The list of vaccine side effects and injuries is long. Review each package insert to see what can happen…anything from a sore arm to a seizure to death. The Tenpenny Research Library is continually growing with the types of vaccine side effects.
July 21, 2020 – Facial Paralysis Following Influenza Vaccination: A Disproportionality Analysis Using the Vaccine Adverse Event Reporting System Database “Two hundred fifty cases of facial paralysis following influenza vaccination were reported during the study period. The median age of the patients was 45 (interquartile range, 30–57) years; 132 (52.8%) patients were females. The majority of the patients received the injected trivalent or quadrivalent seasonal influenza vaccine by intramuscular route.”
May 27, 2020 – Analysis of health outcomes in vaccinated and unvaccinated children: Developmental delays, asthma, ear infections and gastrointestinal disorders (full text) “In this study, which only allowed for the calculation of unadjusted observational associations, higher ORs were observed within the vaccinated versus unvaccinated group for developmental delays, asthma and ear infections. Further study is necessary to understand the full spectrum of health effects associated with childhood vaccination.”
March 30, 2020 – Fatal outcomes following immunization errors as reported to the EudraVigilance: A case series “Serious adverse reactions after immunization are rare but do occur. In very rare instances, cases with fatal outcome have been reported. These reports can have a huge impact and even more so when due to an immunization error. The aim of this study is to systematically review immunization errors with fatal outcomes in EudraVigilance. … In this study, we showed that fatal outcomes following immunization errors are very rare. Four key issues were the importance of: (1) quality control of multi-dose vaccines, (2) screening patients for immunocompromising factors, (3) education on the importance of adherence, and (4) measures to improve distinction between vaccines and medicines.”
March 30, 2020 – Subcutaneous nodules following immunization in children; in Victoria, Australia from 2007 to 2016 “71% (41/58 reported cases) were consistent with the BCCD for subcutaneous nodule, 14% (8 cases) were ‘possible subcutaneous nodules’, 10% (6 cases) were nodules associated with BCG immunization and 5% (3 cases) were attributable to an alternative diagnosis. The median age at immunization was 12 months, (range 1 month–12 years); 54% male (22/41 cases). 17% (7 cases) had multiple nodules. Nodules were associated with immunizations containing aluminum (74%, 36/49 nodules), no aluminum (8%, 4 nodules) and unknown (18%, 9 nodules).”
January 8, 2018 – Building capacity for active surveillance of vaccine adverse events in the Americas: A hospital-based multi-country network “The study evaluated the associations between measles-mumps-rubella vaccines and two well-recognized adverse events: Immune thrombocytopenic purpura (ITP) and aseptic meningitis. The regional network contributed 63 confirmed ITP and 16 confirmed aseptic meningitis eligible cases to the global study, representing, respectively, 33% and 19% of the total cases. To ensure long-term sustainability and usefulness to investigate adverse events following new vaccine introductions in low and middle-income countries, the network needs to be strengthened with additional sites and integrated into national health systems.”
January 8, 2018 – Enhancing global vaccine pharmacovigilance: Proof-of-concept study on aseptic meningitis and immune thrombocytopenic purpura following measles-mumps containing vaccination “The World Health Organization (WHO) selected 26 sentinel sites (49 hospitals) distributed in 16 countries of the six WHO regions. Incidence rate ratios (IRR) of 5.0 (95% CI: 2.5–9.7) for ITP following first dose of measles-containing vaccinations, and of 10.9 (95% CI: 4.2–27.8) for AM following mumps-containing vaccinations were found. The strain-specific analyses showed significantly elevated ITP risk for measles vaccines containing Schwarz (IRR: 20.7; 95% CI: 2.7–157.6), Edmonston-Zagreb (IRR: 11.1; 95% CI: 1.4–90.3), and Enders’Edmonston (IRR: 8.5; 95% CI: 1.9–38.1) strains. A significantly elevated AM risk for vaccines containing the Leningrad-Zagreb mumps strain (IRR: 10.8; 95% CI: 1.3–87.4) was also found.”
January 4, 2018 – Anxiety-related adverse events following immunization (AEFI): A systematic review of published clusters of illness “Of 1472 abstracts reviewed, we identified eight published clusters, from all six World Health Organization (WHO) regions except the African Region. Seven clusters occurred among children in school settings, and one was among adult military reservists. The size and nature of these clusters ranged from 7 patients in one school to 806 patients in multiple schools. Patients’ symptoms included dizziness, headache, and fainting with rapid onset after vaccination. Implicated vaccines included tetanus (2), tetanus-diphtheria (1), hepatitis B (1), oral cholera (1), human papillomavirus (1), and influenza A (H1N1)pdm09 (2). In each report, all affected individuals recovered rapidly; however, vaccination program disruption was noted in some instances, sometimes for up to one year.”
December 18, 2017 – Non-specific effects of childhood vaccinations – A case control study nested into a Health and Demographic Surveillance System in rural Burkina Faso “Overall, there was no statistically significant association between vaccine status and mortality. However, among children in the age group 2–8 months, there was a consistent sex-differential pattern for all doses of oral polio vaccine combined with pentavalent vaccine (OPV + Penta), with the vaccines being associated with lower mortality in boys, but not in girls.
December 4, 2017 – Patterns of childhood immunization and all-cause mortality “Among 312,388 children in the study, 199,661 (64%) were vaccinated according to the schedule, and 112,727 (36%) were delayed or not vaccinated for at least one vaccine dose. … We identified 91 deaths. We excluded 67 deaths due to either injuries or congenital anomalies, and 6 deaths in children who had diseases with onset prior to 19 months of age that were related to the death. As a result, 18 deaths were eligible for our primary analysis. Of those, 11 occurred in children following the recommended schedule(2.28 per 100,000 person-years), and 7 occurred in undervaccinated children (2.57 per 100,000 person-years). Table 2 shows the mortality rates by vaccination pattern. There were 3 deaths due to respiratory causes, 1 death due to diseases of the nervous system, 2 deaths due to malignancies, 3 deaths due to infectious diseases, and 9 deaths with an unknown cause of death. The deaths due to infectious diseases had causes that were not preventable by routinely recommended vaccines.”
December 4, 2017 – European Court of Justice ruling on vaccine liability and its implications for the United States “On June 21, 2017, the European Court of Justice (“ECJ”) held that, in the absence of scientific consensus as to whether a vaccine is linked to a particular injury, member state courts may permit plaintiffs to introduce circumstantial evidence prov … Although the U.S. Court isn’t bound by the findings of the ECJ ruling, the decision can affect U.S. public confidence in immunization, which is critical to sustaining vaccination coverage rates preventing outbreaks of vaccine-preventable diseases. In an era of vaccine hesitancy, the media may easily misinterpret such a complex ruling. For instance, some press headlines seem to denote the ruling as an anti-vaccine triumph that no science is needed to blame vaccines for illness in Europe. Misleading information surrounding this decision could fuel the anti-vaccine movement and public suspicion of immunizations. And, in the unlikely event if EU courts apply this precedent erroneously in concluding that certain vaccines are defective basked upon circumstantial evidence, this could have eroded vaccine confidence in the U.S. and potentially driven up spurious vaccination claims in the U.S. in the hope that favorable decisions against vaccine manufacturers in Europe would find their way into the U.S. proceedings.”
September 5, 2017 – Infanrix hexa and sudden death: a review of the periodic safety update reports submitted to the European Medicines Agency (full text) “In its periodic safety update reports, GSK, the company manufacturing Infanrix hexa, evaluates whether the number of sudden deaths reported after vaccination with their product exceeded the number that could be expected by chance. The clustering of deaths soon after immunisation suggests that the deaths could have been caused by the vaccine. Furthermore, our analysis shows that the deaths acknowledged in the PSUR 16 have been deleted from the PSUR 19. The observed deaths are spontaneously reported to GSK and are likely to be underestimated. Adding in the deaths deleted from the PSUR 16, there is a statistically significant increased risk of death in the first four days after vaccination, compared to the expected deaths. The manufacturers will need to explain why these deaths were not included in the PSUR 19. The increased risk of death was not communicated to the regulatory authorities or to the health personnel administering this vaccine. Given the above, it is difficult to understand how the EMA accepted the PSUR 19 at face value. It may be argued that due diligence was not exercised, as a result of which numerous children were unnecessarily exposed to the risk of death. The DCGI must be made aware of these infirmities in the PSUR on Infanrix hexa.
September 5, 2017 – Risk of bursitis and other injuries and dysfunctions of the shoulder following vaccinations “Subdeltoid or subacromial bursitis and other shoulder lesions may be more common than suspected. Such lesions predominantly affect women. The cause may be related to antigens or adjuvants contained in the vaccines that would trigger an immune or inflammatory response. However, they are more likely to be the consequence of a poor injection technique (site, angle, needle size, and failure to take into account patient’s characteristics, i. e., sex, body weight, and physical constitution). Therefore, vaccination-related shoulder injuries would be amenable to prevention. Comment: It’s not the vaccine.
September 1, 2017 – One needle, one syringe, only one time? A survey of physician and nurse knowledge, attitudes, and practices around injection safety “Unsafe injection practices were reported by both physicians and nurses across all surveyed physician specialties and nurse practice locations. Twelve percent (12.4%) of physicians and 3% of nurses indicated reuse of syringes for >1 patient occurs in their workplace; nearly 5% of physicians indicated this practice usually or always occurs. A higher proportion of oncologists reported unsafe practices occurring in their workplace.”
September 1, 2017 – Risk of Nontargeted Infectious Disease Hospitalizations Among US Children Following Inactivated and Live Vaccines, 2005–2014“311663 children were included. In adjusted analyses, risk of hospitalization for NTI from ages 16 through 24 months was reduced for those who received live vaccine alone compared with inactivated alone or concurrent live and inactivated vaccines (HR, 0.50; 95% confidence interval [CI], 0.43, 0.57 and HR, 0.78; 95% CI, 0.67, 0.91, respectively) and for those who received live and inactivated vaccines concurrently compared with inactivated-only (HR, 0.64; 95% CI, 0.58, 0.70). Conclusions We found lower risk of NTI disease hospitalizations from age 16 through 24 months among children whose last vaccine received was live compared with inactivated vaccine, as well as concurrent receipt compared with inactivated vaccine.
September 2017 – Elevated Immune Response Among Children 4 Years of Age With Pronounced Local Adverse Events After the Fifth Diphtheria, Tetanus, Acellular Pertussis Vaccination (full text) “In summary, it was previously suggested that the AEs after the DTaP preschool booster vaccination were most likely due to the repeated administration of the aP vaccine antigens, because the increase in AEs was mainly seen after introduction of aP combination vaccines in the primary vaccination schedule. We now demonstrated high immune responses in children with pronounced AEs not only to the pertussis vaccine antigens but also to diphtheria and tetanus, and Th2 skewing for all antigens in all participants. The variation in the individual immune responses of children with an AE indicates that these events are associated with an accumulation of high Th2-skewed responses in combination with an additional biologic factor. This needs to be evaluated in further studies. On the long run, new DTaP vaccines that would elicit a more Th1-skewed response might reduce the risk of these rare local, but pronounced, reactions.”
