Legal notice

1. N.G.R.PRASAD Andhra Insurance Building
& 156, Thambu Chetty Street,
R.RAJARAM II Floor, Chennai 600 001.
Advocates Tamil Nadu, India.
Mobile: +919884711597/
+919841156893
______________________________________________________________________
BY R.P.A.D.:
21.11.2020
To
1. Director General, ICMR
Indian Council of Medical Research
Ansari Nagar, New Delhi – 110029
2. CEO, Serum Institute of India Private Limited
212/2, Hadapsar, Off Soli Poonawalla Road,
Pune-411028. India
3. Drugs Controller General of India
Central Drugs Standard Control Organization
Directorate General of Health Services,
Ministry of Health and Family Welfare, Government of India
FDA Bhavan, ITO, Kotla Road
New Delhi 110002
4. CEO, Astra Zeneca UK
1 Francis Crick Avenue
Cambridge Biomedical Campus
Cambridge, CB2 0AA, United Kingdom
5. Professor Andrew Pollard
Chief Investigator, Oxford Vaccine Trial
The Jenner Institute Laboratories
University of Oxford
Old Road Campus Research Building
Roosevelt Drive
Oxford OX3 7DQ
6. Vice Chancellor
Sri Ramachandra Higher Education and Research
(Deemed University)
No.1, Ramachandra Nagar,
Porur, Chennai – 600 116
Sirs,
Under the instruction from our client …….., aged about 40 years and
residing at No.44, U.R. Nagar Extension 1st
Street, Off Park Road, Anna Nagar
Western Extension, Chennai-600 101, Tamil Nadu, India, we are issuing the
following Legal Notice to all of you.

2. -: 2 :-
1) Our client states that he is married and has two kids, aged about 12 and 7.
He is an independent business consultant, after having completed Masters
in Business Administration from Massey University, Auckland, New Zealand.
He is a public-spirited person and is concerned about the healthcare system
in the society, particularly its impact on the poor and the disadvantaged. He
states that the Covid-19 pandemic exposed the weakness in the medical
and public healthcare system all over the world. The death of millions of
people all over the world due to the attack of the Covid-19 virus has affected
him emotionally. Therefore, the public spirit in him wanted to help in
whatever way he could in the effort to find a solution to end the current
dismal situation because of Covid-19. Our client further states that when he
came to know that there was a call for volunteers for the 3rd
phase of the
human trial in Sri Ramachandra Institute of Higher Education and Research
(formerly called Sri Ramachandra Medical College & Research Institute -
SRMC) for testing the Covid-19 vaccine developed by the Oxford University,
UK, the public spirit in him wanted to volunteer.
2) Our client further states that he opted to be a volunteer and when he
approached SRMC, which is a Deemed University, he was informed that it
was a randomized controlled study to determine the safety and
immunogenicity of COVIDSHIELD (Covid-19 vaccine) in the health of Indian
adults. The “Participant Information Sheet” given to him says that the
sponsors were (a) Serum Institute of India Pvt. Ltd. (SII) and (b) The Indian
Council of Medical Research (ICMR); and the Investigation site is Sri
Ramachandra Higher Education and Research (Deemed University) No.1,
Ramachandra Nagar, Porur, Chennai – 600 116, Tamil Nadu and the
Investigator is Dr. S.R. Ramakrishnan.

3. -: 3 :-
3) Our client further states from page 1 of the “Participant Information Sheet”
that:-
“……………Oxford University has developed a vaccine against
COVID-19 (chAdox1 cov-19). This vaccine has been previously
tested in around 500 health adults of 18 to 55 years of age in United
Kingdom (U.K) and was found to be safe and induce an immune
response. Currently three large clinical trials in thousands of healthy
adults are ongoing with this vaccine in the U.K., Brazil and South
Africa. SII has collaborated with the Oxford University and Astra
Zeneca (a pharmaceutical Company in the U.K) to manufacture this
vaccine on a commercial scale, which is called as COVISHIELD.”
4) Our client states that Covishield is a vaccine developed by the Oxford
University against the Covid-19 virus. The paragraph extracted above from
the Participant Information Sheet is categorical that the vaccine developed
by the Oxford University was “found to be safe” and “induces immune
response”. In SRMC, the trial investigator also assured our client that the
vaccine was already found to be safe and that this study is to further confirm
the safety and immune response of Covishield in Indian adults.
5) Our client states further that the Participant Information Sheet is categorical
when it states that “chadox ncovid-19 vaccine has been shown to be safe
and induce immune response in healthy adults in the U.K. COVISHIELD is
similar to ChAdox nCov-19 vaccine and has to undergo the testing for its
safety and its ability to work in India. Therefore, we invite you to participate
in this study”
Thus, the Participant Information Sheet was absolutely certain that
Covishield, the vaccine developed by the Oxford University, is safe. Our
client, a very healthy 40-year-old, further states that he was therefore led to
believe that taking the Covishield test vaccine was safe and the risks
associated with taking the said vaccine would hardly lead to any serious

