The factsheet details information that would enable recipients to understand the benefits and common side-effects of the Covishield vaccine, to prevent Coronavirus Disease 2019 (COVID-19) caused by the coronavirus called SARS-CoV-2.

 

DOSE: The Covishield vaccination course consists of two separate doses of 0.5 ml each. The second dose should be administered between four to six 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.

If you miss your second dose and 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.

CAUTION: It also cautioned that the vaccine may not protect everyone.

BACKGROUND: COVID-19 disease is caused by a novel corona virus called SARS-CoV-2. 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, averaging 5 days. 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; diarrhoea.

WHAT IS THE 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 COVISHIELDTM vaccine



* If you have a 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 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.
HAS THE COVISHIELD VACCINE BEEN USED BEFORE?



The CovishieldTM 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 MANAGEMENT:



• Assurance, Observation of the progress of the symptoms, Maintenance of body hydration, Tab PARACETAMOL 500 -650 mg tablets 3 times a day

(Not more than 3-4 gm/day) can be given to alleviate the symptoms for 2-3 days or as required.

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
MANAGEMENT:



• Assurance, Observation of the progress of the symptoms, Maintenance of body hydration, Tab PARACETAMOL 500 – 650 mg tablets 3 times a day (Not more than 3-4 gm/day) can be given to alleviate the symptoms for 2-3 days or as required.

• Rest for 72 hours

• Anti-histamines, antitussive agents

• Steam Inhalation

Uncommon (may affect up to 1 in 100 people)

* Feeling dizzy



* Decreased appetite
* Abdominal pain
* Enlarged lymph nodes

* Excessive sweating, itchy skin or rash

MANAGEMENT:



• Observation for symptoms

• Deteriorating / persisting symptoms: Admission to hospital preferred

• Checking vitals, sending routine investigations including LFT, Creatinine,
CPK, Troponin T, LDH, D-Dimer

• Tab Famotidine/ Pantoprazole, Antihistamines, Oral hydration or Intravenous
hydration if required

• Decision to be taken by the treating doctor

• 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.

• Anaphylaxis and Neuroinflammatory diseases may occur • MANAGEMENT:



Early recognition of anaphylaxis

Because anaphylaxis requires immediate treatment, diagnosis is primarily made based on recognition of clinical signs and symptoms, including:

• Respiratory: sensation of throat closing, stridor (high-pitched sound while breathing), shortness of breath, wheeze, cough

• Gastrointestinal: nausea, vomiting, diarrhea, abdominal pain
• Cardiovascular: dizziness, fainting, tachycardia (abnormally fast heart

rate), hypotension (abnormally low blood pressure)

• Skin/mucosal: generalized hives, itching, or swelling of lips, face, throat

• Symptoms often occur within 15-30 minutes of vaccination, though it can

sometimes take several hours for symptoms to appear.

• Early signs of anaphylaxis can resemble a mild allergic reaction, and it is often difficult to predict whether initial, mild symptoms will progress to become an anaphylactic reaction.

• In addition, not all symptoms listed above are necessarily present during anaphylaxis, and not all patients have skin reactions.

• Symptoms are considered generalized if there are generalized hives or

more than one body system (e.g., cardiovascular, gastrointestinal) is

involved.
• If a patient develops itching and swelling confined to the injection site, the

patient should be observed closely for the development of generalized symptoms (beyond the recommended observation periods noted above, if necessary).

If anaphylaxis is suspected, take the following steps:

• Rapidly assess airway, breathing, circulation, and mentation (mental activity).

• Call ICU specialists.

• Place the patient in a supine position (face up), with feet elevated, unless
upper airway obstruction is present or the patient is vomiting.

• Epinephrine (1 mg/ml aqueous solution [1:1000 dilution]) is the first-line
treatment for anaphylaxis and should be administered immediately.

o In adults, administer a 0.3 mg intramuscular dose using a premeasured or prefilled syringe, in the mid-outer thigh.

o The maximum adult dose is 0.5 mg per dose.

o Epinephrine dose may be repeated every 5-15 minutes (or more often) as needed to control symptoms while waiting for emergency medical services.

o Because of the acute, life-threatening nature of anaphylaxis, there are no contraindications to epinephrine administration.

• In addition, patients should be instructed to seek immediate medical care

if they develop signs or symptoms of an allergic reaction after their

observation period ends and they have left the vaccination site.
• Antihistamines (e.g., H1 or H2 antihistamines) and bronchodilators do not treat airway obstruction or hypotension, and thus are not first-line treatments for anaphylaxis. However, they can help provide relief for hives and itching (antihistamines) or symptoms of respiratory distress (bronchodilators) but should only be administered after epinephrine in a

patient with anaphylaxis.

• Because anaphylaxis may recur after patients begin to recover, monitoring in a medical facility for at least several hours is advised, even after complete resolution of symptoms and signs.

• Older adults, including long-term care facility residents: There are no contraindications to the administration of epinephrine for the treatment of anaphylaxis. Although adverse cardiac events, such as myocardial infarction or acute coronary syndrome, have been reported in

some patients who received epinephrine for treatment of anaphylaxis (particularly among older adults with hypertension and/or atherosclerotic heart disease) epinephrine is the first-line treatment for anaphylaxis. It is important that sites providing vaccination to older adults, including long-term care facility residents, have healthcare personnel on hand who are able to recognize the signs and symptoms of anaphylaxis. This will help to not only

ensure appropriate and prompt treatment in patients with anaphylaxis, but also to avoid unnecessary epinephrine administration in patients who do not have anaphylaxis.

• Pregnancy:
Pregnant people with anaphylaxis should be managed the same as non- pregnant people. They should be closely monitored to ensure adequate

perfusion, and their fetus should be closely monitored as well, as appropriate.

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