https://journals.sagepub.com/doi/abs/10.1177/09246479261453789

Batch-dependent safety signal: Nationwide analysis of suspected adverse events following COVID-19 vaccination in Germany

Vibeke Manniche vibeke@vibekemanniche.dkVít Karásek https://orcid.org/0009-0007-1638-2778[…], and Peter Riis Hansen https://orcid.org/0000-0002-9056-535X+3View all authors and affiliations

Abstract
Background

Preliminary reports have suggested a batch-dependent safety signal for COVID-19 vaccines. It is important to establish if these findings can be replicated.

Methods

We used publicly available nationwide data from Germany spanning the first 3.5 years of the vaccination campaign to calculate weekly rates of spontaneously reported suspected adverse events (SAEs) per 1000 administered vaccine doses.

Results

SAE rates ranged between 2.2 and 22.8 per 1000 doses and women accounted for 72% of all SAEs. Crucially, SAE rates for Comirnaty (Pfizer-BioNTech), Spikevax (Moderna), and Vaxzevria (AstraZeneca) were very high in the initial phase of vaccination rollout and hereafter declined precipitously. For example, SAE rates in weeks 1–4 of 2021 were 8.2, 50.8, and 620.9 per 1000 doses of Comirnaty, Spikevax, and Vaxzevria, respectively, but fell to 4.4, 11.6, and 7.4 per 1000 doses in weeks 12–16 of 2021.

Conclusions

SAE rates in Germany were highly elevated in the initial phase of COVID-19 vaccination rollout and then fell precipitously, a pattern compatible with a batch-dependent safety signal. Furthermore, there was a considerable overrepresentation of women with SAEs. These preliminary results call for more definitive studies of batch-dependent COVID-19 vaccine safety

Natural Immunity vs Vaccination
​Why antibodies are not the same as true immunity — and how vaccine-free parents build healthier, more resilient children.
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*What natural immunity really means
*Why natural immunity is more than “getting sick”
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*Why vaccine failure and booster shots raise important questions
*Why fever, mucus, fatigue, rash, cough, and appetite changes can be part of the immune response
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Larry Duane Cook
www.UnvaccinatedChildren.com

https://www.change.org/p/the-us-senate-calling-for-a-congressional-investigation-of-the-cdc-idsa-and-aldf/u/34959511

Vinyard Gazette: Scientists Study Martha’s Vineyard to Get to Root of Chronic Lyme

Carl TuttleHudson, NH, United States

Jul 13, 2026

God forbid we find better antimicrobials for treating Lyme disease because that would give the public an excuse not to take the Lyme vaccine soon to be released!!!

—– Forwarded Message —–
From: CARL TUTTLE <runagain@comcast.net>
To: egenter@vineyardgazette.com <egenter@vineyardgazette.com>; bill@vineyardgazette.com <bill@vineyardgazette.com>; news@vineyardgazette.com <news@vineyardgazette.com>
Cc: linden.hu@tufts.edu <linden.hu@tufts.edu>; cseguin@partners.org <cseguin@partners.org>; jayanta.bhattacharya@nih.hhs.gov <jayanta.bhattacharya@nih.hhs.gov>; Stephanie.Haridopolos@hhs.gov <stephanie.haridopolos@hhs.gov>; kalachakra108@aol.com <kalachakra108@aol.com>; kbliegnermd@optonline.net <kbliegnermd@optonline.net>
Sent: Tuesday, June 30, 2026 at 02:26:37 PM EDT
Subject: Vinyard Gazette: Scientists Study Martha’s Vineyard to Get to Root of Chronic Lyme

Vinyard Gazette
Scientists Study Martha’s Vineyard to Get to Root of Chronic Lyme
https://vineyardgazette.com/news/2026/06/28/scientists-study-marthas-vineyard-get-root-chronic-lyme
By Ethan Genter June 28, 2026

Excerpt:
“We don’t really have any idea,” said Dr. Linden Hu, an infectious disease specialist at Tufts who is helping lead the research. “We had the same hypotheses we had 30 years ago with no clear .
“People are recruited when they have the tell-tale rash – one of the earliest signs of Lyme disease.”

