors of many vaccine safety investigations are being personally
criticized rather than the actual science being methodologically assessed and
critiqued. Unfortunately, this could result in making vaccine safety science a
hazardous occupation. Critiques should focus on the science and not on the
authors and on the scientists that publish reasonably high-quality science
suggesting a problem with a given vaccine. These scientists require adequate
professional protection so there are not disincentives to publish and to carry out
researches in the field. The issues for vaccine safety are not dissimilar to other
areas such as medical errors and drug safety.
2. Meanwhile, the U.S. Centers for Disease Control has issued a gag order on employees
talking to the press, from an article yesterday in Axios.com:
The Centers for Disease Control and Prevention is trying to crack down on its employees
conversations with the press, according to an internal email obtained by Axios. The messagesent
by public affairs officer Jeffrey Lancashire and dated Aug. 31instructs all CDC employees not to
speak to reporters, even for a simple data-related question.
What it said:
Effective immediately and until further notice, any and all correspondence with any member of the
news media, regardless of the nature of the inquiry, must be cleared through CDCs Atlanta
Communications Office, Lancashire wrote. This correspondence includes everything from formal
interview requests to the most basic of data requests.
Ill let the reader draw their own conclusions on these two developments.
Let the science speak

So now you know that you may not get the truth about vaccine science from a Washington
Post reporter. Well, what does the science actually say about flu shots? Heres 10 published studies
(and a bonus) that I hope will help you better understand this topic.
Are we getting played?
1. Influenza: marketing vaccine by marketing disease

Background: Johns Hopkins scientist and British Medical Journal editor delivers critique of the
marketing and limited studies of flu vaccine.
Excerpt: Closer examination of influenza vaccine policies shows that although proponents employ
the rhetoric of science, the studies underlying the policy are often of low quality, and do not
substantiate officials claims. The vaccine might be less beneficial and less safe than has been
claimed, and the threat of influenza appears overstated.
2. Comparison of VAERS fetal-loss reports during three consecutive influenza seasons:
Was there a synergistic fetal toxicity associated with the two-vaccine 2009/2010 season?
Background: This study found the exact same flu vaccine/spontaneous abortion link when comparing
the 200809 to the 200910 flu season.
Excerpt: Thus, the concomitant administration of the seasonal influenza and pandemic A-H1N1 vac-
cines during 2009/2010 suggests a synergistic toxicity and a statistically significant higher rate of
fetal loss reporting relative to the single-dose seasons.
3. Influenza Vaccination During Pregnancy: A Critical Assessment of the Recommendations
of the Advisory Committee on Immunization Practices (ACIP)
Background: CDCs recommendation to vaccinate pregnant women has no science to support it.
Excerpt: The ACIPs citations and the current literature indicate that influenza infection is rarely a
threat to a normal pregnancy. There is no convincing evidence of the effectiveness of influenza
vaccination during this critical period. No studies have adequately assessed the risk of influenza
vaccination during pregnancy, and animal safety testing is lacking. Thimerosal, a mercury-based
preservative present in most inactivated formulations of the vaccine, has been implicated in human
neurodevelopment disorders, including autism, and a broad range of animal and experimental
reproductive toxicities including teratogenicity, mutagenicity, and fetal death. Thimerosal is classified
as a human teratogen. The ACIP policy recommendation of routinely administering influenza vaccine
during pregnancy is ill-advised and unsupported by current scientific literature, and it should be
withdrawn. Use of thimerosal during pregnancy should be contraindicated.
4. Vaccination against Human Influenza A/H3N2 Virus Prevents the Induction of
Heterosubtypic Immunity against Lethal Infection with Avian Influenza A/H5N1 Virus
Background: From Neil Z. Miller: Mice that were infected with a seasonal influenza virus survived
exposure to a lethal influenza strain; vaccinated mice died.
Excerpt: As a result H3N2-vaccinated mice continued to loose body weight after A/H5N1 infection,
had 100-fold higher lung virus titers on day 7 post infection and more severe histopathological
changes than mice that were not protected by vaccination against A/H3N2 influenza.These findings
may have implications for the general recommendation to vaccinate all healthy children against
seasonal influenza in the light of the current pandemic threat caused by highly pathogenic avian
A/H5N1 influenza viruses.
5. Effectiveness of Influenza Vaccine during Pregnancy in Preventing Hospitalizations and
Outpatient Visits for Respiratory Illness in Pregnant Women and Their Infants
Background: This study showed no benefit in health outcomes for women who received a flu vaccine
while pregnant.
Excerpt: Although the immunogenicity of influenza vaccination in pregnancy in mother and infant
has been well documented, in this study, we were unable to demonstrate the effectiveness of
influenza vaccination with data for hospital admissions and physician visits.
6. Mandatory influenza vaccination? First we need a better vaccine
Background: Highly respected Canadian scientists questioning efficacy of the flu vaccine.
Excerpt: Two research groups have recently reanalyzed the literature supporting influenza
vaccination, including the vaccination of health care workers as a patient-safety measure. 7, 8 Both
concluded that influenza vaccination is considerably less effective than is commonly accepted. These
conclusions are not new: in 2007, Simonsen and colleagues 9 similarly challenged the results of
published influenza vaccine efficacy studies involving elderly patients.9
7. Evidence of bias in estimates of influenza vaccine effectiveness in seniors.
Background: This study claims the benefits to the elderly from getting a flu vaccine has been
overstated. In fact, it says there are no benefits.
Excerpt: The reductions in risk before influenza season indicate preferential receipt of vaccine by
relatively healthy seniors. Adjustment for diagnosis code variables did not control for this bias. In this
study, the magnitude of the bias demonstrated by the associations before the influenza season was
sufficient to account entirely for the associations observed during influenza season.
8. Efficacy and effectiveness of influenza vaccines: a systematic review and meta-analysis.
Background: The authors reviewed 31 published studies on the flu vaccine and found little data to
support the benefits of the vaccine.
Excerpt: Influenza vaccines can provide moderate protection against virologically confirmed
influenza, but such protection is greatly reduced or absent in some seasons. Evidence for protection
in adults aged 65 years or older is lackingNew vaccines with improved clinical efficacy and
effectiveness are needed to further reduce influenza-related morbidity and mortality.
9. Yearly influenza vaccinations: a double-edged sword?
Background: Vaccinating children every year for the regular flu could make them more at risk to
pandemic strains of the flu in the future. Not good.
Excerpt: Preventing infection with seasonal influenza viruses by vaccination might prevent the
induction of heterosubtypic immunity to pandemic strains, which might be a disadvantage to
immunologically naive peopleeg, infants.
10. Association between the 200809 Seasonal Influenza Vaccine and Pandemic H1N1
Illness during SpringSummer 2009: Four Observational Studies from Canada
Background: Further proof that prior vaccination with flu vaccine can make you MORE susceptible to
future strains.
Excerpt: Prior receipt of 200809 TIV was associated with increased risk of medically attended
pH1N1 illness during the springsummer 2009 in Canada. The occurrence of bias (selection,
information) or confounding cannot be ruled out. Further experimental and epidemiological
assessment is warranted. Possible biological mechanisms and immunoepidemiologic implications are
considered.
11. Influenza vaccine effectiveness in the community and the household.
Background: From Neil Z. Miller: The current seasons influenza vaccine will not work in people who
also received the previous seasons influenza vaccine.
Excerpt: Vaccine effectiveness estimates were lower than those demonstrated in other observational
studies carried out during the same season. The unexpected findings of lower effectiveness with
repeated vaccination and no protection given household exposure require further study.
In conclusion: we want the truth, we can handle it
Lena Sun of the Washington Post
Parents are tired of hype and misdirection when it comes to vaccines. Vaccines have risks, vaccines
have benefits. I dont personally understand what purpose reporters like Ms. Sun serve to this debate
except obscuring the truth. Luckily, science on this topic is readily available for anyone willing to
spend the time to do research.
The new study in Vaccine looking at flu vaccines and spontaneous abortions is a credible, peer-
reviewed study that found a very high correlation between successive seasons of flu vaccines and
miscarriages. It deserves our attention, and it deserves an honest appraisal of where it fits into a
growing body of literature raising serious concerns about the benefits of annual flu vaccines.
Earlier this year, I wrote a lengthy article detailing the emerging science that appeared to clearly
explain how autism was caused. I highlighted the pioneer of all this learning, Dr. Paul Patterson from
Caltech, and his seminal work Pregnancy, Immunity, Schizophrenia, and Autism. A quote from
Dr. Patterson feels like an appropriate way to end this article. Parents, please do your own research:
Finally, I want to ask a question thats come up in the literature in the last few
yearsshould we really be promoting universal maternal vaccination? The flu
vaccine has been recommended routinely to pregnant women in the United States
since 1957. The official policy of the Centers for Disease Control states that
administration of vaccines to women seeking prenatal care is an opportunity for
preventative intervention that should not be wasted. Now you might say, Well,
of course, you dont want to get the flu if youre pregnant! But remember that
double-stranded RNA experimentwe activated the immune system, and it caused
all these downstream effects on the fetus. And what does a vaccination do? It
activates the immune system. Thats the point of vaccination. In practice, not all
pregnant women receive flu shots, and I think that universal vaccination of
pregnant women could get us into a whole new set of problems.
Addendum:
The news on this study is coming out fast and furious. Given what you just read about the science
that has long been published that seems to corroborate the findings from this new study, I think you
will share my shock in reading this article, which says the Committee that makes vaccination
recommendations in the U.S. (the ACIP) has known about this data for more than TWO YEARS.
What do you say to women who have experienced a miscarriage after flu shot anytime after
June, 2015?
Excerpts from article, bold added by me:

