Vaccination: Reporting and tracking adverse side-effects in the app

[NilsHempel]

Feature description

Add a box below "Wurden Sie getestet?": "Impfung" that includes a two buttons:

1. Register Vaccination
2. Register adverse side-effect

1. Button: Register Vaccination

1. Question: How would you like to enter the details? a) Scan a QR-Code via the camera (when two doses are required this option should remain open after a first vaccination) b) Enter the Information manually, possibly with additional verification
2. Produces an overview over the vaccination
3. Follow up: Would you like to share this with RKI and PEI to help?
   • if yes: possibly additional information such as age bracket and risk factors to offer additional metrics on how the vaccination effort is progressing

2. Button: Register adverse side-effects

1. Button only in active state after registering a vaccination
2. Auto-fill with the information about the used vaccine
3. Implement online reporting form in the app; possibly with additional questions.
   • Enable uploading documents such as lab reports, etc.
4. Button: Share with PEI
5. Overview over report including case number
6. Possible: Additional information about the reported side-effects ans possible remediation

In a dialogue between the Ministry of Health, PEI and representatives for doctors a similar and easy way of reporting directly should be set up additionally.

Problem and motivation

Current way of reporting

Doctors report adverse side effects (both Impfnebenwirkungen and Impfkomplikationen) to their local Health Authority (Gesundheitsamt). These processes are typically paper-based and use personell resources that could better be used for contact-tracing. With the high number of vaccinations it is questionable if this is a good use of doctor's time. They should be able to access a quicker method of reporting as well.

Consumers may report adverse side-effects direct to Paul-Ehrlich-Institut (PEI) both digitally as well as with a paper form.

Accessing and filling these forms will be a deterrence for many consumers and doctors. The number and quality of reports sent to PEI and in turn EudraVigilance will be smaller than is desirable.

This will not allow the national and international authorities to react quickly enough to specific vaccinations` adverse side-effects, thus not protecting public health as well as is possible.

Background

Several new vaccinations are currently in trials to test their safety and efficacy for immunization against SARS-CoV-2. Their development and approval is being sped up considerably, leading to shortened clinical trials in phase III. These will likely include only the required and smaller than usual number of 3000 participants that are required to finde side-effects that occur in at least 0,1% of all cases.

This means that phase IV - after approval and general use - is very important to monitor for unknown adverse side-effects of the different vaccinations. Safety of these vaccines is critical for trust in them and a high rate of vaccination to reach enough immunity throughout the population for the transmission of the SARS-CoV-2 to slow down dramatically.

As of today (Oct. 23rd 2020) some Local Health Authorities have become overwhelmed with cases and cannot trace individual case's contacts anymore. If Corona Warn App had more functionality for keeping a manual diary of one's contacts and possible super-spreading events already, this might alleviate some strain. The coming month's will likely remain challenging and public trust is vital for succeeding in the immunization effort.

Challenges

Privacy concerns

Corona Warn App is specifically designed not to contain personally identifiable data. With an implementation such as above users will be de-anonomized once they submit a report about an adverse side-effect.

It will need to be clearly communicated that this data isn't linked to contact-tracing data and will not allow authorities to create a profile of a user's geolocations.

Lower quality of reports

Self-reporting by consumers will generally be less precise that a doctor's report. With a high enough number of reports it should allow trends to emerge and be followed up by PEI. Allowing users to attach documents such as lab reports might further mitigate this issue.

Additionally, a diary of symptoms and structured questionnaires should mitigate this issue furthermore.

Abuse

Much like registering an infection within Corona Warn App there is potential for abuse; a similar system that (a) registers that a vaccination has been made and (b) filtering reports for plausibility might address this.

Is this something you're interested in working on

I am happy to help with the implementation; my coding skills do not allow me to productively participate in coding though.

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Internal Tracking ID: EXPOSUREAPP-3429

[heinezen]

Hey @NilsHempel ,

Thank you for the (very detailed) suggestion. I have created an internal Jira ticket (EXPOSUREAPP-3429) for your request. The feature will now be discussed by the developers and the RKI who will then decide when and how to implement it. We will post the status on the progress here, if we get any updates regarding your issue.

Regards, CH

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Corona-Warn-App Open Source Team

[jucktnich]

Like in #283 mentioned a message on wich date you have to get your second vaccination would be also great.