Vineyard Gazette
Edgartown, MA
Attn: Ethan Genter, News Editor

Dear Ethan,
Please see the following eleven articles published in the peer-reviewed literature on dapsone combination therapy for Lyme disease and the MSIDS model. Does Dr. Hu really not know about them, or dismisses Dr. Horowitz’ results because it’s not based on a randomized trial? It is interesting that Tufts received millions of dollars of research money from the NIH and Horowitz couldn’t get a 250k grant approved for a randomized, multicenter trial. More on that found here:

Dr. Jay Bhattacharya; Fund Dr. Richard Horowitz’ R34 NIH grant on Dapsone treatment for Lyme disease
https://www.change.org/p/the-us-senate-calling-for-a-congressional-investigation-of-the-cdc-idsa-and-aldf/u/34365550

As for Hu’s research, it is focusing on the acute or early stage of the disease while patients who are the sickest went years or decades before obtaining a diagnosis ignoring the late-stage Lyme epidemic seen all across this nation. What academic discipline would Hu encounter if he focused on better antimicrobials???
11 Dapsone Articles on The Effective Treatment of Chronic LD & Associated Co-infections Including Bartonella: As of April 2026
Horowitz, R. Improving biomarkers of inflammation including phosphorylated tau in a patient with chronic Lyme disease/post-treatment Lyme disease syndrome using dapsone combination therapy: A case study and literature review. Journal of Alzheimer’s Disease Reports. April 27, 2026. DOI: 10.1177/25424823261445434 https://journals.sagepub.com/…/10.1177/25424823261445434
Horowitz, R.I.; Fallon, J.; Freeman, P.R. Combining Double-Dose and High-Dose Pulsed Dapsone Combination Therapy for Chronic Lyme Disease/Post-Treatment Lyme Disease Syndrome and Co-Infections, Including Bartonella: A Report of 3 Cases and a Literature Review. Microorganisms 2024, 12, 909. https://doi.org/10.3390/microorganisms12050909
Horowitz, R.I.; Fallon, J.; Freeman, P.R. Comparison of the Efficacy of Longer versus Shorter Pulsed High Dose Dapsone Combination Therapy in the Treatment of Chronic Lyme Disease/Post Treatment Lyme Disease Syndrome with Bartonellosis and Associated Coinfections. Microorganisms 2023, 11, 2301. https://doi.org/10.3390/microorganisms11092301
Horowitz RI, Freeman PR. Efficacy of Short-Term High Dose Pulsed Dapsone Combination Therapy in the Treatment of Chronic Lyme Disease/Post-Treatment Lyme Disease Syndrome (PTLDS) and Associated Co-Infections: A Report of Three Cases and Literature Review. Antibiotics. 2022; 11(7):912. https://doi.org/10.3390/antibiotics11070912
https://www.mdpi.com/2079-6382/11/7/912/htm
Horowitz, R.I.; Freeman, P.R. Efficacy of Double-Dose Dapsone Combination Therapy in the Treatment of Chronic Lyme Disease/Post-Treatment Lyme Disease Syndrome (PTLDS) and Associated Co-infections: A Report of Three Cases and Retrospective Chart Review. Antibiotics 2020, 9, 725. https://doi.org/10.3390/antibiotics9110725
Horowitz, R.I., Murali, K., Gaur, G. et al. Effect of dapsone alone and in combination with intracellular antibiotics against the biofilm form of B. burgdorferi. BMC Res Notes 13, 455 (2020). https://doi.org/10.1186/s13104-020-05298-6
https://bmcresnotes.biomedcentral.com/…/s13104-020
Horowitz, R.I.; Freeman, P.R. Precision Medicine: retrospective chart review and data analysis of 200 patients on dapsone combination therapy for chronic Lyme disease/post-treatment Lyme disease syndrome: part 1. International Journal of General Medicine 2019:12 101–119
https://www.dovepress.com/precision-medicine
https://www.ncbi.nlm.nih.gov/pubmed/30863136
https://www.ncbi.nlm.nih.gov/pubmed/30863136
Horowitz, R.I.; Freeman, P.R. Precision Medicine: The Role of the MSIDS Model in Defining, Diagnosing, and Treating Chronic Lyme Disease/Post Treatment Lyme Disease Syndrome and Other Chronic Illness: Part 2. Healthcare 2018, 6, 129.
https://www.ncbi.nlm.nih.gov/pubmed/30400667
Horowitz RI, Freeman PR (2016) Are Mycobacterium Drugs Effective for Treatment Resistant Lyme Disease, Tick-Borne Co-Infections, and Autoimmune Disease?. JSM Arthritis 1(2): 1008.
Horowitz RI, Freeman PR (2016) The Use of Dapsone as a Novel “Persister” Drug in the Treatment of Chronic Lyme Disease/Post Treatment Lyme Disease Syndrome. J Clin Exp Dermatol Res 7: 345. doi:10.4172/2155-9554.1000345
Tardo AC, McDaniel CE and Embers ME (2023). Superior efficacy of combination antibiotic therapy versus monotherapy in a mouse model of Lyme disease. Front. Microbiol. 14:1293300. doi: 10.3389/fmicb.2023.1293300
https://www.frontiersin.org/…/fmicb.2023.1293300/full
Dapsone documentary 2024:
https://drtalks.com/…/discover-healing-18-dapsone…/
Dapsone documentary 2025:
https://drtalks.com/…/dapsone-documentary-9-stories-of
Dr. H Podcast with Dr Alain Mass and Dr Charlie Bizilj on The Success of Dapsone Combination Therapy in the Treatment of Chronic Lyme Disease. May 21, 2025
https://us06web.zoom.us/…/TSVaYe6azIti
Passcode: &0yqten0
Dr. Horowitz has a new book and website, which has the 2000+ scientific references in Ending Chronic Illness listed on the site for review.
https://cangetbetter.com/

