Exhaustive RAND Corporation review of vaccine side effects finds strong evidence that vaccines cause Guillain-Barre Syndrome, myalgia, seizures, meningitis, encephalitis and more

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A little-known vaccine safety review published by RAND Corporation in 2014 and labeled a “RAND External Publication” reveals that vaccines are almost certainly causing serious, permanent damage in some children. Titled Safety of Vaccines Used for Routine Immunization in the United States, the analysis was published in Evidence Report/Technology Assessment No. 215 (Prepared by Southern California/RAND Evidence-Based Practice Center, under Contract No. 290-2007-10062-1). AHRQ Publication No. 14-E002-EF. (Rockville, MD: Agency for Healthcare Research and Quality, July 2014), 740 p

See the executive summary of the analysis at this link. It is authored by Margaret Maglione, Courtney A. Gidengil, Lopamudra Das, Laura Raaen, Alexandria Smith, Ramya Chari, Sydne Newberry, Roberta M. Shanman, Tanja Perry, Matthew Bidwell Goetz.

As a starting point, the paper takes for granted the Institute of Medicine’s 2011 pro-vaccine paper titled, “Adverse Effects of Vaccines: Evidence and Causality.” The IOM, of course, has already been exposed for researchers having financial ties to the vaccine industry, bringing into question the IOM’s neutrality on the issue of vaccine safety.

Yet even when RAND accepts the IOM position as “trustworthy,” RAND’s own researchers independently find that vaccines cause serious, permanent side effects in some children.

This is even true when the RAND analysis excludes the most toxic vaccines that have been discontinued. As stated in the executive summary of the paper:

Studies using formulations never available or discontinued in the United States were excluded at full-text review (e.g., H5N1 vaccine, vaccines with the squalene adjuvant ASO3, and BCG vaccine against tuberculosis).

This means that vaccines which were found to be so damaging that they were pulled from the market are NOT included in the analysis below. Thus, the real story here is that vaccines have been causing a greater number of serious adverse events than even this RAND analysis admits.

Even more shockingly, the entire database of voluntarily reported vaccine adverse events was excluded from this analysis, meaning the conclusions vastly underestimate real-world vaccine side effects. As stated in the executive summary: (bold added)

Passive surveillance systems such as the U.S. Vaccine Adverse Event Reporting System are crucial in identifying signals regarding AEs postlicensure, but they are not designed to assess a statistical association so were excluded from this project.

Even when VAERS data were excluded and the most toxic vaccines were excluded because they were pulled from the market, the analysis still finds convincing evidence that links vaccines to a vast array of neurological and biological disorders. Keep in mind that this analysis also excludes any consideration of real-world vaccine catastrophes such as 75% of the children being hospitalized after routine vaccinations in a small town in Mexico.

HIGH evidence for febrile seizures, arthralgia, myalgia, GBS and more

According to the RAND analysis, Strength of Evidence (SOE) was determined to be HIGH for:

* MMR vaccine causing anaphylaxis and febrile seizures in children under age 5. From the analysis results table: Evidence “convincingly supports” causal relationships with febrile seizures and anaphylaxis. Evidence “convincingly supports” a causal relationship with measles inclusion body encephalitis in immunocompromised patients.

Evidence “favors acceptance” of a causal relationship between MMR and transient arthralgia.

* The flu shot causing arthralgia, myalgia, malaise, fever and pain at injection site. (Arthralgia is defined as “Sharp, severe pain, extending along a nerve or group of nerves, experienced in a joint and/or joints.”)

* The 2009 monovalent H1N1 vaccine causing Guillain-Barré syndrome (GBS), a severe nervous system disorder.

* Flu shots NOT causing cardiovascular events in the elderly.

* MMR vaccines NOT causing autism spectrum disorders, yet the abstract also admits the data are sketchy: “The vast majority of studies either did not investigate or could not identify risk factors for adverse events (AEs) associated with vaccination. Similarly, the severity of AEs was inconsistently reported, as was information that would make independent severity determination possible.”

