The risk of thrombosis at 11 excess events per 100 000 vaccinations are higher than estimated by the European Medicines Agency. The EMA estimates the risk of thrombosis to be between 1 and 2 per 100 000 people, depending on age. Among the venous thromboembolic events, the most notable was cerebral venous thrombosis, which was about 20 times more common after the Oxford-AstraZeneca vaccine than expected with an excess risk of 2.5 per 100 000 vaccinations. Venous thromboembolic events were more common in women than in men and were also more common in people aged 18-44 than in those aged 45-65. Thrombocytopenia and bleeding were mildly increased after vaccination, but not significantly.
Study Paper here: Arterial events, venous thromboembolism, thrombocytopenia, and bleeding after vaccination with Oxford-AstraZeneca ChAdOx1-S in Denmark and Norway: population based cohort study
“I can confirm that we have received another report of a suspected death linked to vaccination last week,” writes Veronica Arthurson, unit manager at the Medical Products Agency in a text message to SVT. The woman in her 70s was completely healthy when she was vaccinated with Astra Zeneca’s vaccine, according to relatives. A few days later, she got the unusual side effects – blood clots and low levels of platelets – which have been the focus of the EU Medicines Agency’s review of the vaccine, according to SVT.
Dr John Campbell discusses the need for aspiration before coronavirus vaccination, and the technique for doing so.
The Spanish Health Department is investigating the death of a corporal, aged 35, assigned to the Infantry Regiment América 66 de Cazadores de Montaña, based in the Aizoáin barracks, Navarra, after suffering a “cerebral sinus thrombosis with thrombocytopenia and cerebral hemorrhage”, 17 days after receiving the AstraZeneca vaccine. The military man died this morning at the University Clinic of Navarra.
The corporal, married and expecting a child, was vaccinated with AstraZeneca on the afternoon of April 7 in his own unit. The Spanish Troop and Sailor Association (ATME) explained that in the following days he suffered “severe headaches and acute discomfort”, which forced him to go to the barracks first aid service and then to the emergency room of a health center from Pamplona. On the night of this last Wednesday, April 21, the corporal suffered a faint while he was at his home, according to the Army, to which America 66 belongs.
Update: “This Friday, the Pharmacovigilance Center of the Health Department of the Government of Navarra has received a notification of a “adverse event with fatal outcome” of a person who had been vaccinated with Vaxzevria (AstraZeneca) on April 7 against Covid-19. Despite the fact that the Provincial Government has reported that he had died after suffering a “cerebral sinus thrombosis with thrombocytopenia and cerebral hemorrhage”, the affected person has not died and is in a situation of brain death.”
The Australian Therapeutic Goods Administration is investigating three new cases of a rare blood clot syndrome “likely” linked to the AstraZeneca vaccine. The cases are a 35-year-old woman, a 49-year-old man and an 80-year-old man. It is the first time the syndrome has been reported in a person over 50 in Australia. The TGA said in a statement all cases were likely linked to the AstraZeneca vaccine. The TGA said one patient developed symptoms “unusually late” – 26 days after the vaccination.
The risk of a serious blood clot from AstraZeneca jab has doubled in a fortnight, new data show. Cases have gone up from 79 to 168 and deaths from 19 to 32. The chance of having a clot following vaccination has gone from one in 250,000 to one in 126,582.
The second case of rare blood clots linked to the AstraZeneca COVID-19 vaccine has been detected in a woman vaccinated in Western Australia. The Therapeutic Goods Administration said the woman in her 40s is in hospital in a stable condition, receiving treatment.
“The Vaccine Safety Investigation Group (VSIG), a panel of expert advisers to the Therapeutic Goods Administration (TGA) met yesterday evening and has concluded that a recently reported case of thrombosis with thrombocytopenia is likely to be linked to vaccination,” the TGA said in a safety alert.
This is the second Australian case of “thrombosis with thrombocytopenia following the AstraZeneca COVID-19 vaccine”.
“As of April 2, 2021, 42 cases of a central venous / sinus vein thrombosis reported after vaccination with Vaxzevria. In 23 Thrombocytopenia has also been reported in cases.
In one case where post mortem a central sinus vein thrombosis with cerebral hemorrhage was found, the platelet count could no longer be reliably determined. With the exception of seven cases, they affected all others. Cases in women aged 20 to 63 years. The men were 24 to 58 Year old. Eight patients (5 women, 3 men) died.
For some of the patients who have had post-vaccination sinus thrombosis with thrombocytopenia, high platelet antibodies were found which are common with the clinical picture of a disease similar to an autoimmune one Heparin-induced thrombocytopenia (aHIT). And a HIT Thromboses can also occur without the administration of heparin.
The Paul Ehrlich Institute has numerically more case reports from Sinus vein thrombosis after vaccination with Vaxzevria in women before (83.3% vs. 16.7%), whereby young women were particularly often affected. However, according to the information provided by Robert Koch Institute, women were also vaccinated more often than men. There were significantly more cases for women aged 20-59 years observed than expected based on the background incidence.”
