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DN has taken note of all the reactions that have been reported to the database of adverse reactions of the European Medicines Agency EMA Eudravigilance, from EU countries, UK and vaccine manufacturers, up to 8 March. In total, there are 559,750 suspected side effects from the Pfizer / Biontech, Modernas, and Astra Zeneca vaccines. To give an indication of the context, 38.2 million doses of the covid-19 vaccine had been administered in the EU / EEA to date, according to the EU infection control authority, ECDC.
Reactions are divided into different categories and the pattern is the same for all three vaccines. General symptoms and reactions end at the injection site first, such as fatigue, fever, chills, and pain in the arm where you received the injection. The next most common are nervous system reactions, such as headaches and dizziness. Third are reactions in muscles, bones, and connective tissue, such as muscle pain and joint pain.
When it comes to individual symptoms, headaches, fever, chills, fatigue, muscle aches, joint pain, malaise, and nausea are among the top ten most common reactions.
DN has asked two vaccine researchers to review the content of the database.
Ali Harandi, associate professor and director of the Sahlgrenska Academy’s vaccine laboratory, emphasizes that vaccination elicits an immune response that can cause side effects, usually mild. Millions of doses of the corona vaccine have been administered in the EU and, so far, serious reactions have been rare. He still reacts to the fact that nervous system symptoms are the second most common category among reactions and thinks it is not as common for other vaccines.
– A relatively large number of people, who reported side effects after receiving the vaccine, experienced symptoms such as dizziness, he says.
Ali Harandi.
Photo: Johan Wingborg / University of Gothenburg
It also reacts to the fact that some have reported gastrointestinal tract disorders, such as stomach pain and diarrhea, and that some people have temporarily lost their sense of taste and smell. The latter may have to do in part with the fact that some people may have been infected with the coronavirus when they received the injection, as it is one of the symptoms of covid-19, he says.
– We cannot say that this is directly related to the vaccine, but there are unusually many who experience these problems.
Ali Harandi also thinks the number of hemiplegia cases, which have been reported for the Pfizer / Biontech and Moderna vaccines, is a bit of a concern.
– Although there are not as many cases and the symptoms are transient, it is not as common for such side effects to be reported for vaccines administered to humans.
The EMA is investigating a batch of the Astra Zeneca vaccine, after people suffered blood clots, but when Ali Harandi looks at the reports of side effects, he sees very few cases of blood clotting disorders.
Ali Mirazimi, Adjunct Professor in clinical virology at the Karolinska Institutet, agrees that the proportion of reports related to the nervous system, gastrointestinal tract, sense of taste and smell, and semi-lateral facial paralysis appears to be slightly higher than normal. However, he does not think it is remarkable, as there is no evidence yet that they are linked to the vaccine.
– There’s nothing to worry about based on what we know today, he says.
The reactions reported by all three vaccines are what you would expect when the immune system is activated with the syringe, he says.
– If you look at the symptom picture, the three vaccines are very similar. These are generally common symptoms such as fever, cold symptoms, headache, dizziness, tremors, and nausea. I don’t think there is anything special that stands out.
Ali Mirazimi.
Photo: Henrik Montgomery / TT
The Medical Products Agency He also does not consider anything special to highlight in the reports of suspected side effects sent to the EMA and sees no cause for concern.
– It is not uncommon for neurological side effects to occur from other vaccines as well, such as headaches, says Karin Vengemyr, head of the authority’s side effects group.
Half-sided facial paralysis is a known, but rare, side effect of the Pfizer / Biontech and Moderna vaccines and is already included in the product information. GI system symptoms aren’t noticeable either, he says.
– In the latest EMA safety report for Comirnaty (Pfizer / Biontech vaccine), diarrhea and vomiting were evaluated as related to the vaccine and will be added to the product information. All three vaccines have nausea as a known and very common side effect, but it is common with other vaccines as well.
Karin Vengemyr, head of the side effects group at the Medical Products Agency.
Photo: Medical Products Agency
However, Karin Vengemyr is unaware that taste and smell effects would be a common side effect of the vaccine. It emphasizes that in this case it is a question of suspected side effects, where there is not yet an established causal relationship with the vaccine. It is also possible that those affected were infected with the coronavirus at the same time.
– It is a common symptom of covid-19.
How safe do you think these vaccines are?
– We judge they are safe. The vast majority of reported adverse reactions are mild and expected based on clinical trials conducted prior to authorization. It is also important to highlight the benefits of the vaccine, which provides protection against a potentially serious disease.
Does the number of reports stand out in any way?
– It is difficult to compare with established vaccines. The fact that we have received a lot of spontaneous reports may have to do with the fact that you are alert and that the vaccine has received attention in the media. If you experience a suspicious side effect, it is important to report it.
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