* Chicken pox vaccines having “high” strength of evidence for causing pneumonia, meningitis and hepatitis in some individuals, along with “vaccine viral strain reactivation” leading to infections that cause meningitis or encephalitis in some immunocompromised individuals. From the results table published in the study:

High: Anaphylaxis; disseminated Oka VZV without other organ involvement; disseminated Oka VZV with subsequent infection resulting in pneumonia, meningitis, or hepatitis in individuals with demonstrated immunodeficiencies; vaccine strain viral reactivation without other organ involvement; vaccine strain viral reactivation with subsequent infection resulting in meningitis or encephalitis

* Evidence was also found to be of “moderate” strength linking influenza vaccines to febrile seizures. DTaP-IPV-Hib vaccinations were also linked with febrile seizures with a “moderate” association ranking.

Keep in mind that the entire pro-vaccine “fake science” media automatically labels anyone who claims vaccines cause any harm whatsoever to be “anti-science.” Yet the RAND analysis reaches the exact same conclusion as vaccine critics, even when swallowing the IOM’s report as a biased pro-vaccine starting point: It is irrefutable that vaccines cause serious harm in some children. Any person who denies that simple truth is not a scientist; they are a propagandist.

(It seems the entire media owes vaccine skeptics a serious apology.)

“Some vaccines are associated with serious adverse events…”

The conclusion of the analysis blows away the false narrative of the CDC and the “fake news” mainstream media, which ridiculously (and routinely) claims that vaccines never have side effects and harm no children whatsoever.

Even RAND, which admits it blindly accepts the Institute of Medicine’s biased pro-vaccine research as “trustworthy,” comes to the conclusion that vaccines cause “serious adverse events.” Not surprisingly, RAND argues that such events are “extremely rare” and are outweighed by the “protective benefits” of vaccines, but that’s not what the public has been told about vaccines. The BIG LIE everyone’s being told is that vaccines harm no one and only provide positive benefits. Thus, the very debate of being able to rationally weigh risks vs. potential benefits is silenced by the vaccine industry and all its obedient propagandists.

What America really needs is an honest, open debate about vaccine risks vs. potential vaccine benefits. We need to discuss vaccine quality control, immunization schedules, and most importantly vaccine ingredients such as mercury (Thimerosal), aluminum and inadvertent contaminants.

Until that debate can be honestly and openly held without the vaccine propagandists immediately proclaiming vaccine skeptics have no right to be heard because “the science is settled,” the vaccine industry has no claim to be based on scientific reality at all. As run today, it is nothing but a “vaccine cult” built on circular logic and hucksterism, not evidence and rationality. Thus, the very idea that vaccine policy is rooted in “science” doesn’t pass even the most basic tests for scientific integrity.

Harmful medical interventions must not be mandated in a free society

Furthermore, the pushing of mandatory vaccination policies (such as California’s SB 277) when vaccines irrefutably cause serious, permanent harm to some children reveals the gross violation of medical ethics and human rights found in the twisted demands of the vaccine propagandists. To mandate a medical intervention that knowingly causes serious damage to some children is to condemn those children to a life of suffering and pain. It is the greatest expression of the coercive force of the medical police state which enforces a genuine “medical tyranny” over the population while simultaneously lying to the public about the risks associated with compliance.

No medical intervention can be ethically mandated when the risk of harm is greater than zero. There is no question whatsoever that vaccines present a greater-than-zero risk of serious, permanent harm to children. The continued requirement that parents expose their children to risky, harmful vaccine interventions — enforced by the coercion of the State — echoes the gross medical ethics violations of the Third Reich’s eugenics science which pushed mandatory euthanasia and sterilization, all enforced essentially at gunpoint.

SB 277 must be repealed, and vaccine choice rights must be reestablished for parents across America.

Stay informed on the ethics and medical science revelations about immunizations at Vaccines.news and Medicine.news.

See the original RAND Corporation research paper at:

http://www.rand.org/pubs/external_publications/EP50517.html

Here’s a compressed version of Table D from the report, which describes the summary of the associations found:

Table D. Summary: safety of vaccines used for routine immunization of adults (including pregnant women) and children

