TL; DR: India’s National AEFI Committee reviewed 2,712 serious adverse events following COVID-19 vaccination between January 2021 and May 2023. Of these, 1,110 (40.9%) died; the rest were hospitalised and recovered or had severe but non-fatal outcomes. Among the 1,110 deaths, more than 1,000 were ultimately deemed either coincidental or impossible to classify in terms of any causal connection to the vaccine. Correlation, in most instances, did not amount to causation. Further, out of the total reported AEFI events, the committee classified only 408 cases (15%) as definitively vaccine-product related (A1), meaning the committee found a consistent causal link to the vaccine.

Context

India’s COVID-19 vaccination drive, one of the largest public health interventions in history, also brought renewed attention to Adverse Events Following Immunisation (AEFI) and the challenge of attributing harm in mass immunisation programmes. While the government maintained that vaccines were safe and that AEFI surveillance systems were robust, families of individuals who experienced severe outcomes or deaths argued that existing mechanisms were inadequate for accountability and redress. In response, the Supreme Court recognised that proving causality and negligence in such cases imposes an unfair burden on affected families, especially in a complex scientific domain. Emphasising the State’s obligation under Article 21, the Court held that surveillance alone is insufficient and directed the formulation of a no-fault compensation framework, ensuring support for rare but serious adverse events without requiring proof of fault in each case.

In this article, we look at the AEFI cases reported and examined by the national AEFI committee.

Who compiles this data?
The data comes from Causality Assessment reports on Adverse Effects Following Immunisation (AEFI) cases, examined by the National AEFI committee, under the Ministry of Health and Family Welfare.

Where can I download clean & structured data related to AEFI cases in India?

Clean, standardised, structured, and ready-to-use detailed data of causality assessment reports of AEFI cases can be downloaded from Dataful.

Key Insights

Who were the 2,712 cases? Age, Gender, and Vaccine

The 2,712 cases cover serious AEFIs reported between January 2021 and the end of 2022, the core period of India’s mass vaccination drive. The data is nearly perfectly split by gender: 1,359 females (50.1%) and 1,353 males (49.9%), and the mean age was 46.2 years.

The age distribution is an important context: 58.8% of cases were in individuals aged 41 and above, and the 60+ group (830 cases) was the single largest age cohort. This is not surprising given that older individuals were vaccinated first as a priority group, and that comorbidities, which are more common in older age, complicate the clinical picture when an adverse event occurs. The 30-44 year cohort contributed 554 cases; the 18-29 cohort, 420. Notably, 283 cases involved those aged 17 and below.

By vaccine, Covishield accounted for 2,209 of 2,712 cases (81.4%), consistent with its dominant share of doses administered. Covaxin contributed 355 cases (13.1%), Corbevax 145 (5.3%), and Sputnik V just 3. Year-wise, 2,342 cases (86.4%) were from 2021, and 370 (13.6%) from 2022, reflecting the mass vaccination surge of the first year and the more targeted follow-up phases in the second.

Half of the reported cases could not be classified

The Committee’s job is not to record complaints; it is to answer a specific question: is this event consistent with a causal link to the vaccine, or is it more likely coincidental, or is there simply not enough information to say? The answer is encoded in a WHO-defined classification, and understanding those codes is important.

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  Source: WHO 

In the 2712 cases examined by the national committee, almost 60% of the cases are classified under C & D (unclassifiable). The single largest category by a wide margin is coincidental (C): 1,373 cases (50.6%), and 237 cases (8.7%) are unclassifiable. So, essentially, the committee is neither saying the vaccine caused these 1,373 events nor is it saying the vaccine didn’t. It is saying the evidence in hand is not sufficient to make a determination.

Sudden Cardiac Death Tops the List

The single most common diagnosis across all 2,712 AEFI cases is Sudden Cardiac Death: 266 cases. This is followed by Anxiety/Panic/Conversion Reaction (262 cases), Sudden Unexplained Death (215 cases), Ischemic Stroke/CVA (153 cases), Fever (152 cases), and Acute Myocardial Infarction (114 cases). Together, cardiovascular events such as heart attacks, strokes, and sudden cardiac deaths account for the largest share of diagnoses and the largest share of deaths within those diagnoses.

The 98 cases of Guillain-Barré Syndrome (GBS) are also particularly worth noting. GBS is a neurological condition in which the immune system attacks peripheral nerves, causing progressive weakness. It has been previously associated with certain vaccines (notably the 1976 swine flu vaccine) and with COVID-19 infection itself. Of the 98 GBS cases in this dataset, 95 (96.9%) were classified B1: coincidental, meaning the committee found that they were temporal associations rather than vaccine-caused. Only 3 were classified B2 (unclassified). None were confirmed as A1 (vaccine-caused).

Anaphylaxis, Fever, and Blood Clots common among vaccine related effects

The 408 A1 classified cases cluster around a small set of well-understood adverse reactions. Fever, allergic reactions, and anaphylaxis account for the majority of the kinds of post-vaccine responses that are known, monitored for, and manageable. The 30-minute observation protocol after vaccination exists specifically to catch and treat anaphylaxis on the spot. Of 75 anaphylaxis cases in the record, 73 were classified A1, the highest confirmation rate of any diagnosis, and the clearest signal in the entire record.

The most serious confirmed safety signal is Thrombosis with Thrombocytopenia Syndrome (TTS), a rare but dangerous combination of blood clots and low platelet counts that triggered regulatory review of the AstraZeneca vaccine in several European countries. Of 69 total TTS cases reviewed, 38 were classified A1, and 23 of those resulted in death, making TTS the deadliest confirmed vaccine-related adverse event.

Why does it matter?

India ran one of the most extraordinary public health operations in human history. The vaccine drive almost certainly saved millions of lives. It also, as every vaccine drive does, caused some harm. There is a question that sits beneath all the numbers, and it is worth asking plainly: how representative is this data? India administered approximately 2.2 billion COVID-19 vaccine doses. This data contains 2,712 serious AEFIs that reached the national committee, a rate of about 1.2 per million doses. This is comparatively smaller than the UK and Canada, which had lower vaccination rates.

Further, India’s surveillance infrastructure, originally designed for childhood immunisation, stretched beyond its capacity by a mass adult vaccination drive, and dependent on a reporting system that most adult physicians had never used, captured a tiny fraction of what actually occurred. The gap between what happened and what the data shows is the real finding for building a more robust post-vaccination surveillance system for the future.

Key numbers

• 2,712 Serious AEFIs reviewed by National AEFI Committee, 2021–2022

• 1,110 Deaths among reviewed cases (40.9% of total)

• 408 Cases confirmed vaccine-related (A1) — 15% of total

• 1,373 Cases classified Indeterminate (C) — insufficient evidence to decide, 50.6% of total

• 27 Deaths confirmed caused by vaccine (A1) — 2.4% of all deaths reviewed

• 16 TTS deaths — largest confirmed cause; all linked to Covishield (adenoviral vector)