August 23, 2017 – Adverse events following immunization with pentavalent vaccine: experiences of newly introduced vaccine in Iran “This study was a mixed cohort study that included 1119 children less than 1 year of age. In 2015, the children were referred to Hamadan health centers to receive pentavalent vaccine at 2, 4 and 6 months of age. … The cumulative incidence rate of pentavalent-related adverse events during 48 h following immunization was estimated to be 15.8% for swelling, 10.9% for redness, 44.2% for pain, 12.6% for mild fever, 0.1% for high fever, 20.0% for drowsiness, 15.0% for loss of appetite, 32.9% for irritability, 4.6% for vomiting and 5.5% for persistent crying. There is no evidence for the occurrence of convulsion and encephalopathy among children who receive pentavalent vaccines. Conclusion Further large studies with long time follow up are required to address rare events include convulsions, encephalopathy or persistent crying. However, Findings urge immunization programs to use pentavalent vaccinations and to continue implementing the current immunization program in children under 1 year of age.
August 2017 – Research Priorities in Sudden Unexpected Infant Death: An International Consensus “Despite the success of safe sleep campaignsand the progress in understanding risk factors, the rate of reduction in the cases of sudden infant death syndrome has now slowed and it remains a leading cause of postneonatal mortality in many developed countries. Strategic action is needed to tackle this problem and it is now vital to identify how the sudden infant death research community may best target its efforts. Comment: Oh my, could it be the developed countries give more combination vaccines?
August 2017 – A New Approach to the Investigation of Sudden Unexpected Death “Achievements in research and new approaches in medical care have created possibilities for understanding unapparent biological vulnerabilities in a small child that may become lethal.”
July 25, 2017 – Safety and immunogenicity of a mRNA rabies vaccine in healthy adults: an open-label, non-randomised, prospective, first-in-human phase 1 clinical trial “reported solicited injection site reactions, and 50 (78%) of 64 intradermally vaccinated participants and 29 (78%) of 37 intramuscularly vaccinated participants reported solicited systemic adverse events, including ten grade 3 events. One unexpected, possibly related, serious adverse reaction that occurred 7 days after a 640 μg intramuscular dose resolved without sequelae.” … “This first-ever demonstration in human beings shows that a prophylactic mRNA-based candidate vaccine can induce boostable functional antibodies against a viral antigen when administered with a needle-free device, although not when injected by a needle-syringe. The vaccine was generally safe with a reasonable tolerability profile.”
July 4, 2017 – Deaths following pentavalent vaccine and the revised AEFI classification (full text) “Given that a causal association between AEFI and vaccination is usually difficult to prove, the purposes of the precautionary principle and scientific enquiry are best served if one acknowledges, where appropriate, that the association of death with vaccine is “probable” or “possible” although it is difficult to be “certain”. Also in the new scheme of evaluating AEFI there is no transparent mechanism to decide when reactions labelled as (B) “Indeterminate” will be evaluated as a new signal. These ambiguities erode confidence in the scheme’s ability to evaluate rare adverse events and act decisively to protect children.
July 1, 2017 – Determining the Best Strategies for Maternally Targeted Pertussis Vaccination Using an Individual-Based Model “For firstborn infants aged less than 2 months, antenatal immunization reduced annual pertussis incidence by 60%, from 780 per 100,000 firstborn children under age 2 months (interquartile range (IQR), 682–862) to 315 per 100,000 (IQR, 260–370), while postnatal vaccination produced a minimal reduction, with an incidence of 728 per 100,000 (IQR, 628–789).” Comment: Simulated statistics of saving cases of pertussis are not accurate. Australia should be more concerned about SIDS deaths in the country.
July 2017 – Measles Outbreak with Unique Virus Genotyping, Ontario, Canada, 2015 (full text) “TPH investigated an additional 140 suspected measles cases during the outbreak period. Clinical presentations of patients with suspected infection were compared with the provincial case definition, and clinical samples were collected from these patients to confirm or rule out measles. Patients were provided with health education and asked to temporarily self-isolate from group settings. In a break from usual policy, persons living in Toronto who were recently vaccinated before onset of a measles-like rash and suspected of having an adverse event after immunization were investigated by genotyping to rule out the possibility of an actual measles infection, given that measles might be circulating in parts of the community. … “Among the 8 PCR-positive patients with measles vaccine strain, 6 were IgM positive, 1 was IgM indeterminate, and 1 was IgM negative. Excluding the 7 IgM-reactive specimens in persons documented to have been shedding vaccine strain, most (28/40 [70%]) of IgM-reactive specimens reported did not represent measles infection.”
July 2017 – Vaccinations and risk of systemic lupus erythematosus and rheumatoid arthritis: A systematic review and meta-analysis. “This study suggests that vaccinations are related to increased risks of SLE and RA. More and larger observational studies are needed to further verify the findings above and to assess the associations of vaccinations with other rheumatic diseases.”
June 24, 2017 – Cardio-Respiratory Events and Inflammatory Response After Primary Immunization in Preterm Infants < 32 Weeks Gestational Age: A Randomized Controlled Study. “Results: In the placebo group, immunization was associated with significantly increased CRP levels and an increase in CRE (8.6 +/- 11.1 before vs. 14.0 +/- 12.8 after) which did not reach statistical significance (p=0.08), and no change in PgE2. The increase in CRP was correlated with changes in CRE (r=0.4, p<0.05). In the ibuprofen group, immunization significantly increased CRP levels but was not associated with change in CRE (6.7 +/- 7.7 before vs. 6.8 +/- 9.7 after) and PgE2 levels. Comparing the groups, variation in CRE ([DELTA]CRE before vs. after immunization) was significantly lower in the ibuprofen group (0.1 +/- 7.9 vs. 5.4 +/- 10.0 [DELTA]CRE, p<0.05).”
June 13, 2017 – Study compares non–vaccine-preventable illness in vaccinated, unvaccinated children – A new study comparing the incidence of non–vaccine-preventable illnesses found that unvaccinated children were significantly more likely to suffer from flu and colds than vaccinated children. “Also, unexpectedly, 50.9% of children in the fully vaccinated group reported ear infections compared with 19.6% in the partially vaccinated group and 29.4% in the unvaccinated group.”
July 17, 2017 – How much atopy is attributable to common childhood environmental exposures? A population-based birth cohort study followed to adulthood “The absolute risks attributable to these exposures will be different in other cohorts and we cannot assume that these associations are necessarily causal. Nevertheless, the findings suggest that identifiable childhood environmental factors contribute substantially to atopic sensitization.” Comment: What no mention of vaccination?
June 7, 2017 – Cause of the Obesity, Type 2 Diabetes and Metabolic Syndrome Epidemics, Vaccine Induced Immune Overload versus Nutrition Overload (pdf) “The medical industry must take ownership for causing of the epidemics through the inappropriate recommendations and gross over utilization of vaccines. Once a patient has developed metabolic syndrome with type 2 diabetes providers are too frequently subjecting their patients to further immune overload by administering yearly influenza vaccines and many other vaccines. This action makes metabolic syndrome more difficult to reverse. The epidemics of obesity and metabolic syndrome can be reversed through discontinuation of medical vaccine practices that result in immune overload.”
June 2017 – Childhood vaccinations and risk of acute lymphoblastic leukaemia in children “It has been proposed that childhood vaccinations protect against acute lymphoblastic leukemia (ALL) in children by modulation of future responses to common infections in childhood. However, the available studies provide inconsistent findings, and population-based cohort studies with longitudinal information on vaccinations are lacking. … This nationwide cohort study provides no support of the proposed protective effect of childhood vaccination against childhood ALL.”
- Acknowledgments The authors would like to thank the funders of this study and all those who agreed to take part in our research. We are also grateful to Bruno Rigole (Sanofi Pasteur), Rebecca da Cunha, Brian Larkin, Sofia Lombera and Natasha Phillips (Double Helix), and Nicole Huyghe and Kerry O’Neill (solutions-2) for their valuable advice and management support throughout this study.
June 2017 – Racial and Ethnic Trends in Sudden Unexpected Infant Deaths: United States, 1995–2013 (full text) “Racial/ethnic differences in SUID rates were observed from 1995 to 2013. Rates were consistently highest for AIANs, followed by NHBs. No significant change in NHW and AIAN SUID rates were observed (Table 1, Fig 1). The NHB SUID rate decreased significantly (APC: −0.7; 95% confidence interval: −0.42 to −0.96), whereas the NHW rate decreased, but nonsignificantly. Consequently, a slight narrowing of the disparity between NHWs and NHBs occurred. In 2013, the SUID rates for NHBs and AIANs were double the rates for NHWs. The SUID rates for both Hispanics and APIs were lower than the rates for NHWs throughout the study period, with APIs experiencing the greatest decrease (APC: −3.3; 95% confidence interval: −2.8 to −3.8). This finding resulted in an increase in the Hispanic and API survival advantage over NHWs. In 2013, the NHW SUID rate was almost two- and threefold higher than for Hispanics and APIs, respectively.” Comment: The deaths have nothing to do with medicaid support, and the fact that the covered believe vaccine requirements must be met.
June 2017 – Race, Ethnicity, and SIDS (full text) “In this important research, the authors provide further evidence that we may be complacent when we treat SIDS/SUID as a tragic mishap due only to risk in the sleep environment and tend to ignore the possibility that it is the consequence of biological vulnerabilities in at least some of these infants.” Comment: aka vaccines.
May 31, 2017 – Carbohydrate fatty acid monosulphate esters are safe and effective adjuvants for humoral responses (full text) “To annihilate these adverse effects while retaining adjuvanticity, we examined several factors influencing E/T-ratio including dose of adjuvant and antigen, number of injections and chemical structure of the active molecule. Results on a third generation of carbohydrate derivatives are reported here.”
May 2, 2017 – Efficacy of a novel, protein-based pneumococcal vaccine against nasopharyngeal carriage of Streptococcus pneumoniae in infants: A phase 2, randomized, controlled, observer-blind study (full text) “Six serious adverse events reported during the entire study period were fatal. None was assessed by the investigator as causally related to vaccination. Aspiration pneumonia was reported for one infant in the PHiD-CV/dPly/PhtD-30 (3+0 schedule) group 82 days after administration of the third vaccine dose. Bronchopneumonia was reported for one infant in the PCV13 group 55 days following administration of the third vaccine dose. Sepsis was reported for one infant in the PCV13 group 45 days following administration of the third vaccine dose. Gastroenteritis was reported for one infant in the PHiD-CV/dPly/PhtD-30 (2+1 schedule) group 72 days following administration of the second vaccine dose. Sudden infant death syndrome was reported for one infant in the PHiD-CV/dPly/PhtD-30 (2+1 schedule) group 7 days following administration of the first vaccine dose. Gastroenteritis was reported for one infant in the PHiD-CV (2+1 schedule) group 80 days following administration of the second vaccine dose.
May 2, 2017 – Assessment of sex-specific differences in adverse events following immunization reporting in Ontario, 2012–15 (full text) “There is growing evidence of sex-based biological differences in vaccine response. Higher immunogenicity and reactogenicity of vaccines in females has been consistently demonstrated including evidence of more frequent and severe adverse reactions such as fever, injection site pain and inflammation, across a range of vaccines and ages.”…”Serious AEFIs (n = 113) were more evenly distributed between the sexes (57.5% female, RRR 1.3), with a median age of 3.2 years for females and 1.8 years for males. Serious reporting rate ratios were highest for those aged 18–64 and ≥65 years (RRR 5.6 and 1.9, respectively) followed by <1 and 1–3 years (RRR 1.1 and 1.5, respectively); whereas the 4–10 and 11–17 year categories were male-predominant (RRR 0.8 and 0.3, respectively).”