Respectfully Submitted,
Carl Tuttle
Independent Researcher
Hudson, NH
Cc:
-Dr. Linden Hu, Professor of Immunology at Tufts Medical School
-Claire Seguin, DNP, President and Chief Operating Officer of Martha’s Vineyard Hospital
-Bill Eville, Editor Vinyard Gazette
-Stephanie E. Haridopolos, MD, DABFM Principal Deputy Assistant Secretary for Health
-Jay Bhattacharya, Director of the National Institutes of Health
-Dr. Richard Horowitz, MD Board certified internist in private practice in Hyde Park, New York
-Dr. Kenneth B. Liegner Board Certified Internist with additional training in Pathology and Critical Care Medicine, practicing in Pawling, New York.
Paralyzed by Lyme, they were helped with combo treatments (please read!!!)
https://www.change.org/p/the-us-senate-calling-for-a-congressional-investigation-of-the-cdc-idsa-and-aldf/u/31772769

Sign this petition

https://childrenshealthdefense.org/defender/exclusive-sen-ron-johnson-demands-journal-turn-over-records-related-sids-vaccines-study/

Exclusive: Sen. Ron Johnson Demands Journal Turn Over Records Related to SIDs and Vaccines Study

In a letter made public today, Sen. Ron Johnson called on the editor-in-chief of Toxicology Reports and the CEO of Elsevier, which owns the journal, to release all records related to the decision to remove vaccine researcher Neil Z. Miller’s peer-reviewed analysis of VAERS data showing that many more SIDS reports were filed in VAERS in the first few days after vaccination compared to later on after vaccination.

by Suzanne Burdick, Ph.D.

June 30, 2026

This article was originally published by The Defender — Children’s Health Defense’s News & Views Website.

screenshot of removed journal and question mark

Sen. Ron Johnson (R-Wis.) is demanding to know why a 2021 peer-reviewed paper that presented data suggesting a possible link between vaccination and sudden infant death syndrome (SIDS) was recently removed from the Toxicology Reports website.

In a letter dated June 29 and made public today, Johnson called on the editor-in-chief of Toxicology Reports and the CEO of Elsevier, which owns the journal, to release all records related to the decision to remove vaccine researcher Neil Z. Miller’s analysis: “Vaccines and sudden infant death: An analysis of the VAERS database 1990-2019 and review of the medical literature.”

The analysis showed that from 1990 to 2019, many more SIDS reports were filed in the Vaccine Adverse Event Reporting System (VAERS) in the first few days after vaccination compared to later on after vaccination.

The paper also included a comprehensive review of the scientific literature on vaccines and SIDS, including documentation of large increases in SIDS rates following the rollout of national immunization campaigns and numerous case reports of SIDS in babies who were recently vaccinated.

