Chennai: A city-based 40-year-old business consultant, who was a volunteer for the Covishield vaccine that is under development at the Pune-based Serum Institute of India (SII), has sought Rs 5 crore compensation for the neurological complications he developed after being administered the test dose, said an advocate.
The volunteer had signed the consent form on September 29. As the test for antibodies against Covid-19 was negative, the Covishield study vaccine was given to him on October 1.
For 10 days after vaccination, there was no adverse reaction, but on October 11, the volunteer woke up at 5.30 a.m. with 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 severe headache.
There was a total behavioural 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 Covishield volunteer vomited in the ambulance enroute 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 stating 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, that is, to connect it to some factor other than the test vaccine that was administered on him on October 1.
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. Citing his wife, the notice stated that the volunteer is still not stable, has severe mood swings, has problems with comprehending and focusing on things, is finding it difficult to even do simple routine things like making online payments, leave alone focusing on work-related matters. So much so that he is feeling utterly frustrated and lacking confidence totally.
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 and investigate the severe reaction the test vaccine has had on him.
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 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 shows ‘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 is undergoing and with an uncertain future in his health, and also the testing, manufacturing and the distribution of the vaccine should also be stopped immediately. When contacted, a spokesperson of Sri Ramachandra Higher Education said that the matter is subjudice and cannot comment on the matter.