Over 60% cases with adverse effects causally linked to vaccination

The Union health ministry's latest analysis of adverse events following immunization (AEFI) shows that more than 60% of the cases analysed had a causal association to vaccination.

As many as 48 out of 78 cases of severe side effects that were analysed had a consistent causal association to vaccination, said the report. None of these 48 cases resulted in death.

"Of these 48 cases, 28 cases were vaccine product related reactions and 20 cases were immunization anxiety related reactions. 22 cases have inconsistent causal association to vaccination (coincidental - not linked to vaccination), including seven cases of death. Seven cases were in indeterminate category including two death cases. There was one death case in unclassifiable category," the report said.


Vaccine product related reactions are reactions that can be attributed to vaccination based on current scientific evidence like allergic reactions and anaphylaxis.

Indeterminate reactions are those reactions which have occurred soon after vaccination but there is no definitive evidence in current literature or clinical trial data that the event could have been caused due to the vaccine. In these cases, further observations, analysis and studies are required.

Unclassifiable events are those which have been investigated, but there is not enough evidence for assigning a diagnosis due to missing crucial information. "When this relevant information becomes available, the case may be reconsidered for causality assessment," it said.

According to the experts of the AEFI committee, overall, the benefits of vaccination are overwhelmingly greater than the small risk of harm.