Preprint Post-Vaccination Syndrome: A Descriptive Analysis of Reported Symptoms & Patient Experiences After Covid-19 Immunization, 2023, Krumholz, Iwasaki +

Post-Vaccination Syndrome: A Descriptive Analysis of Reported Symptoms and Patient Experiences After Covid-19 Immunization
Harlan M Krumholz; Yilun Wu; Mitsuaki Sawano; Rishi Shah; Tianna Zhou; Adith S Arun; Pavan Khosla; Shayaan Kaleem; Anushree Vashist; Bornali Bhattacharjee; Qinglan Ding; Yuan Lu; Cesar Caraballo; Frederick Warner; Chenxi Huang; Jeph Herrin; David Putrino; Danice Hertz; Brianne Dressen; Akiko Iwasaki

Introduction
A chronic post-vaccination syndrome (PVS) after covid-19 vaccination has been reported but has yet to be well characterized.

Methods
We included 241 individuals aged 18 and older who self-reported PVS after covid-19 vaccination and who joined the online Yale Listen to Immune, Symptom and Treatment Experiences Now (LISTEN) Study from May 2022 to July 2023. We summarized their demographics, health status, symptoms, treatments tried, and overall experience.

Results
The median age of participants was 46 years (interquartile range [IQR]: 38 to 56), with 192 (80%) identifying as female, 209 (87%) as non-Hispanic White, and 211 (88%) from the United States. Among these participants with PVS, 127 (55%) had received the BNT162b2 [Pfizer-BioNTech] vaccine, and 86 (37%) received the mRNA-1273 [Moderna] vaccine. The median time from the day of index vaccination to symptom onset was three days (IQR: 1 day to 8 days). The time from vaccination to symptom survey completion was 595 days (IQR: 417 to 661 days). The median Euro-QoL visual analogue scale score was 50 (IQR: 39 to 70). The five most common symptoms were exercise intolerance (71%), excessive fatigue (69%), numbness (63%), brain fog (63%), and neuropathy (63%). In the week before survey completion, participants reported feeling unease (93%), fearfulness (82%), and overwhelmed by worries (81%), as well as feelings of helplessness (80%), anxiety (76%), depression (76%), hopelessness (72%), and worthlessness (49%) at least once. Participants reported a median of 20 (IQR: 13 to 30) interventions to treat their condition.

Conclusion
In this study, individuals who reported PVS after covid-19 vaccination had low health status, high symptom burden, and high psychosocial stress despite trying many treatments. There is a need for continued investigation to understand and treat this condition.


Link | PDF (Preprint: MedRxiv)

 

"exercise intolerance" is not "well characterised" if existence of PEM is not investigated, as does not seem to be the case here - I certainly couldn't find any mention of PEM/PESE in any form.

 

I have not read the paper but the abstract suggests that this is the worst sort of sham science. 12% of patients did not even live in the USA. 88% were non-hispanic whites, which is not demographically representative. Basically they have just got anyone who thought their symptoms might be due to vaccination to join.

3 days does not fit with any known immune response. Allergies occur within an hour or two. Other specific immune responses require at least ten days and generally a bit more.

Considering the pretty much everyone gets vaccinated I suspect that the number of people due to get ME, for instance, within days of a vaccination in the study period (which seems to allow report from more than a year ago) to be many thousands.

As I have said elsewhere, if this is the top level of science in the field then things are still woefully inadequate.

 

Participants were all users of a particular app.

"Study Design

LISTEN is a cross-sectional study that collects participant-reported, participant generated, and clinical data. Deep immune phenotyping is carried out for a subset of individuals, which involves comprehensive profiling of immune cell subtypes, their related products, and their functional states.19 LISTEN participants were recruited from Hugo Health Kindred, an online patient community. This platform, for which recruitment occurs mainly through social media and word of mouth, provides opportunities for information exchange, and allows members to share survey responses and health data with research studies. The LISTEN study began recruiting participants who reported PVS in May 2022. PVS was defined by self-report in response to whether the individual thought the vaccine had injured them. We summarized these individuals' symptoms, diagnoses, treatments, and experiences."

