Adverse reactions following the vaccine. How common are they?

With any COVID-19 vaccine, as with drugs, adverse body reactions can occur. The most common post-vaccination NOPs are redness, soreness at the injection site, and hand swelling. However, there are also more serious ailments.

1. In Poland, over 15 million vaccines against COVID-19 have already been administered
2. Four preparations are currently used in our country: Pfizer, Moderny, AstraZeneki and Johnson & Johnson
3. Until May 13, a total of 8 thousand jobs were recorded in our country. 209 adverse post-vaccination reactions, of which 6 935 was mild
4. More information can be found on the Onet homepage.

Where and how to report adverse vaccine reactions?

To begin with, let us briefly recall who and how can report NOPs in our country after vaccination against COVID-19:

1. Having diagnosed a patient with NOP, a doctor reports him / her to the State Sanitary Inspection (PIS) by electronic means, via the office office. 
2. anyone can submit an NOP to the Department of Monitoring Undesirable Effects of Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPL) via a special website: https://smz.ezdrowie.gov.pl. 
3. Anyone can report an NOP directly to the vaccine manufacturer (MAH), using the contact details provided on the vaccine package insert.

Data on NOPs occurring after vaccinations against COVID-19, which are published daily on the official government website of the “Vaccinate” campaign, are based on reports made in the first of the above-mentioned ways, i.e. from the State Sanitary Inspection (specifically from the records system called SEPIS). Attention! Therefore, if you have submitted your NOP online to the URPL, do not expect to find it in the list available on the “We vaccinate” page.

What happens next with notifications from SEPIS?

– The next step is to submit the applications to the NIPH-PZH. Here the process of verification and detailed epidemiological analysis takes place. We analyze many detailed issues, for example: after how many days after vaccination, side effects appeared, whether they were reactions after the first dose of the vaccine or after the next dose, whether there were completely new, other than previously observed side effects after vaccination, or those that appeared many times, whether the reaction required a medical consultation in a hospital, how long was hospitalization – enumerates dr hab. Iwona Paradowska-Stankiewicz from the National Institute of Public Health-National Institute of Hygiene (NIZP-PZH).

How common are NOPs following COVID-19 immunization?

NIPZ-PZH specialists start each analysis with an assessment of whether a given application can be classified as NOP at all, and if so, they qualify NOPs according to the degree of severity.

– Our analyzes show that the vast majority (over 85%) are mild NOPs, several percent are serious NOPs, and several percent (2-3%) are severe NOPs, which also include deaths – informs dr hab. Iwona Paradowska-Stankiewicz.

1. See also: More and more cases of thrombosis after vaccination [REPORT]

Interestingly, NIPH-PZH also analyzes the incidence of NOPs after administration of various COVID-19 vaccines.

– According to the available data from reports for the period from December to mid-April, the percentage of vaccinated people who developed NOPs is as follows: Comirnaty (Pfizer) 0,036%. vaccinated, Moderna 0,022 percent, AstraZeneca 0,128 percent, or a total of 0,054 percent. On the other hand for the total number of doses administered of these vaccines, the incidence of NOPs was 0,1%. This confirms the high level of safety of all vaccines – emphasizes dr hab. Iwona Paradowska-Stankiewicz.

At the same time, the specialist urges everyone to carefully interpret the information on the number of deaths that occurred after vaccination against COVID-19. Why?

– The list of NOPs published on the website of gov.pl contains cases of deaths. However, these deaths should not be automatically associated with a causal relationship with vaccination. To confirm such a relationship, numerous additional tests must be performed. There is a special team operating at the health minister to investigate such cases. However, such analyzes are very complicated and long-lasting, and determining a possible cause-and-effect relationship is very difficult, and sometimes even impossible – emphasizes Dr. Iwona Paradowska-Stankiewicz.

1. The editorial board recommends: Thrombosis after vaccination or death by COVID-19. What’s more common? [WE EXPLAIN]

According to the expert, the only thing that can be stated with certainty in such cases is the temporal relationship between vaccination and death, i.e. that it occurs within one month of vaccination.