April-June 2017 – Lessons learnt in Japan from adverse reactions to the HPV vaccine: a medical ethics perspective “Public health and human rights have an intrinsic link, and any public health programme can be successful if the rights of people are respected, and upheld. A routine or compulsory vaccine programme tends to ignore rights of people that augment the legal and ethical issues relating to vaccinations. This article aims to identify the legal and ethical issues in the development of vaccines and in vaccination processes.pril 25, 2017 – Lifestyle, socioeconomic characteristics, and medical history of elderly persons who receive seasonal influenza vaccination in a tax-supported healthcare system “Among the 4237 elderly persons completing the survey, 1718 (41%) had received an influenza vaccination. Vaccinated persons had more comorbidity than unvaccinated persons (aPR for high comorbidity level: 1.51 95% CI 1.24–1.84), were less likely to never have smoked (aPR: 0.88, 95% CI 0.80–0.97), and had a higher prevalence of physical inactivity (aPR: 1.08, 95% CI 1.03–1.13). Levels of education and income were similar in the two groups. Vaccinated persons had a higher prevalence of major physical limitations (aPR: 1.40, 95% CI 1.17–1.66) and need for assistance with activities of daily living (aPR: 1.29, 95% CI 1.13–1.47).”
April 24, 2017 – Pilot comparative study on the health of vaccinated and unvaccinated 6- to 12- year old U.S. children (full text) “The vaccinated were also more likely to have used antibiotics, allergy and fever medications; to have been fitted with ventilation ear tubes; visited a doctor for a health issue in the previous year, and been hospitalized. The reason for hospitalization and the age of the child at the time were not determined, but the latter finding appears consistent with a study of 38,801 reports to the VAERS of infants who were hospitalized or had died after receiving vaccinations. The study reported a linear relationship between the number of vaccine doses administered at one time and the rate of hospitalization and death; moreover, the younger the infant at the time of vaccination, the higher was the rate of hospitalization and death. The hospitalization rate increased from 11% for 2 vaccine doses to 23.5% for 8 doses (r2 = 0.91), while the case fatality rate increased significantly from 3.6% for those receiving from 1-4 doses to 5.4 % for those receiving from 5-8 doses.”
April 19, 2017 – Doses per vaccine vial container: An understated and underestimated driver of performance that needs more evidence “Of the ten studies in the literature review, five mentioned the greater safety risk of adverse events following immunization (AEFI) associated with higher-capacity MDCs; of these one study provided a serious discussion on safety but this did not include metrics or further analysis. This greater risk, which is due to risks of contamination between vaccinations, improper labeling of opened vials, and in some cases the presence of preservatives, is suggested but not well quantified in immunization programming.”
April 11, 2017 – Facilitators and barriers of parental attitudes and beliefs toward school-located influenza vaccination in the United States: Systematic review “Barriers have cost; concerns regarding vaccine safety, efficacy, equipment sterility, and adverse effects; perception of school setting barriers; negative physician advice of contraindications; distrust in vaccines and school-located vaccination programs; and health information privacy concerns.”
April 2017 – Influenza Vaccine Effectiveness Against Pediatric Deaths: 2010–2014 (full text) “Deaths were reported from 43 states, New York City, Chicago, and Washington, DC. Vaccination status was unknown for 67 (19%) children who died. Of 291 deaths in children with known vaccination status, 75 (26%) children had received seasonal influenza vaccination ≥14 days before illness onset and were considered vaccinated.” … Among 31 deaths in vaccinated children aged 6 months through 4 years, 16 (52%) were partially vaccinated.”
March 1, 2017 – Metabolites as biomarkers of adverse reactions following vaccination: A pilot study using nuclear magnetic resonance metabolomics “Metabolomics involves the study of the low molecular weight metabolite profile of cells, tissues, and biological fluids, and provides a functional readout of the phenotype. Metabolomics may help identify a particular metabolic signature in serum of subjects who are predisposed to developing AEFIs. … This study is the first to describe pre- and post-vaccination metabolic profiles of subjects who developed an adverse event following immunization. The study demonstrates the promise of metabolites for determining mechanisms associated with subjects who develop AEFI and the potential to develop predictive biomarkers.”
March 27, 2017 – Kawasaki disease and immunisation: A systematic review ‘Kawasaki disease is a complex and potentially serious condition. It has been observed in temporal relation to immunisation.” … We identified twenty seven publications reporting a temporal association between immunisation and Kawasaki disease. We present a systematic review of data drawn from randomised controlled trials, observational studies, case series and reports, and reviews.”
February 1, 2017 – Nicolau syndrome induced by intramuscular injection of a hexavalent vaccine in a 6-month-old girl. “Nicolau syndrome, also known as embolia cutis medicamentosa or livedo-like dermatitis, is a sudden tissue necrosis, a rare complication of intramuscular injection of some drugs. We report a case of a 6-month-old girl who received intramuscularly the third dose of hexavalent vaccine (DTaP- HVB-IPV/HIb), and immediately presented a livedoid lesion around the injection site, progressing to necrosis.”
February 2017 – Lot-to-lot Consistency, Safety, Tolerability and Immunogenicity of an Investigational Hexavalent Vaccine in US Infants “There were 5 SAEs assessed as vaccine-related (all HV group): 1 case of ileocolic intussusception, considered related to third dose of RV5; 3 cases of fever, considered related to all study vaccines; and 1 case of diarrhea, considered related to first dose of RV5. No participants discontinued due to a vaccine-related SAE. During the entire study duration, 5 participants (0.2%) of 2308 participants in the HV group died: obstructive hydrocephalus (1 participant) 1 day postdose 2; death of unknown cause (1 participant) 44 days postdose 1; group A streptococcal sepsis (1 participant) 2 days postdose 1; and sudden infant death syndrome (2 participants) 10 days postdose 2 and 49 days postdose 1, respectively. No death was assessed to be related to the study vaccinations. None of the participants in the Control group (N = 402) died.
Volume 13 2017 – Issue 6 – Hypotonic-hyporesponsive episodes after administration of hexavalent DTP-based combination vaccine: A description of 12 cases “Hypotonic-hyporesponsive (HHE) episodes are known and recognized phenomena, which typically occur within 48 hours of immunisation.” … “Five out of 12 were brought to Emergency Department, where 2 were symptomatic (one was hyporeactive, the other had fever). No infant died during the episode, or the follow-up, nor developed neurological disease after subsequent vaccinations.
Volume 4 Issue 1 – 2017 – New Quality-Control Investigations on Vaccines: Micro- and Nanocontamination “After being injected, those microparticles, nanoparticles and aggregates can stay around the injection site forming swellings and granulomas. But they can also be carried by the blood circulation, escaping any attempt to guess what will be their final destination. We believe that in many cases they get distributed throughout the body without causing any visible reaction, but it is also likely that, in some circumstances, they reach some organ, none excluded and including the microbiota, in a fair quantity. As happens with all foreign bodies, particularly that small, they induce an inflammatory reaction that is chronic because most of those particles cannot be degraded. Furthermore, the protein-corona effect (due to a nano-bio-interaction can produce organic/inorganic composite particles capable of stimulating the immune system in an undesirable way. It is impossible not to add that particles the size often observed in vaccines can enter cell nuclei and interact with the DNA.
December 20, 2016 – The changing face of vaccines and vaccination (full text)” Monitoring vaccine safety is a shared responsibility and healthcare providers are encouraged to report all adverse events after vaccination, for assessment of the cause. Verification of causality is critical to maintaining public confidence in vaccines.”…”It is important to note that vaccination can modify disease epidemiology and that this will require changes in vaccine strategies. Ultimately, ensuring the continued success of vaccination is a shared responsibility of all aspects of the global community.” Comment:
December 20, 2016 – Vaccine safety evaluation: Practical aspects in assessing benefits and risks (full text) “Allegations that vaccines may cause an AEFI must be dealt with diligently and either confirmed or refuted based on scientific evidence. Misleading data can rapidly undermine confidence in an individual vaccine, or can lead to groundless suspension or withdrawal of the product from the market; ultimately having dramatic consequences for public health including decreased coverage and disease resurgence (Table 2). In some cases it takes a long time after an AEFI is reported to generate sufficient scientific data to determine that the AEFI was not caused by the vaccine; such as the unfounded fears that measles-mumps-rubella vaccine (MMR) caused autism or that whole-cell pertussis vaccines caused encephalopathy.”…”The quality of information provided may be insufficient to either confirm the diagnosis, or assess the likelihood of a causal association. Underreporting is a well-recognised limitation of passive surveillance systems. Comment: If the final phase study, phase 3, only involves thousands of children before being approved, when it finally is out in public and millions of people are receiving them, the reactions are claimed to be occasional. Many doctors and clinics are NOT reporting adverse events when they hear about it from a patient. 9 out of 10 doctors and pediatricians are telling parents this is normal.
- Disclosures: ADP and FTDS are employees of the GSK group of companies and report ownership of stock/restricted shares/shares in the GSK group of companies.
- PB has received grants and personal fees from Pfizer, and personal fees from GSK, Novartis, and Sanofi Pasteur MSD, unrelated to the present work.
- NG was previously an employee of the GSK group of companies, declares stock ownership and is also inventor on patents owned by the GSK group of companies.
- LRS reports consulting fees from Vical, Genocea, and Janssen Pharmaceuticals, and is a member of the scientific advisory board of Abivax.
- MEl-H has received a speaking honorarium from the GSK group of companies, unrelated to the present work.
Sources of support
GlaxoSmithKline Biologicals SA was the funding source and was involved in the preparation, review and approval of the manuscript.
December 12, 2016 – Reference set for performance testing of pediatric vaccine safety signal detection methods and systems “Criteria for the selection of vaccines considered in the reference set were routine and global use in the pediatric population. Adverse events were primarily selected based on importance. Outcome based systematic literature searches were performed for all identified vaccine-adverse event pairs and complemented by expert committee reports, evidence based decision support systems (e.g. Micromedex), and summaries of product characteristics.”
December 12, 2016 – Spontaneous reports of vasculitis as an adverse event following immunization: A descriptive analysis across three international databases “We retrieved 1797 reports of vasculitis in EV, 1171 in VAERS, and 2606 in VigiBase®. Vasculitis was predominantly reported in children aged 1–17 years, and less frequently in the elderly (>65 years). The generic term “vasculitis” was the most frequently reported AEFI in this category across the three databases (range 21.9% to 27.5% of all reported vasculitis for vaccines). For the more specific terms, Henoch–Schoenlein Purpura (HSP) was most frequently reported, (19.1% on average), followed by Kawasaki disease (KD) (16.1% on average) and polymyalgia rheumatica (PMR) (9.2% on average).” Comment: VigiBase is a WHO Global Database System
December 12, 2016 – Vasculitis as an adverse event following immunization – Systematic literature review “Most of the larger, higher quality studies found no causal association between vaccination and subsequent development of vasculitis, including several studies on Kawasaki disease and Henoch-Schönlein purpura (IgA vasculitis). Smaller case series reported a few cases of vasculitis following BCG and vaccines against influenza and hepatitis. Only 24% of the articles reported using a case definition of vasculitis.”