4. -: 4 :-
side-effect, leave alone the ‘severe adverse effect’ he has had to painfully
endure.
6) Our client further states that the contents in page 8 of the Participant
Information Sheet further assured the safety of the vaccine, though two
participants in the U.K. developed unexplained neurological symptoms that
were concluded to not be related to the vaccine.
It reads as follows:-
“The chAdox1 ncov-19 vaccine developed by the Oxford University
has been given to several thousand healthy adults in ongoing clinical
trials. In a phase 1/2 trial U.K., 543, healthy adults aged 18-55 years
received this vaccine. No serious adverse reactions to ChAdox1
ncov-19 vaccine occurred in this trial. In another ongoing study of
the ChAdox1 ncov-19 vaccine in U.K., safety reviews were carried
out after 2 participants who received the vaccine developed
unexplained neurological symptoms, including changes in sensation
or limb weakness. After review by independent experts, these
symptoms were either considered unlikely to be associated with the
vaccine or there was not enough information to say for certain that
the symptoms were or were not related to the vaccine. In each of
these cases, after considering the information, independent
reviewers recommended that the vaccine should continue. Close
monitoring of all the study participants will be continued. The study
vaccine, COVISHIELD, is similar to this vaccine.”
7) Our client further states that there was a categorical assertion about the
safety of the vaccine in more than one place in the Participant Information
Sheet. In page 8 of the Participant Information Sheet, it was further
explained what might happen after vaccination, which is not even remotely
close to what our client experienced. (Even an allergic reaction after
vaccination is termed as an “extremely rare possibility”.)
It reads as follows:

5. -: 5 :-
• “Due to vaccine administration, you may have injection site reaction
such as pain, tenderness, redness, warmth, itch, swelling and
hardening.
• Some other side effects may occur such as fever, chills, fatigue,
feeling of discomfort, headache, joint pain, muscle pain and nausea.
• In addition to this, there is an extremely rare possibility that you may
develop an allergic reaction immediately following vaccination.
Allergic reaction may include rash, hives, difficulty in breathing and in
very rare instances if not treated it may be fatal. Therefore, Doctor
will monitor you at least 30 minutes after each vaccination and treat
you immediately in case of such a reaction.
• After receiving the study vaccine, if you get infected with Corona
virus, then there may be a very rare possibility of increase in severity
of the disease. This is called disease enhancement due to vaccine.
Currently, it is not known whether COVISHIELD or Oxford/A2-
ChAdox 1 ncov-19 vaccine can cause disease enhancement.’
• Drawing blood can cause pain, redness, swelling at the site of blood
draw.
• In addition to the risks described above, all clinical trial participants
are likely to experience increased inconvenience due to the visits.
• In addition, there could be other side effects that we have not
foreseen.”
8) Our client states that 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. All through the Participant Information
Sheet, the categorical assertion has thus been that taking the vaccine is
safe. Our client states that he believed the assertion about the “safety” of
the vaccine in the Participant Information Sheet and decided to volunteer to
take the vaccine.

6. -: 6 :-
9) Our client states that after being satisfied about the assertion of safety of the
said vaccine by studying the Participant Information Sheet he decided to
become a volunteer and signed the “INFORMED CONSENT FORM” on 29th
September 2020. The test for antibodies-against-Covid-19 was done on the
same day (29th
September 2020). As the test for antibodies-against-Covid-
19 was negative, the Covishield study vaccine was given to him on October
1, 2020.
Our client states that proof that the vaccine administered on him on October
1st
was indeed Covishield, and not a Placebo, is established from the
antibodies-against-Covid-19 test done after he was admitted in the Hospital
on October 11th
(11 days after the vaccination), which was positive.
10) Our client states that there was no adverse reaction for the first 10 days
after the vaccination, but on 11th
October 2020, he woke up at 5.30 a.m. with
severe headache and went back to sleep. Our client’s wife states that she
tried to wake him up at 9 a.m. but he did not get up nor speak with her. He
did not have breakfast and kept repeating that he was having severe
headache and went back to sleep. His wife says that she woke him up again
at 2.00 p.m. He was still having severe headache and went to the bathroom
and vomited. He did not get up from his bed the whole day and kept saying
that he had a severe headache. Our client’s wife says that in the evening,
she fetched a doctor, a Radiologist who lived in the next street, to examine
him. The doctor suggested a CT-Scan and MRI as our client was
complaining of severe headache, was not able to respond to questions and
was oblivious of what was happening around him.
Our client’s wife says that there was a total behavioural change in her
husband - 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. She decided to take him to the hospital and called for the