– In practice, however, the causes of death can be very different, e.g. resulting from e.g. from multiple diseases, deterioration of health that occurred, for example, two weeks after vaccination. Concerns about a causal relationship between vaccination and death or severe NOP generally do not occur in anaphylactic shock, occurring most frequently shortly after vaccination. And by following the surveillance data, such deaths have been recorded in Poland – admits Dr. Iwona Paradowska-Stankiewicz.

The expert emphasizes, however, that with regard to other possible complications after vaccinations, e.g. recent high-profile thromboembolic events, such certainty is no longer certain and a cause-and-effect relationship with vaccination is very difficult to demonstrate. Especially since thromboembolic episodes occur much more frequently in the general population than as a result of vaccination.

– In most cases of severe NOP reports, which is usually related to the hospitalization of the patient, we contact the hospital or the reporting physician to thoroughly analyze the case. Sometimes, when analyzing such a report from the perspective of a longer period of time, we come to the conclusion that the symptoms initially recognized as NOP had nothing to do with it, as evidenced by the subsequent development of events and the related medical documentation, or that the reaction the undesirable side resolved quite quickly and was not as severe as it seemed at the time of reporting – says Dr. Iwona Paradowska-Stankiewicz.

It is worth knowing that the supervision system of NOPs in Poland includes, in addition to the three above-mentioned institutions, also GIF (Main Pharmaceutical Inspectorate), which mainly watches over the quality of vaccines – in terms of detecting possible quality defects or adulterations of these preparations that threaten patient safety.

In the context of the functioning of this system and ensuring an adequate flow of information, it should be added that the reports of NOPs diagnosed by doctors are sent to all the above-mentioned institutions, i.e. to PIS, NIPH-PZH, URPL and GIF. But this is not the end. The national system of supervision over NOPs is, of course, also related to the EU system.

– URPL assesses the occurrence of new, unexpected, other than previously observed side effects and diseases that occurred in vaccinated persons within one month of vaccination. URPL has constant and direct contact with the EMA (European Medicines Agency), including the European NOP base (i.e. the Eurovigillance base). It is on the basis of this monitoring that the lists of adverse effects in the SPCs, i.e. the characteristics of medicinal products, are supplemented, but also the safety analysis of vaccines is carried out – explains Dr. Iwona Paradowska-Stankiewicz.

Also, vaccine producers themselves, if they receive direct reports on NOPs, should provide related information to the relevant institutions, including, inter alia, EMA or WHO.

Where to find information about NOPs

According to the data as of May 9, 2021, available on the government website of the action “We vaccinate”, from the first day of vaccination against COVID-19 (December 27.12.2020, 7676), medics reported to the State Sanitary Inspection a total of 6496 adverse post-vaccination reactions, of which XNUMX was mild.

1. See also: Side effects of COVID-19 vaccines [COMPARISON]

Attention! From May 7 this year. Everyone interested in the occurrence of NOPs after vaccinations against COVID-19 in Poland also has the opportunity to familiarize themselves with in-depth analyzes and statistics on this subject – developed by the NIPH-PZH. They will be regularly published / updated (every 2 weeks) in the form of special reports – on the NIZP-PZH website. You can find them here.

More practical information on NOPs can also be found on the “Vaccinations Info” website run by NIPH-PZH.

We vaccinate ourselves and others

In the context of the ongoing fight against the pandemic and the discussion on vaccination, the NIPH-NIH specialist also points out that although mass vaccination against COVID-19, as shown by examples from countries such as Israel and the United Kingdom, helps to contain the epidemic, they also have your limitations.

– Nobody has yet come up with a drug or vaccine that is 100 percent effective. In every population there is always a certain percentage of people, estimated at 5%, for whom a given medicinal product simply does not work. We call such people non-responders. This is why it is so important to achieve herd immunity, because then also such people, as well as people who cannot be vaccinated for health reasons, gain protection – summarizes Dr. Iwona Paradowska-Stankiewicz.

Wiktor Szczepaniak, Zdrowie.pap.pl

Also read:

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2. Why are so many people dying from COVID-19? The doctor explains
3. “Coronavirus catches people who live unhealthy and they usually get sick”
4. French vaccine will protect against new SARS-CoV-2 mutations? More countries interested in purchasing

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