Section 4 subsection 13 of the German Medicinal Products Act (Arzneimittelgesetz, AMG) distinguishes between "adverse reactions" and "serious adverse reactions".
Adverse reactions are harmful and unintended reactions to a medicinal product.
Serious adverse reactions are adverse reactions that are fatal or life-threatening, require hospitalisation or prolongation of hospitalisation, lead to persistent or significant disability, incapacity, congenital anomalies or birth defects.
For the safety monitoring (pharmacovigilance) of COVID-19 vaccines, further "Adverse Events of Special Interest" (AESI) were classified as "serious" from the outset in accordance with the agreement of the pharmaceutical authorities of the European Economic Area (EEA) in order to recognise their occurrence promptly and to be able to react with risk reduction measures.
Adverse reactions that are identified in clinical trials before authorisation or in large-scale studies after authorisation are listed in Chapter 4.8 "Undesirable effects" in the vaccine product information.
There is a difference between a "severe" vaccination side effect and a "serious" vaccination side effect: Affected persons may experience a reaction such as one that leads to an (even prolonged) incapacity to work as a "severe reaction" to vaccination. However, this is not synonymous with a serious adverse reaction within the meaning of the Medicinal Products Act or an adverse event of special interest (AESI).
Updated: 05.08.2024
The frequency of side effects is determined in clinical trials before or large-scale studies after authorisation. Confirmed adverse drug reactions of medicinal products authorised in Germany and the European Economic Area (EEA) are listed with their frequency determined in corresponding studies in the product information (SmPC and package leaflet) of the respective medicinal product under point 4.8:
The current product information (information for healthcare professionals and instructions for use) for vaccines and biomedical medicinal products can be accessed via the Paul-Ehrlich-Institut website.
The frequency of adverse reactions (confirmed and included in the product information) cannot be inferred from the number of suspected case reports received by the Paul-Ehrlich-Institut as part of the spontaneous reporting system alone, nor from their reporting data.
Product information (SmPC and package leaflet) at www.pei.de/medicinal-products
Updated: 01.11.2024
Confirmed possible side effects of a medicinal product, e.g. a vaccine, with information on the frequency can generally be found in the respective product information (Summary of Product Characteristics, SmPC).
The Paul-Ehrlich-Institut provides links to the product information for vaccines and biomedicines at www.pei.de/medicinal-products. After selecting a medicinal product category, you will find the link in the column titled "Further information". This page also links to the European Public Assessment Report (EPAR) for medicinal products that have received a central EU authorisation. The EPAR also contains the product information. For all other medicinal products, you will find the link to the PharmNet.Bund portal, where the SmPCs are stored.
A distinction must be made between confirmed possible side effects listed in the product information and suspected adverse reactions to vaccines and medicinal products. The reporting of a suspected adverse reaction closely following vaccination or the use of a medicinal product does not automatically mean that there is a causal connection.
The Paul-Ehrlich-Institut publishes a compilation of suspected vaccination reactions and vaccination complications reported in Germany from 2000 onwards on its website in a data protection-compliant manner. The data records include information on the vaccine administered and the age group and gender of the vaccinated persons. They can be searched using the PDF reader search function.
All suspected cases of vaccine and drug side effects reported in Germany are also entered into the EudraVigilance database of the European Medicines Agency (EMA). The EMA publishes this data so that everyone has access to the same information that the European regulatory authorities use when assessing the safety of a medicinal product or active substance. The EudraVigilance database includes suspected case reports from across the European Economic Area (EEA) and other countries worldwide where centrally authorised medicines are used.
In the EMA's EudraVigilance database, you can view reports of suspected adverse reactions sorted by product or substance. Medicinal products that do not have EU authorisation are not available in the EudraVigilance database by product name, only by the name of the active substance.
If necessary, e.g. if certain suspected adverse drug reaction reports accumulate in connection with a vaccination or the use of a medicinal product, the Paul-Ehrlich-Institut also conducts pharmacovigilance studies to verify causality.