7. -: 7 :-
Ambulance from SRMC, as he could not even walk to the car, leave alone
getting into it. He vomited again inside the Ambulance as he was taken to
the Sri Ramachandra Medical College Hospital emergency ward. He was
conscious but was not recognizing anyone nor speaking to anyone. He was
sedated. He was very weak as he had not eaten any food the whole day.
According to the Hospital’s discharge summary he was brought into the
Hospital “in an altered mental state” and was “disoriented”.
The following is broadly the sequence of events that followed after his
admission into the hospital as stated by the wife of our client, who was
attending to him in the Hospital.
Date Where he was How he was Tests Done
11th
October 2020
Sunday
At Home Woke up with severe headache at
5.30 a.m. Did his prayers with
difficulty, and slept off again.
Tried to wake him up for
breakfast at 9. Again, complained
of severe pain; no talking at all.
Didn’t have breakfast. Went back
to sleep. Woke him again at 2
pm. Showed the same pain in
addition to frequent burping. Went
to bathroom, vomited.
Came out from his room and did
afternoon prayers, again with
difficulty. Still had the headache,
took one sip of ginger tea, went
back to sleep.
Called a doctor living in the next
street to see him. He checked his
limbs and neck movements and
was satisfied. Ruled out danger
but suggested to take CT Scan
and MRI if needed as he did not
respond to questions and was
very drowsy.
Soon, he showed signs of
behavioural changes. He wasn’t
aware of his surroundings,
showed irritation towards light
and sound, was resisting. He
responded using only Malayalam
words though he is fluent and
more comfortable in English (In
Malayalam he said “enough”,
“what are you all doing to me.”).
Was reluctant and resisted
coming out of the house.
Covid Test done
CT scan of
brain and
throat
MRI of chest
done.
Failed to take
MRI of brain
as he didn’t
cooperate

8. -: 8 :-
Called Ambulance, vomited
second time inside the
Ambulance on way to the
Hospital. Taken to SRMC.
Was conscious there (emergency
ward). But wasn’t recognizing
anyone nor speaking to anyone.
Totally disoriented. Had to
undergo Covid test. Showed high
level of aggression and
resistance. He was sedated.
No food whole day. Put on IV
fluids
12th
October 2020
Monday
Emergency
ward
Next day, shifted to ICU in
emergency ward. I wasn’t allowed
to enter. I was told that he was
agitated and not cooperating.
Heard him scream of pain.
He was put on fluids and
antibiotics
Second attempt
for
brain MRI
giving
anesthesia-
failed
Late night
shifted to
ICU in
the 4th
floor
(C4)
Lumbar
Puncture (LP)
done-taking fluid
from spinal cord
13th
October 2020
Tuesday
ICU Sleeping when I visited
Eyes opened, looked at me &
doctor (whoever was talking), but
not recognizing for sure as there
was no emotion on his face.
Mouth was slightly open - making
sound from throat -aaaaaaaah –
as if in pain
LP result
negative, some
other blood tests
were negative
as well.
3rd
attempt for
Brain MRI
early afternoon.
Evening I was
informed MRI
was normal
Blood sample
taken to Apollo
Hospital to
check Serum
osmolality
(This particular
test facility
unavailable in
this hospital)
14th
October 2020
Wednesday
ICU Condition same - staring at roof.
On calling, looked at me briefly,
eyeballs then went back to the
roof.
Constantly making sounds of
extreme pain.
Serum
osmolality test
negative – ruled
out the effect of
Esoz and
Finasteride, the
medicines that

