Vaccines and sudden infant death: An analysis of the VAERS database 1990–2019 and review of the medical literature

Miller, Neil Z.

doi:10.1016/j.toxrep.2021.06.020

Cited by 5 publications

(7 citation statements)

References 43 publications

(46 reference statements)

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“…A recent study published in Toxicology Reports [ 27 ] analyzed an association between pediatric vaccines and sudden infant death. Of the 2605 infant deaths reported to the Vaccine Adverse Event Reporting System (VAERS) from 1990 through 2019, 58% clustered within three days post-vaccination, and 78% occurred within seven days post-vaccination, confirming that infant deaths tend to occur in temporal proximity to vaccine administration.…”

Section: Discussionmentioning

confidence: 99%

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Reaffirming a Positive Correlation Between Number of Vaccine Doses and Infant Mortality Rates: A Response to Critics

Goldman¹,

Miller²

2023

Cureus

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Introduction In 2011, we published a study that found a counterintuitive, positive correlation, r = 0.70 ( p < .0001), demonstrating that among the most highly developed nations ( n = 30), those that require more vaccines for their infants tend to have higher infant mortality rates (IMRs). Critics of the paper recently claimed that this finding is due to "inappropriate data exclusion," i.e., the failure to analyze the "full dataset" of all 185 nations. Objective In the present study, we examine various claims postulated by these critics and the validity of their scientific methods, and we perform several investigations to assess the reliability of our original findings. Methods The critics select 185 nations and use linear regression to report a correlation between the number of vaccine doses and IMRs. They also perform multiple linear regression analyses of the Human Development Index (HDI) vs. IMR with additional predictors and investigate IMR vs. percentage vaccination rates for eight different vaccines. We perform odds ratio, sensitivity, and replication analyses. Results The critics' reanalysis combines 185 developed and Third World nations that have varying rates of vaccination and socioeconomic disparities. Despite the presence of inherent confounding variables, a small, statistically significant positive correlation of r = 0.16 ( p < .03) is reported that corroborates the positive trend in our study. Multiple linear regression analyses report high correlations between IMR and HDI, but the number of vaccine doses as an additional predictor is not statistically significant. This finding is a likely consequence of known misclassification errors in HDI. Linear regression of IMR as a function of percentage vaccination rates reports statistically significant inverse correlations for 7 of 8 vaccines. However, several anomalies in the scatter plots of the data suggest that the chosen linear model is problematic. Our odds ratio analysis conducted on the original dataset controlled for several variables. None of these variables lowered the correlation below 0.62, thus robustly confirming our findings. Our sensitivity analysis reported statistically significant positive correlations between the number of vaccine doses and IMR when we expanded our original analysis from the top 30 to the 46 nations with the best IMRs. Additionally, a replication of our original study using updated 2019 data corroborated the trend we found in our first paper ( r = 0.45, p = .002). Conclusions A positive correlation between the number of vaccine doses and IMRs is detectable in the most highly developed nations but attenuated in the background noise of nations with heterogeneous socioeconomic variables that contribute to high rates of infant mortality, such as maln...

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Section: Discussionmentioning

confidence: 99%

“…A recent study published in Toxicology Reports [27] analyzed an association between pediatric vaccines and…”

Section: Additional Concernsmentioning

confidence: 99%

Reaffirming a Positive Correlation Between Number of Vaccine Doses and Infant Mortality Rates: A Response to Critics

Goldman¹,

Miller²

2023

Cureus

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“…It is noted that, although models of various types have been developed for different vaccine reports based on exploratory data analyses and the application of ML techniques on VAERS data [ 4 , 6 , 7 , 9 , 10 , 11 , 12 , 13 , 15 , 16 , 20 , 28 ], the model development for evolving VAERS data can be exposed to unseen situations that would neither be available for model training nor for validation. Despite the anticipated outcome from the ML perspective, the monitoring and testing strategies should be carefully implemented.…”

Section: Discussionmentioning

confidence: 99%

“…VAERS datasets have been used in various studies for recommendations and proactive strategies for regulatory bodies (CDC and FDA) [ 4 , 5 , 6 , 7 , 8 , 9 , 10 , 11 , 12 , 13 , 14 , 15 , 16 , 17 , 18 , 19 , 20 , 21 ]. To date, only limited studies have comprehensively focused on the protocols to be followed when VAERS datasets are used for statistical analyses ( Supplementary Materials—Section S1 ).…”

