Saturday, October 01, 2022

Lancet Preprint: Self-Reported Adverse Events Following SARS-CoV-2 Vaccination (Denmark SSI)


Over the past two years we've seen ample evidence of Post-COVID Syndrome, ranging from temporary fatigue and `brain fog', to more permanent life-changing sequelae (see partial list below).

MMWR: Post–COVID-19 Symptoms and Conditions Among Children and Adolescents

More Evidence On The Long-term Impact of SARS-CoV-2 Infection

Nature: Long COVID After Breakthrough SARS-CoV-2 Infection

BMJ: Elevated Risk Of Blood Clots Up To 6 Months After COVID Infection

Diabetologia: Incidence of Newly Diagnosed Diabetes After Covid-19

Of perhaps even greater concern are the as yet undetermined long-term cardiovascular and neurological impacts of infection (see Nature: Long-term Neurologic Outcomes of COVID-19). 

Despite these known after-effects of COVID infection (in as many as 20%-30% of cases), there are still many who are leery of taking a COVID vaccine after reports of (mostly mild) adverse reactions in a relatively small number of cases (see here, here, here, and here).

Although modern vaccines have excellent safety profiles - like all drugs and medications - they aren't 100% safe or benign for everyone, and unwanted side effects can occur. 

Studies have shown, however, that you are far more likely to develop myocarditis from the COVID infection than you are from the vaccine, and that there is a Greater Risk Of Neurological Complications From COVID Infection Than From Vaccine, but many are still hesitant to get vaccinated or boosted. 

While it probably won't convince any hardcore anti-vaccine activists, the following research out of Denmark may ease the concerns of those who are still on the fence. 

This from Denmark's SSI.

Covid-19 vaccination did not worsen physical, mental and cognitive health

Vaccinated Danes did not report worse physical, mental or cognitive health in the months after covid-19 vaccination compared to the experiences of non-vaccinated people. That is the conclusion from a large questionnaire survey of the safety of covid-19 vaccines in the Danish population.

Last edited on September 30, 2022
Researchers at Statens Serum Institut (SSI) have investigated whether covid-19 vaccination is associated with more physical, mental and cognitive symptoms than compared to non-vaccinated people. The researchers have investigated a wide range of symptoms, which range widely from headaches, dizziness and pronounced fatigue to anxiety, depression and difficulty concentrating.

Questionnaire survey with 36,436 participants
The large study was based on 36,436 Danes, who had each completed two questionnaires. One about their general health and lifestyle factors and one about experienced symptoms. The researchers combined the questionnaire information with the covid-19 vaccination status from the nationwide Danish vaccination register and could thereby see how many reported the individual symptoms in the vaccinated and the unvaccinated, respectively.

Reassuring results

The results were reassuring. Overall, the researchers found no evidence that physical, mental or cognitive health had deteriorated several months after vaccination.

“Our study is quite unique. It is one of the first to investigate at all whether there is a connection between covid-19 vaccination and physical, mental and cognitive symptoms. It is also quite large with more than 36,000 participants. Reassuringly, our study paints a picture of a safe vaccine", says Professor Anders Hviid from SSI, who has been at the head of the study.

Distinct fatigue more frequent in the unvaccinated

Some of the things that were frequently reported by everyone in the study were physical and mental exhaustion and cognitive difficulties. Physical exhaustion was reported by 27.4% of the vaccinated and 29.8% of the non-vaccinated. For mental exhaustion the figures were 30.5% and 32.1%, and for the cognitive difficulties they were 31.9% and 33.2%. There were thus no significant differences. One of the only points where the vaccinated and non-vaccinated differed was marked fatigue and exertional aggravation (in English called post-exertional malaise). But here it was the unvaccinated who experienced the symptoms more frequently. Marked fatigue was reported by 37.5% of the unvaccinated, but it was only reported by 28.7% of the vaccinated. The corresponding figures for exercise-induced exacerbation were 24.2% and 15.5%.

"The vaccines protect against covid-19, and this is perhaps a close explanation for the fact that the vaccinated experienced less pronounced fatigue. However, the participants in the study did not test positive for covid-19, but there are probably some who slipped through the testing system, especially when the micron wave was at its peak", says Anders Hviid.

The study, which has not yet been peer-reviewed, has just been published as a so-called preprint in The Lancet.

28 Pages Posted: 27 Sep 2022

Elisabeth O'Regan
Statens Serum Institut - Department of Epidemiology Research

Ingrid Bech Svalgaard
Statens Serum Institut - Department of Epidemiology Research

(Continue . . . )

While a lot of people believe COVID is `over', it is still infecting tens of thousands of people each day in the United States, and killing between 200 and 300. A number that is tolerable only because we saw numbers 10 times worse during the height of the Delta wave.

What this winter portends, with the concurrent circulation of COVID and Flu, remains uncertain. Hopefully COVID continues to decline, and we escape without seeing a new, more virulent, variant emerge.

But there are no guarantees, which is why I'll go into the fall fully vaccinated against both threats.  Between that, and wearing a mask when and where appropriate, and using hand sanitizer religiously, I'm hoping to avoid a second bout this winter.