Nine cases of severe side effects linked to vaccines in recent AEFI report

Of these nine cases, five were vaccine product related reactions, four were immunisation anxiety related reactions

The Union Health Ministry's recent analysis of serious adverse events following immunisation (AEFI) of 22 cases show that nine had causal link or association to vaccination.

The results of the causality assessment for 22 cases completed on October 18, 2021 after review by the National AEFI Committee showed that nine cases had causal link to vaccination. Of these nine cases, five were vaccine product related reactions, and four were immunisation anxiety related reactions. The report said that 12 cases have inconsistent causal association to vaccination (coincidental - not linked to vaccination), including five death cases. There was one death in the indeterminate category.

Vaccine product related reactions are expected reactions that can be attributed to vaccination based on current scientific evidence. Examples of such reactions are allergic reactions and anaphylaxis, etc. Indeterminate reactions are reactions which have occurred soon after vaccination but there is no definitive evidence in current literature or clinical trial data that this event could have been caused due to the vaccine. Further observations, analysis and studies are required in such cases.

Coincidental events are events that are reported following immunization but for which a clear cause other than vaccination is found on investigation.  

Of the cases found to be linked to vaccination, a 21 year old female had anaphylaxis (allergic shock) which was severe, but she recovered. There have been two more cases of anaphylaxis. Another 44 year old female was hospitalised with fever, headache and vomiting. She recovered. A 25 year old male had an allergic rash, and was hospitalised.

The government report said that  "Overall, the benefits of vaccination are overwhelmingly greater than the small risk of harm. However, as a measure of utmost precaution, all emerging signals of harm are being constantly tracked and reviewed periodically."