Vaccine	EPC Conclusions and Strength of Evidence	IOM Findings	Additional Findings From EPC
ADEM = acute disseminated encephalomyelitis; AE = adverse event; CI = confidence interval; CIDP = chronic inflammatory demyelinating polyneuropathy; DTaP = diphtheria, tetanus, and pertussis vaccine; EPC = Evidence-based Practice Center; GBS = Guillain-Barré syndrome; Hep B = hepatitis B; Hib = Haemophilus influenzae type B; HPV = human papillomavirus; IgE = immunoglobulin E; IOM = Institute of Medicine; LAIV = live attenuated influenza vaccine; MMR = measles, mumps, rubella vaccine; MS = multiple sclerosis; SIDS = sudden infant death syndrome; SLE = systemic lupus erythematosus; Td = tetanus-diphtheria; TIV = trivalent influenza vaccine; IPV = inactivated polio vaccine; IRR = incidence rate ratio; MCV = meningococcal conjugate vaccine; MPSV = meningococcal polysaccharide vaccine; PCV = pneumococcal conjugate vaccine; RR = relative risk; Tdap = tetanus, diphtheria, and acellular pertussis vaccine; VZV = varicella-zoster virus.
Diphtheria Toxoid, Tetanus Toxoid, and Acellular Pertussis Vaccines (Td, Tdap)	High: Anaphylaxis	Evidence “convincingly supports” a causal relationship between the tetanus toxoid vaccine and anaphylaxis.	We identified 2 additional trials in adults. No AEs were associated with vaccine.
Hepatitis A Vaccine	Insufficient: Acute disseminated encephalomyelitis, transverse myelitis, MS, GBS, chronic inflammatory demyelinating polyneuropathy, Bell’s palsy, anaphylaxis, and autoimmune hepatitis	Evidence is “inadequate to accept or reject” any causal relationships with AEs the committee was tasked with investigating: acute disseminated encephalomyelitis, transverse myelitis, MS, GBS, chronic inflammatory demyelinating polyneuropathy, Bell’s palsy, anaphylaxis, and autoimmune hepatitis.	We identified 1 additional postlicensure study; there was no association of the vaccine with any AEs or onset of medical conditions.
Hepatitis B Vaccine	Insufficient: Optic neuritis, first demyelinating event, GBS, SLE, onset or exacerbation of vasculitis, polyarteritis nodosa, and onset or exacerbation of rheumatoid arthritis Moderate: No association with MS onset or exacerbation Moderate: Anaphylaxis in patients allergic to yeast	Although no epidemiological studies were identified on anaphylaxis, mechanistic evidence “favors acceptance” of a causal relationship between the vaccine and anaphylaxis in yeast-sensitive individuals. Epidemiological studies of the following AEs in adults had evidence “inadequate to accept or reject” a causal relationship: optic neuritis, first demyelinating event, GBS, SLE, onset or exacerbation of vasculitis, polyarteritis nodosa, and onset or exacerbation of rheumatoid arthritis. A 2002 IOM review on Hep B vaccine and demyelinating neurological disorders concluded that the evidence “favors rejection” of a causal relationship with incident MS or MS relapse. No epidemiological studies of the following AEs in adults were found and evidence is also “inadequate to accept or reject” a causal relationship: encephalitis, encephalopathy, ADEM, transverse myelitis, neuromyelitis optica, chronic inflammatory demyelinating polyneuropathy, brachial neuritis, erythema nodosum, onset or exacerbation of psoriatic arthritis, onset or exacerbation of reactive arthritis, and fibromyalgia.	No additional studies met our inclusion criteria.
Influenza Vaccines	High: Arthralgia, myalgia, malaise, fever, pain at injection site. Anaphylaxis in allergic persons. High: 2009 monovalent H1N1 vaccine with GBS High: No association with cardiovascular events in the elderly Insufficient: MS onset and exacerbation	Two forms of influenza vaccine were studied: live attenuated form, administered intranasally (LAIV), and inactivated form (TIV), administered intramuscularly. Evidence “convincingly supports” a causal relationship between influenza vaccines and anaphylaxis in people allergic to egg or gelatin. However, in recent years, manufacturers have reduced the egg protein content.	Many clinical trials reported that influenza vaccines are associated with arthralgia, myalgia, malaise, fever, and pain in the short term in adults. These AEs were not considered serious; severity was graded mild to moderate. Odds of experiencing these events were 1.5 to 2 times higher in vaccinated patients than in unvaccinated people. Risk factors were not discussed in the trials. A high-quality meta-analysis found an association between 2009 monovalent H1N1 vaccine and GBS in the 42 days postvaccination; results translate to about 1.6 excess cases per million vaccinated. Postlicensure studies have found inconsistent evidence associating influenza vaccines with onset or exacerbation of MS in adults. Postlicensure studies have found influenza vaccines are NOT associated with increased risk of cardiovascular or cerebrovascular events in the elderly. Postlicensure studies have shown that influenza vaccines are NOT associated with increased risk of serious AEs in renal patients.