Together with the Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM), the Paul-Ehrlich-Institut regularly publishes information on current aspects of medicinal product risk assessment in the “Bulletin zur Arzneimittelsicherheit”.
In the Newsroom and in the Medicine Safety sections of the Paul-Ehrlich-Institut’s website you will also find announcements, positions, and safety information on aspects relating to medicinal product safety monitoring.
The safety and press newsletters keep subscribers up to date with the latest news in the field of pharmacovigilance.
Data on Adverse Drug Reactions
EudraVigilance Database
Pharmacovigilance Studies (German only)
Pharmacovigilance Bulletin
Subscribe to the Newslettters of the Paul-Ehrlich-Institut
Updated: 07.08.2024
Before a vaccine is placed on the market, it must undergo an extensive marketing authorisation procedure, either in Germany (national marketing authorisation) or at the European Medicines Agency (EMA) (centralised authorisation procedure by the EU Commission).
The quality, efficacy, and safety of the vaccines are thoroughly assessed and evaluated during the authorisation procedure in clinical trials with many study participants. A favourable benefit-risk assessment is a prerequisite for authorisation of a vaccine.
Before a newly produced vaccine batch may be placed on the market in Germany, this production unit (batch) is tested by an official medicines control laboratory (OMCL) independent of economic interests. These tests usually include experimental lab tests. The Paul-Ehrlich-Institut is an OMCL. The final step before a batch is released for Germany is carried out by the Paul-Ehrlich-Institut either after it conducts its own examination or after acceptance of the examination by another control laboratory of the European OMCL network.
From Vaccine Authorisation to Recommendation by the Standing Commission on Vaccination in Germany: Criteria for the Objective Assessment of Benefits and Risks (German only)
Vaccine Testing: The Challenge of Testing Complex Combination Vaccines (German only)
Updated: 11.09.2024
When a marketing authorisation is first issued, knowledge on the safety of vaccines is naturally incomplete, because in clinical trials both the duration of the follow-up monitoring and the number of vaccinated persons are limited. It is possible that not all the rare or very rare adverse effects associated with administration of a vaccine are identified in the clinical trials. They are, however, of great importance for the overall evaluation of a new vaccine. In general, new knowledge about the safety of vaccines, especially with regard to very rare occurrences, can be obtained even a long time after marketing authorisation – as is the case with all vaccines. For this reason, experts in the safety of medicinal products (pharmacovigilance) never stop monitoring the vaccines, even after marketing authorisation.
Routine pharmacovigilance measures after marketing authorisation include the recording and evaluation of reports of suspected vaccination complications or adverse reactions to vaccination. These reports are recorded and evaluated centrally both at the Paul-Ehrlich-Institut (PEI) and in the EudraVigilance database for the whole of Europe. The marketing authorisation holder must regularly prepare safety reports on adverse reactions, which are assessed jointly by the various marketing authorisation agencies in the European Union. As part of the marketing authorisation process, the marketing authorisation holder must submit "risk management plans", which summarise what is known – and what is not yet known – about the safety of the vaccines. In addition, it must describe precisely the measures that will be used to fill the remaining gaps in knowledge – e.g. further studies after marketing authorisation – and in what timeframe this will be achieved. These gaps in knowledge may, for example, relate to safety in particular groups of people who were not sufficiently represented in the clinical trials.
Updated: 22.08.2024
Decades of experience has shown that most vaccine side effects occur within a few hours or a few days after a vaccination. In rare cases, vaccine side effects occur or are recognised only after weeks or a few months.
There are no known side effects of vaccines that occur years after vaccination.
Updated: 12.08.2024
Samples from each vaccine batch are experimentally tested by a European Official Medicines Control Laboratory (OMCL). The Paul-Ehrlich-Institut only grants national batch release for the German market if the samples meet the criteria and specifications stated in the marketing authorisation documentation. This ensures a high level of quality for each batch of the vaccine products. To date, there is no evidence that individual batches were associated with a higher number of adverse events or any specific adverse events.