December 5, 2016 – Human immune system variation “A wide range of factors can perturb the human immune system, but the most convenient to investigate for systems immunology is the response to standard vaccinations such as influenza virus vaccines and, in particular, the very effective and robust yellow fever vaccine. Systems vaccinology can reveal which components of the immune system change and how they change in response to perturbations, and this in turn yields information about the sensitivities of a given person’s immune system and the variation of immune responses between individuals. This information might predict responsiveness or non-responsiveness to vaccines, which is an important problem for less robust vaccines, such as the influenza vaccines, and especially when administered to very young or elderly individuals.
November 2016 – Disclosure of Adverse Events in Pediatrics “The magnitude of harm to patients from AEs can be estimated but has not been quantified reliably. One investigation reported 12.91 AEs per 1000 hospital discharges among patients from birth through 15 years of age, with “negligence” identified in 28% of events.6 In a study of 3700 pediatric hospitalizations, 1% of patients experienced AEs, and 60% of these were determined to be preventable.”
Novenber 9, 2016 – Report of recurrent immune thrombocytopenia after flu shot “The authors note that the patient presented at age 4.5 years with cutaneous and mucosal bleeding. He had a decreased platelet count, with normal hemoglobin levels and white blood cell counts. His platelet level returned to normal 10 days after treatment with a single dose of intravenous immunoglobulin. On review of the patient’s medical history, he was found to have been hospitalized twice before, with similar signs and symptoms, in 2010 and 2012. It was noted that all three admissions occurred within one week of immunization with the trivalent inactivated influenza vaccine. In 2011, the patient did not receive the annual influenza immunization and no symptoms of ITP were seen. It was advised that the child discontinue annual influenza vaccinations. No further recurrences have been reported.”
August 31, 2016 – Contrasting female-male mortality ratios after routine vaccinations with pentavalent vaccine versus measles and yellow fever vaccine. A cohort study from urban Guinea-Bissau (full text) “The effect of DTP on all cause-mortality was not tested prior to the vaccine being rolled out in low-income countries in the 1970s. The present study adds to the large body of evidence indicating that female mortality is higher than male mortality after vaccination with inactivated DTP-containing vaccines. Since the female/male MRR did not differ in the pre-vaccination era and did not differ among children who had not been registered at a vaccination contact for Penta after 42 days of age, this supports that DTP-containing vaccines are associated with increased mortality for females relative to males.”
August 5, 2016 – Vaccinology in the twenty-first century (full text) “Some individuals have strong immune responses, whereas others have weak or even undetectable responses. Similarly, the reactogenicity of a particular vaccine varies at the individual level. Many of these differences are due to the host response to vaccination. Despite learning much about the host innate and adaptive immune response to vaccination at the population level, our understanding is somewhat rudimentary at the individual level, although it is clear that genetic factors have a role in our response to individual vaccines. We have much to learn.”
July 25, 2016 – Heterologous vaccine effects “The heterologous or non-specific effects (NSEs) of vaccines, at times defined as “off-target effects” suggest that they can affect the immune response to organisms other than their pathogen-specific intended purpose. These NSEs have been the subject of clinical, immunological and epidemiological studies and are increasingly recognized as an important biological process by a growing group of immunologists and epidemiologists. Much remain to be learned about the extent and underlying mechanisms for these effects.”
June 19, 2016 – Acute flaccid myelitis in the United States – August – December 2014: Results of nation-wide surveillance “Most experienced respiratory (81%) or febrile (64%) illness before limb weakness onset. MRI abnormalities were predominantly in the cervical spinal cord (103/118). All but one case was hospitalized; none died. CSF pleocytosis (>5 white blood cells/mm3) was common (81%). At CDC, one CSF specimen was positive for EV-D68 and Epstein-Barr virus by real-time PCR, although the specimen had >3,000 red blood cells/mm3.”…”There is some evidence to suggest that the nasal spray vaccine may not protect children against H1N1 viruses during the 2014-2015 season because the same H1N1 vaccine virus from the 2013-2014 vaccine is included in the 2014-2015 vaccine“…”Acute onset of limb weakness in children, CDC has been working with healthcare professionals and state and local health departments to investigate reports of children across the United States who developed a sudden onset of weakness in one or more arms or legs, MRI scans show an inflammation predominantly of the gray matter—nerve cells—in the spinal cord. This illness is now being referred to as acute flaccid myelitis. From August 2 to November 26, 2014, CDC has verified reports of 90 children in 32 states who developed acute flaccid myelitis that meets CDC’s case definition.” Comment: Mass campaigns usually start with fear.
June 2, 2016 – Cervical Infection With Vaccine-Associated Human Papillomavirus (HPV) Genotypes as a Predictor of Acquisition and Clearance of Other HPV Infections “Females infected with vaccine-targeted types were generally at higher risk of acquiring additional types (HRs, > 1.0) and at equal risk of clearing existing infections. Accounting for multiple comparisons, none of the HRs of < 1.0 or >1.0 were statistically significant in our analyses of acquisition or clearance.”
April 29, 2016 – Local innate immune responses in the vaccine adjuvant-injected muscle (full text) “However, when alum was given i.m. to NLRP3-deficient or wild-type mice, respectively, similar antibody titers were observed. Inflammatory responses in the muscle mediated by alum have also been associated with cell death and host-derived immunostimulatory molecules, that is, danger-associated molecular patterns (DAMPs). Of note, the innate immune responses to alum-adjuvanted antigens delivered i.p. and i.m. may not be the same.”
April 2016 – Postural Orthostatic Tachycardia Syndrome (POTS) – A novel member of the autoimmune family (pdf) “There are several plausible explanations for the appearance of abnormal cardiac including death, following HPV vaccination. Namely, in exploring the primary sequence of the HPV major capsid L1 protein (one of the four antigens in Gardasil) for peptide sharing with human proteins, Kanduc found that pentamers from the HPV viral capsid protein are shared with human proteins that, when altered, have been linked to arrhythmias, cardiovascular diseases and sudden death. In particular, out of the viral pentamers are present in the human protein, Titin, alterations of which have been linked to cardiac failure and sudden cardiac death.
April 2016 – Commentary: Assessing the impact of temporally associated adverse events on neonatal hepatitis B vaccination“Swift investigation, response and communication with the public are also important to prevent a loss in public confidence following reports of adverse events following immunization (AEFI). Hepatitis B vaccination at birth is particularly prone to association with coincidental deaths because infant mortality is highest during the early neonatal period.
April 2016 – Global Vaccine Safety Assessment: Challenges and Opportunities (full text) “Key challenges in vaccine safety monitoring begin first with the identification of risks. The risks need to be detected, and most countries rely on passive pharmacovigilance by spontaneous reporting of healthcare providers. However, WHO estimates that only 35% of 192 countries had an adequately functioning system for monitoring AEFI in 2012. Although the value of spontaneous reporting systems is evident, the quality of available data is limited because of incomplete reports and underreporting, even in established immunization programs.”
March 18, 2016 – Adverse events following immunization in patients with primary immunodeficiencies “Evidence of AEFI was found in 26 medical records and represented a total of 29 reactions. Most of the AEFI were observed in patients with idiopathic hypogammaglobulinemia (IHG), chronic granulomatous disease (CGD) and severe combined immunodeficiency (SCID), representing 10, 4 and 4 cases, respectively. A total of 21 reactions were associated with replicative vaccines, 7 of which were serious cases related to Bacille Calmette-Guérin (BCG). BCG was also the vaccine more often associated with definitive AEFI in PID. In addition to BCG-related complications, seizures were the most serious AEFI among PID patients.”
March 14, 2016 – Evaluation of the Intussusception Risk after Pentavalent Rotavirus Vaccination in Finnish Infants “52 IS cases were reported during the 7 years prior to the vaccines were available (January 1999-December 2005), and 37 cases during the 3 years and 8 months while the vaccine was available in the market but not in the national programme (2006- August 2009). The corresponding cumulative incidences at 1 year of age during the three periods were 7.4 cases per year prior, 10.1 cases per year while vaccine was sold and 13.8 annual cases during the universal vaccination programme.”…”Thus, the benefits of rotavirus immunisation programme clearly outweigh possible small risks of intussusception.” Comment: The benefits outweigh the risks? Ask the parents of the children affected if they agree with that statement.
March 2016 – Risk of Herpes Zoster in Auto-immune and Inflammatory diseases: Implications for Vaccination “We identified 8,395 SLE, 7,916 IBD, 50,646 RA, 2,629 PsA, 4,299 PsO, 1,019 AS, 58,934 gout, 214,631 diabetes and 330,727 enrollment periods without AI and diabetic conditions. Highest to lowest, the IRs ranged from 19.9 per 1,000 pys for SLE cohort to 6.8 for gout cohort, versus 5.3 in patients without AI and diabetic conditions. The age-specific IRs of HZ for RA and SLE patients aged ≥40 were 1.5-2 times greater than those observed in healthy adults for whom the vaccine is currently recommended (8.5/1000).”
2016 – Alum-Containing Vaccines Increase Total and Food Allergen-Specific IgE, and Cow’s Milk Oral Desensitization Increases Bosd4 IgG4 While Peanut Avoidance Increases Arah2 IgE: The Complexity of Today’s Child with Food Allergy “Alum-containing vaccines increased IgE, a phenomenon we have previously observed, whereas milk desensitization increased milk-component IgG4, a trend we have reported post-peanut OIT. (Also on JACI)
December 28, 2015 – Timing of routine infant vaccinations and risk of food allergy and eczema at one year of age “There was no overall association between delayed DTaP and food allergy, however children with delayed DTaP had less eczema and less use of eczema medication. Timing of routine infant immunizations may affect susceptibility to allergic disease.
November 27, 2015 – Enhancing vaccine safety capacity globally: A life cycle perspective“Major vaccine safety controversies have arisen in several countries beginning in the last decades of 20th century. Such periodic vaccine safety controversies are unlikely to go away in the near future as more national immunization programs mature with near elimination of target vaccine-preventable diseases that result in relative greater prominence of adverse events following immunizations, both true reactions and temporally coincidental events.
November 27, 2015 – Value of post-licensure data on benefits and risks of vaccination to inform vaccine policy: The example of rotavirus vaccines “RotaTeq (RV5) and Rotarix (RV1), did not find an association with intussusception, post-licensure studies have documented a risk in several high and middle income countries, at a rate of ∼1–6 excess cases per 100,000 vaccinated infants.”…”Because the risk and benefit data from affluent settings may not be directly applicable to developing countries, further characterization of any associated intussusception risk following rotavirus vaccination as well as the health benefits of vaccination is desirable for low income settings.”
November 2015 – FDA Safety Reviews on Drugs, Biologics, and Vaccines: 2007–2013“There were 6930 serious adverse event reports in 181 reviews. These findings resulted in 33 (18%) recommended labeling changes, and 21 (64%) of these changes were adopted. For 10 products, information was added to the Warning and Precautions section of the label. The PAC also discussed or recommended additional studies for certain products.”… “CONCLUSIONS: This article highlights the importance of the FDA’s ongoing pediatric postmarketing safety reviews of regulated products, advice from the PAC, and FDA actions in the best interest of pediatric patients. This mandated process facilitates detection of safety concerns that may not be identified in prelicensure clinical trials. It continues to identify critical safety concerns, including unlabeled adverse events, frequent off-label use, product misuse, and secondary exposures in children.