ACIP has known about this work for a couple of years and to date has chosen not to
change its recommendation that pregnant women at all stages of pregnancy get a flu
shot. The researchers made a preliminary report to the panel in June of 2015.
ACIP next meets at the end of October and will discuss the finding further then, said Dr. Amanda
Cohn, senior adviser for vaccines at the CDC and executive secretary of the ACIP. Cohn said she
couldnt predict at this point whether those deliberations will lead to a vote on a policy
recommendation.
Dr. Laura Riley, an ACIP member, is not convinced the finding is real [she obviously hasnt
considered the 11 studies above]. Riley, who is vice chair of obstetrics at Massachusetts General
Hospital, said she doesnt think theres a biologically plausible explanation for why repeated
flu shots would increase the risk of miscarriage [even though we have biological scince
telling us why]. I remain skeptical, she said, adding the question needs more study.
Its not going to change my practice, thats for sure, [cognitive dissonance?] Riley told
STAT. I feel like women should be vaccinated when the vaccine becomes available and when theyre
in my office. And if thats in the first trimester, second trimester, third trimester, Im vaccinating.
She and other doctors will be doing a lot of that in the weeks to come. This is, after all, flu shot
season in the Northern Hemisphere.
Belongia said while its not clear whether flu shots could increase the risk of miscarriage, it is known
that contracting the flu during pregnancy can be dangerous for both a woman and her fetus.
But he and the CDCs Cohn advised that pregnant women who are concerned should talk with their
doctors. One option might be to time the flu shot for some point after the first trimester, if thats
possible, they suggested.
J.B. Handley is the father of a child with Autism. He and his wife co-founded autism charity Generation Rescue.
He spent his career in the private equity industry and received his undergraduate degree with honors from
Stanford University. He is also the author of The Only Vaccine Guide a New Parent Will Ever Need;,An Angry
Fathers Guide to Vaccine-Autism Science, and 7 reasons CDC employees should be crying in the
hallways; Podcast
Disclaimer: This article is not intended to provide medical advice, diagnosis or treatment. Views expressed
here do not necessarily reflect those of GreenMedInfo or its staff.
Internal Site Commenting is limited to members.

Disqus commenting is available to everyone.
http://www.greenmedinfo.com/blog/devastating-flu-vaccine-miscarriage-study-sparks-ridiculous-spin
Vaccine
Volume 35, Issue 40, 25 September 2017, Pages 53145322
Association of spontaneous abortion with receipt of inactivated influenza

vaccine containing H1N1pdm09 in 201011 and 201112
James G. Donahuea, , ,
Burney A. Kiekea, ,
Jennifer P. Kinga, ,
Frank DeStefanob, ,
Maria A. Mascolac, ,
Stephanie A. Irvingd, ,
T. Craig Cheethame, ,
Jason M. Glanzf, ,
Lisa A. Jacksong, ,
Show more
https://doi.org/10.1016/j.vaccine.2017.06.069
Get rights and content