[Sundie1]

(sorry for my englisch) As i wrote in #283 in addition of the reporting and tracking i want to do the next step with the App and make it to an "digitaler Corona Impfpass" I think it will be possible that companies(Airlines) or concerts or in Stadion you only can get in if you have an vaccination. So How to Check this. There are two ways. 1.Oldscool or of i have no Smartphone i habe to carry a copy of my Impfpass. I think that is Not secure becouse i can copy it severel Times and give it to my friends who have no vaccination The second way: use the App. On entrance of a concert, Bundesliga, airline,.. I go in my cwa app on menu "Impfpass" and the Smartphone Shows up an qr Code which can be scanned or acivates the nfc (Not every Smartphone has an nfc so the qr Code way needes to be implemented too, but with nfc i can use in future my smartwatch too) The qr Code can be secured (Short validation timespan, secureid,...) that make it harder to fake (Screenshot that i send to my friends with no vaccination) On my opinion this way has a great advantage: fast! (fastline on Bundesligastadion, so the security has more time to Check the Papers from the Persons who use the oldscool way) and secure. (i dont have to write All my datas to an paper like it is for now on Restaurants) and at least the Datenschutz is given to, i only send my vaccination Status, Not my Adress (oldscool Impfpass or on the Papers on the kontaktverfolgung in Restaurants i always wrote my Adress visible to All)

[jucktnich]

Are there any updates yet? I heard about the SafeVac-App from the PEI (Paul Ehrlich-Institut). Is there the possibility to integrate this in the cwa?

[dsarkar]

Hi @NilsHempel, @jucktnich, thanks again for proposal and contributing here. We will raise this issue again in one of the next meetings. Stand by for feedback. Best, DS

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Corona-Warn-App Open Source Team

[MikeMcC399]

@jucktnich

I heard about the SafeVac-App from the PEI (Paul Ehrlich-Institut).

https://www.zusammengegencorona.de/impfen/wirksamkeit-und-sicherheit/#faqitem=80f1f47f-b2b9-54d7-90b6-e518e0c5a731 said: (Edit: This link no longer works.)

Wo kann ich den Verdacht einer Nebenwirkung melden?

Sollten Sie den Verdacht einer Nebenwirkung haben, können Sie dies sowohl Ihrer Ärztin/Ihrem Arzt als auch beim Paul-Ehrlich-Institut (PEI) als oberster Bundesbehörde, Ihrem örtlichen Gesundheitsamt oder online melden. Weiterhin können Sie Nebenwirkungen in der "SafeVac"-App des PEIs melden.

Hier können Sie die App im Apple AppStore und hier im Google Play Store herunterladen.

Stand: 23.12.2020

See https://www.zusammengegencorona.de/impfen/impfkomplikation-das-koennen-sie-tun/#id-624346878 and https://www.pei.de/DE/service/faq/coronavirus/faq-coronavirus-safevac-app-tabelle.html instead.

[Sundie1]

Die Frage ist ja schon, wo will das RKI mit der Corona App hin? A) Zentrale Plattform zum Thema Corona, denn gehört das Thema impfen dringend mit in die App. Und da auch siehe oben für mich das Thema Digitalisierung Impfstatus. B) Die App sollte nur Kontakte aufzeichnen. Das bedeutet aber auch das ich in dem Moment der Impfung die App deinstallieren muss (denn unterscheiden zwischen geimpft oder nicht kann sie nicht und ich würde sinnlose Alarme bekommen) Ich persönlich würde a gut finden. Und auch während der Impfung einen Qr Code zu scannen um wesentliche Daten zu meiner Impfung zu erfassen finde ich nicht schlimm.

Falls B das ziehl ist, könnte ja in der App ein Link zur PEI App eingebaut werden. Oder soll die PEI app das Thema impfen vollumfänglich übernehmen? Das Problem daran. Niemand kennt diese. Und erweitert werden muss die denn wohl ebenso.

[tinne]

Let me suggest to split the ticket into two. Whether CWA would trace vaccination side effects or link to a separate facility as it is today provided by PEI can be discussed separately from the question whether contact tracing should include information on vaccination or not.

The news[1] currently report that there is currently one study conducted by Pfizer on whether immunization protected people can effectively transmit the desease, and it might take months to give results.

Thus in preparation to a possible positive outcome of this and related study and as a means to start adjusting the severity algorithm for contacts the moment the results are there (with enough time on its sociological consequences) distribution of the vacciation state of contacts should be expidited.

Also, when discussing adjusting the algorithm, maybe the state of reconvalescense must be taken into account as well, as today's figures signal it is about 1,92% of the German population already.

[1] Harro Albrecht, Andrea Böhm et. al., Eine Ampulle Normalität (07.01.2021). Hamburg, Germany: DIE ZEIT Politik