Preprint Postacute sequelae of SARS-CoV-2 in the population: Risk factors and vaccines, 2025, Bhargava et al

Postacute sequelae of SARS-CoV-2 in the population: Risk factors and vaccines

Aditi Bhargava, Sabra Inslicht

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Abstract
The contribution of pre-existing conditions to severe versus mild postacute sequelae (PASC) of SARS-CoV-2 in the population is lacking. Here, we evaluated reproductive and other PASC side-by-side in unvaccinated and vaccinated individuals after 1st SARS-CoV-2 infection.

In an online global survey of 7,541 individuals from 95 countries, high grade fever (> 102˚F)/ hospitalization after a first SARS-CoV-2 infection were more likely to be reported by vaccinated males than unvaccinated males (13.64% vs. 8.34%; p = 0.0483; HR = 1.63 [95% CI: 1.008, 2.65]).

Women reported experiencing more frequent PASC than men. More women than men reported vaccine-associated adverse events (AEs) after the 1st dose (60.85% vs 48.79%, p < 0.01).

Vaccine-associated hospitalization was reported by 6.24% SARS-CoV-2 naïve respondents versus 1.06% of unvaccinated after 1st SARS-CoV-2 infection.

Pre-existing thyroid disease, osteoporosis, and autoimmune disorders were more prevalent in women, whereas more men reported back problems, elevated cholesterol, and hypertension; several pre-existing conditions posed ≥ 2.0 relative risk of developing severe vs mild COVID-19. Individuals aged < 55 years had an absolute risk of 6.01%, whereas individuals ≥ 55 years had an absolute risk of 11.69% of getting severe vs mild COVID-19 disease.

Vaccinated women reported significantly greater menstrual cycle-associated reproductive PASC compared to unvaccinated women. Vaccinated men reported hormonal changes and sexual dysfunction as reproductive PASC compared to unvaccinated men.

A detailed and thorough follow-up is needed to better understand if pre-existing health conditions and/or vaccine-associated AEs exacerbated COVID-19 sequelae.

Link | PDF (Preprint: Research Square) [Open Access]

 

First, what does "unvaccinated but vaccine-naive" mean?

Second, are they saying more than one in twenty people who got a vaccine was hospitalized for vaccine related adverse events? So it seems like a lot of selection bias and makes no sense to compare hospitalizations in unvaccinated and vaccinated people.

 

A Medium post by the lead author from April 2022. My bolding.

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Seeking participation from both unvaccinated and vaccinated individuals worldwide with or without COVID and/or adverse events for a study approved by institutional review board.

COVID-19 pandemic caused by SARS-CoV-2 has touched all of us in some way or the other. There are 3 different categories of vaccines being used- (i) Inactivated whole virus or traditional vaccine; (ii) mRNA (Moderna and Pfizer), and (iii) recombinant AAV-DNA (AstraZeneca J&J and others). The numbers of breakthrough infections in fully vaccinated people are on the rise. New emerging variants may evade vaccine-induced immunity, but whether the naturally immune are protected, remains unclear. Recent data from Israel and other countries suggests that natural immunity is superior and provides protection against other emerging variants. The mental trauma from this pandemic is different for the vaccinated versus the unvaccinated and remains to be evaluated. The misinformation about the vaccines, adverse events, and efficacy is rampant. FDA recently cautioned against use of J&J due to blood clot events. Many European countries do not recommend use of Moderna for children. Despite citing efficacy in clinical trials for children, Pfizer announced that 2 doses are not sufficient in children. Full datasets for clinical trials conducted by the Pharma will not be released for several decades. Thus, it is imperative to obtain this information by independent investigators to validate findings.

Using questionnaire-based measures, we expect to gain valuable information on severity of COVID illness, health outcomes, course of recovery, vaccine efficacy, safety, and mortality in vaccinated and unvaccinated people of all ages, worldwide. VAERS and other adverse event reporting systems only collect data from a subset of people. Data from unvaccinated individuals and their health outcomes is severely lacking. Data from vaccinated individuals without any serious side effects is also not collected by VAERS or other such agencies. This study will allow us to independently answers questions about COVID-19 vaccine safety and efficacy in a properly controlled manner. Independent studies are essential for scientific process especially given that data from original clinical trials will not be released for decades. In this study, we will survey both vaccinated and unvaccinated people about their mental health, stress, anxiety, COVID symptoms, and vaccine-induced events, if any. The objective is to ascertain vaccine safety and mental health status by surveying people’s response to vaccine efficacy and safety in an unbiased manner.

Medical research studies include only people who choose to take part. You may discuss your decision with your family and friends. All questions are self-explanatory.

Anyone can participate in this study. Participation in this study is entirely voluntary. Participants will fill an online one-time survey. Working knowledge of English is required. After participants sign an online consent (parents/legal guardian consent is needed for minors), they will be taken to the survey. Depending upon your health history, internet speed, and other factors, the survey may take 40–120 min of your time. There is no direct benefit to you. The survey results will be used for research. This research can impact understanding safety and efficacy of COVID vaccines or and other vaccines that may be used for decades on general populations. The research will also help us understand how the pandemic, shutdowns, and vaccines impacted mental health.