MMR Vaccine	Moderate: No association with Type 1 diabetes Moderate: Transient arthralgia in women Insufficient: MS onset, GBS, chronic arthralgia in women, and chronic arthritis and arthropathy in men	Evidence “favors acceptance” of a causal relationship with transient arthralgia in women. Evidence is “inadequate to accept or reject” a causal relationship with MS onset, GBS, chronic arthralgia in women, and chronic arthritis and arthropathy in men.	MMR was NOT associated with onset of type 1 diabetes in adults in 1 large high-quality epidemiological study: RR=0.71 (95% CI, 0.61 to 0.83).
Pneumococcal Polysaccharide Vaccine	High: No association with cardiovascular or cerebrovascular events in the elderly	Not covered.	We found no placebo-controlled trials of the current formulation that reported AE data. (We found trials of the current formulation that reported pneumonia or mortality; these were considered efficacy outcomes.) Postlicensure studies of pneumococcal polysaccharide vaccine found vaccination was not associated with increased risk of cardiovascular events in older adults.
Zoster Vaccine	Moderate: Injection site reactions, allergic reactions, cellulitis possibly related to allergy	Recommended for U.S. adults 60 years and older; AEs specific to this age group were not covered.	In some reports of clinical trials, AEs were reported only in categories such as “injection-related adverse events,” “systematic adverse events,” or “serious adverse events.” Vaccination was associated with injection site reactions. In postlicensure studies, vaccination was associated with cellulitis possibly related to allergy and allergic reactions such as redness and swelling 1 to 7 days postvaccination. These mild AEs occurred in less than 1% of patients and were more likely in the younger (aged 50-59) vaccinees.
Diphtheria Toxoid, Tetanus Toxoid, and Acellular Pertussis-Containing Vaccines (DTap, Td, Tdap)	Moderate: No association with type 1 diabetes Insufficient: Infantile spasms, seizures, cerebellar ataxia, autism, ADEM, transverse myelitis, MS relapse, serum sickness, immune thrombocytopenic purpura, and SIDS	Evidence “favors rejection” of a causal relationship between vaccines containing diphtheria toxoid, tetanus toxoid, and acellular pertussis antigens and type 1 diabetes. Evidence is “inadequate to accept or reject” causal relationships between vaccination and the following: infantile spasms, seizures, cerebellar ataxia, autism, ADEM, transverse myelitis, MS relapse in children, serum sickness, immune thrombocytopenic purpura, and SIDS.	We found no additional studies that met our inclusion criteria.
Hepatitis B Vaccine	Insufficient: Food allergy Moderate: No association with MS	Although no epidemiological studies were identified by the IOM, mechanistic evidence “favored acceptance” of a causal relationship between the vaccine and anaphylaxis in yeast-sensitive individuals. The IOM found evidence “inadequate to accept or reject” a causal relationship with any other AEs. A 2002 IOM report “favors rejection” of a causal relationship with MS onset or exacerbation.	Hep B vaccine in the first 6 months of life was associated with elevated total IgE in a postlicensure study of children with a family history of food allergy, but not with clinical allergy.
Hib Vaccine	Moderate: No association with serious AEs in short term	Not covered.	No serious AEs were associated in 3 high-quality clinical trials.
HPV Vaccine	Moderate: No association with juvenile rheumatoid arthritis, type 1 diabetes, appendicitis, GBS, seizures, stroke, syncope, venous thromboembolism Moderate: Anaphylaxis in persons with allergies, fever, headache, mild gastrointestinal AEs, skin infection High: Pain at injection site Insufficient: ADEM, transverse myelitis, neuromyelitis optica, MS, onset of Hashimoto’s disease, chronic inflammatory demyelinating polyneuropathy, brachial neuritis, amyotrophic lateral sclerosis, transient arthralgia, pancreatitis, thromboembolic events, spontaneous abortion, and hypercoagulable states	Evidence “favors acceptance” of a causal relationship between the HPV vaccine and anaphylaxis. Evidence is “inadequate to accept or reject” causal relationships between HPV vaccines and the following: ADEM, transverse myelitis, neuromyelitis optica, MS, GBS, chronic inflammatory demyelinating polyneuropathy, brachial neuritis, amyotrophic lateral sclerosis, transient arthralgia, pancreatitis, thromboembolic events, and hypercoagulable states.	