Updated: 28.03.2024
Mild vaccine reactions occur around six to 12 days after vaccination. These reactions often involve redness and swelling at the injection site and fever (in 5 to 15% of individuals) for one to two days. Headaches or fatigue may also occur. Approximately 5 to 15% of those vaccinated get a moderate to high fever that lasts for one to two days between the 7th and 12th day after vaccination. A rash (known as vaccine measles) can occur in about 5% of vaccinated individuals in the second week after vaccination. The rash can last for one to three days and is not contagious. About 1% of those vaccinated report joint pain after vaccination. The symptoms described only rarely occur after the second vaccination. Serious adverse vaccine effects are rare.
The repeated claim that the measles vaccination can cause inflammatory bowel diseases (such as Crohn's disease) or autism has long since been refuted by a variety of studies.
Known side effects of medicinal products, including vaccines, are listed in chapter 4.8 of the Summary of Product Characteristics and package leaflet.
Updated: 19.09.2024
The spontaneous reporting system is an essential component in the vaccine safety monitoring. The collection and evaluation of suspected vaccine adverse reactions and vaccine complications reported to the Paul-Ehrlich-Institut serves to identify possible risk signals at an early stage and, if necessary, to take, coordinate or initiate measures to minimise risk.
Suspected case reports are not subject to an individual medical or clinical assessment by the Paul-Ehrlich-Institut.
The data from the spontaneous reports are supplemented by data from the periodic safety update reports (PSURs) specified in the marketing authorisations, which the pharmaceutical companies (marketing authorisation holders) must submit to the committees of the European Medicines Agency (EMA) and thus also to the national drug authorities.
If there is any indication of a new risk signal for an authorised vaccine, the Paul-Ehrlich-Institut will, if necessary, take or initiate measures to minimise the risk or, if necessary, coordinate measures with the sister medicines authorities in the EMA committees and report on them.
Suspected cases of adverse reactions are not identical to adverse reactions as listed in the product information.
Updated: 05.08.2024
As with other medicinal products under the Institute’s responsibility, the Paul-Ehrlich-Institut receives reports of suspected side effects or vaccine complications following vaccination from the following sources:
Updated: 19.04.2024
The Paul-Ehrlich-Institut compiles the reports it receives regarding adverse events and vaccination complications. It is important to set the reporting threshold low in order to identify any new safety signals at an early stage. This means that reports linked purely by time and not necessarily causally with the vaccination are also significant. The Paul-Ehrlich-Institut seeks out additional information on a large number of reports and it also receives further data on reports from a variety of reporting sources. The current status of information on the cumulatively submitted reports is analysed on an ongoing basis. The description of the suspected cases may therefore be subject to changes compared to the previous reports as a result of additional information.
The Paul-Ehrlich-Institut carries out "observed-versus-expected" (OE) analyses on an ongoing basis for the early detection of potential safety signals. These analyses compare the frequency of the adverse events reported after vaccination to the Paul-Ehrlich-Institut to the statistically expected frequencies in a comparable (non-vaccinated) population, taking variation in time intervals into consideration. If the reporting rate for an adverse event after vaccination is significantly higher than would be statistically expected in a comparable population, then the Paul-Ehrlich-Institut presumes the presence of a potential safety signal that should be examined further in predominantly epidemiological studies.
The reporting data is also entered into the European database of adverse drug reactions, EudraVigilance, maintained by the European Medicines Agency (EMA), so that they can also be taken into account in risk analyses at the EU level.
Updated: 30.08.2024
A suspected adverse event report is assessed by the Paul-Ehrlich-Institut according to the criteria of the World Health Organization (WHO).
In its user manual for the revised WHO classification, the WHO states the following regarding the assessment of an adverse event following immunisation (AEFI):
"Causality assessment is the systematic review of data about an
AEFI case; it aims to determine the likelihood of a causal association between the event and the vaccine(s) received. For individual cases, one tries to apply the evidence available on the basis of the history and time frame of the event to arrive at a causal likelihood. (...) Causality assessment usually will not prove or disprove an association between an event and the immunization. It is meant to assist in determining the level of certainty of such an association. A definite causal association or absence of association often cannot be established for an individual event."