Abstract
Introduction
Inactivated influenza vaccine is recommended in any stage of pregnancy, but evidence of safety in
early pregnancy is limited, including for vaccines containing A/H1N1pdm2009 (pH1N1) antigen. We
sought to determine if receipt of vaccine containing pH1N1 was associated with spontaneous abortion
(SAB).
Methods
We conducted a case-control study over two influenza seasons (201011, 201112) in the Vaccine
Safety Datalink. Cases had SAB and controls had live births or stillbirths and were matched on site,
date of last menstrual period, and age. Of 919 potential cases identified using diagnosis codes, 485
were eligible and confirmed by medical record review. Exposure was defined as vaccination with
inactivated influenza vaccine before the SAB date; the primary exposure window was the 128 days
before the SAB.
Results
The overall adjusted odds ratio (aOR) was 2.0 (95% CI, 1.13.6) for vaccine receipt in the 28-day
exposure window; there was no association in other exposure windows. In season-specific analyses,
the aOR in the 128 days was 3.7 (95% CI 1.49.4) in 201011 and 1.4 (95% CI 0.63.3) in 2011
12. The association was modified by influenza vaccination in the prior season (post hoc analysis).
Among women who received pH1N1-containing vaccine in the previous influenza season, the aOR in
the 128 days was 7.7 (95% CI 2.227.3); the aOR was 1.3 (95% CI 0.72.7) among women not
vaccinated in the previous season. This effect modification was observed in each season.
Conclusion
SAB was associated with influenza vaccination in the preceding 28 days. The association was
significant only among women vaccinated in the previous influenza season with pH1N1-containing
vaccine. This study does not and cannot establish a causal relationship between repeated influenza
vaccination and SAB, but further research is warranted.
Keywords
Influenza vaccine;
Spontaneous abortion;
Influenza;
Pregnancy
Abbreviations
SAB, spontaneous abortion;
VSD, Vaccine Safety Datalink;
pH1N1, influenza virus type A/H1N1pdm2009;
aOR, adjusted odds ratio;
LMP, last menstrual period;
IIV, inactivated influenza vaccine
1. Introduction
Since 2004, the Centers for Disease Control and Prevention (CDC) Advisory Committee on
Immunization Practices (ACIP) and other organizations have recommended routine influenza
vaccination for pregnant women regardless of gestational age [1] ; [2]. Influenza in pregnancy can
cause serious, life-threatening illness in both the mother and fetus, as demonstrated during the 2009
pandemic [3] ; [4]. Numerous studies of influenza vaccine during pregnancy have not identified
serious safety concerns [5]; [6]; [7]; [8]; [9]; [10]; [11] ; [12], but relatively few investigations have
evaluated vaccination in the first trimester, a period when the embryo is highly vulnerable to
teratogens and other factors [5] ; [13]. A case-control study conducted by the Vaccine Safety
Datalink (VSD) demonstrated that influenza vaccination during early pregnancy in the 200506 and
200607 influenza seasons was not associated with spontaneous abortion (SAB) [14].
The emergence of a pandemic influenza virus, A/California/7/2009 (H1N1)pdm09 (pH1N1), led to
rapid development and widespread use of vaccines containing pH1N1 antigens. Several studies have
evaluated the safety of vaccines containing pH1N1 in pregnancy, but few have focused on outcomes
in early pregnancy [15]; [16]; [17]; [18] ; [19]. Using a design and protocol similar to the previous
study [14], we conducted a case-control study to determine if receipt of influenza vaccine containing
pH1N1 was associated with SAB.
2. Methods
2.1. Study population
This study included women who were pregnant during the 201011 or 201112 influenza seasons
and members of one of six integrated healthcare delivery organizations in VSD: Group Health
Cooperative, Seattle, WA; Kaiser Permanente (Colorado, Northern California, Southern California,
Oregon); and Marshfield Clinic, Marshfield, WI. VSD was established in 1990 as a collaborative
project between several healthcare organizations and CDC to monitor vaccine safety.[20].
The study was approved by the Institutional Review Boards of each organization and CDC.
2.2. Cases
Potential cases of SAB (gestational age 5 to <20 weeks) were initially identified at each site through a
search of VSD databases for diagnosis codes for spontaneous and unspecified abortion (International
Classification of Diseases, 9th Revision, Clinical Modification (ICD9-CM) 634.x and 637.x)
(Supplemental Table 1) assigned in ambulatory, urgent care, emergency department, and inpatient
settings. Because influenza vaccine is administered seasonally, we required SAB diagnoses be
assigned between September 1, 2010 and April 28, 2011 and September 1, 2011 and April 28, 2012
to avoid including cases that had no chance of being vaccinated. Pregnancy was confirmed using
information from the medical record: clinic or hospital-based assay, obstetric ultrasound, patient-
reported test, or physician diagnosis.
Study eligibility criteria included: (1) SAB confirmed by ultrasound or clinical diagnosis in the absence
of ultrasound results; (2) age 1844 years on date of SAB; (3) date of last menstrual period (LMP)
reported in the medical record; and (4) continuous enrollment in the healthcare organization for
12 months prior to LMP. Exclusion criteria included ectopic pregnancy, therapeutic abortion, or SAB
occurring <5 weeks of gestation. An ultrasound was not required to minimize selection bias.
Trained abstractors reviewed medical records to collect ultrasound results and other information,
including gestational age and biometrics. The estimated date of SAB was based on interpretation of
ultrasound results by the investigators who were blinded to vaccination status; ambiguous ultrasound
results were adjudicated by an obstetrician (M.A.M.) [21]. For women without ultrasound results, the
date was based on the earliest clinical diagnosis. The SAB date was defined as the LMP date plus
the gestational age at the time of the SAB. Women were excluded if after careful review of ultrasound
and menstrual data, we could not estimate gestational age with reasonable precision (e.g., report of
an empty gestational sac not consistent with the LMP date).
2.3. Controls
Controls met the same inclusion criteria as cases (except SAB diagnosis) and had a live delivery or
stillbirth (infant born dead 20 weeks of gestation) as determined by ICD9-CM codes (Supplemental
Table 1). Abstractors reviewed the records of controls to confirm the pregnancy outcome and abstract
additional information.
2.4. Matching
Cases and controls were individually matched (1:1 ratio). LMP was a matching variable to ensure
nearly identical gestational age relative to calendar time since opportunities for influenza vaccination
vary over time. To ensure close matching on LMP, we randomly selected 10 potential controls having
LMP dates within seven days of the case LMP; the eligible control with the LMP closest to the case
LMP was selected. Cases and controls were also matched by VSD site and maternal age (<30 years,
30 years). The reference date for each case-control pair was the estimated SAB date for the case.
2.5. Influenza vaccine exposure

Only women vaccinated with inactivated influenza vaccine (IIV) before the reference date were
considered exposed for this study. The composition of the inactivated influenza vaccine (IIV) was
identical in each season: A/California/7/2009 (H1N1)pdm09-like, A/Perth/16/2009 (H3N2)-like, and
B/Brisbane/60/2008-like [22] ; [23]. Vaccination dates for influenza and other vaccines were
abstracted from medical records. We also documented influenza vaccinations administered in the
previous season. Women pregnant in 201011 could have been vaccinated in 200910 with the
monovalent (H1N1)pdm09 vaccine, the seasonal vaccine (A/Brisbane/59/2007 (H1N1)-like,
A/Brisbane/10/2007 (H3N2)-like, B/Brisbane 60/2008-like), both, or neither [24].
The primary exposure window was defined as 128 days before the reference date because the
immune response to influenza vaccine peaks in the first four weeks after vaccination [25] ; [26]. We
also assessed exposure windows further removed from the reference date (2956 and >56 days).
2.6. Statistical analysis

