Govt reviews about side effects confirm 1 death after a vaccine dose
The person who gave up because Anaphylaxis was a 68-year-old man who received his shot on March 8, 2021, showing a report accessed by HT.
Three of the millions of people who received the Covid-19 vaccine between February 5 and March 31, developed anaphylaxis due to vaccines, and one of them died, according to government reviews for serious side effects that could be associated with the Coronavirus vaccine.
This finding represents the first time the fatality has been associated with a vaccine, and strengthens the trend that this is rare: three cases are among nearing 60 million doses given during this period. Overall, 28 people died after getting a dose during this period but most did not seem to be linked, while the cause could not be determined at least 9 of them.
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“This is the first death where causality has been established, with a vaccine resulting in anaphylaxis reaction. But if you see the overall number (crores dosage given), and there is only a small number that gets a severe reaction. There are 31 cases investigated and one death is caused by Vaccines, and among the cases of anaphylaxis, only two are found related to the product. Most of the anaphylaxis reaction is managed, “said Dr. NK Arora, Chair, National AEFI Committee.
Anaphylaxis is a severe allergic reaction, potentially threatening life.
The person who gave up because Anaphylaxis was a 68-year-old man who received his shot on March 8, 2021, showing a report accessed by HT.
Two other cases officially declared a reaction related to vaccine products (anaphylaxis) were 21-year-old women, and a 22-year-old man who received their respective shots on January 19 and 16. Both were restored after hospital treatment.
This analysis in a set approved for causal investigations by the National AEFI Committee between February 5 and March 31. HT data shows that there are 59.1 million doses given during this period.
“Of the 31 cases that are considered causal, 18 are classified as having causal associations that are inconsistent with vaccination (by chance – not related to vaccination), 7 is classified as uncertain, 3 cases found related to vaccine products, 1 is a reaction related to anxiety. , and 2 cases found cannot be classified, “Committee report said.
Special groups have been formed to conduct causality assessments to AEFIS after vaccination Covid-19. The results of the causality assessment carried out by this particular group are discussed at the National AEFI Committee meeting for the final approval.
In accordance with the data in the first week of April 2021, the reporting rate was 2.7 deaths per million doses managed and 4.8 inpatient per million doses of vaccines provided.
The Committee in the report explains that the reaction related to vaccine products is expected to reaction that can be associated with vaccination based on current scientific evidence, and examples of such reactions are allergic and anaphylaxis reactions.
Inapular reaction is things that happen as soon as vaccination but where there is no definitive evidence or clinical trial data. Further observations, analysis and studies are needed to build causal relationships in these cases.
Events that cannot be classified are investigated events but there is not enough evidence to determine the diagnosis because important information is lost. When this relevant information is available, this case can be reconsidered for the assessment of causality.
And incidental events are events reported following immunization but which is a clear cause other than vaccination is found in the investigation.
“Only reporting of death and hospitalization as a serious bad event does not automatically imply that the event is caused by a vaccine. Only investigations and correct causality assessments can properly help in understanding if there is a causal relationship between events and vaccines. For the assessment of causality, Priority has been given in the case of death, “experts said in the report.
Among the 18 cases of coincidence that is not associated with vaccination is a stroke case, a heart attack, septic shock and chronic obstructive pulmonary disease.
Among seven deaths classified as cases of intracranial bleeding, acute myocardial infarction with pulmonary edema, cerebral arterial ischemic infarction, sudden heart death, and severe venous infarction cases with thrombocytopenia.
The two reactions that cannot be classified are the deaths of a 55-year-old man, and a 43-year-old man. A 26-year-old man who was classified as a ‘reaction related to immunization anxiety’ was hospitalized because of syncope (temporary awareness loss).
Experts say it is important to get accurate information about the death of vaccines through the right investigation.
“Investigations need to be skilled even though our competence to investigate vaccines causes scientific mortality is very inadequate. As our nation does not care about accurate information but it is very important to get to the cause,” said Dr. Jacob John, former head, Department of Virology, Christian Medical College, Vellore, Tamil Nadu.