9. -: 9 :-
he had been
taking.
Suspect Viral
Injection
MRI again
tomorrow, as
they claim to
have detected
something mildly
enhanced.
15th
October 2020
Thursday
ICU I was called inside, he was
surrounded by doctors. They said
he was slightly responding but
only in Malayalam.
So I asked him who am I – he
replied “Areela” (don’t know)
(tongue was getting twisted).
Gave same reply for a few more
questions, then got frustrated and
told me to go away.
He was extremely weak and
drowsy.
Made him pronounce Aadam (his
son’s name), which he did with
great difficulty.
16th
October 2020
Friday
ICU Was calm in the morning. Held
my hands tightly, as if in fear,
when I touched his hand. Though
he was not aware who I was.
Making continuous shivering
sound from throat. Didn’t
recognize me yet. Responded to
doctor’s commands, when he
said lift your hand, show one
finger, put out your tongue.
At night I talked to him, he was
listening but there was not much
reaction. When I mentioned Aami
and Annu (kids names), his eyes
teared up. But he did not speak.
17th
October 2020
Saturday
ICU Was sleeping. Nurse said not on
sedation.
Didn’t recognize me yet.
Hesitating to take food.
Evening, spoke a couple of words
very softly and with difficulty.
I kept telling him to eat food to
gain energy but he was saying
“can’t understand anything” -
(“food thinnan parannaal enthaa”
“food entha” - Malayalam only)
I stopped talking as he was
Feeling helpless not
understanding what I was telling
him.
18th
October 2020
Sunday
ICU Memory not yet regained. He was
sleeping. I kept on pleading with
With all tests
turning out to be

10. -: 10 :-
him to eat or drink something.
Suddenly he woke up and asked
for water. Drank almost a litre of
water little by little. Coffee was
given.
Complained of pain in hand. The
automatic pressure checker was
loosened.
While sitting near him for a while,
I could see some kind of emotion
(as that of pain) coming from him,
he was calling God (“Rabbi
Rabbi”), then calmed down
Later doctor said he wasn’t
supposed to drink water like that.
At night I was called in around
8.30 to 9.30 to calm him down as
he was aggressive.
Then around 10 again I was
called in. He was showing high
level of agitation.
He was physically restrained –
hands, foot and body tied up to
the bed – as he was pushing
nurses when they controlled him
as he was trying to get up and
walk. He was screaming, Only
when doctors threatened him
loudly with a firm warning did he
calm down.
This aggression was repeated in
regular intervals. They were
planning to sedate him. During
all this his eyes were closed. I
was asked to go out at around
1.30 a.m.
Note: He was physically
restrained all the time
negative, the
doctors said
there could be
some problem
that might be at
its earliest
stages, hence
not appearing in
the tests or
scans.
19th
October 2020
Monday
ICU I was called in again at 5 a.m. He
was the same as previous night.
Didn’t sleep till 7 - then started
sleeping
Second time
CSF (LP) done.
Repeated as
first one was
negative.
20th
October 2020
Tuesday
ICU Morning – Recognized me
vaguely.
Pronounced mine and kids
names with great difficulty.
Was confused – as to what
happened to him.
He was vaguely smiling and
gestured as if thanking doctors.
Was getting emotional.
Was informed that he would be
shifted to a room.

11. -: 11 :-
He was showing mild impatience
for not getting shifted throughout
the day.
Shifted to ward (A4) late at night.
Couldn’t sleep the whole night.
Whole body was trembling though
not severely.
Showed irritation at me for
expressing my worry.
He was trying to sit, kneel and get
out of the bed (was making some
sound as well, of that of pain,
though he said there wasn’t
paining anywhere). This was
repeated throughout the night.
He was not feeling comfortable
lying on the bed. Had to call the
nurse couple of times. Later,
junior doctors came and
prescribed psychiatric tablets.
They said he had MILD ICU
PSYCHOSIS
21ST
October
2020
Wednesday
Room A4 Finally slept in the morning at
6.30. But woke up around 7. Had
coffee and I fed him breakfast.
Had an appetite
but was quiet throughout. He
seemed totally lost in thoughts.
He was trembling continuously,
but with less intensity.
22nd
October 2020
Tuesday
Room A4 Drowsy and sleepy most part of
the day and night.
Politely answered doctors
questions in monosyllables.
Physiotherapy started. He walked
a short distance with some
support. Was not steady.
Slowly recollecting things.
Remembered that he took
vaccination from this hospital.
Asked for his phone. But was
unable to speak with anyone.
Spoke patiently with the
Psychiatric Head when he asked
him questions, though his speech
was slow and he was not very
fluent.
2nd
CSF
antibody test
also negative
23rd
October 2020
Friday
Room A4 Drowsy. Sleeping. Wakes up for
food and whenever doctors visit.
Had pain and irritation due to the
urine bag attached. Got it
removed later in the evening.
Passed motion. Insisted and took
shower himself with difficulty.
Did prayers.
Insisted he wanted his laptop.
Doctors agreed and asked me to
give him his laptop. He got his
Doctor said
Vitamin-D is
very low.
Further tests
needed for
confirming RA.
Blood samples
taken.