Cases and controls were compared using Wilcoxon signed-rank tests for continuous variables,
McNemar tests for dichotomous variables, and Bowkers test of symmetry for categorical variables
with >2 levels. All P values were based on two-sided tests. SAS 9.3 (SAS Institute, Cary, NC) was
used for the analysis.
We performed conditional logistic regression to estimate the association between SAB and receipt of
IIV in each exposure window. The final model included specific covariates selected a priori because
they were suspected to be associated with SAB or vaccination: maternal age, smoking during
pregnancy, history of type 1 or 2 diabetes, pre-pregnancy body mass index (BMI), and previous
health care utilization (defined as the number of days with an outpatient or inpatient encounter in the
year before the LMP) [27]. Age, BMI, and health care utilization were included in the model as
quadratic splines [28]. In addition, we adjusted for vaccinations given concomitantly with influenza
vaccine; the only concomitant vaccine was Tdap. Race variables were excluded from the model
because the adjusted and unadjusted odds ratio estimates differed by less than 10% [29]. Other
variables omitted because they were not associated with SAB in this study included parity, gravidity,
asthma, and hypertension. The referent exposure group in all odds ratio (OR) calculations was
women unvaccinated as of the reference date.
Because the OR varied by season of enrollment, we performed a post hoc analysis to determine if
receiving pH1N1-containing vaccine in the previous influenza season modified the relationship
between SAB and current-season IIV receipt. A dichotomous variable representing receipt of pH1N1-
containing vaccine in the previous influenza season was evaluated as an effect modifier. Effect
modification was assessed in the model by including a cross-product term for prior season
vaccination and current-season IIV receipt in the various risk windows; the main effect terms were
also included in this model. We performed this analysis for the 201011 and 201112 seasons
separately and combined. In addition, the association between IIV and SAB was examined within
strata defined by prior season receipt of pH1N1-containing vaccines and maternal age 35 years by
including the appropriate cross-product terms in the model, since advanced maternal age is a well-
established risk factor for SAB. We decided a priori not to adjust for history of prior SAB because
doing so could result in biased estimates [30]. However, because recurrent miscarriage may have a
distinct etiology [31], we performed a separate effect modification analysis in which women with a
history of 2 SABs were excluded.
Chart-abstracted vaccination data were used in the analyses for the 201011 and 201112 influenza
seasons. For the 200910 season, vaccination data extracted from the VSD vaccine database were
used. The accuracy of the latter data source was assessed by examining kappa statistics for the
201011 and 201112 seasons where both chart-abstracted and electronic data were available. In
addition, to assess potential protopathic bias[32] (i.e., reverse causality) we extracted and compared
all diagnosis codes (ICD-9) assigned to vaccinated cases and controls on the same day as their
influenza vaccination.
Using information from the previous study [14], we estimated that 500 matched case-control pairs
would provide 80% power to detect an OR of 2.2 in the 28 day exposure window ( = 0.05).
3. Results
There were 919 presumptive SAB cases identified based on diagnosis codes. Of these, 434 were
excluded (Fig. 1); 485 eligible women (53%) were matched to 485 controls. Women enrolled in the
201011 and 201112 influenza seasons were similar in most respects (Supplemental Table 2), as
were cases and controls (Table 1). However, cases were significantly older than controls and more
likely to be African-American, to have a history of 2 SABs, and to have smoked during pregnancy.
The overall proportion of women vaccinated for influenza before the reference date was similar for
cases and controls whether they were vaccinated in the previous season or not. Among women not
receiving pH1N1-containing influenza vaccine in the prior season, the proportion vaccinated for
influenza in the current season was similar for cases and controls within all exposure windows (Table
1). For women that did receive pH1N1-containing influenza vaccine in the prior season, the
corresponding proportions were similar in the windows 2956 and >56 days before the referent date,
but there was a fivefold elevation in the 128 day exposure window for cases versus controls (17.0%
versus 3.1%). As many as seven different manufacturers produced the vaccine administered during
the 201011 and 201112 influenza seasons; the distribution of manufacturer was similar among
cases and controls in each season. The mean within-pair difference in LMP between matched cases
and controls was -0.55 days; the median was zero. The median gestational age at the time of SAB
was 7 weeks (Supplemental Fig. 1). Medical record review included obstetric ultrasounds for most
cases (89%).
Fig. 1.
Identification and confirmation of spontaneous abortions. Flow chart describing how spontaneous abortion cases
were selected for study. *SAB date outside of the targeted date range for this study (n = 32) or failed to satisfy
enrollment criteria (n = 37). SAB: spontaneous abortion, LMP: last menstrual period.
Figure options
Table 1.
Demographic and medical characteristicsa of SAB cases and controls.b
Cases Controls P
(n = 485) (n = 485)
Age in years at reference date 0.02
1824 87 (18) 68 (14)
2534 241 (50) 289 (60)
3544 157 (32) 128 (26)
Median (IQR) 31.8 (2737) 31.6 (2835) 0.02
BMI 0.46
<18.5 13 (3) 9 (2)
18.5 to <25 203 (42) 234 (48)

Cases Controls P
(n = 485) (n = 485)
25 to <30 128 (27) 129 (27)
30 134 (28) 112 (23)
Median (IQR) 25.7 (2231) 24.9 (2230) 0.08
Racec
White 261 (55) 268 (57) 0.77
African American 42 (9) 20 (4) 0.008
Asian Indian 12 (3) 13 (3) 1.00
Chinese 8 (2) 18 (4) 0.06
Native American 6 (1) 4 (1) 0.75
Other 164 (35) 165 (35) 1.00
Parity (1) 277 (57) 273 (56) 0.79
Gravidity, median (IQR) 1 (03) 1 (02) 0.40
Multiple gestation pregnancy 5 (1) 7 (1) 0.77
Previous SAB
1 138 (29) 125 (26) 0.32
2 43 (9) 26 (5) 0.03
Smoked during pregnancy 52 (11) 34 (7) 0.05
Same season influenza vaccination before reference date among 56 (56.0) 53 (41.7)
those vaccinated in the previous seasond
128 days before reference date 17 (17.0) 4 (3.1)
>56 days before reference date 34 (34.0) 44 (34.6)
Same season influenza vaccination before reference date among 71 (18.6) 70 (19.7)
those not vaccinated in the previous seasond
>56 days before reference date 38 (10.0) 39 (11.0)
Concomitant IIV and Tdap vaccination before reference date 2 (0) 4 (1) 0.62
Type I/II diabetes 4 (1) 12 (2) 0.08