September 3, 2015 – Testing for Infectious Diseases in Sudden Unexpected Infant Death: A Survey of Medical Examiner and Coroner Offices in the United States (pdf) “Without appropriate infectious disease testing, such deaths are likely to remain unreported and/or nonspecifically reported (eg, pneumonia, not otherwise specified) by ME/C offices. The public health implications are myriad, as pediatric influenza death surveillance is used to determine children at risk for influenza complications, influenza vaccination recommendations, and vaccine strain selection, among other purposes.”
August 2015 – A Patient with Kawasaki Disease Following Influenza Vaccinations “The cause of KD remains unknown, but it is thought that the immune system is activated by infectious or environmental triggers in genetically susceptible hosts. Although some patients with postvaccination KD have been described, patients with postinfluenza vaccination KD have never been reported. Herin, we describe the case of a patient with postinfluenza vaccination KD”
July 9, 2015 – Reactogenicity of trivalent inactivated influenza vaccine in young children: Pronounced reactions by previous successive vaccinations (full text) “For subjects aged ≥3 years, prior successive annual vaccinations were associated with substantially increased local reactions, with clear dose-response relationships (P for trend: <0.001 for each); for example, an 9.8-fold greater risk of swelling following three successive annual vaccinations before the study season.”
July 2015 – The incidence of unprovoked seizures and occurrence of neurodevelopmental comorbidities in children at the time of their first epileptic seizure and during the subsequent six months “The incidence of unprovoked seizures was between 30 and 204/100,000 person years (n = 766) in the different age groups. It was highest among the youngest children and lowest among the 18-year-olds with small gender differences. The most common neurodevelopment comorbidities were developmental delay (22%, CI: 19–25%), speech/language and learning difficulties (23%, CI: 20–26%) and intellectual disability (16%, CI: 13–18%). The types of neurodevelopmental comorbidity varied by age at the time of seizure onset, with cerebral palsy being more common among the 0–5-year-olds, attention deficits among the 6–16-year-olds, and autism and psychiatric diagnosis among the older children.” Comment: Did the study subjects receive vaccines?
June 1, 2015 – Adverse Events After Routine Immunization of Extremely Low-Birth-Weight Infants (full text) “Timely immunization of premature infants in the neonatal intensive care unit (NICU) is associated with improved immunization coverage throughout childhood. However, the immunization of extremely low-birth-weight (ELBW; birth weight ≤1000 g) infants has been associated with adverse events, including fever and adverse cardiorespiratory events, such as apnea and bradycardia, in the immediate postimmunization period. These adverse events can mimic serious diseases in ELBW infants, including true sepsis, presenting a diagnostic dilemma for physicians.
June 2015 – Febrile seizures: emergency medicine perspective (full text)”Finally, there is growing evidence regarding the genetic basis of both febrile seizures and vaccine-related seizures/febrile seizures.”…”Summary: Routine diagnostic testing for simple febrile seizures is being discouraged, and clear evidence-based guidelines regarding complex febrile seizures are lacking. Thus, clinical acumen remains the most important tool for identifying children with seizures who are candidates for a more elaborate diagnostic evaluation.
June 2015 – The first steps towards the era of personalised vaccinology: predicting adverse reactions (full text) “As an example, we estimated recently the incidence of post-HPV vaccine ADEM to be of 0.26/106 vaccinations (CI 95%: 0.16/106–0.37/106). Even assuming a 10-fold higher incidence because of biases such under-reporting to the surveillance databases, still the retrieving of a number of case large enough would require a large scale, national or international study.”…”On the basis of the data reviewed above we feel that that a correlation between vaccine adverse reactions and genetics exists and deserves further studies. The idea of identifying the genetic variants predictive for vaccine adverse events and suitable for the introduction in clinical practice is, in our opinion, feasible as the cost of genotyping is falling rapidly and large-scale genotyping at birth is not too far off the horizon.”
April 20, 2015 – Influenza Vaccination as a Novel Trigger of Wells Syndrome in a Child “Possible mechanisms include hypersensitivity reactions to antigens. There are four reports in the literature of Wells syndrome precipitated by vaccinations (hepatitis B vaccine, tetanus vaccine, tetanus-diptheria vaccine and triple antigen vaccine). We present a further case of Wells syndrome in a 22-month-old child after influenza vaccine as a novel trigger not previously reported.”
April 1, 2015 – An unusual occurrence of Kleine-Levin syndrome in a man with refractory immune thrombocytopenic purpura: a case report “Kleine-Levin syndrome is an extremely rare neurological entity characterized by recurrent episodes of hypersomnia which are sometimes associated with compulsive hyperphagia and behavioral changes. Autoimmunity has recently been proposed as a factor contributing to its pathogenesis. Immune thrombocytopenic purpura is a relatively common autoimmune disease showing a lot of complexity and uncertainty regarding its treatment regimens and its refractory nature in some cases. A 32-year-old Persian White man visited his private hematologist complaining of recent episodes of epistaxis and appearance of petechial lesions 24 hours after receiving a meningococcal vaccine”
January 16, 2015 – Vaccine-elicited CD4 T cells induce immunopathology after chronic LCMV infection “Virus-specific CD8 T cells or antibodies abrogated the pathology. These data demonstrate that vaccine-elicited CD4 T cells in the absence of effective antiviral immune responses can trigger lethal immunopathology.” Comment: for more see Vaccine-induced CD4 T cells have adverse effect in a mouse model of infection
January 15, 2015 – Demographic Evidence of Sex Differences in Vulnerability to Infectious Diseases (full text) “We directed a population observatory in Niakhar, Senegal, West Africa, in which a comprehensive demographic surveillance system (DSS) monitored causes of death, as well as family behavior. In this population, there was no evidence of any differential behavior between boys and girls, as is generally true in African countries. But mortality was higher for girls than for boys for selected diseases (measles and pertussis), despite similar incidences. Furthermore, a randomized controlled trial of the Edmonston-Zagreb high-titer measles vaccine demonstrated a higher susceptibility to measles virus among girls.”
January 2015 – Two Cases of Extensive Limb Swelling After Influenza Vaccination “Due to its striking appearance, ELS might be mistaken for bacterial cellulitis or a type I allergic reactions.”
January 2015 – Etiology of Vaccine-Related Seizures “Investigators at the University Medical Centre Utrecht, Netherlands, reviewed the medical data on children with seizures after vaccination during the first 2 years of life, reported to the National Institute for Public Health and Environment in the Netherlands over a 10-year period, 1997 through 2006.”
December 29, 2014 – FDA Summary Basis for Regulatory Action Gardasil 9 (pdf)
- “Thus, compared with GARDASIL, GARDASIL 9 contains 2.25-fold more total protein antigen (270 µg vs. 120 µg) and 2.22-fold more aluminum adjuvant (500 µg vs. 225 µg).“…
- “GARDASIL 9 and GARDASIL treatment groups except multiple sclerosis (MS); there were 5 cases of MS in the GARDASIL 9 group compared with 2 cases in the GARDASIL group. The clinical significance of this apparent imbalance is unclear due to the small case numbers involved. The incidence rate of MS in the GARDASIL 9 group is within the limits of the population background. Post-marketing assessment for immune-mediated medical conditions will be conducted using the FDA Mini-Sentinel surveillance system.”…
- “Spontaneous abortions and other pregnancy-related outcome data for GARDASIL 9 will be collected through a post-marketing pregnancy registry conducted by Merck (using the same methodology as the pregnancy registry for GARDASIL). In addition, a post-marketing targeted observational study through the Vaccine Safety Datalink (VSD) administered by the Centers for Disease Control and Prevention (CDC) is being considered. Consultations are ongoing between CBER and CDC on a VSD study protocol for assessing SA in recipients of GARDASIL 9.”
December 26, 2014 – Progressive Decrease in the Potential Usefulness of Meningococcal Serogroup B Vaccine (4CMenB, Bexsero®) in Gipuzkoa, Northern Spain (full text) “The incidence of meningococcal disease in our region has substantially declined in the last decade, and most recent circulating isolates lacked antigens against which vaccinated people would have been protected. In the current situation, and considering the high incidence of fever from the vaccine, the introduction of the 4CMenB vaccine in our community does not seem to achieve the necessary priority to be recommended. If an outbreak caused by a hypervirulent clone were to occur, especially if the clone was the ST11 clone, the vaccine would be extremely useful.”
December 18, 2014 – Clinically mild encephalitis with a reversible splenial lesion (MERS) after mumps vaccination
- The five patients (all males, aged 1 to 9) presented with fever, vomiting, or headache as the initial symptoms (day 0), suggesting meningitis, at 13 to 21 days after mumps vaccination. Consciousness disturbance, delirious behavior, seizures, or dysarthria was observed on days 1 to 3, which had completely resolved before day 11.
- A cerebrospinal fluid study showed pleocytosis, and confirmed the vaccine strain genome.
- MERS after mumps vaccine may be more common than previously considered.
October 2014 – Thimerosal-Containing Hepatitis B Vaccination and the Risk for Diagnosed Specifi c Delays in Development in the United States: A Case-Control Study in the Vaccine Safety Datalink (pdf) “The present study provides compelling new epidemiological evidence supporting a significant relationship between increasing organic-Hg exposure from Thimerosal-containing childhood vaccines and the subsequent risk of a diagnosis for specific delays in development among both males and females. Many recent studies support the biologically plausible role of organic-Hg exposure from Thimerosal-containing vaccines in the pathogenesis of specific delays in development.”
October 2014 – Rapid Online Identification of Adverse Events After Influenza Immunization in Children by PCIRN’s National Ambulatory Network (full text) “Of the 99 events reported, 5 were easily tolerable, 27 were uncomfortable and the remaining 65 met the criteria for severe. No neurologic symptoms were reported online or in the subsequent follow up of severe events. The severe event reporting rate in online respondents was 5.1% (95% confidence interval: 3.8–6.5; n = 55) compared with a rate of 6.3% (2.5%–10.0%) in telephone respondents (n = 10). Four respondents reported an event severe enough to cause them to seek medical care, 55 reported an event severe enough to prevent daily activities and 6 reported an event severe enough to prevent daily activities and to cause them to seek medical care. The overall frequency of severe events did not vary by age group (data not shown).”
September 29, 2014 – Post vaccine acute disseminated encephalomyelitis as the first manifestation of chromosome 22q11.2 deletion syndrome in a 15-month old baby: A case report “Brain MRI images showed multiple bilateral hyperintense lesions in the white matter typical of acute disseminated encephalomyelitis (ADEM), an autoimmune demyelinating disorder with inflammatory lesions of the central nervous system, due to viral antigens or vaccines.”
September 18, 2014 – Nonspecific effects of neonatal and infant vaccination: public-health, immunological and conceptual challenges “Vaccines can have nonspecific effects through their modulation of responses to infections not specifically targeted by the vaccine. However, lack of knowledge about the underlying immunological mechanisms and molecular cause-and-effect relationships prevent use of this potentially powerful early-life intervention to its greatest benefit. The World Health Organization has identified investigations into the molecular basis of nonspecific vaccine effects as a research priority.”