Toxicology Reports published Miller’s analysis in June 2021 after it passed the peer-review process.

Johnson, who recently held a hearing about attacks on published science, noted that Miller’s paper had been criticized on PubPeer, a platform critics have nicknamed “PubSmear.”

He also noted that on June 11, U.S. Health Secretary Robert F. Kennedy Jr. also wrote to Toxicology Reports’ editor-in-chief demanding details about the process leading up to the journal’s removal of Miller’s analysis.

https://platform.twitter.com/embed/Tweet.html?dnt=false&embedId=twitter-widget-0&features=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%3D%3D&frame=false&hideCard=false&hideThread=false&id=2066551769006538847&lang=en&origin=https%3A%2F%2Fchildrenshealthdefense.org%2Fdefender%2Fexclusive-sen-ron-johnson-demands-journal-turn-over-records-related-sids-vaccines-study%2F&sessionId=a739383cf1b21df5bc27759283ab5e09d07bd182&siteScreenName=ChildrensHD&theme=light&widgetsVersion=6a3ad42b224df%3A1778106238597&width=550px

Kennedy also asked the journal to clarify why it opted to remove the article, rather than issue an expression of concern or a retraction.

‘No one has engaged with the data. They simply made the paper disappear.’

On April 9, Toxicology Reports posted a removal notice for Miller’s article, citing “serious methodological flaws.”

Miller told The Defender why he believes the removal was unjustified. He said:

“The core findings of my paper — the temporal clustering of infant deaths in the immediate post-vaccination window, the historical SIDS rate spike following the national immunization campaign, the full literature review — remain unrefuted.

“No one has engaged with the data. They simply made the paper disappear. That should concern every parent, every researcher, and anyone who believes science advances through open inquiry rather than institutional gatekeeping.”

According to the notice, the editor-in-chief decided to remove Miller’s analysis because it used VAERS data “to infer a correlation between vaccination and sudden infant death syndrome (SIDS).”

However, Miller said he never claimed a causal relationship between vaccination and SIDS. He said:

“My paper stated plainly: ‘While this paper does not prove an association between infant vaccines and sudden infant deaths, it reveals unusual patterns and safety signals highly suggestive of a causal relationship.’ I called for further investigation — nothing more.”

The journal launched an investigation into the article after PubPeer commenters criticized Miller’s paper starting in November 2021.

Some comments cited criticism posted on X by Magdalen R. Wind-Mozley, a former forensic scientist and vaccine advocate based in Newbury, England, who posts under the username “Rosewind,” Retraction Watch reported.

According to Retraction Watch, Wind-Mozley contacted the journal in 2022 to call for the article’s retraction.

COVID Justice Resolution: Sign the Resolution

The journal notified Miller about concerns raised by the commenters. According to the removal notice, “The Editor-in-Chief determined that the author’s response did not satisfactorily address the concerns raised about this article.”

However, Miller tells a different account of how things unfolded. He said:

“Neither Dr. Lash (Toxicology Reports) nor Dr. Papi (Elsevier) ever specified what the alleged methodological flaws were. From subsequent correspondence, I gathered their concern likely centered on reporting bias — an issue I had already explicitly addressed in the paper’s ‘Strengths and Limitations’ section.”

Since Miller had already acknowledged the critics’ concern — reporting bias — as a limitation of the study when it was first published, on what grounds did the journal remove it?

That’s a question that needs answering, Miller said. “I am deeply appreciative of Senator Ron Johnson and Secretary Kennedy for their efforts to get to the root of this problem.”

In his letter, Johnson cited a grieving mother who lost her child to SIDS. The mother said every parent at her SIDS support group brought up vaccines.

According to Johnson, the mother said, “We were all asking our SIDS support group leader, you know, is there a connection? Just seems like all of us feel like vaccines are involved.”

Johnson wrote:

“We owe it to this mother and all parents that have lost a child to SIDS to encourage and promote — instead of discourage and remove — medical research into the potential connection between vaccines and pediatric deaths.”

Miller’s paper cited possible biological explanations for why vaccination might cause SIDS in some babies, including inflammatory cytokines and some babies’ inability to process the toxicity of multiple vaccines given at once.

