Chennai Volunteer Reports ‘Adverse Reaction’ Following Covishield Vaccine, Sends Legal Notice: Report

Sending a legal notice to AstraZeneca, Serum Institute of Indian and Oxford Vaccine Group, a 40-year-old volunteer from Chennai has alleged that the vaccine triggered an adverse reaction which includes neurological impairment and an inability to get back to the life before being inoculated, according to a report by The Hindu.

Demanding Rs 5 crore, the man has also demanded that the trial of the vaccine -- with 1,600 volunteers in India -- be immediately halted. 

Interestingly, even after over a month since the incident, the Central Drug Standard Control Organisation has not issued a statement regarding the incident and the accusations so far, according to Times of India. This is in stark contrast to AstraZeneca and Oxford University’s decision to halt trials when a UK volunteer had felt ill earlier and to wait for the UK regulatory authority’s clearance to resume the trial.

Dr. S.R. Ramakrishnan, who was the lead investigator for the Chennai arm of the trial and had treated the patient, told The Hindu that the “subject was now alright” but directed further questions to the Serum Institute spokesperson. “He recovered very well and we treated him as per protocol and he even came back for a follow-up. All the expenses were borne by the hospital,” he said.

The person’s discharge summary says that the person was discharged on request, and that he was suffering acute encephalopathy. He also had Vitamin B12 and Vitamin D deficiency, and had a probable “connective tissue disorder”.

However, the hospital’s institutional ethics committee has given a letter saying that the adverse reaction was not due to the vaccine, according to Dr Ramakrishnan. 

The person’s wife told The Hindu that her husband had signed up for the trial in the “spirit of public service”. He was enrolled for the third phase of the human trial at the Sri Ramachandra Institute of Higher Education and Research, Chennai. She said that the multiple “categorical assertions” made in the participant information sheet convinced him that the vaccine was safe and did not cause serious reactions.

The volunteer, who signed the ‘Informed Consent Form’ on September 29, 2020, was administered a test for antibodies against COVID-19 to rule out prior infection, and received a vaccine shot on October 1, reported The Hindu. The double dose vaccine is administered in some volunteers 28 days apart while some are given a placebo.

A test 11 days later, in this person’s case, revealed the presence of antibodies, indicating that the person had indeed received the vaccine and not a placebo. Ten days after the shot, he complained of a severe headache, followed by vomiting that confined him to the bed for the rest of the day, reported The Hindu. His wife, according to the legal notice, reported a total “behavioural change” in her husband, who showed “irritation towards light and sound, and was resisting any effort to make him get up from bed”.

He was taken in an ambulance to the emergency ward of the Sri Ramachandra Medical College and Hospital. The hospital’s discharge summary, which The Hindu quoted from, notes that he was “in an altered mental state” and was “disoriented”. During his hospitalisation from the October 11 to October 26, when he was discharged, he underwent a CT scan as well as an MRI, a COVID-19 test, and even his cerebrospinal fluid was examined. He was also shifted to the Intensive Care Unit, reported the daily.

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