Report download (PDF): Suspected side effects and vaccination complications after vaccination to protect against COVID-19 (Verdachtsfälle von Nebenwirkungen und Impfkomplikationen nach Impfung zum Schutz vor COVID-19)
People who have had the Oxford/AstraZeneca vaccine are seeking help at A&E despite having only mild side-effects such as headaches, in the wake of the controversy over whether the jab causes blood clots.
Emergency medicine doctors in England told the Health Service Journal that a growing but unspecified number of people who were anxious after having the Oxford/AstraZeneca jab were coming to A&E units, some apparently after being advised to do so by a GP.
Dr Katherine Henderson, the president of the Royal College of Emergency Medicine, confirmed the trend to the Guardian.
“It’s definitely a thing. Colleagues across England are reporting this. All A&E departments are seeing an increase in the number of people reporting concerns after having the AstraZeneca vaccine. We are seeing people with mild headaches and persistent headaches but who are otherwise alright.
The first cases of a rare blood clot associated with the AstraZeneca vaccine in Ireland is being investigated in a Dublin hospital. A 40-year-old woman is reportedly being treated in the Mater Hospital for cerebral venous sinus thrombosis (CVST), the blood clot on the brain which the European Medicines Agency has said is possibly linked to the AstraZeneca treatment.
A spokesperson for the Health Products Regulatory Authority (HPRA) confirmed to Dublin Live it has been informed about the case.
He said: “The HPRA can confirm that it has received a case of interest, associated with the AZ vaccine, which describes CVST, an unusual clot in the brain.
Under-30s are to be offered an alternative Covid jab to the AstraZeneca vaccine due to mounting evidence linking it to rare blood clots, the UK’s vaccine advisory body says.
A review by the drugs regulator MHRA found by the end of March 79 people in the UK suffered rare blood clots after vaccination – 19 of whom died.
The regulator said this was not proof the jab had caused the clots. But it said the link was getting firmer. The regulator said the side-effects were extremely rare and the vaccine’s effectiveness was proven. It said it meant the benefits of taking the vaccine were still very favourable for the vast majority, but they conceded it was more finely balanced for younger people because the risk from Covid was so much lower.
The Swedish Medical Products Agency has received almost six times as many reports of suspected side effects for Astra Zeneca’s vaccine, compared with the other two EU-approved vaccines Pfizer/Biontech and Moderna, in relation to the number of people vaccinated. By the end of March, the authority had received 14,275 reports – by then, 252,000 people in Sweden had received the Swedish-British vaccine. It will be a share of 5.7 percent. The corresponding figure for Pfizer / Biontech is 0.7 and for Moderna 0.9.
The EMA’s response, along with that of the World Health Organisation, is published below:
Ireland’s Health Products Regulatory Authority (HPRA) has said it has received 16 reports of blood clots occurring following vaccination with the AstraZeneca Covid-19 vaccine. It said that none describe a rare blood clot. The figures are up to the end of March.
The HPRA said that none of the reports describe cerebral venous sinus thrombosis, which is a rare type of blood clot in the brain, nor the occurrence of a blood clot associated with low platelets.
“As part of our enhanced surveillance of thromboembolic disorders, 3 new cases of thrombosis of the large veins of atypical locations associated with thrombocytopenia and/or coagulation disorders were analyzed during the weekly monitoring committee of the ANSM with the network French CRPVs (12 cases in total since the start of vaccination, including 4 deaths).
These cases, mainly located in the brain, occurred within a median time of 9 days after vaccination, mainly in women and with no specific common history identified to date (9 vaccinated people under 55 years old, 3 people over 55 years).”
ANSM report The seventh pharmacovigilance report on adverse reactions reported with the AstraZeneca vaccine (Vaxzevria) covers data validated from March 19 to 25, 2021
Information from the previous (sixth) ANSM report:
“The sixth pharmacovigilance report on adverse reactions reported with the AstraZeneca vaccine covers data validated from March 12 to March 18, 2021 . Since the start of vaccination with the AstraZeneca vaccine, 5,693 cases of adverse effects have been analyzed by the CRPV reporters (Amiens and Rouen). The vast majority of these cases concern flu-like syndromes, often of high intensity (high fever, body aches, headaches). More than 1,430,000 injections have been performed as of March 18, 2021.
As part of our enhanced surveillance of thromboembolic disorders, a total of 16 new cases were analyzed during the weekly ANSM monitoring committee with the French CRPV network, for a total of 29 cases since the start of vaccination. The majority of thromboembolic events have occurred within 15 days of vaccination in patients with risk factors.
Among all these cases, 9 cases of thrombosis of the large veins, atypical by their location (mainly cerebral, but also digestive), which may be associated with thrombocytopenia or coagulation disorders were reported, including 2 deaths. These cases occurred within a median of 8.5 days after vaccination in people with no specific history identified to date (7 patients under 55 years old, 2 patients over 55 years old).”
ANSM report The sixth pharmacovigilance report on adverse reactions reported with the AstraZeneca vaccine covers data validated from March 12 to March 18, 2021