A 2025 study published in the International Journal of Medical Sciences found that underdeveloped liver enzyme pathways in some infants may make it harder for them to process toxic ingredients in vaccines, possibly leading to SIDS.

“I suspect this amplified visibility, and the attendant fear of increased vaccine hesitancy, was instrumental in the decision to pull the article,” he said.

Brian Hooker, Ph.D., Children’s Health Defense (CHD) chief scientific officer, called Johnson’s letter “extremely encouraging and timely” given the lack of transparency surrounding the removal of Miller’s paper.

In April, Sage Journals notified Hooker that it is investigating a 2020 article he co-authored with Miller comparing health outcomes between vaccinated and unvaccinated children following criticisms on PubPeer.

Sage stamped Hooker and Miller’s article with an “expression of concern” as it conducts its review.

Given these recent attacks on studies that raise questions about the safety of vaccines, Hooker said he was “heartened that both Sen. Johnson and Secretary Kennedy are investigating the very real threats of censorship of robust vaccine safety science.”

“Unlike their predecessors, these officials are interested in promoting scientific inquiry for the best health of our nation, rather than Big Pharma dogma focused on profits and institutions,” Hooker said.

Miller said he hopes that “credible research is evaluated on its merits, and that articles are not removed or retracted solely because their findings are controversial or challenge prevailing views.”

Suzanne Burdick, Ph.D.

Suzanne Burdick, Ph.D.

Suzanne Burdick, Ph.D., is a senior reporter for The Defender based in Austin, Texas.

This article was originally published by The Defender — Children’s Health Defense’s News & Views Website under Creative Commons license CC BY-NC-ND 4.0. Please consider subscribing to The Defender or donating to Children’s Health Defense.

__________________

**Comment**

It’s important to remember there are NO ICD CODES in the database to signify deaths caused by vaccines. They do not exist. Coroners simply can not designate a death to vaccines even if the evidence is crystal clear. This means all deaths due to vaccines are designated to something else. SIDS is the most common designation and remains the leading cause of death among infants in the U.S.

Let that sink in a moment.

The leading cause of infant death could very well be caused directly from vaccines but we will never know because of the fraudulent reporting system (similar to Lyme/MSIDS) as well as to being such a hotly contested topic nobody has the cajones to study it and engage with the data. It’s a hot potato and no researcher in his right mind would take that beast on.

Yet…..that’s exactly what a researcher did.

In fact it was even peer-reviewed and published, until it was recently removed. POOF!

That seems to be how ‘the powers that be’ deal with inconvenient data. It gets disappeared.

This tactic was also used with:

  • Dr. Andrew Wakefield’s article about autism and vaccines. They completely destroyed his career AND retracted his paper.
  • Judy Mikovitz’s paper showing retroviral contamination in vaccines. Besides unjustly throwing her in jail without a search warrant, they destroyed her career and retracted her article.
  • Researchers destroying evidence suggesting African-American males who received the MMR vaccine before age 36 months were at increased risk for autism.

And the list goes on. You simply will not survive the medical/research field if you dare to question vaccine dogma. It isn’t tolerated.

And please, don’t trust doctors who receive barely enough education to read vaccine package inserts to give vaccine advice. They receive kickbacks for pushing vaccines at Wellness Visits.

https://popularrationalism.substack.com/p/the-emergency-that-will-not-die-do?

The Emergency That Will Not Die: Do Not Relent

HHS Begins Cutting the COVID EUA Knot. The PREP Act Liability Wall Still Stands. Tell Your Legislators: Tear Down This Wall.

James Lyons-Weiler, PhD

Jul 01, 2026

HHS announced today that Secretary Kennedy signed determinations terminating the COVID-19 EUA declarations for drugs and biological products and for medical devices, because HHS determined that the circumstances justifying those emergency authorities no longer exist. HHS says the drug/biologic declaration ends after a 12-month notice period, while the device declarations end after 180 days.

The Federal Register public-inspection notices give the exact effective dates: June 29, 2027 for COVID-19 drugs and biological products, and December 26, 2026 for the three device declarations covering in vitro diagnostics, personal respiratory protective devices, and other medical devices.

This is an essential first step toward reversing the regulatory capture by Pharma over public health, medicine and our bodies.