The evaluation of suspected adverse event reports is therefore not about the final evaluation of the individual reports.
Updated: 05.08.2024
Yes, multiple reports are possible, but they are merged within the database. In individual cases, this may also occur with a time delay if investigations of the report subsequently reveal that it is a duplicated notification.
Updated: 28.03.2024
Individuals who submit a report to the Paul-Ehrlich-Institut via www.nebenwirkungen.bund.de will receive a confirmation of receipt and a specific PEI number after submission of the report. However, this PEI number is not used for personal contact with the vaccinated person or their relatives, only for queries from the Paul-Ehrlich-Institut.
The spontaneous reporting system and the recording of suspected adverse event reports are primarily used to obtain information on possible, previously unknown adverse events in the form of safety signals. Individual case reports are used to carry out an overall evaluation of the corresponding medicinal products. They are not used for assessments of the individual reports nor to provide personal feedback on the individual cases.
The Paul-Ehrlich-Institut is not a clinical institution and therefore cannot offer individual vaccination advice or other feedback. More specifically, it is not possible for the Institute to give recommendations on diagnosis or therapy, as there are many factors to consider when it comes to issuing medical advice. These factors can only be adequately addressed via personal contact between doctor and patient. Please direct these questions to your physician.
Updated: 30.08.2024
The Paul-Ehrlich-Institut records and evaluates case reports of suspected possible adverse reactions to vaccines and vaccination complications as part of the spontaneous reporting system, an important pillar of medicinal product safety. The spontaneous reporting system has the function of recognising safety signals – indications of a connection between an adverse reaction and the administration of a drug or vaccination – as quickly as possible. Those signals are then followed up by further investigations.
In the case of a safety signal, further investigations are carried out to determine whether the reaction described is actually an adverse reaction caused by the medicinal product. The Paul-Ehrlich-Institut works closely with the EU authorities in the evaluation of safety signals.
No conclusions can be drawn about the frequency of adverse reactions or a causal relationship with the administration of a vaccine or therapeutic on the basis of the suspected case reports submitted to the Paul-Ehrlich-Institut. This is due to the fact that
Updated: 05.08.2024
Despite the risk of misinterpretations of the reported information, the Paul-Ehrlich-Institut publishes reported cases of suspected adverse events as defined in the Medicinal Products Act (Arzneimittelgesetz, AMG) and/or vaccine complications as defined in the Infection Protection Act (Infektionsschutzgesetz, IfSG) after the use of COVID-19 vaccines. This data is published on the Paul-Ehrlich-Institut’s website in consideration of the increased demand for information from some sections of the population and in favour of maximum transparency. The information is offered in a user-friendly Excel spreadsheet and supplemented with batch numbers (when available). The Paul-Ehrlich-Institut would also like to call attention to the disclaimer text displayed before the download link and to the explanations included in line one of the tables.
Data on Adverse Drug Reactions
The following text is provided by the Paul-Ehrlich-Institut to inform the interested public regarding the most important facts, along with detailed explanations, connected to the use of the published suspected adverse event reports in order to prevent misinterpretations.
Spontaneous reports are an important tool in pharmacovigilance for the detection of new safety signals, which can be investigated via such methods as more detailed analyses and comparisons with data from existing clinical studies or literature publications. Reporting a suspected adverse event has been made simple and straightforward for the reporters in order to promote the voluntary submission of reports and to enable everyone to report suspected side effects, regardless of the availability of detailed information. Reports require only the information that can be provided by the reporters without difficulty and that is absolutely necessary in the European context of medicinal product evaluation for the processing and evaluation of the report. The batch numbers are not required information.
The batch numbers have no primary significance for the routine detection of signals. The starting point for signal detection is the reactions reported for the medicinal product or the vaccine. The indication of a specific batch number is also not mandatory for submissions to the EudraVigilance database, the suspected side effect database of the European Medicines Agency (EMA), for this same reason. Information on batch numbers is not published in the EudraVigilance database.
