A 40-year-old business consultant, who was a volunteer for the Covidshield vaccine, has sought Rs 5 crore compensation for the neurological complications he developed after being administered the test dose, said an advocate.
“Our client developed severe neurological health complications after he was given the test dose. We had sent a legal notice to the Serum Institute; Indian Council for Medical Research (ICMR); AstraZeneca, UK; Drugs Controller General of India; Andrew Pollard, Chief Investigator, Oxford Vaccine Trial; The Jenner Institute Laboratories, University of Oxford; and the Vice-Chancellor of Sri Ramachandra Higher Education and Research,” N.G.R. Prasad, Advocate, Row & Reddy, said.
“The notice was issued on November 21, and till now we have not received any reply from any of the parties to whom the notice was sent,” Prasad added.
In his notice, the volunteer claimed that he was assured by the Sri Ramachandra Institute and the trial investigator that the vaccine is safe and the study that he would be a part of, was to further confirm the safety and immune response of Covidshield in Indian adults.
As per the notice, there is nothing in the participant information sheet to educate or warn the participants about any serious side-effects of the said vaccine, like the one suffered by him.
The volunteer had signed the consent form on September 29. As the test for antibodies against Covid-19 was negative, the Covidshield study vaccine was given to him on October 1.
For 10 days after vaccination, there was no adverse reaction. On October 11, the volunteer woke up at 5.30 a.m. with a severe headache and went back to sleep, and did not get up when his wife tried to wake him up at 9 a.m. At 2 p.m., he woke up and vomited and went back to sleep, saying he had a severe headache.
There was a total behavioral change in him – he was not aware of his surroundings. He showed irritation towards light and sound, and was resisting any effort to make him get up from bed, the notice said citing his wife.
The Covidshield volunteer vomited in the ambulance en route to the emergency ward of the Sri Ramachandra Medical College Hospital.
“According to the hospital’s discharge summary, he was brought into the hospital “in an altered mental state” and was “disoriented”.
The Covidshied volunteer was discharged from the hospital on October 26, with the discharge summary stated that he had suffered “acute encephalopathy”.
“He says that in the 16 days that he was in the hospital, almost all possible medical tests and investigations were done on him to connect his neurological set back to any of his earlier health condition. All these test were done to ascertain whether factors other than the test vaccine were responsible for his present health condition.
But all the tests done on him was found to be negative, confirming that the setback in his health was due to the test vaccine he was administered on October 1, and not because of any prior health condition,” the notice said. The volunteer was even fastened to the bed as he was aggressive.
Even after a month of the severe adverse reaction to the vaccine, neither has the regulator (Drugs Controller General of India/Data and Safety Monitoring Committee), the sponsors (ICMR and SII) or the collaborators of the sponsors (AstraZeneca and Oxford University) got in touch with him to find out about the severe adverse effect after vaccination.
According to the notice, this clearly goes against the protocols and guidelines set by the World Health Organization (WHO) in dealing with an Adverse Event Following Immunization (AEFI)/Vaccination.
“The WHO protocol clearly states that ‘the criteria for initiating investigation (an AEFI) could be fixed as within two working days for serious events and five working days for non-serious events’. And ‘a report must be made as quickly as possible so that an immediate decision can be made on the need for action and investigation’,” the notice said.
“Our client’s wife states that EEG tests were done on November 12 (18 days after discharge from the hospital) shows ‘dysfunction involving both hemispheres’, and ‘dysfunction involving the ascending sensory pathways on both sides from both the lower extremities’.
Psychiatric evaluation, done on the same day, showed ‘mild deficit in verbal & visual memory functions’, ‘mild deficit in dealing with complex information’, and ‘an under-functioning in overall cognitive functions’,” the notice stated.
The volunteer is claiming a financial compensation of Rs 5 crore for all the trauma he had undergoing.