COVISHIELD |
FACT SHEET FOR VACCINE RECIPIENT APPROVED FOR RESTRICTED USE IN EMERGENCY SITUATION OF
ChAdOx1 nCoV- 19 Corona Virus Vaccine (Recombinant)
IN PREVENTION OF (COVID-19) DISEASE IN INDIVIDUALS 18 YEARS OF AGE AND OLDER
 |
| COVISHIELD |
You are being offered the Serum Institute of India Pvt. Ltd. (SIIPL) COVISHIELD™
Vaccine to prevent Coronavirus Disease 2019 (COVID-19) caused by
SARS-CoV-2. This Fact Sheet contains information to help you understand the
risks and benefits of the COVISHIELD™ Vaccine, which you may receive because
there is currently a pandemic of COVID-19 disease.The COVISHIELD™ is a
vaccine and may prevent you from getting COVID-19 disease.Read this Fact
Sheet for information about the COVISHIELD™ Vaccine. Talk to thehealthcare
provider if you have questions. It is your choice to receive the COVISHIELD™
Vaccine.The COVISHIELD™ vaccination course consists of two separate doses of
0.5 ml each. The second dose should be administered between 4 to 6 weeks after
the first dose. However, there is data available for administration of the second
dose up to 12 weeks after the first dose from the overseas studies.
For intramuscular (IM) injection only. The COVISHIELD™ may not protect everyone.
- WHAT YOU NEED TO KNOW BEFORE YOU GET THIS VACCINE WHAT IS COVID-19?
COVID-19 disease is caused by a coronavirus called SARS-CoV-2. This type of
coronavirus has not been seen before. You can get COVID-19 through contact
with another person who has the virus. It is predominantly a respiratory illness that
can affect other organs. People with COVID-19 have had a wide range of
symptoms reported, ranging from mild symptoms to severe illness. Symptoms
may appear 2 to 14 days after exposure to the virus. Symptoms may include:
fever or chills; cough; shortness of breath; fatigue; muscle or
body aches;headache; new loss of taste or smell; sore throat; congestion or runny
nose; nausea or vomiting; diarrhea.
- WHAT IS THE SIIPL COVISHIELD™ VACCINE?
The COVISHIELD™ is approved for restricted use in emergency situation vaccine
that may prevent COVID-19 disease in individuals 18 years of age and older.
- WHAT SHOULD YOU MENTION TO YOUR HEALTHCARE PROVIDER BEFORE YOU GET COVISHIELD™ VACCINE?
Tell the healthcare provider about all of your medical conditions, including:
• If you have ever had a severe allergic reaction (anaphylaxis) after any drug, food, any
vaccine or any ingredients of COVISHIELD™ vaccine
• If you have fever
• If you have a bleeding disorder or are on a blood thinner
• If you are immunocompromised or are on a medicine that affects your immune system
• If you are pregnant or plan to become pregnant
• If you are breastfeeding
• If you have received another COVID-19 vaccine
You should consult your healthcare provider before deciding to take the vaccine.
- WHO SHOULD GET THE COVISHIELD™ VACCINE?
COVISHIELD™ Vaccine has been approved for restricted use in emergency
situation in individuals 18 years of age and older.
- WHO SHOULD NOT GET THE COVISHIELD™ VACCINE?
You should not get the COVISHIELD™ Vaccine if you:
• had a severe allergic reaction after a previous dose of this vaccine
• had a severe allergic reaction to any ingredient of this vaccine.
- WHAT ARE THE INGREDIENTS IN THE COVISHIELD™ VACCINE?
The COVISHIELD™ Vaccine includes the following ingredients: L-Histidine,
L-Histidine hydrochloride monohydrate, Magnesium chloride hexahydrate,
Polysorbate 80, Ethanol, Sucrose, Sodium chloride, Disodium edetate dihydrate
(EDTA), Water for injection.
- HOW IS THE COVISHIELD™ GIVEN?
If you miss your second dose
If you forget to go back at the scheduled time, ask your healthcare provider
for advice. It is important that you return for your second dose of
COVISHIELD™ vaccine.
- HAS
THE COVISHIELD™ VACCINE BEEN USED BEFORE?
The COVISHIELD™ is used in clinical trials, a number of participants received
one or two doses in overseas and Indian trials.
- WHAT ARE THE BENEFITS OF THE COVISHIELD™ VACCINE?
In ongoing clinical trials, the COVISHIELD™ Vaccine has been shown to
prevent COVID-19 disease following 2 doses given between 4 and 12
weeks apart. The duration of protection against COVID-19 disease is
currently unknown. You may get protective immune response 4 weeks after
the second dose of COVISHIELD™ vaccine.
- WHAT ARE THE RISKS OF THE COVISHIELD™ VACCINE?
Side effects that have been reported with the COVISHIELD™
Vaccine include:
Very Common
(may affect more than 1 in 10 people)
• tenderness, pain, warmth, redness,
itching, swelling or bruising where the injection
is given
• generally feeling
unwell
• feeling tired
(fatigue)
• chills or feeling feverish
• headache
• feeling sick (nausea)
• joint pain or muscle
ache
Common (may affect up to 1 in 10 people)
• a lump at the injection site
• fever
• being sick (vomiting)
• flu-like
symptoms, such as high temperature, sore throat, runny nose, cough and chills
Uncommon (may affect up to 1 in 100 people)
• feeling dizzy
• decreased appetite
• abdominal pain
• enlarged lymph nodes
• excessive sweating,
itchy skin or rash
These may not be all the possible side effects of the COVISHIELD™
Vaccine. Serious and unexpected side effects may occur. COVISHIELD™
Vaccine
is still being studied in clinical trials.
- WHAT SHOULD I DO ABOUT SIDE EFFECTS?
If you experience a severe allergic reaction, call or go to the
nearest hospital. Call the healthcare provider if you have any side
effects that bother you or do not go away. In addition, you can report side
effects after vaccination to Serum Institute of India Pvt Ltd who is the
manufacturer of COVISHIELD™ vaccine as below.
• 24 x 7 Call Center Toll-Free Number (For Medical and Adverse Event Related
Queries
Only):
+91-1800 1200124
• pharmacovigilance@seruminstitute.com
- WHAT IF I DECIDE NOT TO GET THE COVISHIELD™ VACCINE?
It is your choice to receive or not receive the COVISHIELD™ Vaccine. You
may
prefer to consult your healthcare provider.
- CAN I RECEIVE
THE COVISHIELD™ VACCINE WITH OTHER VACCINES?
There is no information on the use of the COVISHIELD™ Vaccine with other
vaccines.
- WHAT IF I AM PREGNANT
OR BREASTFEEDING?
You may discuss
your options with the healthcare provider.
- WILL THE COVISHIELD™ VACCINE
GIVE ME COVID-19 INFECTION?
No. The COVISHIELD™ COVID-19 Vaccine does not contain
SARS-CoV-2 and cannot give you COVID-19 infection.
- KEEP YOUR VACCINATION CARD
When you get your dose, please discuss with your healthcare provider
regarding the option of your vaccination record
on digital platform, if available.
- HOW CAN I LEARN MORE?
• Ask the healthcare provider.
• Contact
your local or state public health department.
INFORMATION PROVIDED BY :-