"Data collection

The Kindred platform provided a series of surveys (Supplemental Appendix) that collected demographic, infection, vaccination, clinical, and social information. The surveys were developed using an iterative process, including feedback from potential participants reporting PVS, to ensure they were relevant and understandable to those participating. The surveys were provided only in English due to funding limitations. Surveys could be completed on computers or mobile devices, and reminders were sent to encourage completion. Surveys were completed between November 2022 and July 2023, with half completed by December 2022 (Supplemental Figure 2). Data were extracted on July 7, 2023."

 

So it seems, but an app joined mostly because people hear about it through social media and word of mouth as it says, and presumably want to tell somebody about being ill, in the word of mouth context of trawling for people feelingly after vaccination or Covid.

It may be useful to collect immunological data on such people but I think it is irresponsible to write an abstract that ends with 'a need to investigate and treat this condition' when no specific condition has been identified.

 

I haven't read the study but to me it's clear it involves descriptive data based solely on self-reported symptoms. As you suggest, that data can be useful. I agree that the final statement takes it for granted that the data "prove" the phenomenon is a real thing. I would say the data suggest it's worth doing more investigation to see if something's there. But maybe if I read the paper, I'll have a different view of what they're saying.

 

I guess it is a start, in the same way people with LC began to try and find a name for the symptoms that they had and to collect data.

LC people started by self diagnosing and joining together to try and understand what was happening to them.

My own problems with ongoing head and eye pain aren't there but may be in the less experienced group of symptoms.

 

I don't think the data suggest anything David.
This is the very worst way to get maximum ascertainment bias and all you get- as they have got - is a group of people with the sorts of symptoms doctors find difficult to parcel into some other diagnosis. The bias risk here is 1000%.

If anyone is going to do useful studies they should do them quietly out of the social media gaze using valid epidemiological methods. It is likely that the vaccine producers will be doing at least something along those lines. If not then it should be done by health service systems - something tha used to occur in the UK but has largely been abandoned with marketisation.

Any academic who presents data in this form can expect to be considered an embarrassment to the scientific community.

 

If there are a lot of anecdotal reports, as happens in this sort of reporting system, it's worth reviewing what they say and then perhaps conducting a systematic look to find out if there's any reality to the phenomenon. I understand the point about not touting it on social media and agree it should be made clear that the data are not evidence of something larger, given the obvious limitations.

 

But what is 'a lot of reports' when you are using a gossip-based (word of mouth) system that will collect reports without any idea of denominator? @dave30th

This is not a legitimate sampling system because there is no way of knowing what you are sampling from.

Maybe 250 million people have been vaccinated. There are bound to be a few hundred reports of feeling terrible after. And because of Wakefield doing the same thing years ago everyone is primed to associate feeling bad with vaccines.

Long Covid itself was different because nobody had been primed to expect to go on feeling unwell. And even there we don't even really know how much feeling ill can be attributed to Covid or chance.

 

There is the UK Yellow card reporting scheme. I completed one for the adverse reactions I had to the AZ vaccine.

A research group could take one of the categories there and look at the individual reports and investigate. They could narrow it down to reports with medical evidence from doctors if needed.

AZ has asked for medical evidence from some people so they may already have a collection of patients.

They could also look at hospitals. I am not the first at Moorfields Eye Hospital with problems after the AZ vaccine. The Neurologist I saw locally had a few interesting cases of similar events.

A group I belong to is giving evidence to the UK Covid Inquiry. https://covid19.public-inquiry.uk/hearings/vaccines-and-therapeutics-module-4/

 

Depending on where one lives, there may have been many who were not really surprised. North central US, northeast US, west coast US...There, at least, there'd been precedent of sorts.

Too often, this is what medicine is these days.