Based on a recommendation from the Paul Ehrlich Institute (PEI) on March 15, 2021, the German Federal Government suspended COVID-19 vaccinations with AstraZeneca as a precautionary measure. Further investigations were necessary. The European Medicines Agency (EMA) examined whether and how the new findings would affect the vaccine's approval. Following intensive consultations regarding the serious thrombotic events that had occurred in Germany and Europe, the Paul Ehrlich Institute (PEI) recommended the temporary suspension of vaccinations with the AstraZeneca COVID-19 vaccine. As of Monday, March 15, 2021, further cases had been reported in Germany since March 11, 2021. Analyzing the new data, experts at the Paul Ehrlich Institute observed a striking cluster of a specific form of very rare cerebral venous thrombosis (sinus vein thrombosis) in conjunction with a deficiency of blood platelets (thrombocytopenia) and bleeding in close temporal proximity to vaccinations with the AstraZeneca COVID-19 vaccine. The data were further analyzed and evaluated by the European Medicines Agency (EMA). Until the EMA's assessment is complete, vaccinations with the AstraZeneca COVID-19 vaccine have been suspended in Germany. This decision applies to both primary and booster vaccinations. The Paul Ehrlich Institute advised that individuals who have received the AstraZeneca COVID-19 vaccine and experience increasing discomfort more than four days after vaccination, for example, with severe and persistent headaches or pinpoint skin hemorrhages, should seek immediate medical attention.
Prof. Dr. Hartmut Göbel: “The onset of headaches, usually lasting four days or more, in conjunction with neurological symptoms such as dizziness, visual disturbances, tinnitus, and eye muscle paralysis, as well as varying degrees of altered consciousness, is the key symptom constellation for cerebral venous thrombosis. These headaches differ significantly from typical headaches following a COVID-19 vaccination. The latter occur in approximately 50% of cases within 17 hours of vaccination and last an average of 18 hours. Altered consciousness is not a common accompanying symptom.”
The European Medicines Agency (EMA) reviewed the situation and recommended on March 18, 2021, that vaccinations with the AstraZeneca vaccine continue. The federal and state health ministers decided on March 18, 2021, to resume vaccinations with the AstraZeneca vaccine starting March 19, 2021. This decision was based on the fact that the benefits of the vaccine in combating the still widespread threat of COVID-19 continue to outweigh the risk of side effects. A warning was added to the product information.
A Dear Healthcare Professional Letter dated March 24, 2021, explains: “Vaccinated individuals should be advised to seek immediate medical attention if they develop symptoms such as shortness of breath, chest pain, leg swelling, or persistent abdominal pain after vaccination. Furthermore, anyone experiencing neurological symptoms after vaccination, such as severe or persistent headaches or blurred vision, or who develops bruising (petechiae) on the skin outside the injection site a few days later, should seek immediate medical attention.”
Download: Dear Doctor Letter COVID-19 Vaccine AstraZeneca: Risk of thrombocytopenia and coagulation disorders
In this context, the question arises as to why, in Germany, vaccination with the AstraZeneca vaccine was restricted to people under 65, contrary to its approval by the EMA (European Medicines Agency), citing insufficient efficacy data in older people. that young women in the healthcare system , such as nurses and doctors, have been given priority for treatment with this vaccine. The benefit of an additional warning about complications in the package insert, when no alternatives are offered, remains unclear. This would be understandable if no other options existed. However, such options were available, including vaccines from BioNTech/Pfizer. According to current findings, young women belong to the high-risk group for the described complications. Consequently, on March 29, 2021, the Euskirchen district decided with immediate effect to no longer vaccinate women under 55 with the AstraZeneca vaccine. Following the death of a 49-year-old nurse, Rostock University Hospital announced on March 26, 2021, that it is suspending AstraZeneca vaccinations for people with high blood pressure, obesity, and women taking birth control pills. Similarly, the Canadian expert panel for the COVID-19 vaccination campaign currently recommends suspending the AstraZeneca vaccine for people under 55. According to a report from March 30, 2021, the state-owned Charité and Vivantes hospitals in Berlin are also suspending AstraZeneca vaccinations for women under 55. Following Berlin's announcement, the city of Munich also announced on August 30, 2021, that it will no longer administer AstraZeneca to anyone under 60 until further notice. On March 30, 2021, the directors of five university hospitals in North Rhine-Westphalia also advocated for a temporary halt to vaccinations of younger women with the AstraZeneca vaccine. And also on March 30, 2021, the Standing Committee on Vaccination (STIKO) announced: “Based on the currently available, albeit still limited, evidence and taking into account the current pandemic situation, STIKO recommends using the AstraZeneca COVID-19 vaccine for people over 60 years of age. Its use below this age remains possible at the discretion of a physician and with individual risk acceptance after careful consultation. STIKO will issue a statement regarding the second vaccine dose for younger people who have already received a first dose of the AstraZeneca COVID-19 vaccine by the end of April.”
