Source: Johns Hopkins – Side Effects and COVID-19 Vaccines: What to Expect

The CDC issued a report on an adverse event, anaphylaxis, with the Moderna vaccine:

Allergic Reactions Including Anaphylaxis After Receipt Of The First Dose Of Moderna COVID-19 Vaccine — United States, December 21, 2020–January 10, 2021, CDC’s Morbidity and Mortality Weekly Report, 22 January 2021

The report used data from CDC’s Vaccine Adverse Event Reporting System (VAERS). The VAERS website says:

It is not possible to use VAERS data to calculate how often an adverse event occurs in a population.

But the CDC calculated anyway:

VAERS detected 10 cases of anaphylaxis after administration of a reported 4,041,396 first doses of Moderna COVID-19 vaccine (2.5 cases per million doses administered).

VAERS is good at generating hypotheses but because it underreports it’s not good at calculating rates. The two papers below support this:

Electronic Support for Public Health – Vaccine Adverse Event Reporting System (ESP:VAERS), CDC Grant Report, 2010

Fewer than 1% of vaccine adverse events are reported [to VAERS]. Low reporting rates preclude or slow the identification of “problem” drugs and vaccines that endanger public health. New surveillance methods for drug and vaccine adverse effects are needed.

Safety Monitoring In The Vaccine Adverse Event Reporting System (VAERS), Vaccine, July 2015

VAERS data interpreted alone or out of context can lead to erroneous conclusions.

Using VAERS to calculate rates is like, say … out of all the people in the US born with eyes, 7 reported having green eyes … 7 green-eyed people out of 328 million? Or, out of everyone in the state of Pennsylvania licensed to drive a car, 3 reported having an accident in the year 2020 … 3 accidents out of 10 million drivers? You might say that you know more people have green eyes or have had accidents, but that’s not in the database you’re using.

I can understand the drug industry trying to downplay side effects. But it’s the government’s job to counter industry, to regulate them, to stand with the public not the private. That doesn’t seem to be what’s happening here but I don’t know. The only reason I can figure the CDC used VAERS to calculate an adverse event rate is because VAERS underreports. There were other databases they could have used that are more aggressive (“active” instead of “passive”) in documenting vaccine effects. V-safe actually sends messages to your phone, post vaccination, asking “How are you feeling today?” VAERS sits there waiting for people to find it, then take the time and energy to use it.  (After your vaccination, did you or your healthcare worker sign in to VAERS with information about your sore arm or headache?)

These mRNA vaccines (Pfizer/BioNTech and Moderna) have never been on the market. They weren’t tested long enough or with enough people to produce a comprehensive safety profile, let alone reveal long-term effects. Why is the CDC making these vaccines appear safer than what they’re known to be? Where’s CNN on this? The New York Times? Don’t journalists ask these questions anymore?

Presence And Formation Of Cobalamin Analogues In Multivitamin-Mineral Pills, The Journal of Clinical Investigation, October 1982

Various vitamins and minerals can “destroy” Cbl* under certain conditions.
…
In our study, we have shown that the interaction of vitamin C, thiamine, and copper converts CN-Cbl** to a large number of Cbl analogues that appear to contain alterations in the corrin ring.
…
We conclude that CN-cobalamin can be converted to potentially harmful cobalamin analogues by multivitamin-mineral interactions.

* Cbl = Cobalamin = Vitamin B12
** CN-Cbl = Cyanocobalamin, the type of vitamin B12 often found in multivitamins

Not only does the B12 in multivitamins become unavailable because it forms analogues (“20-90% of the cobalamin was present as cobalamin analogues”), but those compounds it forms can be harmful.

I found this study in Dr. Greger’s video:

Using multivitamins can be inefficient and counterproductive for the supplementation of Cbl [vitamin B12]. The Cbl can be degraded in the presence of vitamin C and copper with the formation of inactive by-products. These compounds can inhibit the transport system interacting with transporter proteins.

What to do? Buy a single-nutrient vitamin B12. Dr. Greger prefers cyanocobalamin because it’s more stable than methylcobalamin. Dr. McDougall prefers methylcobalamin. And either chew it or let it dissolve in your mouth, so it mixes with saliva.

This raises the question of weather you should avoid taking it with vitamin-C-containing foods or beverages … or thiamine or copper. Still, it’s best absorbed as part of a meal or shortly after eating.

I just tweeted a few studies about how low vitamin B12 levels affect memory and contribute to depression. There are more where those came from.

I don’t think we take B12 deficiency seriously, myself included.

Vitamin B-12 Concentration, Memory Performance, And Hippocampal Structure In Patients With Mild Cognitive Impairment, American Journal of Clinical Nutrition, April 2016

Conclusions: Low Vitamin B12 concentrations within the normal range are associated with poorer memory performance, which is an effect that is partially mediated by the reduced microstructural integrity of the hippocampus.

Vitamin B(12) Deficiency And Depression In Physically Disabled Older Women: Epidemiologic Evidence From The Women’s Health And Aging Study, American Journal of Psychology, May 2000

Conclusions: In community-dwelling older women, metabolically significant vitamin B(12)deficiency is associated with a twofold risk of severe depression.

Vitamin B12 Supplementation In Treating Major Depressive Disorder: A Randomized Controlled Trial, The Open Neurology Journal, November 2013
This study had two groups. Both had depression, both had low vitamin B12 levels, both took antidepressants. One group (73 patients) added B12, the other (39 patients) didn’t.