12. -: 12 :-
laptop by night. Tried to plug it
and operate. But was unable to.
He gave up and went to sleep.
Later, did video call with kids and
his Mom. But he couldn’t talk
much. Felt frustrated and went off
to sleep.
Mood swings very pronounced
24th
October 2020
Saturday
Room A4 Drowsy. Sleeping.
Sat down with phone and laptop
but didn’t switch them on. Lost in
thoughts. Doctor said he has
lupus (auto immune, but even
that was negated later).
Dr. Kavitha (ICU in-charge)
visited – expressed happiness to
see Asif recognizing people
Was very happy to have home
cooked food for dinner.
Wanted to know everything that
happened on 11th
Oct. Got very
confused and was lost in
thoughts.
Took blood and
urine samples
for test.
25th
October 2020
Sunday
Room A4 Only the duty
doctor visited. A
break from the
various sets of
doctors coming
to see him.
26th
October 2020
Monday
Room A4 Discharged at our request
27th
October 2020
Tuesday
Home At home, he went out in the
afternoon in an agitated mood in
search of REVV car mechanic.
Bapa (his father) had to go and
bring him back.
He seemed quite disoriented at
times, unable to relate to things.
28th
October 2020
Wednesday
Home The same situation continued. He
was on and off with his moods.
Seemed frustrated, unable to do
work.
29th
October 2020
Thursday
Home Psychiatric medicine stopped. Dr
again asked the same old
questions – tablets, drugs, stress
etc.
Went to SRMC
to meet
Psychiatrist.
Told all tests
results were
negative.
Not clear what
caused the
problem of
“Acute
Encephalopathy”
Home Improving, but with mood swings.
Still very sluggish, frustrated and
no confidence to do anything.

13. -: 13 :-
11) Our client states that he was discharged from the Hospital on 26.10.2020
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 1st
. 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 1st
October 2020, and not because of any
prior health condition. The Discharge Summary gives all information
regarding all the tests done on him and the said Discharge Summary is
annexed.
12) Our client states that the severe trauma he went through from 11th
October
2020, because of the “Acute Neuro Encephalopathy” that he suffered, is an
extreme side-effect of the test vaccine that he took on 1st
October 2020. Our
client’s wife states that he 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 totally lacking confidence. He is also feeling very bad and
guilty that his two small children, who get very scared when he has extreme
mood swings, and his family (his wife and old parents) have to go through
the ordeal because of his decision to volunteer for the Covid-19 test
vaccine, which he unfortunately thought was safe based on all the
information that he had at hand.
13) Our client states that it is very disappointing and shocking to note that after
his discharge from the Hospital, there has been no follow-up. No one from

14. -: 14 :-
the Hospital got in touch with him or his family to find out how he was. Even
after a month of the severe adverse reaction to the vaccine, neither have the
regulator (Drugs Controller General of India/ Data and Safety Monitoring
Committee), the sponsors (ICMR and Serum Institute of India) or the
collaborators of the sponsors (Astra Zeneca 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.
14) Our client states that 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.”
15) Our client states that his condition, as described in detail above, after taking
the test vaccination on 1st
October 2020, is without doubt an “Adverse Event
Following Immunization” as given in the World Health Organization’s “Global
Manual on Surveillance of Adverse Event Following Immunzation”, which
defines an Adverse Event following immunization/ vaccination as “any
untoward medical occurrence which follows immunization, and which does
not necessarily have a causal relationship with the usage of the vaccine”.
WHO’s manual also provides guidelines and protocols on how to deal with
an AEFI by the concerned parties. Our client further states that in his case
none of the protocols in dealing with the adverse event, as detailed in the
WHO manual, has been followed.

