A 40-year-old participant for the ongoing trials of Covishield, the vaccine being developed by the Pune-based Serum Institute of India (SII), has allegedly been diagnosed with “acute neuro encephalopathy” days after he was injected, as per reports from India’s Economic Times.

The vaccine technology used by SII was developed by AstraZeneca for the world.

The law firm that represents the vaccine volunteer has sent legal notices to SII, as well as to the country’s drug regulatory authority.

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Reports from India’s Economic Times reveal that the man received the initial shot last October 1, and began experiencing severe headaches by October 11, and was unable to respond to questions.

The man was rushed to the hospital and was diagnosed with “acute neuro encephalopathy” according to the legal notice. While he was discharged last October 26, the man continues to allegedly experience bouts of mood swings, comprehension problems and finds it difficult to perform routine tasks.

Several copies of the legal notice have been sent to the chief executive of AstraZeneca, UK, chief investigator of the Oxford trials and vice-chancellor of Sri Ramachandra Institute of Higher Education and Research in Chennai – where the phase 3 trials are taking place.

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SR Ramakrishnan, principal investigator at Sri Ramachandra Institute, questions the allegations stating that investigations from their institute states that the man’s diagnosis isn’t related to the vaccine.

“An extensive investigation was carried out and we don’t think the adverse event was related to the vaccine. The report was submitted to the Data and Safety Monitoring Board, SII and the drug regulator within the stipulated time.” said Ramakrishnan.