European Database of Suspected Adverse Drug Reaction Reports
The Paul-Ehrlich-Institut has repeatedly received inquiries from the public in which the information on suspected adverse events received from the spontaneous reporting system is regarded as an appropriate means of observing batch-related frequencies of vaccine adverse events. Such a perspective can lead to the expectation that batch-related evaluations of spontaneous reports should be considered standard. However, this perspective is not expedient from a scientific point of view because suspected adverse event reports submitted via the spontaneous reporting system have various system-inherent limitations and are therefore not suitable for making concrete statements about the frequency of reactions. This data is also only one component in the evaluation of medicinal product safety. Spontaneous reporting data is supplemented by information from clinical or non-interventional studies or by information published in the literature. This data is discussed in the context of periodic safety update reports (PSURs). The pharmaceutical companies (marketing authorisation holders) must submit these reports regularly to the European Medicines Agency (EMA), and the assessment and discussion of the reports takes place within the national medicines authorities.
Suspected adverse events after vaccination or medicinal product therapy are retrospectively recorded in the spontaneous reporting system using the information available to the reporting person. The number of recorded suspected adverse events in the spontaneous reporting system is thus a subset of the totality of the actual adverse events that have occurred. The Paul-Ehrlich-Institut has no way of determining the total number of suspected cases that have occurred within the spontaneous reporting system – e.g. the number of people who have been immunised with a particular vaccine in Germany. The exact number of exposed people is also not known, which is required in addition to the exact number of adverse events to calculate a specific frequency. Therefore, the frequency of the reaction cannot simply be inferred from the number of reports. Unlike the spontaneous reporting system, this information is available in clinical studies, so is possible to calculate the frequency of an adverse event in this context.
A valid vaccine batch is only documented for a limited number of the suspected case reports that are submitted to the Paul-Ehrlich-Institut. A batch-related increase in reports cannot be identified on the basis of the information available in the suspected case reports. A scientifically-accurate extrapolation is not possible on the basis of this incomplete data.
It is not uncommon for the number of suspected case reports per batch to vary. This is partly due to the fact that batches contain very different amounts of vaccine doses. In addition, all of the vaccine doses contained in a released batch are not vaccinated exclusively in one single Member State of the European Economic Area (EEA), such as Germany.
The concern that certain batches of a COVID-19 vaccine were more likely to cause adverse events than others is altogether unjustified. The Paul-Ehrlich-Institut would like to point out as an example that none of the safety signals determined to have a connection to the administration of COVID-19 vaccines – such as thrombosis with thrombocytopenia syndrome (TTS) after administration of vector vaccines or myocarditis/pericarditis after mRNA vaccines – were found to be batch-related.
The Paul-Ehrlich-Institut publishes reports of suspected adverse events that it receives within the spontaneous reporting system, one of the building blocks of pharmacovigilance. These reports are intended to provide an early indication of possible vaccine risks. They are not confirmed adverse events. It should be noted here that reported adverse events are chronologically, but not necessarily causally, linked to vaccination. Confirmed adverse events are listed in the vaccine product information. The reactions reported to the Paul-Ehrlich-Institut are also not equivalent to vaccine damage.
According to section 24 of the Social Code (Sozialgesetzbuch, SGB) XIV, persons who have suffered damage to their health due to a prescribed or publicly recommended vaccination that exceeds the usual extent of a reaction to a vaccination or other measure of specific prophylaxis (colloquially: vaccine damage) are to receive benefits under social compensation law. The corresponding prerequisites/criteria are set out in sections 4 and 24 of the SGB XIV. In order to receive these benefits, an application for compensation must be submitted to the Social Welfare Office in the federal state in whose territory the vaccination was carried out in accordance with section 113 subsection 5 of the SGB XIV.
Section 5 of the SGB XIV regulates the degrees of damage and stipulates that temporary health conditions lasting six months or less are not to be considered as damage.
The Paul-Ehrlich-Institut is not responsible for processing applications for benefits under social compensation law.
Updated: 17.01.2025
The reporting rate is the ratio of the number of reported suspected adverse events to the number of uses or administered doses of a medicinal product, such as a vaccine.