15. -: 15 :-
16) Our client states that according to WHO, an adverse event should be
reported immediately. A report must be made as quickly as possible so that
immediate decision can be made on the need for action and investigation.
The WHO guidelines further states that an immediate investigation of a
severe adverse event attributed to vaccine, even if not causally related to it,
is critical primarily for two reasons: ‘To respond to the community’s concern
about vaccine safety and also to maintain public confidence in
immunization.’
17) According to WHO, “the AEFI surveillance system involves different
stakeholders (the immunization programme, the National Regulatory
Authority and National Control Laboratory) and different functions /
responsibilities of different levels, from service delivery to national level.” As
per the WHO guidelines, the DCGI/ Data and Safety Monitoring Committee,
which is the National Regulatory Authority (NRA) for drug trials in India, has
a very critical role to play during an AEFI, as, “Feedback [of the adverse
event] to all levels of the immunization and reporting system, and if
necessary to the public, is essential for building trust in the immunization
programme”.
Our client states that though he suffered severe adverse reaction to the
vaccine, the stakeholders failed to follow any of the guidelines mandated by
WHO. It is a crime against the society to try to conceal the entire episode of
the adverse reaction suffered by him as non-event by trying to push it under
the carpet and going ahead with the trial and even manufacturing the
vaccine for distribution, once approved, as if this adverse event that had
happened to him does not raise safety concerns of the vaccine.
18) Our client states that the trauma he underwent after taking the test vaccine
clearly proves that the vaccine is not safe as it is made out to be. All the

16. -: 16 :-
stakeholders are trying to hide the adverse effect that the vaccine has had
on him and are unethically and unscientifically trying to brush it aside as
inconsequential. There is no definitive conclusion as yet from the said
vaccine study to say categorically that the vaccine is absolutely safe. Our
client states that all the above stated factual material, based on what he had
gone through after the test vaccination, clearly proves that the vaccine is not
to be considered as safe for everyone. He is keen that no one goes through
the pain and ordeal he and his family have suffered. Therefore, he states
that any move to manufacture the said vaccine commercially and distribute
it to the general public as a safe vaccine is totally dishonest and goes
against the WHO guidelines, as also the safety norms laid down by the
ICMR and the Government of India. Therefore, the approval, as also the
manufacturing and distribution of the said vaccine, should be stopped
immediately, until it has been categorically proved that it is safe for everyone
to take the vaccine.
19) Our client’s wife says that her husband’s condition even after over a month
of being afflicted with Acute Neuro Encephalopathy on taking the test
vaccine on 1st
October 2020, is worrisome. His behaviour has changed
significantly. His moods, reactions and responses have undergone a
considerable change. He is no longer the confident, sharp and quick-witted
person that he was. He has extreme mood swings and even if a minor thing
upsets him, he gets extremely angry, which is quite unlike him. He is unable
to process information and finds it difficult to focus on his work. He also finds
it difficult to remember things clearly as he repeatedly keeps asking the
same question.
20) Our client’s wife says further that because of his altered behaviour his two
small children are also affected. She also says that they have approached

17. -: 17 :-
……………, a leading Neurologist in Chennai, for further independent
consultation and care. Thus, the entire family is going through a very
traumatic, painful and difficult phase, both emotionally and financially, which,
in all probability, is not going to go away anytime soon.
21) Our client’s wife states that EEG tests done on 12th
November 2020 (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”.
22) Our client states that he decided to become a volunteer, believing the
statements made in the Participants Information Sheet, which clearly
indicated that the said vaccine was proved to be safe. As described earlier,
he has gone through extreme sufferings, both neurologically and
psychologically. The vaccine had led to a virtual neurological breakdown in
him. Our client states that it is impossible to quantify monetarily, the
sufferings, trauma, pain and humiliation (of hands, legs and body being tied
and fastened firmly to the bed), which he and his family have undergone
and are likely to undergo for a long time to come. Our client further states
that he would not have volunteered for the test vaccine, if all the potential
risk factors of the test vaccine had been known to him. But on the other
hand, there was a clear assertion of the safety nature of the test vaccine in
the Participant Information Sheet, which made him to become a volunteer.
Never, even remotely, did he imagine that he would have had to go through
such ordeal and pain, which he is not even sure when it would all end, if at
all.

18. -: 18 :-
23) Our client states that he must be compensated, in the least, for all the
sufferings that he and his family have undergone and are likely to undergo
in future. He further states that he is still far from being all right and has to
be under medical care for a long time to come. Therefore, for all the trauma
he is undergoing and with an uncertain future in his health, he should be
given a financial compensation of Rs. 5 Crores within a period of two weeks
from the receipt of this notice, and also the testing, manufacturing and the
distribution of the vaccine should also be stopped immediately as stated in
para 18 above, failing which he has no other option except to take
appropriate legal action against all the concerned parties, who would be
made responsible for all the costs and consequences.
(N.G.R. PRASAD)