Section: Introductionmentioning

confidence: 99%

Usefulness of Vaccine Adverse Event Reporting System for Machine-Learning Based Vaccine Research: A Case Study for COVID-19 Vaccines

Flora

Khan

Jin

et al. 2022

IJMS

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Usefulness of Vaccine-Adverse Event-Reporting System (VAERS) data and protocols required for statistical analyses were pinpointed with a set of recommendations for the application of machine learning modeling or exploratory analyses on VAERS data with a case study of COVID-19 vaccines (Pfizer-BioNTech, Moderna, Janssen). A total of 262,454 duplicate reports (29%) from 905,976 reports were identified, which were merged into a total of 643,522 distinct reports. A customized online survey was also conducted providing 211 reports. A total of 20 highest reported adverse events were first identified. Differences in results after applying various machine learning algorithms (association rule mining, self-organizing maps, hierarchical clustering, bipartite graphs) on VAERS data were noticed. Moderna reports showed injection-site-related AEs of higher frequencies by 15.2%, consistent with the online survey (12% higher reporting rate for pain in the muscle for Moderna compared to Pfizer-BioNTech). AEs {headache, pyrexia, fatigue, chills, pain, dizziness} constituted >50% of the total reports. Chest pain in male children reports was 295% higher than in female children reports. Penicillin and sulfa were of the highest frequencies (22%, and 19%, respectively). Analysis of uncleaned VAERS data demonstrated major differences from the above (7% variations). Spelling/grammatical mistakes in allergies were discovered (e.g., ~14% reports with incorrect spellings for penicillin).

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“…Sudden infant deaths (SID) has been argued to be increased after the DTP containing vaccines in the United States [ 12 ]. This concern gained momentum when infant deaths were reported following pentavalent vaccination across several Asian countries and later in India [ 13 ].…”

Section: Introductionmentioning

confidence: 99%

Adverse Events Following Immunization- The Known Unknowns and Black Box

Das

2023

Indian J Pediatr

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Although vaccines are one of the most rigorously tested biological products, the safety concerns persist globally. The vaccine safety concerns linked to measles, pentavalent and human papillomavirus (HPV) vaccines have affected the vaccine coverage significantly in past. While surveillance of adverse events following immunization (AEFI) is part of the national immunization program mandate, it suffers from challenges and biases related to reporting, completeness, and quality. Some conditions of concern, termed as adverse events of special interest (AESI) following vaccination, mandated specialised studies to prove/disprove the association. The AEFIs/AESIs are usually caused by one of the four pathophysiologic mechanisms, but for several AEFIs/AESIs, the exact pathophysiology remains elusive. For the causality assessment of AEFIs, a systematic process with checklists and algorithm are followed to classify into one of the four causal association categories. While the causal association primarily banks on epidemiological observations for several AEFIs, the emerging evidences indicate roles of underlying genetic, gender, age and other pro-inflammatory risk factors for AEFIs and AESIs. The emerging evidences suggest role of antigenic mimicry, autoantibody(ies) and underlying genetic susceptibility for the AEFIs/AESIs. The uncertainty about the frequency, profile, interval, and severity of AEFIs/AESIs and variations across the population, ambiguity about the exact pathophysiology mechanism, absence of definite markers, suggest a possible black box effect of the vaccines. Unless these unanswered questions concerning the AEFIs/AESIs are addressed appropriately and communicated to the stakeholders (professionals, care providers, beneficiaries, general public and media), the anti-vaccine movement shall keep challenging the vaccine and vaccination program.

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Vaccines and sudden infant death: An analysis of the VAERS database 1990–2019 and review of the medical literature

Cited by 5 publications

References 43 publications

Reaffirming a Positive Correlation Between Number of Vaccine Doses and Infant Mortality Rates: A Response to Critics

Reaffirming a Positive Correlation Between Number of Vaccine Doses and Infant Mortality Rates: A Response to Critics

Usefulness of Vaccine Adverse Event Reporting System for Machine-Learning Based Vaccine Research: A Case Study for COVID-19 Vaccines

Adverse Events Following Immunization- The Known Unknowns and Black Box

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