Health authorities are investigating the death of a 36-year-old man from a town in the Sierra Sur de Sevilla who suffered a stroke in early July, ten days after receiving the Janssen vaccine against covid-19. The truth is, thrombosis syndrome with thrombocytopenia is one of the adverse reactions of the Janssen vaccine. The full list is as follows.
The most common side effects of the Janssen vaccine
The (AEMPS) has revealed that until July 11, 2021, when a total of 1,461,846 doses were administered, 720 notifications of adverse events have been registered. Of all adverse event reports received, 140 were considered serious. Likewise, the agency has revealed the 10 most reported adverse events.
– Fever: 49%
– Headache: 33%
– Muscle pain: 23%
– Discomfort: 16%
– Fatigue: 9%
– Dizziness: 8%
– Nausea: 8%
– Asthenia: 7%
– Chills: 7%
– Pain in the vaccination area: 6%
The new side effects of the Janssen vaccine
In the application phase of the Janssen vaccine to the general population, several serious but infrequent side effects have been detected, which are the following:
1. Thrombosis with Thrombocytopenia Syndrome (TTS): the technical data sheet and the package insert of the Janssen vaccine already include the very rare risk of thrombosis (formation of blood clots in the blood vessels) with thrombocytopenia (low levels of platelets ), known as thrombosis with thrombocytopenia syndrome (TTS).
Until June 27, 21 cases combining thrombosis and thrombocytopenia had been reported in the EEA, of which four had a fatal outcome, with around seven million doses of the vaccine having been administered in this territory until June 20, 2021. In Spain, until July 11, two cases have been registered, one probable and one confirmed.
2. Capillary leak syndrome. This condition is a very rare but serious disorder that causes leakage of fluids from the blood capillaries, resulting in edema, fluid retention, decreased blood pressure, thickening of the blood, and low levels of albumin (a protein normally present in the blood) in the blood. This syndrome, of which only three cases have been registered (none in Spain), has been added to the information in its technical data sheet and prospectus as a new possible adverse reaction.
3. Guillain-Barré syndrome (GBS). The Pharmacovigilance Risk Assessment Committee (PRAC) has recommended inclusion in the technical data sheet and in the package insert of this vaccine as a possible adverse reaction with a very rare frequency.
This syndrome is an immune system disorder that causes inflammation of the nerves and can result in pain, numbness, muscle weakness, and difficulty walking. Until June 27, a total of 15 cases with this vaccine had been reported in the European Economic Area, with around seven million doses having been administered until June 20.
Janssen Side Effects Under Investigation
The AEMPS reports that the PRAC has continued to evaluate the available evidence after receiving cases of myocarditis and pericarditis after vaccination with Janssen. To date, the pharmacovigilance committee has not been able to confirm the relationship.