A large postlicensure study found HPV vaccine was not associated with onset of juvenile rheumatoid arthritis or type 1 diabetes. This study reported an IRR of 1.29 (95% CI, 1.08 to 1.56) of onset of Hashimoto’s disease. However, investigation of a temporal relationship and biological plausibility revealed no consistent evidence of a safety signal. A large postlicensure study found HPV vaccine was NOT associated with GBS, seizures, stroke, syncope, or venous thromboembolism. Several clinical trials found HPV vaccination associated with short-term severe pain at injection site. Trials also found vaccine associated with fever, headache, nausea, and stomach ache. A secondary analysis including only Black women who became pregnant within 3 to 4 years of receiving HPV vaccine in 2 trials reported a higher rate of spontaneous abortion in vaccinated subjects.
Inactivated Polio Vaccine	Insufficient: Food allergy	Not covered.	One postlicensure study reported association between polio vaccine in newborns and sensitivity to food allergens.
Influenza Vaccines	Moderate: Mild gastrointestinal disorders, febrile seizures Low: No association with any serious AEs in the short term in children with cancer or who have received organ transplants Low: Influenza-like symptoms Insufficient: Asthma exacerbation (with live vaccine), ADEM, transverse myelitis	The IOM committee studied seasonal influenza vaccines. The influenza vaccine is administered in 2 forms: a live attenuated form, administered intranasally, and an inactivated form, administered intramuscularly. Evidence was “inadequate to accept or reject” a causal relationship in the pediatric population between seasonal influenza vaccines and the following: seizures, ADEM, and transverse myelitis. Evidence was “inadequate to accept or reject” a causal relationship between LAIV and asthma exacerbation or reactive airway disease episodes.	In postlicensure studies, seasonal influenza vaccines were NOT associated with any serious adverse events in the short term in children with malignancy, inflammatory bowel disease, or urea cycle disorders, or children who had received organ transplants. Both seasonal influenza vaccines and monovalent H1N1 vaccine were associated with mild gastrointestinal disorders, such as vomiting and diarrhea, in children in the short term in several large postlicensure studies. One large study found that younger vaccinated children (aged 5 to 8 years) were more likely to experience these symptoms than older vaccinated children (aged 9 to 17 years). (Children under 5 years of age were not included in that study). Both live and inactivated seasonal influenza vaccines were associated with influenza-like symptoms in children in the short term in multiple studies, while not associated in others. A large U.S. postlicensure study of children under age 5 years found TIV associated with febrile seizures. Risk was increased if PCV13 was administered concomitantly.
MMR Vaccine	High: No association with autism spectrum disorders High: Anaphylaxis in children with allergies, febrile seizures Moderate: Transient arthralgia Moderate: Thrombocytopenic purpura Insufficient: Encephalitis, encephalopathy, afebrile seizures, meningitis, cerebellar ataxia, acute disseminated encephalomyelitis, transverse myelitis, optic neuritis, neuromyelitis optica, MS onset, and chronic arthropathy	Evidence “convincingly supports” causal relationships with febrile seizures and anaphylaxis. Evidence “convincingly supports” a causal relationship with measles inclusion body encephalitis in immunocompromised patients. Evidence “favors acceptance” of a causal relationship between MMR and transient arthralgia Evidence “favors rejection” of a causal relationship between MMR and autism. Evidence is “inadequate to accept or reject” a causal relationship with encephalitis, encephalopathy, afebrile seizures, cerebellar ataxia, acute disseminated encephalomyelitis, transverse myelitis, optic neuritis, neuromyelitis optica, MS onset, and chronic arthropathy.	Four additional postmarketing studies were identified. Vaccination was associated with thrombocytopenic purpura in the short term. MMR vaccination was associated with increased emergency department visits within 2 weeks; this is indirect support of the IOM’s findings that MMR vaccine is associated with febrile seizures.