100% of the B12 treatment group showed at least a 20% reduction in [depression] score. (vs. 69% in controls)

Those at risk of vitamin B12 deficiency:

• Older adults
• People with gastrointestinal disorders, such as Crohn’s disease or celiac disease
• Those who have had gastrointestinal surgeries, such as bariatric surgery or bowel resection surgery
• People on vegetarian diets
• People who take metformin (for diabetes)
• People who take proton pump inhibitors (for heartburn: e.g. Prilosec, Nexium)

It’s so nice to see someone I’ve always liked still singing. Just her voice and her piano. And her charm.

Peter Doshi in the BMJ, 2017:

Labeling people concerned about the safety of vaccines as “anti-vaccine” risks entrenching positions. The label (or its derogatory derivative “anti-vaxxer”) is a form of attack. It stigmatizes the mere act of even asking an open question about what is known and unknown about the safety of vaccines.

The label too quickly assumes that there are “two sides” to every question, and that the “two sides” are polar opposites. This “you’re either with us or against us” thinking is unfit for medicine.

Here’s a chart that Peter Doshi included in his article in the BMJ. (Click to enlarge.)

Table 1
Characteristics of ongoing phase III covid-19 vaccine trials

Source: Will Covid-19 Vaccines Save Lives? Current Trials Aren’t Designed To Tell Us, British Medical Journal, 21 October 2020

What he said about this chart:

Peter Hotez, dean of the National School of Tropical Medicine at Baylor College of Medicine in Houston, said, “Ideally, you want an antiviral vaccine to do two things … first, reduce the likelihood you will get severely ill and go to the hospital, and two, prevent infection and therefore interrupt disease transmission.”7

Yet the current phase III trials are not actually set up to prove either (table 1). None of the trials currently under way are designed to detect a reduction in any serious outcome such as hospital admissions, use of intensive care, or deaths. Nor are the vaccines being studied to determine whether they can interrupt transmission of the virus.

It’s not that the vaccines aren’t able to reduce severe illness, reduce deaths, or stop transmission. It’s that the trials cannot tell us that. They would have had to be longer. (If someone is saying these vaccines save lives, well, that’s not the science.) And long trials were not compatable with “Operation Warp Speed.”

I also noted that pregnant or breastfeeding women and immunocompromised patients were excluded. Who knows how these vaccines will affect them? No data.

The active ingredient in MiraLAX, a popular over-the-counter laxative and bowel prep for colonoscopies is polyethlyene glycol (PEG). If you have used any products containing PEG in the past, you may have developed anti-PEG antibodies. That could increase your risk of experiencing an immune reaction when you receive the PEG-containing Pfizer or Moderna vaccines.

The new COVID-19 vaccines by Pfizer/BioNTech and Moderna contain polyethylene glycol (PEG), a common ingredient in skin care products and laxatives. Anti-PEG antibodies are found in people who have been exposed to PEG. Upon re-exposure, those antibodies can elicit an immune response with effects that range from mild to severe.

In the study below, 72% of contemporary human samples contained anti-PEG antibodies. That’s a lot! The authors advise screening patients prior to “administration of therapeutics containing PEG.”

Analysis of Pre-Existing IgG and IgM Antibodies Against Polyethylene Glycol (PEG) In The General Population, Analytical Chemistry, December 2016

Circulating antibodies (Ab) that specifically bind polyethylene glycol (PEG), a biocompatible polymer routinely used in protein and nanoparticle therapeutics, have been associated with reduced efficacy of and/or adverse reactions to therapeutics modified with or containing PEG.

Unlike most antidrug antibodies that are induced following initial drug dosing, anti-PEG Ab can be found in treatment-naïve individuals (i.e., individuals who have never undergone treatment with PEGylated drugs but most likely have been exposed to PEG through other means).

Unfortunately, the true prevalence, quantitative levels, and Ab isotype of pre-existing anti-PEG Ab remain poorly understood. Here, using rigorously validated competitive ELISAs with engineered chimeric anti-PEG monoclonal Ab standards, we quantified the levels of anti-PEG IgM and different subclasses of anti-PEG IgG (IgG1-4) in both contemporary and historical human samples.

We unexpectedly found, with 90% confidence, detectable levels of anti-PEG Ab in ∼72% of the contemporary specimens (18% IgG, 25% IgM, 30% both IgG and IgM).

Anti-PEG Ab’s were also observed in ∼56% of serum samples collected during 1970-1999 (20% IgG, 19% IgM, and 16% both IgG and IgM), suggesting that the presence of PEG-specific antibodies may be a longstanding phenomenon.

The widespread prevalence of pre-existing anti-PEG Ab, coupled with high Ab levels in a subset of the population, underscores the potential importance of screening patients for anti-PEG Ab levels prior to administration of therapeutics containing PEG.

Having anti-PEG antibodies can lead to another unwanted effect. Those antibodies can attack the vaccine (PEG is used as a coating to keep the vaccine from degrading), resulting in reduced vaccine effectiveness:

“… it is increasingly recognized that treating patients with PEGylated drugs can lead to the formation of antibodies that specifically recognize and bind to PEG (i.e., anti-PEG antibodies). Anti-PEG antibodies are also found in patients who have never been treated with PEGylated drugs but have consumed products containing PEG. Consequently, treating patients who have acquired anti-PEG antibodies with PEGylated drugs results in accelerated blood clearance, low drug efficacy, hypersensitivity, and, in some cases, life-threatening side effects.”
– The Importance Of Poly(ethylene glycol) Alternatives For Overcoming PEG Immunogenicity In Drug Delivery And Bioconjugation, Polymers, February 2020