Cases Controls P
(n = 485) (n = 485)
Asthma 55 (11) 56 (12) 0.92
Hypertension 11 (2) 16 (3) 0.44
Febrile illness in the 14 days before reference date 5 (1) 0 ---
Number of days with outpatient diagnoses, vaccinations, or 3 (26) 3 (16) 0.04

hospitalizations in the 365 days before LMP, median (IQR)
BMI had missing data for 7 cases and 1 control. Race had missing data for 13 cases and 13 controls. Parity had
missing data for 2 cases. Smoking had missing data for 10 cases and 6 controls. Diabetes had missing data for 3
cases and 2 controls. Asthma had missing data for 4 cases and 3 controls. Hypertension had missing data for 3
cases and 2 controls. Previous SAB had missing data for 10 cases and 5 controls. Health care utilization had
missing data for 1 control. Gravidity had missing data for 6 cases. Febrile illness had missing data for 5 cases.
Vaccination data was missing for 3 cases and 2 controls.
b
Data are N (%) unless otherwise noted. IQR = Interquartile Range. P values were calculated using a Wilcoxon
signed rank test, Bowkers test of symmetry, or exact McNemar test and excluded observations with missing
values.
c
The frequencies for race exceed 485 for both cases and controls because persons could have been included in
more than one race category. The large number of persons in the Other category is the result of ethnicity (e.g.,
Hispanic) being mistakenly coded as race in the medical record.
d
Statistical tests within prior season influenza vaccination status strata are not presented in Table 1 since the
corresponding McNemars tests would restrict the analyses to matched pairs that are concordant on prior season
influenza vaccination status. This would result in the exclusion of a substantial amount of data from the
calculations (overall, 35% of the matched pairs were discordant with respect to prior season vaccination status).
Percentages were computed using stratum-specific denominators.
Table options
The adjusted OR (aOR) for IIV receipt in the 128 day exposure window was 2.0 (95% CI, 1.13.6);
the aORs were 0.9 for both of the other exposure windows (2956 and >56 days) (Table 2). The aOR
in the 28-day window was 3.7 (95% CI, 1.49.4) in the 201011 season and 1.4 (95% CI, 0.63.3) in
the 201112 season.
Table 2.
Odds of influenza vaccination in SAB cases compared to controls by timing of vaccination during the 201011
and 201112 influenza seasons and both seasons combined.a
Influenza 201011 201112 Both seasons combined
season
Discordant Adj. P Discordant Adj. P Discordant Adj. P

pairsb ORc pairsb ORc pairsb ORc
Time from vaccination to reference date
128 days 25 3.7 0.007 23 1.4 0.47 48 2.0 0.03

(1.4 (0.6 (1.1
9.4) 3.3) 3.6)
Influenza 201011 201112 Both seasons combined
season
Discordant Adj. P Discordant Adj. P Discordant Adj. P

pairsb ORc pairsb ORc pairsb ORc
29 14 1.7 0.31 6 0.1 0.04 20 0.9 0.85

56 days (0.6 (0.0 (0.4
4.8) 0.9) 2.1)
>56 days 51 1.0 0.99 46 0.9 0.72 97 0.9 0.67

(0.5 (0.4 (0.6
1.8) 1.7) 1.4)
The referent exposure group in all odds ratio calculations was comprised of women unvaccinated as of the
reference date.
b
Number of matched pairs where the case was vaccinated in the relevant exposure window (128, 2956, >56
days before the reference date) and the control was unvaccinated as of the reference date or vice versa.
c
Adj. OR represents the odds ratio adjusted for maternal age (spline), BMI (spline), smoking during pregnancy,
maternal diabetes, concomitant Tdap vaccination, and health care utilization in prior 12 months (spline). Numbers
in parentheses represent 95% confidence intervals.
Table options
In a post-hoc analysis, there was significant effect modification (P = 0.02) by prior season vaccination.
The aOR for IIV receipt in the 128 day window was significantly elevated among women who had
also received pH1N1-containing vaccine in the previous season (Table 3). There was no increased
risk among women who did not receive influenza vaccine in the previous season regardless of current
season IIV vaccination status. The aORs for the other exposure windows demonstrated no
statistically significant association between SAB and IIV, regardless of past exposure to pH1N1-
containing vaccine. We also assessed the combined effects of pH1N1-containing vaccine in the
previous season and age 35 years and observed that older women had a larger aOR (22.1, 95%CI
1.7281.2) than younger women (4.8, 95% CI 1.022.2), but the number of women in these
categories was small and the difference was not statistically significant (P = 0.32). In a secondary
analysis, we excluded cases and controls with a history of 2 SABs. The aOR in the 128 day
window for women vaccinated with pH1N1-containing vaccine in the previous season remained
significantly elevated (aOR = 6.5, 95% CI 1.724.3).
Table 3.
Association between SAB and IIV receipt in the current influenza season (2010-11 or 2011-12), by receipt of
pH1N1-containing vaccine in the previous season and advanced maternal age.a
pH1N1- Age Time from vaccination to reference date in current seasonb
containing (years)
vaccine in the
previous
seasonc 1-28 days 29-56 days >56 days
No. of aOR No. of aOR No. of aOR

cases/controlsd (95% cases/controls (95% cases/controls (95%
CI) CI) CI)
Yes All 14/4 7.7 3/4 1.2 34/40 1.4

