48 of the 78 vaccine-related adverse events studied, mostly anxiety: Report

PUNE: The latest analyses of Covid-19 adverse events (AEFI) by the Union health ministry revealed that of 78 cases 48 have a “consistent cause association with vaccinations” (causal association). Of these 48, up to 20 reactions during vaccination were due to anxiety.

In the national cause-effect evaluation report, 22 cases, seven of which were coincidental deaths, were reported. They didn’t have to be vaccinated. In the indeterminate category were seven adverse events, including two deaths, and one in the unclassifiable.

The causality assessment for the 78 cases — six related to Covaxin administration and the rest Covishield — was completed on August 3 after thorough review, deliberation and approval by the national AEFI committee. The latest report stated that of the 48 cases of “consistent causal association to vaccination”, a total of 28 were vaccine product-related reactions such as anaphylaxis, allergic reactions and dizziness. The rest 20 were of immunization anxiety-related reactions.

The “consistent causal association” to vaccination is a cause-and-effect relationship between the vaccine and the adverse event that follows. Vaccine product-related reaction refers to an adverse event following immunization (AEFI) caused by a vaccine because of one or more of the inherent properties of its product, such as the adjuvant, preservative or stabilizer. Immunization anxiety-related reaction refers to an AEFI arising from anxiety about the immunization.

Dr Narendra Arora, advisor, National AEFI Committee, said a chunk of reactions were driven by only panic or fear of vaccination, such as nausea, increase in heart rate and increased sweating, among others. “There has been a higher incidence of anxiety among women than men, after which they had to be admitted to healthcare facilities to alleviate their condition,” he said.

Dr Arora said coincidental events were the AEFIs caused by something other than the vaccine product, immunization error or vaccination anxiety. “So far, among all the AEFIs assessed after the vaccination drive against Covid began, all the deaths except one were coincidental. Only one death was due to anaphylaxis,” he said.

Among the seven deaths not linked to vaccination, one was a sudden cardiac death, one was related to atypical pneumonia with pulmonary embolism and another was due to chronic diarrhoea and severe malnutrition.

According to the report, seven AEFI cases, including two sudden cardiac deaths, were in the indeterminate category. “Indeterminate category includes reactions which have occurred soon after vaccination but there is no definitive evidence in current literature or clinical trial data that these events could have been caused due to the vaccine. Such cases are later re-assessed after all the post-death documentation is available,” Dr Arora said.

The report stated that there was another sudden unexplained death of a 70-year-old man under the unclassifiable category. Unclassifiable events are those which were investigated but there was not enough evidence for assigning a diagnosis due to missing crucial information, according to an official of the Union ministry of health and family welfare.

The official said in unclassifiable cases, there might be unavailability of complete documents.

“The incidence of AEFI events is very small in comparison to the total doses administered in India so far. Up till recently, only 0.02% AEFIs have been reported among the total vaccinations. This is even less than adverse reactions reported in clinical trials. Covishield is a vaccine widely being used across the world and is considered safe,” the official said.