The reporting rate of suspected adverse events for a medicinal product is often given as a percentage (per 100 uses or administered doses) or in reports per thousand (per 1,000 uses or administered doses).
Updated: 15.01.2025
The reporting rate is an important indicator in the spontaneous reporting system, which is used to detect abnormalities – known as signals – with the help of the observed versus expected (OE) analysis. These analyses compare the frequency of the adverse events reported to the Paul-Ehrlich-Institut (after vaccination, for example) to the statistically expected frequencies in a comparable (non-vaccinated) population, taking variation in time intervals into consideration. If the reporting rate for an adverse event after vaccination is significantly higher than would be statistically expected in a comparable population, then the Paul-Ehrlich-Institut presumes the presence of a potential safety signal that should be examined further in predominantly epidemiological studies.
The reporting rate of suspected adverse events does not allow direct statements about the safety of a medicinal product. However, it can serve as a first indicator in medicinal product monitoring to detect abnormalities, such as previously unknown possible adverse events.
Important to know: the frequency of (confirmed) adverse reactions cannot be inferred from the number of suspected case reports received by the Paul-Ehrlich-Institut as part of the spontaneous reporting system alone, nor from their reporting data.
Let's suppose there are two vaccines: Vaccine A and Vaccine B.
Although the same absolute number of suspected case reports have been received for both vaccines, vaccine B has a significantly higher reporting rate: 1% compared to 0.01%. This higher reporting rate could be a signal that the adverse events connected to vaccine B are more common and should be investigated more closely.
In the spontaneous reporting system, the reporting rate can help to identify medicinal products that may be at an increased risk of certain adverse events, so that further analyses and investigations can be initiated by the medicinal product safety experts.
Updated: 15.01.2025
It should be noted that an observed versus expected analysis (OE analysis) can indicate a safety signal, but only further investigations will show whether or not there is actually a risk. An OE analysis is not suitable for confirming a risk. A safety signal indicated by means of a method such as an OE analysis should be further investigated by additional studies (Guideline in good vigilance practices (GVP): Product- or Population-Specific Considerations I: Vaccines for prophylaxis against infectious diseases EMA/488220/2012 Corr*).
The following aspects pose limitations for an OE analysis: variance in the information on background incidence rates in the original sources, lack of information regarding both the time interval between vaccination and start of symptoms as well as the exposure level, reporting delays, and somewhat shorter observation times post-vaccination for the last dose administered. In addition, age stratifications can only be carried out to the extent that data from the literature on the background incidence is available for individual age groups. Therefore, the individual analyses also differ in regards to the age groups presented.
Updated: 16.04.2024
According to section 24 of the German Social Code XIV (Sozialgesetzbuch, SGB XIV), vaccine damage is defined as a damage to health that goes beyond the usual extent of a reaction to a vaccination.
Section 5 SGB XIV regulates the degree of damage and stipulates that temporary health impairments of up to six months are not considered as damage.
If vaccinated persons or their relatives suspect that they have suffered a vaccine damage following a publicly recommended vaccination, they can submit an application for relief under the Federal War Victims Relief Act (Bundesversorgungsgesetz) in accordance with Section 24 of the German Social Code (SGB) XIV in conjunction with section 4 SGB XIV.
Pursuant to Section 4 subsection 4 of the SGB XIV, the probability of a causal connection is sufficient for the recognition of a health condition as a result of damage.
According to section 113 subsection 5 of the SGB XIV, the application for compensation must be submitted to the Social Welfare Office in the federal state in whose territory the vaccination was carried out. The Paul-Ehrlich-Institut is not responsible for processing applications for recognition of vaccine damage.
Updated: 05.08.2024
Pharmacovigilance records suspected adverse reactions as part of the spontaneous reporting system. These are spontaneously reported, unconfirmed suspected cases of side effects.
Adverse reactions are identified in clinical trials prior to authorisation or in large post-authorisation studies and their frequency is included in the product information.