September 15, 2014 – Etiologies for Seizures Around the Time of Vaccination “Follow-up was available for 23 of 26 children (median age: 10.6 years) with epilepsy onset after vaccination. Twelve children developed epileptic encephalopathy, 8 had benign epilepsy, and 3 had encephalopathy before seizure onset. Underlying causes were identified in 15 children (65%) and included SCN1A–related Dravet syndrome (formerly severe myoclonic epilepsy of infancy) or genetic epilepsy with febrile seizures plus syndrome (n = 8 and n = 1, respectively), a protocadherin 19 mutation, a 1qter microdeletion, neuronal migration disorders (n = 2), and other monogenic familial epilepsy (n = 2).”
September 8, 2014 – A role for impaired regulatory T cell function in adverse responses to aluminum adjuvant-containing vaccines in genetically susceptible individuals “there is only a limited understanding of the response of regulatory T cells to aluminum adjuvants and the vaccines that contain them. Available studies in animal models show that although induced T regulatory cells may be induced concomitantly with effector T cells following aluminum-adjuvanted vaccination, they are unable to protect against sensitization, suggesting that under the Th2 immune-stimulating effects of aluminum adjuvants, Treg cells may be functionally compromised. Allergic diseases are characterized by immune dysregulation, with increases in IL-4 and IL-6, both of which exert negative effects on Treg function. For individuals with a genetic predisposition, the beneficial influence of adjuvants on immune responsiveness may be accompanied by immune dysregulation, leading to allergic diseases.”
September 2, 2014 – The Effect of Prophylactic Antipyretic Administration on Post-Vaccination Adverse Reactions and Antibody Response in Children: A Systematic Review (full text) “If the reactogenicity of these vaccines are decreased in the general population, parental anxiety could be relieved to some extent. But there have been different schools of thought regarding prophylactic antipyretic administration. A systematic review conducted way back in 2007 concluded that parents be counseled to monitor vaccine-related adverse reactions and to treat them if and when they occur. This review summarized the findings pertaining only to DTP vaccination, and not to other childhood vaccinations. Recent clinical trials have found that although febrile reactions were significantly decreased by prophylactic antipyretics, antibody responses to several vaccine antigens were reduced. Meanwhile, the American Academy of Pediatrics (AAP) continues to say that either prophylactic or therapeutic use of antipyretics should not be withheld.”
September 2014 – Contaminated vaccine deaths a serious setback for Syria (full text) “Health experts warned that the vaccine mix-up would severely damage trust in health services in opposition-held areas. “It’s a catastrophe”, said Annie Sparrow, public health expert and deputy director of the Human Rights Program at Icahn School of Medicine, NY, USA. “It’s hard to see any parent letting their child be vaccinated in Syria ever again. It is just awful on so many levels.”
August 20, 2014 – The association between age and the development of respiratory syncytial virus neutralising antibody responses following natural infection in infants “The disease incidence estimates presented in Fig. 1b, suggest that in order to have the greatest impact on disease burden, infants should be vaccinated prior to the period of greatest risk of disease, at about 2 months of age. However the poor response to natural infection in infants under the age of 4 months suggests that such infants are unlikely to mount strong neutralising antibody responses to live vaccines. Nonetheless, the data presented suggest that vaccination of infants aged 4 months and above is likely to provide substantial benefit. To protect very early infants at the period of greatest risk, there is need to explore alternative strategies such as maternal vaccination. The boosting of the titre of trans-placentally transferred antibody will increase the duration of infant protection and delay the age of first infection, at which time infection is less likely to result in severe disease. Comment: So keep using the status quo vaccines with their reactogenicity on poor defenseless infants? There isn’t any guarantee once these new vaccines go into trials, or postmarketing trials they will be safe.
August 14, 2014 – Efficacy of High-Dose versus Standard-Dose Influenza Vaccine in Older Adults “At least one serious adverse event during the safety surveillance period was reported by 1323 (8.3%) of the participants in the IIV3-HD group, as compared with 1442 (9.0%) of the participants in the IIV3-SD group (relative risk, 0.92; 95% CI, 0.85 to 0.99).”…”(Funded by Sanofi Pasteur; ClinicalTrials.gov number, NCT01427309.)”
July-August 2014 – Childhood Vaccine Beliefs Reported by Somali and Non-Somali Parents “Most of them refused vaccines because they had heard of adverse effects associated with the vaccine or personally knew someone who suffered an adverse effect. Somali parents were significantly more likely to believe that autism is caused by vaccines (35% vs. 8% of non-Somali parents). Somalis were also more likely to be uncomfortable with administering multiple vaccines at one visit (odds ratio, 4.0; 95% confidence interval, 1.4–11.9) and more likely to believe that children receive too many vaccines.”
July 31, 2014 – The delicate balance in genetically engineering live vaccines “A central theme driving our discussion will stress that the ultimate success of an engineered vaccine rests on achieving the proper balance between attenuation and immunogenicity. Achieving this balance will avoid over-activation of inflammatory responses, which results in unacceptable reactogenicity, but will retain sufficient metabolic fitness to enable the live vaccine to reach deep tissue inductive sites and trigger protective immunity.”
July 15, 2014 – Sex-based Biology and the Rational Design of Influenza Vaccination Strategies “Females develop higher antibody responses, experience more adverse reactions to influenza vaccines, and show greater vaccine efficacy than males. Despite greater vaccine efficacy in females, both young and older females are often less likely to accept influenza vaccines than their male counterparts. Identification of the biological mechanisms, including the hormones and genes, that underlie differential responses to vaccination is necessary. We propose that vaccines should be matched to an individual’s biological sex, which could involve systematically tailoring diverse types of FDA-approved influenza vaccines separately for males and females.”
July 9, 2014 – Effect on HPV vaccination in Japan resulting from news report of adverse events and suspension of governmental recommendation for HPV vaccination “The recognition rate of the news of the vaccine’s adverse events was 80 %; it was 68 % for awareness of the government’s announcement of the suspension of its recommendation for the vaccine. Among those who had a chance to hear or see the negative news during their vaccination period, 46 (60 %) continued vaccination while knowing of the news, 22 (29 %) discontinued vaccination, and 9 (11 %) continued vaccination without an awareness of the news. Reports of the vaccine’s adverse events were the main reason for not continuing the vaccination series.” Comment: After knowing the vaccine was suspended how could you still receive it?
July 7, 2014 – Stool Microbiota and Vaccine Responses of Infants “Bifidobacterium predo
July 2, 2014 – Vaccination in Elite Athletes “Side effects might be reduced by an optimal selection of vaccines and an appropriate technique of administration. Very few discipline-specific considerations apply to an athlete’s vaccination schedule mainly from the competition and training pattern as well as from the typical geographical distribution of competitive sites.”
July 1, 2014 – Safety of Vaccines Used for Routine Immunization of US Children: A Systematic Review (pdf) “Importantly, some AE signals that warrant future research may not have been identified by this project. Passive surveillance systems such as the US Vaccine Adverse Event Reporting System are crucial in identifying signals regarding AE’s post licensure, but they are not designed to assess a statistical association, so they were excluded as sources of data.
July 1, 2014 – Vaccines: Can Transparency Increase Confidence and Reduce Hesitancy? “The authors did report adverse events associated with vaccines, including high-quality evidence that the MMR vaccine is associated with febrile seizures and the varicella vaccine is associated with complications in immune-deficient people. There was moderate-quality evidence for purpura associated with the hepatitis A and MMR vaccines, febrile seizures with the pneumococcal conjugate 13 vaccine, and intussusception with rotavirus vaccines.
June 24, 2014 – Role of viral RNA and lipid in the adverse events associated with the 2010 Southern Hemisphere trivalent influenza vaccine “Our studies demonstrated that the pyrogenic signal was associated with a heat-labile, viral-derived component(s) in the CSL 2010 SH TIV. Further, it was found that viral lipid-mediated delivery of short, fragmented viral RNA was the key trigger for the increased cytokine/chemokine secretion and NF-κB activation. It is likely that the FS reported in children <5 years were due to a combination of the new influenza strains included in the 2010 SH TIV and the CSL standard method of manufacture preserving strain-specific viral components of the new influenza strains (particularly B/Brisbane/60/2008 and to a lesser extent H1N1 A/California/07/2009). These combined to heighten immune activation of innate immune cells, which in a small proportion of children <5 years of age is associated with the occurrence of FS.”
June 9, 2014 – Risk of febrile seizures after first dose of measles–mumps–rubella–varicella vaccine: a population-based cohort study (pdf) “The risk of seizures 7 to 10 days after vaccination was twice as high with MMRV as with MMR+V (relative risk [RR] 1.99, 95% confidence interval [CI] 1.30–3.05). The excess absolute risk of seizures was 3.52 seizures per 10 000 doses of MMRV relative to MMR+V. In high-risk children, the risk was not differentially higher for MMRV (RR 1.30, 95% CI 0.60–2.79).”…”“Policy-makers need to balance these findings with the potential benefits of administering the combination vaccine or determine whether the choice of vaccine rests with clinicians and/or parents.”
May 30, 2014 – Commentary: Potential implications of non-specific effects of childhood vaccines “Emerging evidence suggests that vaccines can positively or negatively affect the resistance to other infectious diseases—the so-called non-specific effects of vaccines or non-specific immunomodulation by vaccines.The bulk of this evidence has been generated from Guinea-Bissau by researchers led by Peter Aaby. The current status of global evidence has been summarized by them in this issue of IJE4 and elsewhere. On this basis, they also suggest a new definition of vaccines:”
May 30, 2014 – The non-specific effects of vaccines and other childhood interventions: the contribution of INDEPTH Health and Demographic Surveillance Systems “So far there are no studies of the possible NSEs of the many new vaccines, including rotavirus vaccine, PCV, yellow fever, conjugated meningococcal vaccin, or malaria vaccine. Only one study has examined the possible NSEs of vaccination campaigns with OPV or MV. Studies at INDEPTH member centres may help to explain how the immunological profile can change so quickly between different vaccines, why live vaccines have beneficial effects and inactivated vaccines have negative effects, and why the reactions of boys and girls differ.”
- Killed vaccines may be over-reported with events related to the preventable disease.
- This can generate potentially misleading disproportional signals.
- In WHO Global pharmacovigilance database this phenomenon has been confirmed.
- The possibility of false safety signals due to this bias should be considered.
May 12, 2014 – Rapid Online Identification of Adverse Events Following Influenza Immunization in Children by PCIRN’s National Ambulatory Network. “A total of 1230 parents completed an online or telephone survey, for a participation rate of 83%: 72% responded online and an additional 11% were reached by telephone. The rate of severe events in children immunized with an influenza vaccine was 4.7% (3.5% – 5.9%). The frequency and types of events reported were similar between online and telephone reports. Reported rates of severe events were similar after TIV or LAIV (4.0% vs. 5.1%, respectively). The online survey was easy to access and understand. Most respondents (94%) would participate next year.”
April 2014 – Assessing the Evidence: Live Attenuated Influenza Vaccine in Children Younger than 2 Years. A Systematic Review “Current recommendations of universal influenza vaccination will continue to increase demand for IIV; which may lead to similar shortages in the future. Additionally, a response to an influenza pandemic is another scenario that necessitates an alternative for IIV. In these situations, the potential adverse effects that may be greater with LAIV in children <2 years, would be greatly outweighed by the benefits. Additional options for this population, such as LAIV, are extremely needed.”