(2.2 (0.2 (0.7
27.3)e 6.5) 3.0)
No All 21/19 1.3 12/11 1.0 37/38 0.9

(0.7 (0.4 (0.5
2.7) 2.5) 1.6)
Yes 35 7/1 22.1 1/2 0.4 16/10 1.3

(1.7 (0.0 (0.3
281.2)f 5.3) 4.8)
Yes <35 7/3 4.8 2/2 3.4 18/30 1.5

(1.0 (0.4 (0.6
22.2) 32.6) 3.7)
No 35 3/5 1.0 3/5 0.2 12/13 0.4

(0.2 (0.0 (0.2
6.1) 1.0) 1.2)
No <35 18/14 1.4 9/6 1.9 25/25 1.1

(0.6 (0.6 (0.5
3.0) 6.3) 2.1)
Adjusted for maternal age (spline), BMI (spline), smoking during pregnancy, maternal diabetes, concomitant Tdap
vaccination, and health care utilization in prior 12 months (spline).
b
reference date.
c
Recipients of the monovalent pH1N1 vaccine in 200910 may or may not have also received the seasonal
vaccine.
d
Total number of cases and controls in the specific stratum. Number of discordant pairs could not be computed
since the stratum-specific estimates were derived from models with cross-product terms whose components were
not matching factors.
e
P = 0.02 for effect modification by pH1N1-containing vaccine in the previous season (7.7 vs. 1.3).
f
P = 0.32 for effect modification by advanced maternal age among those that received pH1N1-containing vaccine
in the previous season (22.1 vs. 4.8).
Table options
In each of the two influenza seasons under study, we observed a similar relationship between SAB
and IIV. In the 201011 season, the aOR for IIV receipt in the 128 day exposure window was 32.5
(95% CI 2.9359.0) for women who were also vaccinated with the monovalent pH1N1 vaccine with or
without seasonal vaccine in 200910. In the 201112 season, the comparable aOR was elevated, but
the lower bound of the confidence interval was close to the null (aOR = 6.4, 95% CI 1.041.2) for
women who were also vaccinated with the seasonal vaccine (which contained pH1N1 antigens) in
201011. Effect modification in the 28-day exposure window due to prior vaccination with pH1N1-
containing vaccine was present in both the 201011 (P = 0.06) and 201112 (P = 0.05) seasons, and
the magnitude of aOR in the two seasons was not statistically different (aOR 32.5 vs. 6.4, P = 0.30)
(Table 4). The associations in the other windows (2956 and > 56 days), regardless of prior season
influenza vaccination status, were generally smaller and not statistically significant. Finally, the aOR
for women enrolled in 201011 who received only the seasonal vaccine in 200910 was smaller
(aOR = 3.3, 95% CI 0.520.1) and not statistically significant compared to women who had received
the monovalent pH1N1 vaccine in 200910.
Table 4.
Association between SAB and IIV receipt in the current influenza season, by receipt of pH1N1-containing vaccine
in the previous season, stratified by season of enrollment.a
Time from vaccination to reference date in current seasonb
128 daysc 2956 days >56 days

cases/controlsd (95% CI) cases/controls (95% cases/controls (95%
CI) CI)
Vaccination status in 200910 of women enrolled in 201011
pH1N1 seasonal 6/2 32.5, 2/1 4.1, 16/18 3.2,

vaccine (2.9 (0.3 (1.0
359.0) 63.1) 10.5)
Both vaccines 5/2 31.5, 1/1 2.4, 11/12 3.0,

(2.3 (0.1 (0.6
424.8) 58.0) 14.0)
Seasonal only 3/3 3.3, 4/3 1.5, 10/9 2.8,

(0.5 (0.2 (0.8
20.1) 11.9) 10.2)
Unvaccinated 10/5 3.4, 7/4 2.5, 12/13 0.6,

(0.8 (0.6 (0.2
14.2) 11.2) 1.6)
Vaccination status in 201011 among women enrolled in 201112

Time from vaccination to reference date in current seasonb
128 daysc 2956 days >56 days

cases/controlsd (95% CI) cases/controls (95% cases/controls (95%
CI) CI)
Vaccinated 8/2 6.4, 1/3 0.3, 18/22 0.9,

(1.0 (0.0 (0.3
41.2) 4.0) 2.5)
Unvaccinated 8/11 0.7, 1/4 0.04, 15/16 1.0,

(0.32.2) (0.0 (0.4
0.8) 2.7)
Adjusted for maternal age (spline), BMI (spline), smoking during pregnancy, maternal diabetes, concomitant Tdap
vaccination, and health care utilization in prior 12 months (spline).
b
reference date.
c
P = 0.06 among women enrolled in 201011 and P = 0.05 among women enrolled in 201112 for effect
modification by pH1N1-containing vaccine in the previous season.
d
Total number of cases and controls in the specific stratum. Number of discordant pairs could not be computed
since the stratum-specific estimates were derived from models with cross-product terms whose components were
not matching factors.
Table options
Vaccinated cases (n = 74, 58%) were more likely than vaccinated controls (n = 64, 52%) to have 1
diagnosis on the date of their vaccination, but the difference was not statistically significant (P = 0.39).
The mean number of diagnoses was similar for cases and controls (1.7 vs. 1.6, P = 0.64). The most
common diagnoses were for routine care; the distribution was similar for cases and controls (see the
V codes in Table 5). Ten cases were assigned diagnoses consistent with early signs/symptoms of
SAB compared to four controls. Of these, three cases and no controls were assigned the diagnosis in
the 128 days before the SAB diagnosis, the only exposure window in which there was a statistically
significant association. The SAB-IIV association among women vaccinated in the previous influenza
season changed minimally after exclusion of these three cases and their matched controls (OR = 7.0,
95% CI 1.925.2).
Table 5.
Diagnoses assigned to cases and controls on day of influenza vaccination.a

ICD-9 Diagnosis code description Cases Controls
code (n = 127) (n = 123)
Any code Any diagnosis on day of vaccination 211 182

ICD-9 Diagnosis code description Cases Controls
code (n = 127) (n = 123)
V04.81 Need for prophylactic vaccination and inoculation against 53 (25) 45 (25)
certain diseases, influenza
V22.1 Supervision of other normal pregnancy 15 (7) 7 (4)
V70.0 Routine general medical examination 10 (5) 4 (2)
V72.31 Routine gynecological examination 8 (4) 7 (4)
V76.2 Routine pap smear 6 (3) 5 (3)
625.x Pain/other symptoms associated with female genital organs 3 (1) 3 (2)
626.x Disorders of menstruation & other abnormal bleeding from 3 (1) 0

female genital tract
640-649 Complications related to pregnancy (incl. hemorrhage in early 4 (2) 1 (0.5)