Meningococcal Vaccines (MCV4, MPSV)	Moderate: Anaphylaxis in children with allergies Insufficient: Encephalitis, encephalopathy, ADEM, transverse myelitis, MS, GBS, CIDP, chronic headache	Evidence “convincingly supports” a causal relationship with anaphylaxis in children who may be allergic to ingredients. Evidence is “inadequate to accept or reject” causal relationships between meningococcal vaccine (unspecified) and the following: encephalitis, encephalopathy, ADEM, transverse myelitis, MS, GBS, CIDP, and chronic headache.	Two new trials of quadrivalent meningococcal conjugate vaccines found no association with any AEs assessed.
Miscellaneous and Combination Vaccines	Moderate: DTaP-IPV-Hib vaccination with febrile seizures High: No association of childhood leukemia with MMR, DTaP, Td, Hib, Hep B, and polio vaccines Moderate: Hepatitis A, MMR, and varicella vaccine with purpura	Not covered.	Association of DTaP-IPV-Hib vaccination with febrile seizures in children was found in a very large high-quality postlicensure study. Rate for first dose was estimated as 5.5 cases per 100,000 person/days. Rate for second dose was estimated as 5.7 cases per 100,000 person/days. Multiple large epidemiological studies have assessed MMR, DTaP, Td, Hib, Hep B, and polio vaccine and have found no association with childhood leukemia. In a large postlicensure study of over 1.8 million vaccine recipients, purpura was associated with vaccination against hepatitis A in children aged 7 to 17 years, vaccination against varicella in children aged 11 to 17, and MMR in children from 12 to 19 months of age. These results were based on 1 or 2 cases per vaccine type/age group. According to the authors most cases were mild and acute.
Pneumococcal Conjugate (PCV13)	Moderate: Febrile seizures	Not covered.	A recent study using the U.S. Vaccine Safety Datalink (VSD) found an association with febrile seizures. Estimated rate for 16-month-old patients is 13.7 cases per 100,000 doses for PCV13 without concomitant TIV and 44.9 per 100,000 doses for concomitant TIV and PCV13.
Rotavirus Vaccines: RotaTeq and Rotarix	Moderate: Intussusception	Not covered.	In clinical trials, there was no association between either of the 2 currently available vaccines (RotaTeq and Rotarix) and any serious AEs, including intussusception, in the long or short term. A high-quality epidemiological study in Australia found RotaTeq was associated with intussusception 1 to 21 days following the first of 3 required doses in infants 1 to 3 months of age. Two case-control studies conducted in Latin America found an association of Rotarix with intussusception in children following the first of 2 required doses. Although 1 U.S. epidemiological study found no association, a recent analysis of the U.S. Post-Licensure Rapid Immunization Safety Monitoring (PRISM) program found both RotaTeq and Rotarix associated with intussusception in the short term. Estimated rate was 1.1 to 1.5 cases per 100,000 doses of RotaTeq and 5.1 cases per 100,000 doses of Rotarix.
Varicella Vaccine	High: Anaphylaxis; disseminated Oka VZV without other organ involvement; disseminated Oka VZV with subsequent infection resulting in pneumonia, meningitis, or hepatitis in individuals with demonstrated immunodeficiencies; vaccine strain viral reactivation without other organ involvement; vaccine strain viral reactivation with subsequent infection resulting in meningitis or encephalitis Insufficient: Seizures, ADEM, transverse myelitis, GBS, small fiber neuropathy, onset or exacerbation of arthropathy, thrombocytopenia	Evidence “convincingly supports” causal relationships between varicella virus vaccine and the following: disseminated Oka VZV without other organ involvement; disseminated Oka VZV with subsequent infection resulting in pneumonia, meningitis, or hepatitis in individuals with demonstrated immunodeficiencies; vaccine strain viral reactivation without other organ involvement; vaccine strain viral reactivation with subsequent infection resulting in meningitis or encephalitis; and anaphylaxis. The evidence is “inadequate to accept or reject” a causal relationship between the vaccine and seizures, ADEM, transverse myelitis, GBS, small fiber neuropathy, onset or exacerbation of arthropathy, and thrombocytopenia.	We identified 1 small trial in children with SLE; the trial reported no association with AEs.
Influenza Vaccines	Moderate: No association with serious adverse events	Results not specific to pregnant women.	Both monovalent H1N1 vaccine and seasonal influenza vaccine (inactivated) containing H1N1 strains were not associated with serious adverse events in pregnant women or their offspring in multiple trials and postlicensure studies. Studies report an association with lower risk of adverse pregnancy outcomes.