A Chennai-based business consultant has moved the Madras High Court claiming that he suffered severe side effects and had to be hospitalised due to a dose of Serum Institute of India’s COVIDSHIELD COVID-19 vaccine in its third phase (Asif Riaz v Government of India and ors).
The petitioner claims that he has suffered acute neurological encephalopathy (altered mental state due to systemic factors) due to a vaccine dose he took in October last year.
Asserting that the same amounts to a “serious adverse event” as defined under Rule 2(ff) and sub-rule (a), Rule 41 the New Drugs and Clinical Trial Tules 2019, the petitioner has sought directions from the Court to the Serum Institute so that they pay him Rs 5 crores as damages for the suffering and trauma undergone by him and his family.
The petitioner claims that no one from Serum Institute or associated authorities have got in touch to examine the said side effects, and that the Serum Institute had threatened him with defamation proceedings instead.
“Ironically, the only time one trial sponsor (Serum Institute of India) contacted me, not to inquire about my health or to find out about my sufferance but to intimidate me stating they would file a Rs 100 crore defamation suit on me for sharing my experience with the general public!” reads the petition.
All the stakeholders are trying to hide the adverse effects of the vaccine and are unethically and unscientifically trying to brush it aside as inconsequential; he contends. He adds that the vaccine is not safe for everyone, and that he does not want anyone to suffer the ordeal he has gone through.
He has also registered an objection to an expert committee set up by the Drug Controller of India finding that his reaction was not linked to the vaccine shot. The petitioner says that he was not given an opportunity to present his side and that he came to know of this development only through a newspaper report.
He adds that a request sent on December 4 for a copy of the expert committee report has also not yielded any positive response. It is surprising and even disturbing that the trial volunteer is treated as a non-entity, the petitioner argues.
The prayers made by the petitioner include:
- To constitute an expert committee to go into the issue;
- Declare that side effects suffered by the petitioner is due to the test shot of COVIDSHIELD vaccine;
- Declare COVIDSHEILD not safe;
- Direct the compensation of Rs 5 crores as damages by Serum Institute.
The matter came up this morning before Justice Abdul Quddhose, who issued notice and fixed the matter for further hearing on March 26.
Still facing health issues after vaccination in October, claims petitioner
The petitioner claims that the reaction allegedly triggered by a dose of COVIDSHIELD in September, when he had volunteered to participate in the third phase of trial, was far more drastic than what was indicated in the Participant Information Sheet. Even an allergic reaction after vaccination is termed as an “extremely rare possibility”, he submits.
After 10 days, the petitioner says he woke up with a very severe headache and went back to sleep on October 11. He adds that he remained so the rest of the day and was eventually taken to a doctor that evening. The doctor is stated to have recommended a CT Scan and MRI as the petitioner was unable to respond and was oblivious to what was happening around on account of the pain. The doctor, at the time, suspected that it could be a severe side effect of the vaccine, it is stated.
The petitioner was eventually taken to the Sri Ramachandra Institute of Higher Education and Research hospital, where he had been administered the dose. The petitioner submits that he vomited on the way, was no conscious, that he was unable to recognise anyone and was weak. He stayed hospitalised until October 26, the Court is told.
As per his wife’s testimony, during this time he was disoriented, had mood swings, was unable to recognise others and found it difficult to speak. The discharge summary indicated that he had been brought in with an altered mental state, the plea states. The summary further recorded that he had suffered from “Acute Encephalopathy” (alteration of mental status).
The disorientation continued even after discharge. While his condition improved, there were still mood swings, he was very sluggish and was not confident to so anything, the petitioner says. He emphasises that while the hospital did medical tests to connect his symptoms to earlier health conditions or any other factor apart from the test vaccine, it was unable to prove any such link. This confirms that the health setback was due to the test vaccine and not due to a prior condition, the petitioner asserts.
“I submit that even after three months of the severe side effect, I am not stable, as I often experience trembling of hands, fear, anxiety, trepidation, panic, mood swings, sever dent in self-confidence and extreme problems in focusing on work. I submit I have lost all the projects I was working on… prior to volunteering for the vaccine on 1st October 2020 … “, the plea further reads.
The petitioner adds that he had sent legal notices on the issue, calling for a halt on COVIDSHIELD and seeking compensation to the Union Health Ministry, the Drugs Controller General of India, the Indian Council of Medical Research and the Serum Institute.
The reply from Serum Institute, he adds, does not deny his having suffered the adverse reaction, but only states that the same is not linked to the vaccine. No proof is given for the same, the petitioner asserts. He also disputes the Serum Institute’s stance that his reaction may have been because he refused to take steroids for lupus while hospitalised.
He also states that he consulted three independent medical experts to guage if the reaction may have been a result of the vaccine. A neurologist from Apollo Hospital is stated to have concluded that in the absence of other diagnosis, the neurological dysfunction relates to immunogenicity of COVIDSHIELD covid-19 vaccine. A virologist is stated to have said that the inevitable conclusion is that the medical condition was an adverse reaction to the vaccine as other causes were excluded.
In this backdrop, the move to distribute the vaccine to the public as safe has been challenged as against safety norms and the World Health Organisation’s (WHO’s) guidelines.
“I submit that it is not an issue concerning me alone, it concerns public health, particularly since the Government of India is planning to vaccinate the entire Indian population. Therefore, I submit the there is an urgent need for openness and transparency…”, the petitioner states.