March 25, 2014 – Exploring the risk factors for vaccine-associated and non-vaccine associated febrile seizures in a large pediatric cohort
• We explore risk factors for FS associated with vaccines versus other causes.
• We evaluate a pediatric cohort of 265,275 children with 3348 febrile seizures (FS).
• We detected novel FS risk factors, including non-white race and young maternal age.
• We detected differences in risk factors between vaccine-FS compared with other FS.
• There may be immunogenetic differences in FSs by precipitating event.“This study suggests that there may be immunogenetic differences underlying VA-FSs compared with other FSs. However, further studies are needed. An understanding of the mechanisms behind these findings may help improve vaccine design or policies.
March 19, 2015 – A case of sudden death after Japanese encephalitis vaccination “Inactivated Vero cell culture-derived JE vaccines have not been linked to any fatalities, and few serious adverse events after vaccination have been reported. Here, we report a case of sudden death in which a 10-year-old boy experienced cardiopulmonary arrest 5 min after receiving a Japanese encephalitis vaccination. He had been receiving psychotropic drugs for the treatment of pervasive developmental disorders.
March 10, 2014 – Childhood vaccination associated adverse events by sex: A literature review “Serious adverse events related to vaccinations were rare. We found some possible sex related vaccine adverse events. Few trials however reported adverse events by age and sex and very few analyses evaluated the observed differences.”
February 24, 2014 – Adverse Drug Reactions of Spontaneous Reports in Shanghai Pediatric Population (full text) “A male overrepresentation was observed regarding the total number of reports. The most frequently reported group of drugs were vaccines (42.15%). Skin rash and fever were the commonest symptoms reported in the total pediatric dataset. The proportion of children that suffered from a serious ADR was 2.16% and that for drug related deaths was 0.34%. And we found that the multiple drug exposure experienced a high proportion of serious ADRs compared with the single drug use (χ2 = 15.99, P<0.0001). Sixty-five percent of ADRs were for children less than 6 years of age. And more than half of reports were from doctors.
February 19, 2014 – Adverse events following immunization in Ontario’s female school-based HPV program “Between 2007 and 2011, 133 confirmed AEFIs were reported while 691,994 HPV4 vaccine doses were distributed in the school-based program. The overall reporting rate was 19.2 HPV4 AEFI per 100,000 doses distributed. Annual reporting rates decreased from 30.0 to 18.3 per 100,000 doses distributed. Frequently reported events included ‘allergic reaction—dermatologic/mucosa’ (25%), ‘rash’ (22%), and ‘local/injection site reaction’ (20%); 26% of reports had a non-specific event of ‘other severe/unusual events’ selected. Ten serious AEFIs were reported (7.5% of reports) including 2 anaphylaxis, 2 seizures, 1 thrombocytopenia and 1 death.”
February 12, 2014 – Protecting the Family to Protect the Child: Vaccination Strategy Guided by RSV Transmission Dynamics (pdf) “Another consideration is that maternally‐derived antibodies against RSV can help protect the infant from infection, but may also dampen the endogenous response to neutralization‐sensitive antigenic sites on viral surface glycoproteins, and thus diminish vaccine immunogenicity. In addition to logistical and immunological factors that make implementation difficult and efficacy uncertain there are other features of the neonate that may complicate the vaccine development pathway from a safety or regulatory perspective. One is that there are more idiosyncratic rare adverse events in the neonate including apnea that may be difficult to distinguish from vaccine‐ associated events. Also, the small airway of the neonate increases the likelihood of obstructive events and leaves a relatively small therapeutic window, especially for vaccines administered into the airway, or those that may initially increase the inflammatory response to subsequent infection. This may have been part of the pathogenesis of the enhanced disease syndrome associated with a formalin‐inactivated whole virus vaccine tested in the 1960s, particularly evident in the youngest age group.
February 3, 2014 – DEATHS IN DEVELOPING COUNTRIES WILL COUNT FOR LESS Comment: by Jacob Puliyel “Presume that a healthy child is vaccinated. Suppose she develops high fever within 2 hours, has convulsions, then lapsed into a coma and dies within 10 hours. (Variations of this scenario have been enacted repeatedly with Pentavalent vaccine). Using CIOMS/WHO definitions, as the encephalopathy lasted less than 24 hours, it cannot be classified as encephalitis. In many countries, the facilities for a lumbar puncture may be unavailable, much less those for an EEG and CT/MRI. Under the report’s scheme, this would be labeled, “Insufficient information to distinguish both acute encephalitis and ADEM; Case unable to be definitely classified”. Also, comment on Impact and cost-effectiveness of Haemophilus influenzae type b conjugate vaccination in India.
February 2014 – Pentavalent Vaccine and Adverse Events Following Immunization—Untangling the Misinterpretations “The introduction of LPV in these two states was followed by reported deaths in infants who had received LPV. An exhaustive summary of media reports and previous literature has since been made available at various fora which have been supplemented with estimations of the damage the LPV may cause. It has thus been concluded that the LPV is bound to cause more number of infant deaths than it will save from Hib meningitis and pneumonia. The current paper aims to clear some of the misinterpretations and miscalculations so that lives of 72,000 infants can be saved.”
January 27, 2014 – Evaluation of regression in autism spectrum disorder based on parental reports (full text) “Turning to the question of what event preceded or was associated with the regression, the questionnaire data consisted of responses in four categories: Unknown (n = 26; 31.7%); vaccination (n = 47; 57.3%); infection (n = 6; 7.3%); or other (n = 3; 3.7%). In the group that reported regression after vaccination, the questionnaire responses fell into one of four categories: Multiple vaccines (n = 23; 48.9%); measles, mumps, and rubella (MMR) (n = 19; 40.4%); influenza (n = 3; 6.4%); and diphtheria, pertussis, and tetanus (DPT) (n = 2; 4.3%). Of those who listed vaccination as a factor, five (10.6%) stated that an infection was a cofactor. Of those who listed the DPT vaccine, one was prior to 1996 and one was after 1996. The questionnaires for those children in the ‘other’ category reported pesticide exposure (n = 1) and GI illness (n = 2) as the regression-associated factor. Being R or DR was not significantly related to any factors associated with the onset of regression. For a summary of this information, see [Table 3].
December 23, 2013 – The delicate balance in genetically engineering live vaccines “A central theme driving our discussion will stress that the ultimate success of an engineered vaccine rests on achieving the proper balance between attenuation and immunogenicity. Achieving this balance will avoid over-activation of inflammatory responses, which results in unacceptable reactogenicity, but will retain sufficient metabolic fitness to enable the live vaccine to reach deep tissue inductive sites and trigger protective immunity. The breadth of examples presented herein will clearly demonstrate that genetic engineering offers the potential for rapidly propelling vaccine development forward into novel applications and therapies which will significantly expand the role of vaccines in public health.”
December 4, 2013 – Association between Birth Order and Emergency Room Visits and Acute Hospital Admissions following Pediatric Vaccination: A Self-Controlled Study “Birth order is associated with increased incidence of ER visits and hospitalizations following vaccination in infancy. 1st-born children had significantly higher relative incidence of events compared to later-born children.”
October 25, 2013 – Age-dependent dysregulation of innate immunity “This aging-associated basal inflammation, particularly in humans, is thought to be induced by several factors, including the reactivation of latent viral infections and the release of endogenous damage-associated ligands of pattern recognition receptors (PRRs). Innate immune cell functions that are required to respond to pathogens or vaccines, such as cell migration and PRR signalling, are also impaired in aged individuals. This immune dysregulation may affect conditions associated with chronic inflammation, such as atherosclerosis and Alzheimer’s disease.”
October 4, 2013 – Applicability of the Brighton Collaboration Case Definition for seizure after immunization in active and passive surveillance in Canada “There were 459 IMPACT and 908 non-IMPACT cases analyzed, of which 99.6% and 27%, respectively, were serious reports. The revised reporting form that captured the BCCD components (2009–2011) was associated with increased proportions of IMPACT and non-IMPACT cases meeting the BCCD for generalized seizure.”
September 30, 2013 – Sudden Infant Death Following Hexavalent Vaccination: A Neuropathologic Study. “This study does not prove a causal relationship between the hexavalent vaccination and SIDS. However, we hypothesize that vaccine components could have a direct role in sparking off a lethal outcome in vulnerable babies. In conclusion, we sustain the need that deaths occurring in a short space of time after hexavalent vaccination are appropriately investigated and submitted to a post-mortem examination particularly of the autonomic nervous system by an expert pathologist to objectively evaluate the possible causative role of the vaccine in SIDS.”
September 8, 2013 – Assessment of causality of individual adverse events following immunization (AEFI): A WHO tool for global use “Serious illnesses or even deaths may rarely occur after childhood vaccinations. Public health programs are faced with great challenges to establish if the events presenting after the administration of a vaccine are due to other conditions, and hence a coincidental presentation, rather than caused by the administered vaccines.”
September 2013 – A small jab – a big effect: nonspecific immunomodulation by vaccines
- Routine vaccines may alter resistance to unrelated pathogens in children.
- Live vaccines are associated with increased protection to other pathogens.
- Inactivated vaccines may increase susceptibility to other pathogens.
- ‘Heterologous immunity’ and ‘trained innate immunity’ may explain these effects.
July-September 2013 – AEFI and the pentavalent vaccine: looking for a composite picture (pdf) “Deaths following the use of the vaccine resulted in the suspension of the immunisation drive in Sri Lanka as well. A WHO committee investigated the deaths. The full report of this committee was made available to the Delhi High Court. The report said that although the committee could find no alternative cause for the deaths (which would suggest that the vaccine was very likely to be the cause of the reactions and deaths), the deaths were ‘unrelated’ to the immunisation. The committee did not substantiate why it thought the reactions were ‘unrelated’ to immunisation. The experience in Pakistan was similar. The events surrounding the deaths following the administration of the vaccine were revealed by Professor F Mansoor, an expert on the committee investigating the deaths. One child died within half an hour of receiving the vaccine and two others died within 12–14 hours. No alternative cause of death was found in any of the cases. Two of the deaths were attributed to sudden infant death syndrome (SIDS), probably because the babies died after sunset, but the “experts were not sure of the third case.” In no case was the vaccine blamed.
June 5, 2013 – Vaccinomics, adversomics, and the immune response network theory: Individualized vaccinology in the 21st century “Vaccines, like drugs and medical procedures, are increasingly amenable to individualization or personalization, often based on novel data resulting from high throughput “omics” technologies. As a result of these technologies, 21st-century vaccinology will increasingly see the abandonment of a “one size fits all” approach to vaccine dosing and delivery, as well as the abandonment of the empiric “isolate–inactivate–inject” paradigm for vaccine development. In this review, we discuss the immune response network theory and its application to the new field of vaccinomics and adversomics, and illustrate how vaccinomics can lead to new vaccine candidates, new understandings of how vaccines stimulate immune responses, new biomarkers for vaccine response, and facilitate the understanding of what genetic and other factors might be responsible for rare side effects due to vaccines.” Gregory A. Poland
May 14, 2013 – High-dose vitamin A supplementation administered with vaccinations after 6 months of age: Sex-differential adverse reactions and morbidity “Adverse reactions were rare, mild and transient and may not in their own right cause concern. However, VAS caused sex-differential adverse reactions and may have sex-differential effects on adverse reactions to vaccines.”