pregnancy)
240-246 Disorders of thyroid gland 0 1 (0.5)
249 Secondary diabetes mellitus 0 0
250 Diabetes mellitus 0 1 (0.5)
278.00-01 Obesity, morbid obesity 3 (1) 1 (0.5)
303-304 Alcohol/drug dependence syndrome 0 0
401-405 Hypertensive disease 0 0
Restricted to women vaccinated before the reference date. Numbers in cells are frequency and (% of diagnoses).
The total number of unique diagnosis codes for cases and controls was 87 and 84, respectively.
Table options
4. Discussion
In the primary analysis of this observational investigation, we found a modest but statistically
significant association between SAB and IIV in the 28 days before the reference date. A post hoc
analysis revealed a significant association only among women who had received pH1N1-containing
vaccine in the previous influenza season. This effect modification was present in each season, but
confidence intervals were wide. The aORs among women who were not previously vaccinated with
pH1N1-containing vaccine approximated the null in nearly all risk windows.
Analyses with relatively small numbers of matched pairs may be more susceptible to chance
associations. However, we observed a similar relationship between the influenza vaccine and SAB in
each of the two years under study. In addition, we had previously conducted an investigation of SAB
and IIV during two pre-pandemic influenza seasons (200506 and 200607); the study design and
implementation were nearly identical to the current study [14]. The prior study did not find an
association in the 28-day exposure window (OR = 1.2, 95% CI 0.52.9) or any other exposure
window. The previous and current study populations are similar in most characteristics (Supplemental
Table 3), except that women in the current study were potentially infected with or vaccinated against
the pH1N1 virus, which is antigenically distinct from H1N1 viruses that circulated before 2009 [33].
Because influenza vaccination of pregnant women increased substantially during and after the
pandemic, another difference is that more women in the current study may have received an
influenza vaccine in prior years, whereas most vaccinated women in the first study probably were not
previously vaccinated [34].
Although SABs have been reported among pregnant women infected with the pH1N1 virus, studies of
pH1N1-containing vaccines have not found excess risks [8]; [9]; [10]; [11]; [12] ; [35]. One large
cohort study investigated pregnancy loss occurring after nine weeks of gestation and found that the
monovalent vaccine was associated with a significantly reduced risk of SAB [36]. Unmeasured
confounding was a concern because a comparable association was found outside the influenza
season. Pasternak, et al. conducted a cohort study of >50,000 pregnant women in 200910 and
found no association between SAB and adjuvanted monovalent pH1N1 vaccine [16]. A systematic
review of 19 studies evaluated fetal deaths and congenital malformations among women vaccinated
with influenza vaccine. Of the five studies that reported effect estimates for SAB, the hazard or odds
ratio associated with vaccination ranged from 0.45 to 1.23, with 95% confidence intervals that
included the null in each case [37]. A recent study of 102 spontaneous, pregnancy-specific reports of
adverse events following inactivated influenza vaccination submitted to the United States Vaccine
Adverse Events Reporting System (VAERS) during 20102016 found no unexpected pattern for any
fetal outcome, including SAB [38]. Another passive surveillance study in Taiwan in 200910 found no
association with the monovalent pH1N1 vaccine, although there was substantial under-ascertainment
of SAB cases due to incomplete reporting [39]. None of these studies found an association between
SAB and influenza vaccination, and accordingly, their investigations did not include an evaluation of
effect modification due to vaccination in previous seasons. Finally, one recent, retrospective
investigation examined women in the VSD who were exposed to the influenza vaccine during the first
trimester and assessed the risk of selected birth defects among live-born offspring [40]. Of the
426,000 women studied using electronic health data, the rate of birth defects among the nearly
53,000 vaccinated in the first trimester was nearly identical to the rate in unvaccinated women or
those vaccinated later in pregnancy. Overall, the weight of evidence in support of the safety of the
influenza vaccine in pregnant women found in the literature is substantial, particularly for women
vaccinated after the first trimester.
One possible explanation for these findings is that a second or boosting dose of pH1N1-containing
vaccine may confer risk in early pregnancy, but receipt of an initial or priming dose does not. While a
number of studies have shown potential relationships between vaccination and inflammation, and
inflammation and pregnancy loss, the biological basis for our observations has not been established.
One study followed pregnant and non-pregnant women who were vaccinated in 201112 with
pH1N1-containing vaccine and found significant increases (P < 0.001) in pro-inflammatory cytokines
soon after vaccination, although the increases were mild and transient [41]. Although over 40% of
participants had received an influenza vaccination in the previous year, inflammatory responses did
not vary by prior vaccination status. Another study found that pregnant women when compared to
non-pregnant women had an enhanced chemokine response to pH1N1 influenza virus both before
and especially after vaccination with IIV [42]. Others have shown that infection with pH1N1 virus or
vaccination with pH1N1-containing vaccine induces an expansion of T helper type 1 (Th1) cells,
which are considered to be pro-inflammatory [43] ; [44]. While some degree of inflammation appears
necessary for a successful pregnancy, excessive inflammation is associated with SAB and other
pregnancy complications [45]; [46] ; [47]. Other investigations have reported significant associations
between an increased Th1 response and miscarriage [48] ; [49].
The strengths of our investigation include the relatively large number of women with SAB (n = 485).
Cases and controls were closely matched on LMP to ensure nearly equal opportunities for
vaccination. Medical records were abstracted to collect information on potential confounders and to
confirm pregnancies and SABs. Finally, our data come from six geographically diverse healthcare
organizations, the combined membership of which represents 3% of the U.S. population [20].
This study has several important limitations. First, the most striking findings relate to the association
between SAB and IIV in women who previously received pH1N1-containing vaccine. This interaction
effect was not an a priori hypothesis; the results were generated in a post hoc analysis with small
numbers of women in the various subgroups. Although the interaction was observed in each of the
two seasons studied, the point estimates were substantially larger (though not statistically different) in
the first season for reasons that are unclear. Second, although most cases had an ultrasound,
assignment of a precise date of SAB was challenging. With guidance from an obstetrician we
integrated different types of information from the medical record (e.g., ultrasound results, clinical and
laboratory findings, provider notes) to estimate the timing of the SAB. Estimation of SAB dates was
independent of vaccination status so any error should bias the results toward the null (i.e., non-
differential misclassification). Third, we studied only women who had clinically confirmed SAB; the
proportion of women with clinically unrecognized pregnancy loss is uncertain but may be
substantial [50] ; [51]. Our results could be biased if women who sought care for SAB were more
likely to be vaccinated in the 28-day exposure window. However, an earlier study, similarly designed
and conducted in the same managed care population, showed no association [14]. Fourth, it is
possible that women with certain comorbidities or other risk factors for SAB were preferentially
vaccinated. While selected comorbidities were not associated with SAB in our study (e.g., asthma,
diabetes), information on other risk factors (e.g., autoimmune disease) was not ascertained [27]. In
addition, we attempted to determine if cases had greater opportunity for vaccination because they
sought care for symptoms foreshadowing an SAB diagnosis (i.e., protopathic bias). More cases than
controls (74 vs. 64, P = 0.39) had a diagnosis on the same date as the influenza vaccination,
although the difference was not statistically significant and only three had diagnoses consistent with
an impending SAB in the exposure window of interest. Nevertheless, protopathic bias cannot be ruled
out in our study. Fifth, vaccination status may have been misclassified if women received a vaccine
that was both outside of their health care system and not reported to their provider. However, we
would expect that subjects would have been queried and their vaccination status recorded given the
strong recommendations for vaccination of pregnant women during the study period. It is also
possible that women who were pregnant in the previous influenza season would be more likely to
have been vaccinated in the previous season. Although we did not collect information on inter-
pregnancy intervals, we would expect that the number of women pregnant in consecutive seasons
would be small [52]. Finally, while the odds ratio in a case-control study is generally considered an
estimate of the risk ratio, this is only true if the outcome is rare or controls were chosen using
incidence density sampling [53]. Since neither was the case in this study, the ORs should not be
interpreted as risk ratios.
This study found that the overall odds of vaccine exposure in the 28-day exposure window was
increased by a factor of two in women with SAB compared to controls. A secondary analysis
suggested that the odds among women who were also vaccinated in the previous year with pH1N1-
containing vaccine was almost 8-fold (and statistically significant), while the odds among women who
did not receive such a vaccine in the prior year was approximately null. It is important to note that this
study does not and cannot confirm a causal association, but the validity of the major findings is
supported by the effect modification across two influenza seasons and the observation of elevated
odds ratios in the 128 day exposure window only. More research is needed regarding the
immunologic effects of influenza vaccination during pregnancy. A follow-up study funded by CDC is
currently underway to evaluate the risk of SAB after repeated influenza vaccination during the 2012
13, 201314, and 201415 influenza seasons; results are expected by late 2018.
Acknowledgments
We are grateful to the following individuals for the help with this research: Deanna Cole, Tara
Johnson, Diane Kohnhorst, Madalyn Minervini, Suellyn Murray, Becky Pilsner, Carla Rottscheit,
Cathy Schneider, Sandy Strey (data acquisition/management, compensated, Marshfield Clinic
Research Institute); David McClure, PhD (scientific advice, compensated, Marshfield Clinic Research
Institute); Pat Ross, Cat Magallon, RN, CPC, Margarita Magallon, RHIT, CPC (data
acquisition/management, compensated, Kaiser Permanente Northern California); Donna Gleason and
Carmel Wax (data acquisition, compensated, Kaiser Permanente Northwest); Jennie Covey,
Lawrence Madziwa, and Patti Benson (data acquisition/management, compensated, Group Health
Research Institute); Lina Sy, Denison Ryan, Fernando Barreda, Nancy Canul Jauriga, Bianca
Cheung, Ana Espinosa Rydman, Theresa Im, Gina Lee, Jose Pio, Karen Schenk, Cheryl Mercado,
and Sungching Glenn (data acquisition/management, compensated, Kaiser Permanente Southern
California).
Acknowledgements
Potential conflicts of interests