The COVID emergency did not merely authorize medical products. It reorganized accountability. Here’s how, and what comes next.

The Public Readiness and Emergency Preparedness Act, the PREP Act, created the liability architecture. The statute granted a covered person immunity from suit and liability under federal and state law for claims of loss caused by, arising out of, relating to, or resulting from administration or use of a covered countermeasure when HHS issues a declaration for that countermeasure. The same statutory section extends that immunity to claims causally related to design, development, clinical testing, manufacture, labeling, distribution, marketing, promotion, sale, purchase, donation, dispensing, prescribing, administration, licensing, or use. That is not ordinary product regulation. That is an extraordinary legal shield.

COVID policy went askew because the federal government placed emergency countermeasures inside that shield, then allowed public agencies, employers, hospitals, universities, schools, pharmacies, and media institutions to behave as though the shielded products had entered civic life under ordinary conditions. They had not. The public encountered campaigns, recommendations, employment pressure, access restrictions, and moral messaging. The manufacturers and administrators operated inside a liability regime that ordinary medical products do not enjoy.

That is the first distortion: the burden moved downward. Manufacturers received insulation. Program planners received insulation. Administrators received insulation. Injured individuals moved into a narrow administrative channel, and they carried the burden they never agreed to carry.

The PREP Act also created the covered-countermeasure compensation process. The statute establishes a fund for eligible individuals with covered injuries directly caused by administration or use of a covered countermeasure, but the process does not replicate ordinary civil litigation. HRSA’s own comparison of the Countermeasures Injury Compensation Program and the National Vaccine Injury Compensation Program states that CICP has a one-year filing deadline, does not pay attorneys’ fees or costs, resolves requests through an administrative process, allows one administrative reconsideration step, and permits no judicial appeal. VICP proceeds through the U.S. Court of Federal Claims, uses Special Masters or judges, and permits judicial appeal.

That is the second distortion: injury claims did not enter the legal system the public imagines when it hears the word “compensation.” They entered CICP…… (See link for full article)

The third distortion came from the Emergency Use Authorization structure.

FDA states that an EUA declaration under section 564 of the Federal Food, Drug, and Cosmetic Act differs from and does not depend on a public-health emergency declaration under section 319 of the Public Health Service Act. FDA also states that an EUA may remain in effect beyond the end of the section 319 public-health emergency if the statutory conditions remain satisfied. If the HHS Secretary terminates an EUA declaration, EUAs issued under that declaration cease to be effective, with limited transition exceptions, and FDA may no longer issue EUAs for products covered by that declaration.

That separation turned emergency law into a maze. The public-health emergency could end while the emergency product channel continued. The visible emergency could recede while the legal machinery remained in place. The public could hear that the crisis had ended while COVID products, tests, devices, and therapeutics continued through emergency pathways.

With the termination of the EUA, HHS has now started cutting that maze apart. This is not a small administrative cleanup. It is the first formal admission that the COVID emergency-use structure no longer fits the regulatory facts.

Here is the policy indictment: the government allowed emergency authority to outlive the emergency conditions that justified it.

__________________

Important excerpt:

The PREP Act wall still stands. The twelfth PREP Act amendment extended the time period of PREP Act coverage through December 31, 2029, and it expressly extends liability protections for specified covered countermeasures and qualified persons, including licensed pharmacists, pharmacy interns, and qualified pharmacy technicians administering COVID-19 vaccines to individuals aged three and above through December 31, 2029.

That is the remaining knot.

Weiler recommends a full HHS audit of every vestige of the COVID ’emergency,’ including the liability cord the PREP Act still allows.

Weiler also shows how surfaced NIH emails reveal superficial comprehension of how outbreaks become epidemics and pandemics, and it has nothing to do with transmission – it began with institutions and future trigger for financing, platforms, boards, intellectual property, liability shields, and global coordination. It was all about apparatus.

For more:

For an excellent read by France’s long-time vaccine policy chief, Professor Christian Perronne, on the stupidity of the entire COVID debacle from a scientific perspective: https://madisonarealymesupportgroup.com/2021/08/19/covid-policy-is-completely-stupid-unethical-states-frances-vaccine-policy-chief-who-was-recently-fired-for-stating-this/