May 9, 2013 – Atypical forms of Guillain-Barré syndrome and H1N1-influenza vaccination “We saw five patients with ‘atypical’ GBS variants that started within four weeks of 2010/2011 H1N1-influenza vaccine. There was no evidence for other etiologies of GBS. The patients presented with sensory ataxia, areflexia, extremity and oropharyngeal paresthesias, numbness, pain, weakness, sphincteric disturbances, and dysautonomia.”…”These pilot observations suggest that H1N1-influenza vaccine may be associated with rare and atypical variants of GBS.”
May 1, 2013 – Antityphoid Vaccination in Children – JAMA 100 Years Ago – “The following statistics are based on the records of inoculation of 359 children, between the ages of 2 and 16 years, who have been vaccinated by fifty different physicians in many parts of the United States; the reports here given may be considered as representing an average opinion of the degree of reactions.No attempt has been made to collect statistics regarding the degree of reaction at the site of inoculation” … “The dosage is based altogether on body weight and not on age; the child is given that portion of the adult dose which his weight bears to the average adult, weight, 150 pounds. If the fraction proves inconvenient, a little more, rather than less, is administered. As with adults, the best time for inoculation is 4 o’clock, or later, in the afternoon, since any reaction will then come after bedtime.”
April 26, 2013 – In the United States Court of Federal Claims Office of Special Masters Damages; decision based on proffer hepatitis B vaccine; chronic fatigue syndrome (pdf) “A lump sum payment of $1,076,412.15 representing compensation for life care expenses expected to be incurred during the first year after judgment ($40,357.92), lost future earnings ($838,566.45), pain and suffering ($194,580.48), and past unreimbursable expenses ($2,907.30), in the form of a check payable to petitioner;”
April 9, 2013 – Heterologous (“Nonspecific”) and Sex-Differential Effects of Vaccines: Epidemiology, Clinical Trials, and Emerging Immunologic Mechanisms “Immunologists call these heterologous effects and epidemiologists have called them nonspecific effects, indicating that they manifest against a broad range of pathogens/disease. These effects differ by sex, can be beneficial or detrimental, and appear to be mediated by mechanisms including innate immune memory (also known as “trained immunity”) and cross-reacting lymphocytes. Herein we review recent studies in this emerging field based on a meeting of experts, the recent Optimmunize meeting, held in Copenhagen, Denmark, in August 2012. Further characterization of these effects is likely to expand the way vaccines are evaluated and alter the manner and sequence in which they are given.”
March 27, 2013 – A literature review on optic neuritis following vaccination against virus infections “The risk for these vaccine-induced adverse events may be enhanced by adjuvants. Patient age distribution reflected immunization schedules and advisories, or patient age groups studied.”…”Despite a great deal of scientific uncertainty, the existence of a possible causal link between vaccines and acute ON should not be totally disregarded.”
March 2013 – Distal Acquired Demyelinating Symmetric Neuropathy After Vaccination – “We describe the clinical, laboratory, and neurophysiological findings of 2 patients who developed distal acquired demyelinating symmetric neuropathy after vaccination. Immunomodulatory therapy led to clinical improvement in both cases. The literature is reviewed with attention to the clinical features of chronic immune-mediated neuropathies that follow vaccination.”
March 2013 – Adverse events following immunizations: fact and fiction “Once vaccines are utilized at a population level (in different populations to those in which the clinical trials were performed), it is crucial to have systems in place to detect rare or unexpected AEFI. Capturing these events systematically to detect potential safety signals is one of the challenges for international vaccine safety. Once AEFI are reported it is important to determine whether the temporal association with the vaccine is one of causation (fact) or fiction (coincidence).”
February 2013 – Vaccination Site and Risk of Local Reactions in Children 1 Through 6 Years of Age (pdf) “Accordingly, the outcome of medically attended local reaction after an IM vaccination was defined by an ICD-9-CM diagnosis code of cellulitis (68a2.3, 682.6, and 682.9), ;o,b swelling (729.81), pain in limb (729.5), allergy unspecified (995.3), other unspecified disorder of skin (709.8), unspecified disorder of skin and subcutaneous tissue (709.9), lymphadenitis (289.3, 583, and 785.6), infection after infusion or vaccination (999.3), serum reaction (999.5), complications of medical care (999.9), or adverse effect of medication or biologic substance (995.2) assigned to an outpatient medical encounter on the day after vaccine administration (day 1) through day 5. As in Previous study, to exclude preexisitng conditions, presumptive cases defined by these criteria who also had an ICD code for cellulitis, limb swelling, pain in limb, unspecified skin disorders, allergy unspecified, or lymphadenitis (289.3, 682.3, 682.9, 683, 709.8, 709.9, 729.5, 729.81, 785.6, and 995.3) assigned on the day of vaccination or within the previous 30 days were excluded.”
January 7, 2013 – Immune responses and protection in children in developing countries induced by oral vaccines “The detrimental effect of adverse environment and malnutrition may bring about irreversible changes in the mucosa of children especially in the first 1000 days of life from conception to after birth and up to two years of age. This review aims to summarize the information available on lowered immune responses to mucosal vaccines and on interventions that may help address the constraints of these vaccines when they are used for children living under the greatest stress and under harmful adverse circumstances.”
January 2, 2013 – T cell vaccinology: Exploring the known unknowns “Live attenuated vaccines generate potent cellular and humoral immunity 0005, 0010 and 0015, but numerous problems exist with these vaccines, ranging from production and storage issues to adverse reactions and reversion to virulence. Subunit vaccines are safer, more stable, and more amenable to mass production. However the protection they produce is frequently inferior to live attenuated vaccines and is typically confined to humoral, and not cellular immunity.
October 25, 2012 – Characterizing Vaccine-associated Risks Using Cubic Smoothing Splines “The 2 models are then used to estimate the excess cumulative incidence attributable to the vaccination during the 42-day period after vaccination.”…”The splines revealed well-resolved spikes in fever, rash, and adenopathy diagnoses, with the maximum incidence occurring between 9 and 11 days after vaccination. For the negative control outcomes, the spline model yielded a predicted incidence more consistent with the modeled day-specific risks, although there was evidence of increased risk of diagnoses of congenital malformations after vaccination, possibly because of a “provider visit effect.” The proposed approach may be useful for vaccine safety surveillance.”
October 2012 – Risk of Immunodeficiency Virus Infection May Increase with Vaccine-Induced Immune Response “Thus, in the absence of protective antibodies or cytotoxic T cell responses, vaccine-induced immune responses may increase the susceptibility to acquisition of immunodeficiency virus infection. The results are consistent with the hypothesis that virus-specific T helper cells mediate this detrimental effect and contribute to the inefficacy of past HIV vaccination attempts (e.g., STEP study).
September 2011 – Infant mortality rates regressed against number of vaccine doses routinely given: Is there a biochemical or synergistic toxicity? (full text) “A closer inspection of correlations between vaccine doses, biochemical or synergistic toxicity, and IMRs, is essential. All nations—rich and poor, advanced and developing—have an obligation to determine whether their immunization schedules are achieving their desired goals.”
May 1, 2010 – Adversomics: The Emerging Field of Vaccine Adverse Event Immunogenetics (full text) “An example is that epidemiologic studies have quantified the risk of immune thrombocytopenic purpura (ITP) and anaphylaxis, attributable to the MMR vaccine in the second year of life as 1 case per 40,000 vaccinated children. Recently France et al demonstrated that 76% of ITP cases in children ages 12 to 23 months were related to MMR vaccination. Identification of a genetic association between MMR vaccine and ITP would be important and would inform attempts at developing preventive strategies or improved vaccines. A further example is the expanding recommendations for the use of seasonal influenza vaccine and the potential use of pandemic vaccines globally; studies of the genetic susceptibility to Guillain-Barre Syndrome (GBS) would be important.”
January 4 2010 – In the United States Court of Federal Claims Office of Special Masters Entitlement; hepatitis B vaccine; hepatitis, chronic fatigue syndrome, fibromyalgia, and polyneuropathy (pdf) “Petitioner has proven a prima facie case that hepatitis B vaccine caused her chronic fatigue syndrome, hepatitis, fibromyalgia, and polyneuropathy. Without the vaccination, she would not have these illnesses.”
October 2006 – Sudden infant death syndrome (SIDS) shortly after hexavalent vaccination: another pathology in suspected SIDS? ” Examination of the brainstem on serial sections revealed bilateral hypoplasia of the arcuate nucleus. The cardiac conduction system presented persistent fetal dispersion and resorptive degeneration. This case offers a unique insight into the possible role of hexavalent vaccine in triggering a lethal outcome in a vulnerable baby. Any case of sudden unexpected death occurring perinatally and in infancy, especially soon after a vaccination, should always undergo a full necropsy study according to our guidelines.”
December 11, 2002 – Mumps vaccine-associated acute orchitis with accompanying idiopathic thrombocytopenic purpura “Mumps vaccine is now used routinely by national immunisation programmes in most countries, and mumps morbidity has dramatically declined as a result. Despite its efficacy, adverse reactions to the vaccine have also been reported. The present case is an example of a rare monovalent mumps vaccine-associated acute orchitis with accompanying ITP. Such orchitis is very rare and only a few cases have been reported, but vaccine-associated ITP has been occasionally reported in patients given various vaccines, including poliomyelitis, measles and rubella.
August 2002 – Herpes zoster by reactivated vaccine varicella zoster virus in a healthy child “We report a healthy 2-year-old girl who developed an impressive herpes zoster infection 16 months after vaccination, localised in three cervical dermatoma. As causative virus, VZV vaccine strain was identified by polymerase chain reaction and analysis of restriction fragment length polymorphisms of the amplified products. Conclusion: vaccine varicella zoster virus can occasionally reactivate in healthy children and present as herpes zoster. Virus characterizationis necessary to identify the strain and provide information on the incidence of occurrence.”
May 1999 – Managing the Risks From Medical Product Use Creating a Risk Management Framework – Report to the FDA Commissioner From the Task Force on Risk Management (pdf) “FDA noted that thrombocytopenia following immunization with measles containing vaccines was more severe than was previously perceived. Approximately 40 percent of reports of postimmunization thrombocytopenia described cases with platelet counts # 20,000, a level that has been associated with spontaneous life-threatening hemorrhage. In reviewing all reported cases of post-MMR thrombocytopenia in VAERS, FDA found one case of thrombocytopenia that resulted from positive rechallenge with MMR vaccine. FDA also found two deaths that occurred in children with postimmunization thrombocytopenia;
August 1958 – ECZEMA VACCINATUM – 1) No child with atopic eczema or other skin disorder should be vaccinated. 2) No child should be vaccinated if any member of his family has eczema or other skin disorder. 3) Parents of children with eczema should be notified at the onset of the disease of the danger from vaccination contact. 4) If a sibling of a child with atopic eczema is vaccinated, he must be completely separated from that child for at least 21 days. 5) Forms used by state and local health departments for parents’ consent to vaccination should include an appropriate warning of the contraindications. 6) Eczema vaccinatum should be a reportable disease. 7) Patients recently vaccinated must be excluded from pediatric wards containing patients with atopic eczema, other diseases of the skin, burns or healing surgical incisions. 8) Vaccination may be recommended at 2 months of age, especially for babies from strongly allergic families.”