Dr. Klein reports receiving research support from GlaxoSmithKline, Sanofi Pasteur, Pfizer, Merck,
MedImmune, Novartis, and Protein Science. Dr. Naleway reports receiving research support from
GlaxoSmithKline, MedImmune, and Pfizer. Ms. Irving reports receiving research support from
MedImmune. Dr. Jackson reports receiving research support from Novavax. Dr. Belongia, Mr. Kieke,
and Ms. King report receiving research support from MedImmune. All other authors report no
potential conflicts of interest.
Funding
This work was supported by a contract (200-2012-53587) from the Centers for Disease Control and
Prevention. CDC scientists participated in the design and conduct of the study, analysis and
interpretation of the data, and preparation, review, and approval of the manuscript for publication. The
findings and conclusions in this report are those of the authors and do not necessarily represent the
official position of Centers for Disease Control and Prevention.
Contributor statement
JGD had full access to all of the data in the study and takes responsibility for the integrity of the data
and the accuracy of the data analysis. The following authors made substantial contributions to the
study concept and design: JGD, BAK, JPK, FD, MAM, SAI, EW, EAB. BAK supervised the statistical
analysis and received contributions from JGD, JPK, and EAB. All authors were involved in the
acquisition, analysis, or interpretation of data. All authors were involved in the drafting of the
manuscript or making critical revisions of the manuscript for intellectual content. All authors approved
the final manuscript.
Appendix A. Supplementary material
Supplementary data 1.
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MAJOR REPORT: FLU VACCINE PROVEN TO

BE IN FACT AN ANTI FERTILITY VACCINE

MAJOR DOCUMENTED STUDY PROVES THE FLU VACCINE IS AN ANTI FERTILITY

FINAL OUTCOME: Normal miscarriage rates are 14 percent after pregnancy is

Abstract introductions Inactivated influenza vaccine is recommended in any stage of

Devastating Flu Vaccine-Miscarriage

Thursday, September 14th 2017 at 2:00 pm

J.B. Handley, Jr.

This article is copyrighted by GreenMedInfo LLC, 2017

The mainstream media is doing their best to minimize a

Among women who received pH1N1-containing vaccine in the previous influenza

The authors write:

Let the science speak

1. Influenza: marketing vaccine by marketing disease

In conclusion: we want the truth, we can handle it

Lena Sun of the Washington Post

Excerpts from article, bold added by me:

Internal Site Commenting is limited to members.

Association of spontaneous abortion with receipt of inactivated influenza

Get rights and content

2.5. Influenza vaccine exposure

2.6. Statistical analysis

Age in years at reference date 0.02

1824 87 (18) 68 (14)

2534 241 (50) 289 (60)

3544 157 (32) 128 (26)

Median (IQR) 31.8 (2737) 31.6 (2835) 0.02

<18.5 13 (3) 9 (2)

18.5 to <25 203 (42) 234 (48)

25 to <30 128 (27) 129 (27)

30 134 (28) 112 (23)

Median (IQR) 25.7 (2231) 24.9 (2230) 0.08

White 261 (55) 268 (57) 0.77

African American 42 (9) 20 (4) 0.008

Asian Indian 12 (3) 13 (3) 1.00

Chinese 8 (2) 18 (4) 0.06

Native American 6 (1) 4 (1) 0.75

Other 164 (35) 165 (35) 1.00

Parity (1) 277 (57) 273 (56) 0.79

Gravidity, median (IQR) 1 (03) 1 (02) 0.40

Multiple gestation pregnancy 5 (1) 7 (1) 0.77

1 138 (29) 125 (26) 0.32

2 43 (9) 26 (5) 0.03

Smoked during pregnancy 52 (11) 34 (7) 0.05

128 days before reference date 17 (17.0) 4 (3.1)

2956 days before reference date 5 (5.0) 5 (3.9)

>56 days before reference date 34 (34.0) 44 (34.6)

128 days before reference date 21 (5.5) 20 (5.6)

2956 days before reference date 12 (3.1) 11 (3.1)

>56 days before reference date 38 (10.0) 39 (11.0)

Type I/II diabetes 4 (1) 12 (2) 0.08

Asthma 55 (11) 56 (12) 0.92

Hypertension 11 (2) 16 (3) 0.44

Febrile illness in the 14 days before reference date 5 (1) 0 ---

Number of days with outpatient diagnoses, vaccinations, or 3 (26) 3 (16) 0.04

Discordant Adj. P Discordant Adj. P Discordant Adj. P

Time from vaccination to reference date

128 days 25 3.7 0.007 23 1.4 0.47 48 2.0 0.03

Discordant Adj. P Discordant Adj. P Discordant Adj. P

29 14 1.7 0.31 6 0.1 0.04 20 0.9 0.85

>56 days 51 1.0 0.99 46 0.9 0.72 97 0.9 0.67

No. of aOR No. of aOR No. of aOR

Yes All 14/4 7.7 3/4 1.2 34/40 1.4

No All 21/19 1.3 12/11 1.0 37/38 0.9