Vaccine damage is recognised on the basis of the Social Code XIV (Sozialgesetzbuch XIV, SGB XIV). The vaccine damage assessment is always performed as an individual medical and clinical assessment. Procedures for the recognising vaccine damage involve the assessment of an individual case within the framework of social compensation law.
Updated: 05.08.2024
The short development time for the COVID-19 vaccine candidates during the pandemic was possible thanks to a number of factors:
However, as is the case for all other new vaccines and therapeutic drugs, not all potential or very rare side effects could be recorded at the time of authorisation for COVID-19 vaccines. Vaccines and all other newly authorised medicines are therefore also monitored for safety after marketing authorisation. One component of post-authorisation monitoring (surveillance) is the analysis of spontaneous reports of suspected adverse reactions or vaccination complications. Additional studies have been carried out on the COVID-19 pandemic vaccines, including active safety studies.
Updated: 11.10.2024
Suspected cases of adverse events or vaccination complications that were reported to the Paul-Ehrlich-Institut on or before 31 March, 2023, as having occurred after administration of the authorised COVID-19 vaccine products were presented in periodically published safety reports along with reports on safety signals. All reported cases of suspected adverse events and vaccination complications from Germany were taken into account, regardless of how they were received – by post, email, telephone, electronically via the Paul-Ehrlich-Institut’s reporting portal www.nebenwirkungen.bund.de, via the EudraVigilance database at the European Medicines Agency (EMA) and/or via the SafeVac 2.0 app.
www.pei.de/safety-report
Online-Reporting of Side Effects - www.nebenwirkungen.bund.de
Updated: 19.04.2024
From the beginning of the vaccination campaign in Germany on 27 December, 2020, through 31 March, 2023, there were 340,282 suspected cases of adverse events and 56,432 suspected cases of serious adverse events following administration of COVID-19 vaccine products (primary or booster vaccination) reported to the Paul-Ehrlich-Institut.
Suspected case reports of adverse events and vaccination complications are reports of reactions that occurred in temporal association to vaccination and are not directly clearly attributable to other causes. When reactions that occurred after vaccination are reported as a suspected adverse event or vaccination complication, the Paul-Ehrlich-Institut examines whether such reactions could be causally related to vaccination with a specific vaccine product, specific batches of a vaccine product or vaccine products of a specific vaccine type. If necessary, the Paul-Ehrlich-Institut will take, coordinate or initiate appropriate measures to reduce risk.
Updated: 30.08.2024
The term "Post-Vac Syndrome" is used in connection with certain symptoms observed after COVID-19 vaccination, some of which are similar to Long COVID symptoms.
Currently there is no internationally recognised, standardised case definition for Post-Vac Syndrome. In the evaluations of suspected case reports of Long COVID/Post COVID-like symptoms after COVID-19 vaccination, it was not possible to identify an increased risk of these symptoms for such reports after COVID-19 vaccinations from Germany or from the Member States of the European Economic Area (EEA) and the non-EEA countries (worldwide) in which the centrally authorised COVID-19 vaccines were administered.
The Paul-Ehrlich-Institut would like to note that in each of the evaluations, as described in the statement dated 19 May, 2023, more than 50 percent of the suspected case reports came from Germany. However, less than 50 percent of all vaccine doses administered in the countries from which suspected case reports were submitted were administered in Germany.
The Paul-Ehrlich-Institut currently has no evidence from the scientific literature that could explain the triggering factors for the development of Long COVID/Post COVID-like symptoms.
It is now known that there were also numerous asymptomatic SARS-CoV-2 infections. In such cases, the Long COVID/Post COVID-like symptoms may also be a result of the undetected infection.
Updated: 23.08.2024
The Paul-Ehrlich-Institut developed the SafeVac 2.0 smartphone app as part of a study for the active monitoring of the safety and tolerability of authorised COVID-19 vaccines used in Germany. The aim of the app was to rapidly obtain quantitative information on the safety profile of the COVID-19 vaccines, going beyond the marketing authorisation data. The SafeVac 2.0 app should not be confused with the established online spontaneous reporting system for the recording of suspected adverse reactions, which could be used in parallel and will continue to be available.