In addition to aspirin and ibuprofen, Novaminsulfone is also an option.
The medication should not be taken preventatively, but only when symptoms appear. The vaccination does not have to be canceled if you already have a headache. Over 50% of those vaccinated experience malaise and headaches. The new onset of headaches, usually over four or more days, in conjunction with neurological deficits such as dizziness, visual disturbances, tinnitus and eye muscle paralysis and varying disorders of consciousness is the decisive key symptom constellation for sinus vein thrombosis. These headaches are significantly different from typical headaches after a Covid vaccination. The latter occur in around 50% within 17 hours of vaccination, with an average duration of 18 hours. Disturbances of consciousness do not exist as an accompanying symptom.
The RKI writes about this ( https://www.rki.de/SharedDocs/FAQ/COVID-Impfen/total.html ): Since April 1st, 2021, the STIKO has only recommended vaccination with the Vaxzevria vaccine from AstraZeneca for older people of ≥60 years.
The reason for this age restriction lies in the rare cases of thrombosis in combination with thrombocytopenia, which occurred in a few vaccinated people after vaccination.
These serious, sometimes fatal, side effects were predominantly observed in women aged ≤55 years.
But men and older people were also affected. (see FAQ “What should people <60 years of age who have already been vaccinated with the AstraZeneca vaccine pay attention to?”) The STIKO therefore limits its recommendation to both genders after a risk-benefit assessment.
In the age group of ≥60 years The risk of severe or fatal COVID-19 disease increases, so that the benefit-risk balance here is clearly in favor of vaccination:
vaccination with AstraZeneca effectively prevents (severe) COVID-19 disease in a population group that - compared to those in the 18 to 60 age group - have a more than 60 times higher risk of dying from COVID-19 (source: RKI reporting data). At the same time, 89% of the reported thromboembolic events occurred in people <60 years old and This means that it does not occur in this age group ≥60 years, which is particularly at risk from COVID-19.
The STIKO therefore continues to recommend vaccination with the COVID-19 Vaccine AstraZeneca to people ≥60 years of age. In the older age group, the vaccine is generally better tolerated and leads to less frequent and less severe vaccination reactions.
In addition, regardless of age, a decision based on medical discretion for the first or second vaccine dose with Vaxzevria from AstraZeneca is possible, which is made after careful information based on individual risk acceptance.
To date, there is no data on the risk of a second vaccination. As of: April 1, 2021
Good afternoon Professor Göbel,
as far as I understand, Astra Zeneca has so far been mainly vaccinated against younger people, because until recently it was not recommended for people over 65 years of age.
Shouldn't we conclude from this that this form of thrombosis only occurred in younger people because the older ones have hardly been vaccinated with it up to now? I myself am 71. Thank you and kind regards
Uta Dohmeyer
Dear Professor Göbel,
on April 1st, i.e. in 3 days, I will be vaccinated with AstraSeneca. I received the vaccination certificate because of the chronic migraines, the very severe fibromyalgia that has been present since July and, above all, the severe depression.
Now my doctor asked me, Dr. Seeck-Hirschner to ask you which painkiller I should take if I have a severe headache. In recent years I have been taking Novaminsulfone 500mg/ml, with increasingly moderate success. Would that be suitable or even allowed in the event of a vaccination? Above you recommend aspirin – would that also be an option for me?
Of course, I'm also worried about a sinus vein thrombosis, especially since I wouldn't be able to differentiate between this and the normal migraine pain, because for me it usually lasts for several days, with dizziness, visual and speech problems.
Do I have to cancel the vaccination if I already have a headache on the day of the vaccination?
I would be very grateful for a prompt reply.
Kind regards from Flensburg,
your
Gyde Kuchcinski
Dear Ms. Schröter
, the vaccination usually does not trigger migraines.
In around 50%, the immune reaction causes a moderate headache lasting around 17 hours. These are independent of migraines. Migraines do not cause an increased risk of sinus vein thrombosis.
Triptans do not work for post-vaccination headaches.
Ibuprofen or aspirin would be suitable. Kind regards
Hartmut Göbel
Hello Professor Göbel,
As a migraine sufferer (f, 45, NR, normal weight) with aura (vision problems, periods of numbness, etc.), am I more at risk for the relevant thrombosis due to an Astra Zeneca vaccination?
Thank you very much for your assessment.
Kind regards from the west bank
I (70 years old) will probably be vaccinated with AstraZeneca on April 18th, 2021. Since I have been suffering from migraines for about 60 years, I suspect a severe migraine as a vaccination reaction.
Question: 1. Is there a risk of sinus vein thrombosis in migraine patients due to the vaccination - especially since I was once diagnosed with an anastomosis in the brain?
and 2. Can I take triptans in the event of a vaccine reaction with a headache?
Kind regards,
Annegret Schröter