Users of the SafeVac 2.0 app voluntarily took part in an observational study carried out by the Paul-Ehrlich-Institut, which will ran until the end of 2023. The vaccinated persons’ agreement and consent to participate in the Paul-Ehrlich-Institut’s observational study were preconditions for using the app. Participants who registered in the app by 30 September 2022 were asked questions via the app about their current state of health at defined points in time. The recruiting phase ended on 1 October 2022. No new participants will be included in the SafeVac 2.0 survey.
The SafeVac 2.0 app survey enabled the Paul-Ehrlich-Institut to determine the frequency, severity and duration of an adverse reaction. This app not only gave the Paul-Ehrlich-Institut information on suspected adverse reactions, but also on the proportion of vaccinated persons who tolerated vaccination well.
Updated: 19.04.2024
The SafeVac 2.0 app is a further development of the SafeVac 1.0 smartphone app, which was designed in collaboration with Materna Information & Communications SE and the Helmholtz Centre for Infection Research (HZI) in Braunschweig, and was used to record adverse events after seasonal influenza vaccination. The app was commissioned by the Paul-Ehrlich-Institut and was developed as a cross-platform app for the iOS (Apple) and Android (Google) operating systems.
Updated: 18.04.2024
Individuals who had received the first COVID-19 vaccination in their primary vaccination course by 30 September 2022 had the opportunity to participate in the study. As of 1 October 2022, no new participants were allowed to register for the SafeVac 2.0 study. The tracking of the persons registered up to that point continued according to the study protocol.
The vaccinated persons’ agreement and consent to participate in the Paul-Ehrlich-Institut’s observational study were preconditions for using the SafeVac 2.0 app. Participants were asked questions via the app on seven occasions after the first vaccination and on eight occasions after the second vaccination; this took place within three weeks after the first dose and four weeks after the second dose and was designed to determine how well the vaccines are tolerated. In addition, participants were asked final questions about their state of health after six and twelve months.
The data protection concept was assessed by the Federal Commissioner for Data Protection. Steps were taken to ensure that no participant or individual smartphone could be identified at any time. On the first occasion that data was transmitted to the Paul-Ehrlich-Institut, a random number was created on the federal server and then stored in encrypted form in the participant's smartphone memory; with each new data transmission, this number was checked to ensure it was correct and then transferred with the random key to the Paul-Ehrlich-Institut in a secure connection via the federal government server.
None of this information contained any personal data and nor was it traceable by the Paul-Ehrlich-Institut. Details about the user or his/her smartphone could not be derived from the case ID.
A distinction was made in the requested information between required details and data that was not absolutely necessary. The required fields included the details on age and gender, the vaccine name and the batch number. If required information was not entered, the user received a message and was not be able to move to the other fields until these mandatory fields were completed.
The transmitted data were evaluated for the occurrence of possible adverse reactions. This included a record of how often the vaccination was well tolerated and how often adverse reactions occurred. The type, severity and time interval between vaccination and reactions were also analysed. The data after six and twelve months were evaluated with regard to the frequency of possible SARS-CoV-2 infections and the severity of possible COVID-19 illness after the vaccination.
Reports on vaccination reactions were also included in the Paul-Ehrlich-Institut’s database of adverse reactions. The Paul-Ehrlich-Institut is legally obliged to collect and evaluate all reported suspected cases of adverse reactions and to forward them to the European database of suspected adverse drug reactions.
Updated: 19.04.2024
Suspected adverse reactions to vaccination are indeed recorded via regular spontaneous reporting. What is left unknown, however, is how many reactions are not reported for various reasons. The SafeVac 2.0 study enabled the Paul-Ehrlich-Institut to make quantitative evaluations of the possible adverse reactions, since the number of participants was known and adverse reactions were documented on a daily basis. The Paul-Ehrlich-Institut did not only obtain information via the study’s SafeVac 2.0 app on suspected adverse reactions, but also on the percentage of vaccinated persons who tolerated the vaccination well.
Updated: 19.04.2024
